Post-Traumatic Stress Disorder

Irvine, CA

17 Post-Traumatic Stress Disorder Trials near Irvine, CA

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No Placebo
Highly Paid
Stay on Current Meds
Pivotal Trials (Near Approval)
Breakthrough Medication

MeRT for Post-Traumatic Stress Disorder

Costa Mesa, California
This trial is testing a new treatment called MeRT, which uses magnets to help people with PTSD by improving their brain function.

Trial Details

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

152 Participants Needed

Proud & Empowered Program for Bullying in LGBTQ Youth

Long Beach, California
Efficacy of a Multi-level School Intervention for LGBTQ Youth
No Placebo Group

Trial Details

Trial Status:Recruiting
Trial Phase:Unphased
Age:12 - 20

450 Participants Needed

Stellate Ganglion Block for PTSD

Long Beach, California
This trial tests if an injection near neck nerves can help Veterans with chronic PTSD who need alternative treatments. The injection may calm overactive nerves, reducing PTSD symptoms quickly. This method has been explored for treating various conditions, including PTSD, with mixed evidence.

Trial Details

Trial Status:Recruiting
Trial Phase:Unphased

360 Participants Needed

Suvorexant for PTSD-Related Sleep Disturbances

Long Beach, California
Post-traumatic stress disorder (PTSD) is a common consequence of combat that can result in trauma-related hyperarousal and sleep disturbances. Poor sleep, one of the most common complaints in Veterans with PTSD, can be distressing, impair concentration and memory, and contribute to physical health conditions, such as metabolic syndrome, inflammation, and cardiovascular disease. The orexin neuropeptide system underlies both sleep and stress reactivity. Suvorexant, a drug that reduces orexin, improves sleep in civilians, but has not yet been tested in Veterans with PTSD. This study will test whether suvorexant can improve sleep disturbances and PTSD symptoms in Veterans. Suvorexant may benefit Veterans by improving sleep quickly while also reducing PTSD symptoms over the long term, and with fewer side effects that were common in previous medications used to treat these conditions. Improving Veterans' sleep and PTSD symptoms could lead to better emotional and physical well-being, quality of life, relationships, and functioning.

Trial Details

Trial Status:Recruiting
Trial Phase:Phase 4

144 Participants Needed

Mindful Self-Compassion for PTSD

Pomona, California
Trauma exposure, posttraumatic stress disorder (PTSD), and substance use disorder (SUD) present major threats to public health. PTSD and SUD are major correlates of disability, often resulting in severe social and occupational impairment. Comorbidity between PTSD and SUD (PTSD/SUD) is common and frequently co-occurs with other mental health ailments including depression, anxiety, and suicidality. Comorbidity may be amplified in groups vulnerable to high trauma exposure, such as women with low socioeconomic status including women experiencing homelessness (WEH). Moreover, the reciprocal nature of PTSD/SUD (substances are used to cope with PTSD symptoms; substance use can create high-risk situations for new traumas to occur), can create a cycle of trauma and symptomatology leading to a critical health disparity. PTSD/SUD can be costly and difficult to treat, with treatment completion often low and relapse rates often high. Low-cost, complementary interventions, such as self-compassion (SC) interventions, which target key mechanisms that maintain PTSD/SUD, could improve treatment outcomes. SC interventions include practices that build skills to improve emotional responses, cognitive understanding, and mindfulness. Recent research supports the benefit of SC interventions for reducing PTSD, SUD, and related comorbidities, potentially with large effects. However, sample sizes have generally been small and randomized designs infrequently used. Moreover, while SC interventions may act to improve key mechanisms of treatment response and/or symptom maintenance (e.g., emotion regulation/dysregulation, trauma-related guilt, trauma-related shame, moral injury, and craving), such mediating factors have been underexplored. To address these limitations, the present proposal will implement community-based research principles and use a two phase, mixed-method design to adapt and test a widely used SC intervention (Mindful Self Compassion; MSC) for use with a sample of WEH with PTSD/SUD. The project will be conducted in partnership with a state-funded drug treatment facility that serves women and families experiencing high health disparities. Phase I was completed in 2023 and adapted the standard MSC course for use with trauma-exposed WEH with PTSD/SUD using the ADAPT-ITT model, an eight-stage model that engages community partners to increase feasibility and acceptability of interventions for at-risk populations. Phase II will be an open-label cluster randomized clinical trial (N=202) to test the benefit of the adapted MSC at improving primary (PTSD, substance use) and secondary outcomes (depression, anxiety, hopelessness) among a sample of WEH with PTSD/SUD residing in a residential drug treatment site. MSC (n=101) will be compared to Treatment as Usual (TAU; n=101). WEH in the MSC group will complete a 6-week (six sessions plus a half-day retreat) MSC intervention. The TAU group will engage in weekly check-ins with the research team but will not receive an intervention. WEH will be assessed at baseline, immediately post-intervention, and at a 4-month follow-up. One-on-one interviews will be conducted with the MSC group to collect qualitative data on experiences. An exploratory aim will be to elucidate mechanism of treatment-response and maintenance or remission of PTSD symptoms. These potential mechanisms will include SC, emotion regulation/dysregulation, trauma-related guilt, trauma-related shame, moral injury, and craving. Results may inform treatment for PTSD/SUD in WEH and other groups experiencing high health disparities and provide valuable insights into mechanisms underlying PTSD/SUD symptoms over time. Findings are relevant to military populations, which experience high rates of PTSD/SUD, and other populations disproportionately exposed to trauma.
No Placebo Group

