Depression

Raleigh, NC

53 Depression Trials near Raleigh, NC

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SP-624 for Depression

Cary, North Carolina
This trial is testing the efficacy of an investigational drug, SP-624 (study drug) to see how well it might work to treat major depressive disorder.

Trial Details

Trial Status:Recruiting
Trial Phase:Phase 2
Age:18 - 65

456 Participants Needed

Zuranolone for Depression Following a Stroke

Durham, North Carolina
The goal of this Phase II clinical trial is to learn if the oral synthetic allopreganolone analog (zuranolone) is safe to take and is well tolerated by stroke survivors experiencing moderate to severe post-stroke depression and if it will help with the symptoms of depression. The main questions it will aim to answer are: * Is zuranolone safe to take by participants who have moderate to severe post-stroke depression? * Is zuranolone well-tolerated by participants who have moderate to severe post-stroke depression? * Does zuranolone treat moderate to severe post-stroke depression? The study will enroll six participants. All participants will be given 50 mg of zuranolone for 14 days. Participants will be asked to provide blood samples, complete some questionnaires including those related to mood and a cognitive assessment.
No Placebo Group

Trial Details

Trial Status:Not Yet Recruiting
Trial Phase:Phase 2
Age:21 - 65

6 Participants Needed

Healthy Minds Program for Adolescent Depression

Chapel Hill, North Carolina
Starting at puberty, female adolescents are nearly three-times more likely to develop internalizing disorders, like depression, while male adolescents are two-times more likely to develop externalizing disorders, like attention deficit hyperactivity disorder (ADHD). This divergence between the sexes during puberty suggests sex-specific pathways of risk and differential effects of sex hormones. The purpose of this research is to determine: 1) sex-specific neural and endocrine features of the pubertal transition that may mediate sex differences in adolescent mood disorders, and 2) the neurophysiological basis of susceptibility to hormone change during puberty.
No Placebo Group

Trial Details

Trial Status:Recruiting
Trial Phase:Unphased
Age:11 - 14

60 Participants Needed

Pregnenolone for Anxiety and Depression

Durham, North Carolina
Anxiety and depression symptoms occur at high rates in Veteran populations and can significantly impact function, compromising the ability to work and to successfully form and maintain valued relationships. Several other symptoms commonly occur with anxiety and depression, including poor sleep quality and chronic pain. Since all these symptoms frequently occur together, they may have a common underlying biological basis. A single medication that could effectively treat all these symptoms would be ideal. Converging data suggest that pregnenolone is a promising pharmacological agent for treating multiple psychiatric symptoms and functional impairment. The investigators thus propose to conduct a clinical trial of pregnenolone in Veterans with anxiety and depression symptoms. Pregnenolone has minimal side effects, and the prior research demonstrates that pregnenolone is well-tolerated by Veterans. Treatment with pregnenolone could thus be an efficacious new therapeutic for Veterans experiencing depression, anxiety, poor sleep quality and chronic pain conditions.

Trial Details

Trial Status:Not Yet Recruiting
Trial Phase:Phase 2
Age:18 - 65

84 Participants Needed

Acceptance Commitment Therapy for Glaucoma

Durham, North Carolina
In this study, using three phases, the investigators will use an iterative development approach to refine a behavioral intervention for managing concomitant psychosocial distress in glaucoma. Phase 1: The investigators will begin by developing a baseline intervention using strategies from Acceptance and Commitment Therapy (ACT), and delivered using a mobile application. Phase 2: The investigators will refine the baseline intervention for glaucoma patients using qualitative interviews conducted with primary open-angle glaucoma (POAG) patients with psychosocial distress (N=20), and health professionals (N=5). Phase 3: Finally, the investigators will measure acceptability and feasibility of the refined intervention through a single-armed pilot study (N=25). The investigators hypothesize that the refined intervention will yield an acceptable and feasible intervention in a POAG patient population, setting the stage for a future efficacy study.
No Placebo Group

