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90 Postpartum Depression Trials Near You
Power is an online platform that helps thousands of Postpartum Depression patients discover FDA-reviewed trials every day. Every trial we feature meets safety and ethical standards, giving patients an easy way to discover promising new treatments in the research stage.
Learn More About PowerRE104 for Postpartum Depression
Columbus, Ohio
This trial is testing whether a single injection of RE104 can help reduce depression in women who have moderate-to-severe postpartum depression. The goal is to see if this treatment works effectively. The exact way RE104 works isn't detailed, but it likely helps by affecting brain chemicals related to mood.
No Placebo Group
Trial Details
Trial Status:Active Not Recruiting
Trial Phase:Phase 2
Age:18 - 45
Sex:Female
Key Eligibility Criteria
Disqualifiers:Bipolar, Schizophrenia, Psychosis, Others
Must Be Taking:SSRIs
72 Participants Needed
MOMI PODS for Postpartum Health
Columbus, Ohio
The investigator's long-term goal is to mitigate pregnancy-related mortality (PRM) risk by systematically delivering integrated clinical and supportive care that is effective, equitable, and scalable. The investigator's central hypothesis is that the Multi-modal Maternal Infant Perinatal Outpatient Delivery System (MOMI PODS) will mitigate postpartum (PP) risk and reduce disparities in PP risk by improving biopsychosocial profiles and facilitating access to evidence-based clinical and supportive care. To test this hypothesis, the investigators will conduct a hybrid type 1 randomized controlled trial (RCT) of MOMI PODS versus enhanced usual care (EUC, which we will term MOMI CARE) among a total sample of 384 mother-infant dyads (192/group) following pregnancy affected by a cardiometabolic and/or mental health condition. The investigators will enroll participants on PP day 1 and collect data at baseline and 6 months and 1 year PP. The investigators will collect implementation and service data across sites.
No Placebo Group
Trial Details
Trial Status:Recruiting
Trial Phase:Unphased
Sex:Female
Key Eligibility Criteria
Disqualifiers:Seizure Disorder, Major Infant Complications, Others
384 Participants Needed
Nurse Family Partnership for Pregnancies
Columbus, Ohio
The goal of this clinical trial is to test the Nurse Family Partnership (NFP) in mothers with previous live births (multiparous or multip individuals). The main aims are:
Specific Aim 1-Determine the effectiveness of NFP among multiparous women for reducing maternal morbidity and improving pregnancy outcomes.
Specific Aim 2-Determine the effectiveness of NFP among index children (child from pregnancy when mother was enrolled) of multiparous women for improving child outcomes.
Specific Aim 3 (Exploratory)-In preparation for a future study of the effects of preventive home-visiting programs on mother-index child-sibling triads, describe siblings (characteristics, role, influence) in the context of nurse home-visiting and evaluate the effectiveness of NFP on outcomes for prior-born siblings younger than 6 years old living in the home, including cognitive development, socioemotional development, and identification and referral to needed services.
A supplemental study to this study, led by investigators at Yale and Columbia, includes the following Aims:
Aim 1: Test whether the NFP causes variation in DNAm at Glucocorticoid-sensitive sites in infants over the first year of life.
Aim 2: Determine whether NFP causes differences in epigenetic age in infants over the first year of life.
Aim 3: Evaluate DNAm signatures as predictors of infant development at 12 months of age.
No Placebo Group
Trial Details
Trial Status:Recruiting
Trial Phase:Unphased
Age:16 - 46
Sex:Female
Key Eligibility Criteria
Disqualifiers:Non-English/Spanish Speakers, Under 16, Others
500 Participants Needed
This trial tests a program that helps pregnant minority women manage their thoughts and emotions to reduce stress. It aims to improve mental health and birth outcomes for Black and Hispanic women who are emotionally distressed.