Trial Details

Trial Status:Recruiting
Trial Phase:Unphased
Sex:Female

202 Participants Needed

MDMA-Assisted Psychotherapy for PTSD in Adolescents

Los Angeles, California
The primary objective of this study is to determine the safety and feasibility of 3,4-methylenedioxymethamphetamine (MDMA) -assisted psychotherapy to treat resistant post-traumatic stress disorder (PTSD). The secondary objectives are the exploration of effectiveness for treatment-resistant PTSD, symptoms of depression, and anxiety symptoms.
No Placebo Group

Trial Details

Trial Status:Not Yet Recruiting
Trial Phase:Phase 2
Age:16 - 17

10 Participants Needed

MDMA-Assisted Therapy for PTSD

Los Angeles, California
This trial is testing two treatments for adults with moderate to severe PTSD. One treatment uses MDMA to help patients feel more comfortable during therapy, and the other uses a small dose of d-amphetamine to help them stay focused. The goal is to see if these treatments can reduce PTSD symptoms. MDMA has recently been shown as a novel therapeutic agent with promising results in the treatment of PTSD.
No Placebo Group

Trial Details

Trial Status:Recruiting
Trial Phase:Phase 2

40 Participants Needed

Transcendental Meditation vs Present Centered Therapy for PTSD

Los Angeles, California
This trial tests two treatments, Transcendental Meditation (TM) and Present Centered Therapy (PCT), for veterans and first responders with PTSD. TM uses meditation to calm the nervous system, while PCT focuses on current issues and coping strategies. Early research shows that Transcendental Meditation (TM) can help with PTSD. The goal is to find helpful treatments for PTSD in this group.
No Placebo Group

Trial Details

Trial Status:Active Not Recruiting
Trial Phase:Unphased

360 Participants Needed

MDMA-Assisted Psychotherapy for PTSD

Los Angeles, California
This is an add-on substudy to an already-approved clinical trial "A Multi-Site Phase 3 Study of MDMA-Assisted Psychotherapy for PTSD" (ClinicalTrials.gov Identifier: NCT03537014) which is to be a phase 3 clinical trial studying the efficacy of MDMA-Assisted Psychotherapy for Post Traumatic Stress Disorder. The parent study has been approved by Copernicus Group IRB and is being run by the MAPS Public Benefit Corporation, and is a randomized controlled trial comparing the clinical efficacy of MDMA-assisted psychotherapy to Placebo-assisted psychotherapy. The parent study will recruit participants with Post Traumatic Stress Disorder and involves 20 total study visits over the course of 18 weeks including 3 preparatory psychotherapy visits plus 3 separate treatment sessions involving psychotherapy plus the administration of MDMA vs. placebo and 3 follow up psychotherapy visits after each treatment session. This substudy adds on the collection of saliva in a salivary DNA collection kit at baseline and after treatment to the parent study clinical trail so as to assess whether the MDMA-Assisted Psychotherapy exerts influence on the epigenetic regulation of stress-associated genes as assessed in the salivary epithelial and white blood cells of the research participants. We aim to further assess whether any such changes are correlated with improvements in PTSD symptoms.
Pivotal Trial (Near Approval)

Trial Details

Trial Status:Active Not Recruiting

45 Participants Needed

Suvorexant for Insomnia

Los Angeles, California
This study is to determine if suvorexant (SUV) will reduce insomnia in 76 men and women veteran and non-veterans between the ages 21-65 with posttraumatic stress disorder (PTSD) symptoms and alcohol use disorder (AUD). All participants will have a 7-day placebo run-in period, followed by a random assignment to receive placebo or suvorexant for an additonal 14 days. Post-randomization, participants will attempt to stop drinking for two weeks and will complete daily virtual diaries and study outcome assessments via in-person clinic visits on days 7 and 14.