Trial Details

Trial Status:Recruiting
Trial Phase:Unphased

45 Participants Needed

Coping Skills Training for Anxiety and Stress

Durham, North Carolina
Conditions treated in intensive care units (ICUs) such as the acute respiratory distress syndrome (ARDS), congestive heart failure, COVID pneumonia, and sepsis are common. These can lead to high rates of depression, anxiety, and PTSD that worsen quality of life. Yet there are few effective strategies able to overcome barriers of limited access to mental health care. Even less is known about the experiences of patients from racially and ethnically minoritized populations because of they haven't been included well in past research. To address this problem, the investigators developed Blueprint, a mobile app that coaches people to use adaptive coping skills to self-manage their symptoms. The investigators found that it reduced depression symptoms and improved quality of life compared to placebo. To confirm these promising findings, the investigators are doing a formal test of Blueprint. The investigators will enroll 400 people who received ICU care from 4 hospitals (Duke, UCLA, Colorado, and Oregon). These patients will be randomized to receive either the Blueprint mobile app or a special Education Program mobile app the investigators developed. -both delivered through similar mobile app platforms. Our specific aims are to see which program improves symptoms better across 6 months of follow up. This project addresses national research priorities and could advance the field with a personalizable yet population-focused therapy that could be scaled broadly and efficiently to enhance mental health equity.
No Placebo Group

Trial Details

Trial Status:Recruiting
Trial Phase:Unphased

400 Participants Needed

Allopregnanolone for Traumatic Brain Injury

Durham, North Carolina
This study will determine if allopregnanolone (ALLO) improves depression and pain symptoms in patients who have a history of mild traumatic brain injury (TBI) \[primary endpoints\]. The investigators will also determine if ALLO improves functional outcome \[secondary endpoint\]. Participants in this study will receive an intravenous infusion of either ALLO or placebo. Behavioral assessments will be conducted during the infusion and at several time points post-infusion.

Trial Details

Trial Status:Not Yet Recruiting
Trial Phase:Phase 2
Age:21 - 62

132 Participants Needed

Behavioral Intervention for Lung Cancer

Durham, North Carolina
The purpose of this study is to develop a brief assessment and need-based behavioral intervention for addressing aging-specific concerns in older adults with lung cancer. The long-term goals of this research include identifying the unique concerns of these patients, providing patients with behavioral skills to address their symptom management needs, and enhancing patient engagement with healthcare specialties targeting aging-specific concerns. In the first phase of this study, participants (12 patients with lung cancer, 6 caregivers, 12 providers) will be asked to participate in two individual interviews (each 30-45 minutes in length) via teleconference. During the first interview, participants will be asked to provide feedback on the current version of the assessment and behavioral intervention. Participants will be asked to describe strengths and weaknesses of the materials, topics to add or remove, and any other suggested changes. After the research team has made changes to the materials, participants will be invited to complete a second interview to provide feedback on the updated materials. In the second phase of the study, 16 older adults with lung cancer will complete the revised assessment and participate in the behavioral intervention, in order to a) evaluate the feasibility and acceptability of the program and b) measure change in depression, anxiety, pain, and dyspnea.
No Placebo Group

Trial Details

Trial Status:Recruiting
Trial Phase:Unphased
Age:60+

46 Participants Needed

PTSD Mobile App for Cancer Survivors

Durham, North Carolina
The purpose of this study is to use a stepped-care approach in treating symptoms of posttraumatic stress disorder (PTSD). The information learned by doing this study may help us to develop some target treatments for PTSD symptoms in survivors of stem cell transplant. Participants in this study will be randomized to a mobile app or usual care. An assessment will be made after 4 weeks and a determination made of adding more intensive treatment. Participants will be asked to complete a questionnaire 4 times over a period of 6 months, at the time your participation is complete.
No Placebo Group

Trial Details

Trial Status:Active Not Recruiting
Trial Phase:Unphased

524 Participants Needed

TEAM-LEADS for Lupus and Dermatomyositis

Durham, North Carolina
The objectives of this study are to determine if the 'Teams Engaged in Accessible Mental Health Interventions for Lupus Erythematosus and Dermatomyositis Stress' (TEAM-LEADS) intervention is feasible and acceptable to adolescents and young adults with lupus and dermatomyositis and whether it can help reduce stress and promote cardiovascular health behaviors in these individuals.
No Placebo Group

Trial Details

Trial Status:Not Yet Recruiting
Trial Phase:Unphased
Age:12 - 22

25 Participants Needed

Hormone Withdrawal for Depression

Chapel Hill, North Carolina
The goal of this clinical trial is to learn how hormonal changes over the menstrual cycle affect mood symptoms in reproductive-aged women with depression that worsens during the premenstrual period. The main questions it aims to answer are: --How do fluctuations in estradiol and progesterone across the menstrual cycle affect the ability to experience pleasure and the neural sensitivity to reward in hormone-sensitive, depressed women? And consequently, how does stabilizing the luteal phase decline in estrogen and progesterone (using estradiol patches and progesterone pills) affect these changes? Participants will: * Receive hormones followed by placebo, or vice versa, for a total of four weeks across three menstrual cycles * Complete daily mood ratings * Collect home urine samples for hormone testing * Complete five biobehavioral testing sessions during which neural responses are recorded (via electroencephalography, or EEG) during an acute stress task and computer tasks