No Placebo Group
Trial Details
Trial Status:Completed
Age:18 - 40
Sex:Female
Key Eligibility Criteria
Disqualifiers:Not Listed
299 Participants Needed
Babies with single ventricle congenital heart disease (SVCHD) are often diagnosed during pregnancy. While prenatal diagnosis has important clinical benefits, it is often stressful and overwhelming for parents, and many express a need for psychological support. HeartGPS is a psychological intervention for parents who receive their baby's diagnosis of SVCHD during pregnancy. It includes 8 sessions with a psychologist, coupled with tailored educational resources, and a personalized care plan. The intervention focuses on fostering parent psychological adjustment and wellbeing, and supporting parents to bond with their baby in ways that feel right for them. Through this study, the investigators will learn if HeartGPS is useful and effective for parents and their babies when it is offered in addition to usual fetal cardiac care. The investigators will examine the effects of the HeartGPS intervention on parental anxiety, depression, and traumatic stress; fetal and infant brain development; parent-infant bonding; and infant neurobehavioral and neurodevelopmental outcomes. The investigators will also explore mechanisms associated with stress biology during pregnancy, infant brain development and neurodevelopmental outcomes, and parent and infant intervention effects.
No Placebo Group
Trial Details
Trial Status:Recruiting
Trial Phase:Unphased
Key Eligibility Criteria
Disqualifiers:DiGeorge Syndrome, Untreated Psychiatric, Others
50 Participants Needed
Ketamine for Postpartum Depression
Pittsburgh, Pennsylvania
The purpose of this study is to identify pharmacokinetics of postpartum ketamine infusion. This study will assess ketamine kinetics and metabolism in this setting. Ketamine is expected to exert different kinetics during the physiologic state of post-pregnancy. The goal in conducting this study is to better understand the pharmacokinetics and pharmacodynamics of postpartum ketamine infusion. A secondary goal is to compare these kinetics to reproductive age matched controls and to assess sex differences in ketamine pharmacokinetics.
The peripartum group of this study will receive ketamine after cesarean delivery, while the control group will consist of non-pregnant female subjects and male subjects receiving the same infusion protocol.
No Placebo Group
Trial Details
Trial Status:Recruiting
Trial Phase:Phase 1
Key Eligibility Criteria
Disqualifiers:Schizophrenia, Psychosis, Hypertension, Others
Must Not Be Taking:Psychedelics, Antipsychotics
50 Participants Needed
Prenatal Yoga for Postpartum Depression
Detroit, Michigan
Although psychological interventions exist for the prevention of PPD, a yoga-based intervention to prevent PPD among at-risk women utilizes a similar theoretical foundation (i.e., mindfulness), may be more acceptable to women of minority status, and may confer additional physical activity benefits. The purpose of this pilot study is to determine the effectiveness of using a virtually delivered prenatal yoga intervention for the prevention of PPD among at-risk women in a diverse health care system and explore preliminary factors which influence implementation of the intervention. This study has 2 phases: Phase 1 will evaluate facilitators and barriers to intervention implementation among patient, clinician, and health system stakeholders, followed by an open trial, and Phase 2 will include conducting an 8-session pilot randomized controlled trial to assess the feasibility and acceptability of the proposed prenatal yoga intervention among women with a history of depression, as well as the onset and course of PPD and mediating factors. The specific aims are to: 1) Optimize delivery of a yoga intervention within a healthcare system to prevent PPD through examining facilitators and barriers of implementation, 2) Examine feasibility, acceptability and satisfaction of the intervention within a health care system, and 3) Evaluate preliminary effectiveness of the intervention on PPD and proposed mechanisms. For Phase 1, separate focus groups with patient stakeholders and clinician and administrative stakeholders will inform intervention implementation, and an open trial to refine and optimize the intervention. For Phase 2, women with a history of depression who are 8-28 weeks pregnant will be randomized to the intervention group (n=24) or treatment-as-usual (n=24) and will complete survey measures at baseline, post-intervention, and 1 and 3 months postpartum. It is hypothesized that the intervention will be feasible and acceptable, engage women of racial/ethnic minority status, and contribute to lower rates of PPD onset. Embodiment and mindfulness are the proposed mediators. Knowledge gained from this study can support prevention efforts for PPD and improve the adverse public health impact of this disorder.
Stay on current meds
No Placebo Group
Trial Details
Trial Status:Recruiting
Trial Phase:Unphased
Sex:Female
Key Eligibility Criteria
Disqualifiers:Non-English Speakers, Exercise Restrictions
62 Participants Needed
Morning Light Treatment for Postpartum Depression
Ann Arbor, Michigan
This study will test a consumer health light therapy device (Re-Timer) for women with postpartum depression to better understand how it affects mood and the body clock (also called the circadian clock).