Trial Details

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

76 Participants Needed

Brief Exposure Therapy for PTSD

Los Angeles, California
The goal of this clinical trial is to develop a new behavioral treatment for U.S. combat veterans with post-traumatic stress disorder (PTSD), very brief exposure to combat-related stimuli. The main questions it aims to answer are: 1. How does Very Brief Exposure (combat images and control everyday images) and Visible Exposure to combat stimuli affect brain activity and subjective fear ratings? 2. To what extent are participants aware of the stimuli presented and tolerating the exposures? All participants will view both very brief exposure and visible exposure to combat stimuli in the functional magnetic brain imaging (fMRI) scan. They will provide ratings of fear, awareness, and tolerability. Researchers will compare U.S. combat veterans with PTSD and healthy controls to confirm differences in brain region activation and ratings.
No Placebo Group

Trial Details

Trial Status:Recruiting
Trial Phase:Unphased
Age:18 - 50

80 Participants Needed

Therapist-Assisted Self-Management Program for PTSD

Sepulveda, California
This trial tests a program called EMPOWER that helps veterans who have completed PTSD therapy manage their own symptoms with some help from a therapist. It aims to maintain or improve their mental health and reduce the number of therapy sessions they need.
No Placebo Group

Trial Details

Trial Status:Enrolling By Invitation
Trial Phase:Unphased

90 Participants Needed

MDMA-Assisted Psychotherapy for PTSD

Loma Linda, California
This will be a single-site, open-label phase 2 study designed to test the feasibility of administering MDMA in conjunction with psychotherapy for combat-related treatment-resistant PTSD in US military veterans currently enrolled in VA. MDMA will be given in conjunction with structured psychotherapy in three single-dose psychotherapy sessions in a hospital setting over the course of 12 weeks, along with preparatory and integration psychotherapy sessions in-between each active-dose session. The overall objective of this study is to evaluate the risks, benefits, and feasibility of MDMA used in conjunction with manualized psychotherapy, on reduction of symptoms, or remission of PTSD, as evaluated by standard clinical measures, in a VA Healthcare System. The primary outcome measure for the study is the Clinician-Administered PTSD Scale (CAPS-5), a semi-structured interview used in the majority of clinical trials for PTSD, which will be assessed at baseline, primary endpoint, and at the long-term 12-month follow-up visit. Secondary safety and efficacy measures will also be collected. The planned duration of this study is 1-3 years, with each active treatment period lasting approximately 12 weeks, along with a long-term follow-up 12 months after the last active-drug session.
No Placebo Group

Trial Details

Trial Status:Active Not Recruiting
Age:18 - 55

5 Participants Needed

Positive Psychiatry for PTSD

Los Angeles, California
Objective: Posttraumatic stress disorder (PTSD) is a prevalent neuropsychiatric disorder in children and is associated with increased neurovascular inflammation, suicidality, adulthood mental health disorder, and major adverse events. Reminder focused positive psychiatry (RFPP) has been shown as well tolerated feasible trauma focused intervention that is associated with improved core PTSD symptoms, decreased severity of reactivity to PTSD trauma reminders, and increased vascular function. This study evaluates the clinical and biomolecular characteristics of RFPP in adolescents with PTSD. Research Design/Overall Impact: After obtaining parents' informed consent and adolescent's assent, 60 adolescents aged 11-15 years old with PTSD, and free of known medical and other major psychiatric disorders will be recruited from the pool of eligible adolescents at Olive View UCLA Pediatrics Clinics (\>3000 adolescents with PTSD). Eligible adolescents will be randomized to 1) RFPP group intervention, or 2) an attentional control condition (group process). Thirty subjects in each group will receive twice weekly telehealth intervention of either RFPP or group process, for 6 weeks, and undergo 4 blinded neuropsychiatric assessments at baseline, 3, 6, and 24 weeks. Parents will receive weekly interventions of either positive psychoeducation or group process, for 6 weeks and undergo baseline, 3, 6- and 24-weeks neuropsychiatric assessment. Vascular function, inflammatory biomarkers including CRP, homocysteine, and stress involved gene expression biomarkers (i.e. changes in gene expression of FKBP5, DDX6, B2M, LAIR1, RTN4, NUB1, and a multi-gene Conserved Transcriptional Response to Adversity score (CTRA) will be measured at baseline and 6-week. The primary and secondary endpoints are a) changes in PTSD core and reactivity to trauma reminder severity score in response to RFPP intervention, b) changes in wellbeing, biopsychosocial trait, vascular function, neuroinflammation and gene expression biomarkers in response to RFPP, and c) changes in parents' wellbeing and biopsychosocial trait as well as child-parent interactions.