Trial Details

Trial Status:Recruiting
Trial Phase:Phase 4
Age:18 - 45
Sex:Female

75 Participants Needed

Multiple Medications for Bipolar Depression

Chapel Hill, North Carolina
This trial is testing four different medications to find the best treatment for adults with bipolar disorder type 1 who are currently depressed. The medications work by balancing brain chemicals that affect mood. The goal is to help patients recover from depression and stay well.
No Placebo Group

Trial Details

Trial Status:Not Yet Recruiting
Trial Phase:Phase 4

2726 Participants Needed

Transcranial Alternating Current Stimulation for Prenatal Depression

Chapel Hill, North Carolina
The purpose of this study is to develop the safety, feasibility, and tolerability of a personalized transcranial alternating current stimulation (tACS) approach in antenatal depression.
No Placebo Group

Trial Details

Trial Status:Not Yet Recruiting
Trial Phase:Unphased
Age:18 - 45
Sex:Female

10 Participants Needed

Brain Stimulation for Depression

Chapel Hill, North Carolina
The purpose of this research study is to study a closed-loop transcranial alternating current stimulation (tACS) device to evaluate feasibility of the product in a clinical trial and collect preliminary data on potential effects on symptoms of depression in people with major depressive disorder.

Trial Details

Trial Status:Recruiting
Trial Phase:Unphased

40 Participants Needed

Psychotherapy for Depression

Chapel Hill, North Carolina
The goal of this study is to learn the extent to which client-therapist brain activity may synchronize during a psychosocial intervention for depression symptoms. The study will compare behavioral activation, a client-centered type of cognitive-behavioral therapy, to psychoeducation which delivers information on strategies to recover from depression symptoms. Participants will answer questions about their mental and physical health, attend one psychosocial intervention session receiving either Behavioral Activation or Psychoeducation with simultaneous brain activity measurement and complete follow up surveys two weeks and one month following the intervention.
No Placebo Group

Trial Details

Trial Status:Recruiting
Trial Phase:Unphased
Age:18 - 30

45 Participants Needed

Stress Testing for Heart Disease

Chapel Hill, North Carolina
Depression is a known risk factor for cardiovascular disease (CVD), and this comorbidity contributes significantly to the morbidity and mortality of women. The menopausal transition or perimenopause is a period of vulnerability for both depression and CVD, making it a key time to study this critical public health issue. This research will preliminarily explore whether disruption in two novel stress pathways 1) the renin-angiotensin-aldosterone system (RAAS) and autonomic nervous system (ANS) and their relationship may underlie the link between these illnesses. Findings will provide important insight into potential mechanisms by which depression during perimenopause may increase risk for CVD in midlife women, which will inform potential risk reduction and treatment strategies that can improve health outcomes in this population.
No Placebo Group

Trial Details

Trial Status:Recruiting
Trial Phase:Unphased
Age:44 - 55
Sex:Female

30 Participants Needed

Teacher-Led Mental Health Care for Children

Chapel Hill, North Carolina
Purpose: The purpose of this research is to pilot test a novel, alternative, potentially sustainable system of teacher-delivered, task-shifted child mental health care. Participants: \~300 estimated Procedures: This is a RE-AIM (Reach, Effectiveness, Adoption, Implementation, Maintenance) guided, mixed methods, clustered evaluation of Tealeaf-NC's Reach, Adoption \& Implementation (Primary Outcomes, implementation-based), as well as evaluating for preliminary indicators of Effectiveness \& Maintenance (Secondary Outcomes, clinically-based).
No Placebo Group

Trial Details

Trial Status:Enrolling By Invitation
Trial Phase:Unphased
Age:5 - 99

312 Participants Needed

RE104 for Postpartum Depression

Chapel Hill, North Carolina
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

72 Participants Needed

Chronotherapy for Perinatal Depression

Chapel Hill, North Carolina
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

158 Participants Needed

Brief Behavioral Activation Treatment for Postpartum Depression

Chapel Hill, North Carolina
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

1230 Participants Needed

Why Other Patients Applied

"I have dealt with depression my entire adult life. I have been on multiple different meds, went through 10 weeks of TMS treatments (didn't work for me personally), done fairly extensive counseling. I’ve kind of lost hope that anything will ever help me to feel better. But I learned about new meds in clinical trials and I'm ready to try."