Eligible participants will be enrolled and randomized after baseline assessments. In addition to using the Re-Timer light for 5 weeks participants will complete questionnaires at various timepoints, record sleep information, wear an actigraph watch, and provide saliva samples. Additionally, the sleep of the participants' infants will also be monitored using an ankle-worn device (actigraph) and sleep diary at certain time-points as this may influence the mother's mood/sleep, and in turn affect the results.
The hypotheses regarding the bright light versus the placebo dim light of the study are:
* morning bright light therapy will produce greater improvement from pre- to post-treatment on the Hamilton Rating Scale for Depression
* morning bright light therapy will lengthen the Phase angle difference (PAD) and this will mediate change in depression symptoms.
* morning bright light therapy will produce greater improvements on self-reported depression symptoms, excessive daytime sleepiness, maternal-infant bonding, social functioning, and sleep-related impairment from pre- to post-treatment.
Trial Details
Trial Status:Active Not Recruiting
Trial Phase:Unphased
Sex:Female
Key Eligibility Criteria
Disqualifiers:PTSD, OCD, Substance Abuse, Others
Must Not Be Taking:Photosensitizing, Melatonin, NSAIDs, Beta-blockers
120 Participants Needed
Mindfulness-Based Cognitive Therapy for Psychological Distress During Pregnancy
Pittsburgh, Pennsylvania
This trial studies how Mindfulness-Based Cognitive Therapy (MBCT) helps pregnant women manage their thoughts and emotions to reduce psychological distress. The goal is to see if MBCT improves mental health during pregnancy and if these benefits last after childbirth. Mindfulness-Based Cognitive Therapy (MBCT) has been shown to be effective in reducing depression and anxiety in pregnant women.
No Placebo Group
Trial Details
Trial Status:Active Not Recruiting
Trial Phase:Unphased
Sex:Female
Key Eligibility Criteria
Disqualifiers:Suicidal Ideation, Psychosis, Mania, Others
80 Participants Needed
Perinatal depression (PND) is the most common complication in pregnancy and postpartum, which increases risk for adverse perinatal outcomes such as preterm birth, maternal suicidal thoughts, and impaired mother-infant bonding. Insomnia often precedes PND cases and may serve as an entry point for interventions preventing PND. The proposed project is a large-scale clinical trial to test the effectiveness of a mindfulness-based sleep program designed for pregnant women to improve sleep and alleviate cognitive arousal to reduce risk for PND across pregnancy and postpartum.
No Placebo Group
Trial Details
Trial Status:Recruiting
Trial Phase:Phase 2
Sex:Female
Key Eligibility Criteria
Disqualifiers:High Risk Pregnancy, Suicidal Intent, Others
500 Participants Needed
Mindfulness-Based Therapy for Pregnancy-Related Insomnia
Novi, Michigan
Nearly half of women develop insomnia during pregnancy, which is associated with increased risk for developing perinatal depression. The purpose of this research is to evaluate the implementability and effectiveness of a mindfulness-based therapy for insomnia relative to cognitive-behavioral therapy for insomnia in pregnant women with insomnia and comorbid depression. The investigators aim to examine whether a mindfulness-based intervention effectiveness reduces symptoms of insomnia and comorbid depression.
