ACTIVE PSYCHEDELIC-ASSISTED THERAPY STUDIES
Dose Optimization of MDMA-Assisted Therapy for PTSD in Veterans-- Recruiting
This clinical trial is designed to evaluate the optimal number of MDMA-assisted therapy cycles for the treatment of PTSD in U.S. military veterans. All participants will complete three preparatory sessions, and then complete from one to five cycles of MDMA-assisted therapy. Each cycle is comprised of one all-day MDMA session followed by three non-drug integration therapy sessions. After each cycle, participants will decide with their therapists whether they want to continue with another cycle or terminate treatment, based on their progress, treatment burden, or other factors. Blood samples are also collected before and after treatment for analyses of potential biological predictors of outcome or changes associated with recovery.
Contact:
Joshua Park, study coordinator
email: Joshua.Park1@va.gov
phone: 929-736-3104
Psilocybin for Intergenerational Trauma-- Recruiting
This study investigates whether psilocybin-assisted therapy can help reduce depression, anxiety, and stress in people whose parents survived genocide. Research has demonstrated that trauma and PTSD in parents can affect the mental health and biology of their children, even after the threat has passed. This study represents the first trial of a psychedelic treatment for the intergenerational effects of trauma. Outcomes will include the safety and tolerability of the treatment for this population of patients, its effectiveness in reducing distress and improving resilience, and whether it affects how people relate to the trauma experienced by their parents.
Contact:
Evie Alkin, study coordinator
email: IntergenStudy@mssm.edu
phone: 929-489-7440
MDMA-Assisted Therapy for Therapists in Training -- Recruiting
This study will examine the effects of MDMA-assisted therapy on mental wellbeing in mental healthcare professionals. Participants will be mental health providers in training to become MDMA-assisted therapists, and this protocol will provide an opportunity for them to understand the treatment and the effects of MDMA-assisted therapy that they will be providing to others. The study includes collection of blood at baseline and study termination for biomarker analysis in healthy volunteers, which can be compared to biomarker data from our clinical trials with patients with PTSD.
Contact: Lily Fischer, study coordinator
Email: therapistwellbeing@mssm.edu
Psilocybin for the Treatment of Major Depressive Disorder-- Recruiting
In collaboration with the Depression & Anxiety Center at Icahn School of Medicine at Mount Sinai, this mechanistic study investigates the role of the 5-HT2A receptor on the subjective effects of psilocybin. Past research has shown that blocking this receptor in humans weakens the psychedelic effects, but in an animal study the block completely stopped the hallucinogenic effects but did not reduce the antidepressant benefits. This hints that the part of the brain responsible for the mood-boosting effects may function separately from the part that causes the psychedelic experience. This randomized trial will test the subjective and treatment effects of psilocybin administered with a drug to block that 5-HT2A receptor or placebo in participants with depression.
Contact:
Depression and Anxiety Center
email: dac@mssm.edu
phone: 212-241-6539
Ketamine-Assisted Psychotherapy for Depression-- Recruiting
In collaboration with the Depression & Anxiety Center at Icahn School of Medicine at Mount Sinai, this study is a randomized clinical trial comparing ketamine administered with psychotherapy versus ketamine infusions without therapeutic support in a typical medical setting. Both treatments will last four weeks. Outcome measures include depression, mental wellness, and brain function before, during, and after treatment up to two months post-treatment.
Contact: Rachel Fremont, MD, PhD
email: rachel.fremont@mssm.edu
Psilocybin for depression, (Usona multi-site Phase III trial)-- Closed for Enrollment
The purpose of this sponsored, Phase III, multi-site, randomized clinical trial is to evaluate the efficacy, safety, and tolerability of psilocybin 25 mg versus placebo in veterans with Major Depressive Disorder, and to characterize the durability of the initial treatment effect and subsequent response to optional psilocybin re-administration(s) during a 1-year follow-up period.
Contact:
Lesley Lu, study coordinator
email: lesley.Lu@mssm.edu
Novel Therapies Neuroimaging study
These studies leverage the Center’s psychedelic clinical trials by adding functional magnetic resonance imaging (fMRI) before and after psychedelic assisted therapy. Neuroimaging data will be analyzed to identify predictors and correlates of symptom improvement, and to generate hypotheses regarding potential mechanisms of action associated with recovery.