YP
Depression PatientAge: 60

"Tried Lexapro, Wellbutrin and another (forget which). Surgical accident destroyed my mental nerve and left me in chronic pain, depression, and anxiety. That was 15 years ago. Disabled and retired. I'm tired of this."

IH
Depression PatientAge: 73

"I was first diagnosed with major depressive disorder and anxiety over twenty years ago. I have tried different medications. Had to come off medications due to pregnancies, and have worked through different side effects like weight gain, nausea, sleepiness, and the more severe where i have tried to claw my way out of my skin it itched so bad. I dont want other people to have to go through this and I wish I could be off of my medication for good but it just hasnt happened. IF something is out there to improve the life of an anxious and/or depressed person I'd like to be able to say I helped find it."

HD
Depression PatientAge: 46

"I have struggled with depression since I was a child. I have experienced about more than 6 major depressive episodes lasting at least 4 months since I was 7 years old. I have tried talk therapy, a plethora of medication, and nothing has worked long term. Medication and talk therapy helps me manage and reduce the length of depressive episodes but I am in search for alternative treatments. My depression has made completing a bachelors degree a major challenge."

UD
Depression PatientAge: 25

"My long history of depression has been met with a long list of trial and error drugs. My current medication (generic Pristiq) has been prescribed for two decades (though I tried several other medications during my last serious episode several years ago. When the episode passed I returned to generic Pristiq. I am interested in a clinical trial because I wonder if I can do something different to more effectively avoid a serious depressive episode and lift the general malaise I often feel."

DD
Depression PatientAge: 62

Transdermal Estradiol for Mental Illness

Chapel Hill, North Carolina
This proposal will examine the effects of estradiol administration on perimenopausal-onset (PO) anhedonia and psychosis symptoms as well as on brain function using simultaneous positron emission tomography and functional magnetic resonance imaging (PET-MR).

Trial Details

Trial Status:Recruiting
Trial Phase:Phase 4
Age:45 - 55
Sex:Female

103 Participants Needed

Physical Activity and Education for Colorectal Cancer

Chapel Hill, North Carolina
RATIONALE: Participating in a physical activity program designed to increase free time physical activity and receiving written health education materials may influence the chance of cancer recurring as well as impact on physical fitness, psychological well-being and the quality of life of patients who have undergone surgery and chemotherapy for colon cancer. It is not yet known whether giving a physical activity program together with health education materials is more effective than giving health education materials alone for patients who have undergone colon cancer treatment. PURPOSE: This randomized phase III trial is studying a physical activity program given together with health education materials to see how well it works compared with giving health education materials alone for patients who have undergone treatment for high-risk stage II or stage III colon cancer.
No Placebo Group

Trial Details

Trial Status:Active Not Recruiting
Trial Phase:Unphased

889 Participants Needed

Pramipexole vs Escitalopram for Depression in HIV

Chapel Hill, North Carolina
A phase II, randomized, open-label, two-arm clinical trial evaluating the safety and efficacy of pramipexole extended release (ER) versus escitalopram for the treatment of major depressive disorder (MDD) and comorbid MDD with mild neurocognitive disorder (MND) in persons with HIV (PWH). Participants will be assessed comprehensively and briefly at intercurrent visits to monitor for toxicity, response to therapy, and to assess for dose changes. An optional sub-study to evaluate treatment impact on the cerebrospinal fluid (CSF) profile will be conducted in a subset of 36 participants.
No Placebo Group

Trial Details

Trial Status:Not Yet Recruiting
Trial Phase:Phase 2

186 Participants Needed

Psilocybin-Assisted Therapy for Depression

Chapel Hill, North Carolina
The goal of this clinical trial is to test how well psilocybin-assisted therapy works in treating people with depression. The main questions this study aims to answer are: * Does psilocybin with assisted therapy help improve symptoms for people with depression? * How long do the effects of this treatment last? Participants will: * Take part in a couple of screening and preparation visits. * Be given psilocybin in one or two treatment sessions. * Attend a series of follow-up sessions over the following year. * Complete forms and surveys to test how their symptoms have changed and what they thought of their experience. Researchers will also compare whether one treatment or two treatments help improve symptoms more for participants.
No Placebo Group
Pivotal Trial (Near Approval)