No Placebo Group
Trial Details
Trial Status:Active Not Recruiting
Trial Phase:Unphased
Age:18 - 40
Sex:Female
Key Eligibility Criteria
Disqualifiers:High Risk Pregnancy, Night Shift, Others
100 Participants Needed
ROSE Program for Postpartum Depression
Flint, Michigan
The Reach Out, Stand Strong, Essentials for New Mothers (ROSE) program is an evidence-based intervention that prevents half of cases of postpartum depression and was one of two interventions recommended by the US Preventive Services Task Force in 2019. All effectiveness trials of ROSE and of the other recommended PPD prevention intervention included only low-income women a single risk factor that doubles incidence of PPD. Thus, the existing evidence base for PPD prevention consists primarily of women at increased risk for PPD. Based on data from the PIs' current implementation study of ROSE, many healthcare and community agencies in this implementation trial (78%) find it is more feasible for them to provide or offer ROSE to every woman as part of their standard workflow, than it is to create a screening and referral process for at risk women. In addition to being more feasible for agencies, universal prevention may also be advantageous because the cost of a screening false negative (resulting in a preventable case of PPD; $32,000) far exceeds the cost of ROSE delivery ($50-$300/woman). Effectiveness of ROSE among low-income women at risk for PPD is known (ROSE prevents \~50% of PPD cases). To inform a recommendation about using ROSE as universal vs. selective or indicated prevention, we need to determine the effectiveness of ROSE among general populations of women, including women screening negative for PPD risk. Thus, this project will assess ROSE effectiveness across PPD risk levels and across prevention approaches in a sample of 2,320 women from a large regional health system (based in Detroit, MI). Each proposed aim gathers a piece of information missing that is needed to guide decision-making about ROSE as universal prevention. We will assess ROSE as universal, selective, and indicated prevention in terms of: (1) ROSE effectiveness relative to a control for each prevention approach in preventing PPD and improving functioning; (2) cost outcome, (3) equity and (4) scalability of each prevention approach; and (5) mechanisms of ROSE effects across PPD risk levels. We will integrate results to advise about ROSE as universal prevention. This definitive PPD prevention trial will show how best to get an evidence-based program to those who need it in settings where they receive perinatal care by addressing a pragmatic and novel question (should ROSE be universal prevention?) and by examining equity and cost-outcome of universal vs. other prevention approaches.
No Placebo Group
Trial Details
Trial Status:Recruiting
Trial Phase:Unphased
Sex:Female
Key Eligibility Criteria
Disqualifiers:Major Depressive Episode, Bipolar, Psychotic, Others
2320 Participants Needed
Quetiapine vs Trazodone for Postpartum Depression
London, Ontario
Postpartum depression is a serious disorder that affects approximately 17% of women who have recently given birth. Untreated postpartum depression can negatively affect the mother, the infant, and the family. Lack of sleep is common after delivery and can trigger or worsen depression in some women. Trazodone is used for sleeplessness and depression, but it has not been studied for postpartum depression. There is preliminary evidence that quetiapine, another drug used for depression and sleeplessness, may be effective for postpartum depression. We are planning a study to compare the effectiveness and side effects of quetiapine and trazodone in women with postpartum depression. The results of this study will help us carry out larger studies comparing these drugs with a placebo (a sugar pill) in postpartum depression. We expect the results of our study will improve the mental health of mothers and the well-being of their babies and make it easier for healthcare staff to select the right drug for women with postpartum depression.
No Placebo Group
Trial Details
Trial Status:Not Yet Recruiting
Trial Phase:Early Phase 1
Age:18 - 45
Sex:Female
Key Eligibility Criteria
Disqualifiers:Schizophrenia, Bipolar, Eating Disorders, Others
50 Participants Needed
Quetiapine for Postpartum Depression
London, Ontario
This trial is testing quetiapine, a medication for mood disorders and sleep problems, on women with postpartum depression who don't respond well to typical antidepressants. The drug works by balancing brain chemicals to improve mood and sleep. Quetiapine has been used for treating schizophrenia, mood disorders, and sleep disturbances.
No Placebo Group
Trial Details
Trial Status:Active Not Recruiting
Trial Phase:Phase 1
Age:18 - 45
Sex:Female
Key Eligibility Criteria
Disqualifiers:Schizophrenia, OCD, Eating Disorders, Others
Must Not Be Taking:Mood Stabilizers, Antidepressants, Sedatives
22 Participants Needed
Chronotherapy for Perinatal Depression
Charlottesville, Virginia
This trial tests if adding light exposure and a set sleep routine to regular care can reduce depression and anxiety in pregnant women. It targets women aged 18-40 in late pregnancy who have depression. The treatment aims to adjust the body's natural rhythms and stabilize sleep patterns to improve mood. Light exposure is a promising treatment for depression during pregnancy, being easily accessible, effective, affordable, and safe for both mother and child.