Safety, Tolerability, Outcomes of Psilocybin in Veterans with Spinal Cord Injury -- Recruiting Soon
In collaboration with the Spinal Cord Injury research team at the Bronx VA, this study proposes to investigate the safety and tolerability of low to high doses of psilocybin in veterans with Spinal Cord Injury and a history of depression. Secondary outcomes including physical function, pain, mood, and quality of life will be assessed. Will include blood draws at baseline and study termination to assess biomarkers of change and outcome predictors.
Name: Thomas W Sutor, PhD
Phone Number: 718-584-9000 ext 5129
Email: Thomas.Sutor@mountsinai.org
MDMA-Assisted Therapy for Bulimia -- Recruiting Soon
In collaboration with the Eating and Weight Disorders Program (Center of Excellence) at Mount Sinai, this trial will investigate the safety and efficacy of MDMA assisted therapy for Bulimia Nervosa in comparison to gold-standard cognitive-behavioral therapy for Bulimia Nervosa. This adapted version of MDMA-AT incorporates interoceptive skills for treating body image disturbance and unhealthy relationship with food into the preparation and integration work that is the foundation of MDMA-AT.
Contact: Center of Excellence in Eating and Weight Disorders
Email: jessica.bibeau@mssm.edu
Long-Term Follow Up for Dose Optimization Study of MDMA-Assisted Therapy for PTSD in Veterans
Study to assess long-term effectiveness, secondary measures (e.g., impairment, depression, moral injury, anger, etc.), and healthcare utilization at 6 and 12 months post therapy. Includes blood draws at both timepoints to assess biomarkers of change and outcome predictors. Need for such data was recently highlighted by the FDA’s Advisory Committee meeting.
ACTIVE TRAUMATIC STRESS STUDIES
PTSD Prevention Using Oral Hyrdocortisone
This two-site study tests a one-time prophylactic treatment for the prevention of symptoms of PTSD and related mental health disturbances and the promotion of resilience using a single dose of hydrocortisone (HCORT) administered within six hours of trauma exposure in an Emergency Department. Blood samples are collected to investigate potential mechanisms of action.
Understanding Gene x Stress Interactions across the Cell Types of the Brain in PTSD
This project extends on previous work and aims to increase our cohort size to increase our confidence in PTSD-specific signatures in both glutamatergic and GABAergic neurons and enable us to assess sex-specific effects. The project expands our investigations to include other major cell types of the brain, and couples transcriptomic readouts with high-content imaging additional cell types. The study also aims to then dissect the functional impact of genetic variants significantly associated with PTSD across all the major cell types and finally to use sophisticated computational analyses to examine gene x environment interactions.
Association of PTSD Dose with Cardiovascular Disease Risk in Multi-ethnic WTC Heart Cohort
This is an observational study of 240 subjects that are part of the World Trade Center Heart Cohort. Participants are recruited from the parent study taking place at Queens College to undergo an in-person visit to measure heart rate variability obtained from EKG data, and biomarkers of chronic stress obtained from blood samples. The study aims to determine how chronic PTSD, resulting from the devastating events of September 11th, 2001, can increase the risk of cardiovascular disease across biological sex and race/ethnicity.
RECENTLY COMPLETED STUDIES
2 vs 3 Sessions of MDMA-Assisted Therapy for Veterans with PTSD
Randomized clinical trial to assess differences in outcome or efficacy of two versus three MDMA-assisted psychotherapy sessions for the treatment of PTSD in veterans. Includes blood draws at baseline and study termination to assess biomarkers of change and outcome predictors.
Long-Term Follow Up for 2 vs 3 Sessions of MDMA-Assisted Therapy for PTSD in Veterans
Study to assess long-term effectiveness, secondary measures (e.g., impairment, depression, moral injury, anger, etc.), and healthcare utilization at 6 and 12 months post therapy. Includes blood draws at both timepoints to assess biomarkers of change and outcome predictors. Need for such data was recently highlighted by the FDA’s Advisory Committee meeting.
Psilocybin for PTSD Pilot Study
Multi-site, sponsored trial to assess safety and tolerability of psilocybin-assisted therapy as a treatment for PTSD, with secondary outcomes examining efficacy. Includes blood draws at baseline and study termination to assess biomarkers of change and outcome predictors. This was the first trial of Psilocybin-Assisted Therapy for PTSD, and will provide data to inform larger clinical trials for veterans and civilians.
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