Trial Details

Trial Status:Recruiting
Trial Phase:Phase 3

20 Participants Needed

CBT vs Mindfulness-Based Therapy for Autism

Chapel Hill, North Carolina
Autistic adults are at a greater risk for mental health problems compared to the general population, with 50% meeting criteria for a co-occurring psychiatric condition. Depression and anxiety are the most common of these conditions among autistic adults, contributing to long-term detrimental effects on health, day-to-day functioning, and quality of life. This study will conduct the first large-scale head-to-head comparison of the two most widely studied mental health interventions for autistic adults: cognitive-behavioral therapy (CBT) and mindfulness-based therapy (MBT). Both interventions are well-established, empirically supported treatments for depression and anxiety in the general population, and both interventions have demonstrated efficacy among autistic adults. However, their comparative effectiveness and heterogeneity of treatment effects have not been established in autistic adults. Both interventions will be delivered by telehealth.
No Placebo Group

Trial Details

Trial Status:Recruiting
Trial Phase:Unphased

300 Participants Needed

Smoking Cessation App for Mental Health Disorders

Durham, North Carolina
This trial will test a new smartphone app called Quit on the Go, designed to help people with serious mental illness quit smoking. The study will compare this app to traditional methods, with both groups also using nicotine patches and gum. The goal is to see if the app helps more people quit smoking and if it is cost-effective.
No Placebo Group

Trial Details

Trial Status:Recruiting
Trial Phase:Unphased

450 Participants Needed

Single Session Psychotherapy for Depression

Chapel Hill, North Carolina
The goal of this clinical trial is to learn whether an single session intervention can reduce psychological impairment in adult individuals with moderate depression. The main questions it aims to answer are: Is this evidence-based intervention acceptable to study participants? Is this evidence-based intervention feasible to implement in a single session? Is there evidence that the evidence-based intervention reduces psychological impairment in adults with moderate to severe depression? Participants will complete: * an in-depth diagnostic screening interview prior to enrollment * a set of mental health questionnaires at baseline and two weeks post-intervention * a 3-hour, evidence-based, single session psychotherapeutic intervention with a trained clinician
No Placebo Group

Trial Details

Trial Status:Active Not Recruiting
Trial Phase:Unphased

15 Participants Needed

Alliance180 Program for Trauma

Chapel Hill, North Carolina
The goal of this clinical trial is to evaluate the effects of the Alliance180 Program on physical and psychological well-being on adults who are/were US Veterans, First Responders and/or Front Line Healthcare Workers. The study aims are: * Aim #1: to evaluate the effect of the Alliance180 Program on physical and psychological well-being in adults who are/were US Veterans, First Responders and/or Front Line Healthcare Workers; * Aim #2: to evaluate the relationship between between feelings of safety and well-being, autonomic functioning, and mental health indices (depression, anxiety, trauma response) before and after the intervention. Participants will be asked to complete self-report measures of feelings of safety and well-being, autonomic functioning, and mental health indices (depression, anxiety, trauma response) before participating in the Alliance180 Program (i.e., baseline research session) and 1 week, 1 month, 3 months and 6 months after completing the Alliance180 Program. Demographic information will be documented during the baseline research session.
No Placebo Group

Trial Details

Trial Status:Recruiting
Trial Phase:Unphased

50 Participants Needed

Pregnenolone for PTSD

Durham, North Carolina
This trial tests pregnenolone, a natural hormone booster, to see if it can help Iraq/Afghanistan-era Veterans with PTSD who need better treatment options. Pregnenolone works by balancing brain chemicals to improve mood and reduce PTSD symptoms. Pregnenolone has been studied for its brain-protective effects, particularly in relation to its conversion to estradiol.

Trial Details

Trial Status:Recruiting
Trial Phase:Phase 2
Age:18 - 65

90 Participants Needed

SinuSonic for Nasal Congestion

Chapel Hill, North Carolina
The goal of this clinical trial is to evaluate the effects of using the SinuSonic on psychological and physical well-being in adults who have nasal/sinus congestion. The study aims are: * Aim #1: to evaluate the effect of the SinuSonic on physical and psychological well-being in individuals with chronic nasal congestion; * Aim #2: to evaluate the relationship between autonomic reactivity and psychological well-being (i.e., anxiety and depression) in individuals with chronic nasal congestion; * Exploratory Aim: to evaluate the impact of adverse experiences on physical and psychological well-being in individuals who experience chronic nasal congestion. Participants will be asked to complete self-report measures of physical health, mental health and autonomic regulation before using SinuSonic (i.e., baseline research session) and after 5 weeks of directed use (post-intervention). Demographic information and adverse experiences will be documented during the baseline research session. Participants will be asked to document (weekly) current nasal symptoms and SinuSonic usage.
No Placebo Group

Trial Details

Trial Status:Recruiting
Trial Phase:Unphased

50 Participants Needed

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