No Placebo Group
Trial Details
Trial Status:Active Not Recruiting
Trial Phase:Unphased
Age:18 - 45
Sex:Female
Key Eligibility Criteria
Disqualifiers:Psychosis, Bipolar, Seizure, Migraines, Others
Must Not Be Taking:Photosensitizing Medications
158 Participants Needed
LPCN 1154A for Postpartum Depression
Chicago, Illinois
The purpose of this research study is to test the study drug, LPCN 1154A, as a possible treatment for postpartum depression (PPD). The trial aims to determine:
* If LPCN 1154A reduces depressive symptoms in subjects with severe PPD
* How well LPCN 1154A is tolerated and what side effects it may cause
* If LPCN 1154A reduces anxiety symptoms in subjects with severe PPD
Pivotal Trial (Near Approval)
Trial Details
Trial Status:Recruiting
Trial Phase:Phase 3
Age:15 - 45
Sex:Female
Key Eligibility Criteria
Disqualifiers:Bipolar, Schizophrenia, Psychosis, Seizure, Others
80 Participants Needed
Pain Management Interventions for Postpartum Pain
Chicago, Illinois
Obstetric anal sphincter injuries (OASIS) encompass both third and fourth degree perineal tears. These tears can have a significant impact on women's quality of life in the short and long term. One of the most distressing immediate complications of this severe perineal injury is perineal pain. Women can also experience postpartum depression, dyspareunia, and altered sexual function after OASIS.
This is a randomized controlled trial to study the effects of three interventions (placebo, low dose intravenous ketamine plus epidural morphine, or epidural morphine alone) on acute pain after OASIS.
The objective of this study is to assess the incidence of perineal pain in postpartum patients 1 week after obstetric anal sphincter injuries.
Trial Details
Trial Status:Active Not Recruiting
Trial Phase:Phase 4
Sex:Female
Key Eligibility Criteria
Disqualifiers:Previous Pelvic Surgery, Chronic Pelvic Pain, Others
Must Not Be Taking:Ketamine, Morphine
67 Participants Needed
NORA520 for Postpartum Depression
Chicago, Illinois
This trial is testing a drug called NORA520 to see if it can help women with severe postpartum depression. The study will check how well the drug works, its side effects, and how much of it gets into the blood and breastmilk. Women in the study will take the drug for a short period.
Trial Details
Trial Status:Recruiting
Trial Phase:Phase 2
Age:18 - 45
Sex:Female
Key Eligibility Criteria
Disqualifiers:Bipolar, Schizophrenia, Psychosis, Others
Must Not Be Taking:Antidepressants, Antipsychotics
90 Participants Needed
Cognitive Behavioural Therapy for Postpartum Depression
Hamilton, Ontario
The primary objective of this study is to determine if online group cognitive behavioral therapy (CBT) for maternal postpartum depression (PPD) added to treatment as usual (TAU) leads to greater improvements in infant emotion regulation (ER) than maternal receipt of TAU alone immediately post-treatment and 6 months later. This study will also aim to determine what mechanisms PPD treatment leads to changes in infant ER.
No Placebo Group
Trial Details
Trial Status:Active Not Recruiting
Trial Phase:Unphased
Sex:Female
Key Eligibility Criteria
Disqualifiers:Bipolar, Psychotic, Substance Use, Others
172 Participants Needed
ROSE Program for Preventing Postpartum Depression
Chicago, Illinois
The goal of this clinical trial is to evaluate the impact of ROSE in individuals with adverse childhood experiences. The main question it aims to answer is, compared to enhanced treatment as usual, does the delivery of ROSE within a collaborative care model improve depressive symptom trajectories and prevent the development of perinatal depression.
Participants will be randomized to either enhanced treatment as usual or the ROSE intervention, delivered by a care manager within a perinatal collaborative care program. They will complete self-reported surveys of their depression symptoms every 4 weeks to inform their symptom trajectories. They will also complete clinical interviews to establish any incident diagnoses of a major depressive episode.
No Placebo Group
Trial Details
Trial Status:Recruiting
Trial Phase:Unphased
Sex:Female
Key Eligibility Criteria
Disqualifiers:Major Depressive Episode, Substance Use Disorder, Others
76 Participants Needed
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"I was diagnosed with stage 4 pancreatic cancer three months ago, metastatic to my liver, and I have been receiving and responding well to chemotherapy. My blood work revealed that my tumor markers have gone from 2600 in the beginning to 173 as of now, even with the delay in treatment, they are not going up. CT Scans reveal they have been shrinking as well. However, chemo is seriously deteriorating my body. I have 4 more treatments to go in this 12 treatment cycle. I am just interested in learning about my other options, if any are available to me."
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Pancreatic Cancer PatientAge: 40
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Arthritis PatientAge: 78
"I changed my diet in 2020 and I’ve lost 95 pounds from my highest weight (283). I am 5’3”, female, and now 188. I still have a 33 BMI. I've been doing research on alternative approaches to continue my progress, which brought me here to consider clinical trials."