Trial Details

Trial Status:Recruiting
Trial Phase:Unphased
Age:11 - 15

60 Participants Needed

Deep Brain Stimulation for PTSD

Los Angeles, California
Posttraumatic stress disorder (PTSD) affects approximately 30 % of American veterans returning from Iraq and Afghanistan. Although the current therapy is effective, a percentage of patients will fail to improve and will develop chronic treatment-resistant PTSD. Patients suffering from PTSD experience intense suffering, lack of productivity and a higher risk of suicide. Unfortunately, combat PTSD has a tendency to be resistant to current treatments. The central goal of this project is to develop a new therapeutic strategy involving the placement of intracranial electrodes to treat the symptoms of PTSD. The project is based on recent evidence showing abnormal activity in a specific brain region of PTSD patients, thought to be responsible for the core symptoms of PTSD.
No Placebo Group

Trial Details

Trial Status:Recruiting
Trial Phase:Unphased
Age:25 - 70
Sex:Male

6 Participants Needed

Responsive Neurostimulation for PTSD

Los Angeles, California
This trial uses a device called Responsive Neurostimulation (RNS) to help veterans with severe PTSD who haven't responded to other treatments. The device records brain activity and sends electrical pulses to reduce fear and trauma responses. This approach aims to improve PTSD symptoms by targeting the brain's fear processing mechanisms.
No Placebo Group

Trial Details

Trial Status:Active Not Recruiting
Age:25 - 60
Sex:Male

6 Participants Needed

Trauma-Informed CBT-I for PTSD-Related Insomnia

West Los Angeles, California
This pilot trial will compare trauma-informed Cognitive Behavioral Therapy for Insomnia (CBT-I) to a psychoeducational intervention in women Veterans with comorbid insomnia and posttraumatic stress disorder (PTSD). The CBT-I intervention includes trauma-informed adaptations to an insomnia treatment and the psychoeducational intervention is modeled after usual care in a VA Women's Mental Health Clinic. The study objectives are to: 1) Iteratively refine the structure and materials of trauma-informed CBT-I in preparation for a pilot trial, 2) Pilot test the effects of trauma-informed CBT-I on PTSD treatment readiness and engagement in a sample of women Veterans, and 3) Examine potential mechanisms underlying variations in PTSD treatment readiness and engagement over time among women Veterans. Women Veterans with insomnia and comorbid PTSD who receive care at Sepulveda and West Los Angeles facilities will be recruited for the study. Those who pass an initial eligibility screen will be enrolled and written informed consent will be obtained. A baseline assessment will be completed that includes measures of PTSD treatment readiness, perceived barriers to PTSD treatment, and sleep and mental health symptoms. Then Veterans who meet all eligibility criteria will be randomly assigned to trauma-informed CBT-I (n=25) or the psychoeducational intervention (n=25). Both treatments will be provided in 5 one-on-one sessions by a trained instructor who is supervised by a behavioral sleep medicine specialist. All randomized participants (n=50) will have 2 follow-up assessments (post-treatment and 3-months). The follow-up assessments will collect information on PTSD treatment readiness, perceived barriers to PTSD treatment, and sleep and mental health symptoms. Chart reviews will be conducted 6-months post-treatment to assess number of PTSD treatment appointments attended (treatment engagement measure). Qualitative interviews will be conducted to identify mechanisms underlying PTSD treatment engagement.
No Placebo Group

Trial Details

Trial Status:Recruiting
Trial Phase:Unphased
Sex:Female

100 Participants Needed

Why Other Patients Applied

"I've tried several different SSRIs over the past 23 years with no luck. Some of these new treatments seem interesting... haven't tried anything like them before. I really hope that one could work."

ZS
Depression PatientAge: 51

"I've been struggling with ADHD and anxiety since I was 9 years old. I'm currently 30. I really don't like how numb the medications make me feel. And especially now, that I've lost my grandma and my aunt 8 days apart, my anxiety has been even worse. So I'm trying to find something new."

FF
ADHD PatientAge: 31

"My orthopedist recommended a half replacement of my right knee. I have had both hips replaced. Currently have arthritis in knee, shoulder, and thumb. I want to avoid surgery, and I'm open-minded about trying a trial before using surgery as a last resort."

HZ
Arthritis PatientAge: 78

"I have dealt with voice and vocal fold issues related to paralysis for over 12 years. This problem has negatively impacted virtually every facet of my life. I am an otherwise healthy 48 year old married father of 3 living. My youngest daughter is 12 and has never heard my real voice. I am now having breathing issues related to the paralysis as well as trouble swallowing some liquids. In my research I have seen some recent trials focused on helping people like me."

AG
Paralysis PatientAge: 50

"As a healthy volunteer, I like to participate in as many trials as I'm able to. It's a good way to help research and earn money."

IZ
Healthy Volunteer PatientAge: 38

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