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Obesity PatientAge: 58
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CBT Workshop for Postpartum Depression
Hamilton, Ontario
Public Health Nurses (PHN) received training to deliver a day-long Cognitive Behavioural Therapy (CBT)-based workshop for treating postpartum depression (PPD). Participants in the study are randomly assigned to the treatment group (1-day CBT workshop) or control group (usual postnatal care). Data will be collected from all participants at baseline, 3 and 6 months later.
The study will aim to determine if online day-long CBT-based workshops delivered by public health nurses can be added to treatment as usual to improve postpartum depression more than treatment as usual alone, iif the workshops are cost-effective, and if the workshops can stably improve depression, its common comorbidities and reduce adverse effects on the family.
Hypotheses: Online 1-Day CBT-Based Workshops delivered by PHNs will be an effective (and cost-effective) way to stably improve PPD, its comorbidities, and reduce its adverse effects on the family.
No Placebo Group
Trial Details
Trial Status:Active Not Recruiting
Sex:Female
Key Eligibility Criteria
Disqualifiers:Not Listed
451 Participants Needed
Online CBT Workshop for Postpartum Depression
Hamilton, Ontario
To conduct a randomized controlled trial (N=408) examining the impact of an online cognitive behavioural therapy (CBT)-based workshop on rates of postpartum depression (i.e., EPDS scores at 2-months postpartum) when added to treatment as usual (TAU) compared to TAU alone.
No Placebo Group
Trial Details
Trial Status:Active Not Recruiting
Trial Phase:Unphased
Sex:Female
Key Eligibility Criteria
Disqualifiers:Current Major Depression, Bipolar, Psychotic, Borderline, Others
412 Participants Needed
Baby2Home Mobile Application for Mental Health Wellness
Chicago, Illinois
This trial tests Baby2Home, a digital program to help new parents and their babies. It aims to improve health outcomes and reduce disparities for families affected by COVID-19. The program provides education, wellness tracking, mental health support, and regular check-ins.
No Placebo Group
Trial Details
Trial Status:Active Not Recruiting
Trial Phase:Unphased
Key Eligibility Criteria
Disqualifiers:Severe Mental Illness, NICU, Others
642 Participants Needed
Cognitive Behavioral Therapy for Postpartum Depression
Hamilton, Ontario
The purpose of this study is to determine the effectiveness of an online 9-week group Cognitive Behavioural Therapy (CBT; a type of talking therapy) intervention that is co-led by public health nurses (PHNs) and individuals who have previously recovered (i.e., lay peers) from postpartum depression (PPD) for treating PPD when delivered in addition to treatment as usual (TAU) compared to TAU alone. The study will also assess the impact of the intervention on common comorbidities (anxiety) and complications (parenting stress, mother-infant relationship, social support, and infant temperament) of PPD and whether it is cost-effective.
No Placebo Group
Trial Details
Trial Status:Recruiting
Trial Phase:Unphased
Sex:Female
Key Eligibility Criteria
Disqualifiers:Bipolar, Psychotic, Substance Use, Others
170 Participants Needed
Brief Behavioral Activation Treatment for Postpartum Depression
Evanston, Illinois
SUMMIT's (Scaling Up Maternal Mental health care by Increasing access to Treatment) overarching goal is to examine the scalability and patient-centered provision of brief, evidence-based psychological treatments for perinatal depression and anxiety (N=1226). Specifically, and through a multi-site, randomized, pragmatic trial, the trial examines whether a brief, behavioral activation (BA) treatment delivered via telemedicine is as effective as the same treatment delivered in person; and whether BA delivered by non-mental health providers (e.g., nurses), with appropriate training is as effective as when delivered by specialist providers (psychiatrists, psychologists and social workers) in reducing perinatal depressive and anxiety symptoms. The study will be conducted in Toronto, NorthShore University HealthSystem in Evanston and surrounding areas including Chicago, and North Carolina. The trial will also identify relevant underlying implementation processes and determine whether, and to what extent, these strategies work differentially for certain women over others.
No Placebo Group
Trial Details
Trial Status:Active Not Recruiting
Sex:Female
Key Eligibility Criteria
Disqualifiers:Not Listed
1230 Participants Needed
Cognitive Behavioural Therapy vs Sleep Hygiene for Sleep Disorders
Hamilton, Ontario
Pregnant and postpartum individuals often have difficulty sleeping and these sleep problems can negatively impact both the parent and infant. Research suggests that pregnant individuals prefer non-medication-based treatment for their sleep difficulties but there is a lack of research on the success of sleep treatment during pregnancy. Currently, there are two main non-medical treatments for sleep difficulties available. The first, cognitive behavioural therapy (CBT), is the first treatment recommended for insomnia and has been found to successfully treat insomnia during pregnancy and the postpartum period. In addition, shortened sessions of CBT for insomnia have also been found to successfully reduce sleep difficulties. The second option is sleep hygiene education which is the most commonly offered treatment for sleep difficulties and has been found to improve sleep problems. The present study will compare the effectiveness of a CBT for insomnia group workshop to a Sleep Hygiene group workshop.
No Placebo Group
Trial Details
Trial Status:Recruiting
Trial Phase:Unphased
Age:18 - 45
Sex:Female
Key Eligibility Criteria
Disqualifiers:Severe Depression, Psychotic, Unstable Condition, Others
Must Not Be Taking:Sleep Aids
102 Participants Needed
At-Home tDCS for Depression in Pregnancy
Toronto, Ontario
This is a randomized, sham-controlled trial to determine whether treatment with transcranial direct current stimulation (tDCS) is superior to a sham condition at reducing the symptoms of depression in pregnant people with moderate to severe depression. The study aims to enrol 156 participants across all sites. Data collection occurs at baseline, immediately after treatment, every 4 weeks during pregnancy and 4-, 12-, 26- and 52-weeks postpartum
Trial Details
Trial Status:Recruiting
Trial Phase:Unphased
Sex:Female
Key Eligibility Criteria
Disqualifiers:Substance Use, Suicidality, Bipolar, Others
Must Not Be Taking:Benzodiazepines, Anticonvulsants
156 Participants Needed
Perinatal depression and anxiety (PDA) are the leading causes of maternal mortality in developed countries. Women with a history of depression have a 20 fold higher risk of PDA at subsequent pregnancies. The adverse outcomes extend beyond maternal well-being to long-term deficits in children and families. The gut-brain axis is a newly recognized key player in mental health disorders. Specifically, the microbial composition of the gut along with their metabolites are directly involved in disease onset and course. Recent clinical studies have identified diet as the most powerful environmental factor in manipulating gut microbiome. Given vulnerability and resistance of pregnant women to pharmacotherapy, particularly in those with a predisposition to mood disorders, as well as pregnant women's high motivation and commitment to improving gestational diet, a dietary/supplemental intervention to 'optimize' gut microbiome, is a favored approach in disease management. The study investigators aim to exploit microbial responsiveness to diet together with this maternal motivation, to alter the risk and severity of a universal public health concern that has dire and long-term consequences for new moms and their children.
The investigators of this trial, will first study the challenges in pursuing a study aimed at changing the microbiome of pregnant women with a history of mood disorders. Pregnant women in their second trimester will be recruited. Each will be assigned or randomized to one of four groups that will use a combination of diet, supplementation with probiotics, fish oil or no intervention. Each participant will meet with the study team virtually every 3 months until 1 year after delivery. At each study visit participants will be required to complete some questionnaires about their food intake, mood, and other health related measures and will provide a stool sample using the stool collection kits provided.
The findings from this study will help strategize for a larger study that will allow for comparison of the effects of diet, and/or supplementation with Omega-3 Fatty Acids (O3FA) and probiotics on the microbiome and the onset and severity of PDA.
No Placebo Group
Pivotal Trial (Near Approval)
Trial Details
Trial Status:Recruiting
Trial Phase:Phase 2, 3
Age:18 - 43
Sex:Female
Key Eligibility Criteria
Disqualifiers:Bipolar, Psychosis, Schizophrenia, Others
100 Participants Needed
Hormone Therapy for Postpartum Depression
Bethesda, Maryland
Determine whether postpartum depression is triggered by the abrupt withdrawal of estrogen and progesterone.
The appearance of mood and behavioral symptoms during pregnancy and the postpartum period has been extensively reported. While there has been much speculation about possible biologically based etiologies for postpartum disorders (PPD), none has ever been confirmed. Preliminary results from two related studies (protocols 90-M-0088, 92-M-0174) provide evidence that women with menstrual cycle related mood disorder, but not controls, experience mood disturbances during exogenous replacement of physiologic levels of gonadal steroids. The present protocol is designed to create a "scaled-down" hormonal milieu of pregnancy and the puerperium in order to determine whether women who have had a previous episode of postpartum major effective episode will experience differential mood and behavioral effects compared with controls and to determine whether it is the abrupt withdrawal of gonadal steroids or the prolonged exposure to gonadal steroids that is associated with mood symptoms. Supraphysiologic plasma levels of gonadal steroids will be established, maintained, and then rapidly reduced, simulating the hormonal events that occur during pregnancy and parturition. This will be accomplished by administering estradiol and progesterone to women who are pretreated with a gonadotropin releasing hormone (GnRH) agonist (Lupron). After eight weeks, administration of gonadal steroids will be stopped in one group of patients and controls, and a sudden decline in the plasma hormone levels will be precipitated. Another group will be maintained on supraphysiologic levels of estrogen and progesterone for an additional month. Outcome measures will include mood, behavioral and hormonal parameters (a separate protocol done in collaboration with NICHD).
...
Trial Details
Trial Status:Recruiting
Age:18 - 50
Sex:Female
Key Eligibility Criteria
Disqualifiers:Not Listed
100 Participants Needed
Rosie Chatbot Assistance for Pregnancy and Infant Care
College Park, Maryland
Rosie the Chatbot is an educational chatbot that moms can have on their computers or cellphones and will work by moms typing in their questions about pregnancy, health, infant milestones, and other variety of health related topics and receiving back a response immediately. Rosie only provides information from verified sources such as children's hospitals, health organizations and government agencies. Rosie does not ask moms to provide any personal information on her or her child, her chat is completely confidential, it works in English and Spanish and will be free.
No Placebo Group
Trial Details
Trial Status:Recruiting
Trial Phase:Unphased
Age:14 - 99
Sex:Female
Key Eligibility Criteria
Disqualifiers:Non-hispanic White, Others
400 Participants Needed
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Frequently Asked Questions
How much do Postpartum Depression clinical trials pay?
Each trial will compensate patients a different amount, but $50-100 for each visit is a fairly common range for Phase 2–4 trials (Phase 1 trials often pay substantially more). Further, most trials will cover the costs of a travel to-and-from the clinic.
How do Postpartum Depression clinical trials work?
After a researcher reviews your profile, they may choose to invite you in to a screening appointment, where they'll determine if you meet 100% of the eligibility requirements. If you do, you'll be sorted into one of the treatment groups, and receive your study drug. For some trials, there is a chance you'll receive a placebo. Across Postpartum Depression trials 30% of clinical trials have a placebo. Typically, you'll be required to check-in with the clinic every month or so. The average trial length for Postpartum Depression is 12 months.
How do I participate in a study as a "healthy volunteer"?
Not all studies recruit healthy volunteers: usually, Phase 1 studies do. Participating as a healthy volunteer means you will go to a research facility several times over a few days or weeks to receive a dose of either the test treatment or a "placebo," which is a harmless substance that helps researchers compare results. You will have routine tests during these visits, and you'll be compensated for your time and travel, with the number of appointments and details varying by study.
What does the "phase" of a clinical trial mean?
The phase of a trial reveals what stage the drug is in to get approval for a specific condition. Phase 1 trials are the trials to collect safety data in humans. Phase 2 trials are those where the drug has some data showing safety in humans, but where further human data is needed on drug effectiveness. Phase 3 trials are in the final step before approval. The drug already has data showing both safety and effectiveness. As a general rule, Phase 3 trials are more promising than Phase 2, and Phase 2 trials are more promising than phase 1.
Do I need to be insured to participate in a Postpartum Depression medical study?
Clinical trials are almost always free to participants, and so do not require insurance. The only exception here are trials focused on cancer, because only a small part of the typical treatment plan is actually experimental. For these cancer trials, participants typically need insurance to cover all the non-experimental components.
What are the newest Postpartum Depression clinical trials?
Most recently, we added Psychotherapy for Postpartum Depression, Psychological Intervention for Parents of Babies with Congenital Heart Defects and Clinical Decision Support Tool for Postpartum Depression to the Power online platform.
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