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Suggestions within category "Mental & Behavioral Health"

3 Study Matches

A Multi-Site Phase 3 Study of MDMA-Assisted Psychotherapy for PTSD

Posttraumatic stress disorder (PTSD) is a debilitating psychiatric disorder that can develop after a traumatic life experience that severely reduces quality of life. This multi-site, double-blind, placebo-controlled, randomized Phase 3 study will assess the efficacy and safety of 3,4-methylenedioxymethamphetamine (MDMA)-assisted psychotherapy compared to psychotherapy with placebo in participants diagnosed with at least moderate PTSD. The study will be conducted in up to N ≈ 100 participants. Participants will be randomized to receive a flexible dose of 80 or 120 mg MDMA or placebo, followed by a supplemental half-dose of 40 or 60 mg MDMA or placebo, unless contraindicated, with manualized psychotherapy in three monthly Experimental Sessions. This ~12-week Treatment Period will be preceded by three Preparatory Sessions with the participant and therapists. During the Treatment Period, each Experimental Session will be followed by three Integrative Sessions of non-drug psychotherapy.
Randall Brown, MD
18 Years and over
Phase 3
This study is NOT accepting healthy volunteers
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Inclusion Criteria:

• Are at least 18 years old.
• Are fluent in speaking and reading the predominantly used or recognized language of the study site.
• Are able to swallow pills.
• Agree to have study visits recorded, including Experimental Sessions, Independent Rater assessments, and non-drug psychotherapy sessions.
• Must provide a contact (relative, spouse, close friend or other caregiver) who is willing and able to be reached by the investigators in the event of a participant becoming suicidal or unreachable.
• Must agree to inform the investigators within 48 hours of any medical conditions and procedures.
• If of childbearing potential, must have a negative pregnancy test at study entry and prior to each Experimental Session, and must agree to use adequate birth control through 10 days after the last Experimental Session.
• Must not participate in any other interventional clinical trials during the duration of the study.
• Must be willing to remain overnight at the study site after each Experimental Session and be driven home after, and commit to medication dosing, therapy, and study procedures.
• At baseline, have moderate PTSD diagnosis.
Exclusion Criteria:

• Are not able to give adequate informed consent.
• Have uncontrolled hypertension.
• Have a marked baseline prolongation of QT/QTc interval (e.g., repeated demonstration of a QTc interval >450 milliseconds [ms] corrected by Bazett's formula).
• Have a history of additional risk factors for Torsade de pointes (e.g., heart failure, hypokalemia, family history of Long QT Syndrome).
• Have evidence or history of significant medical disorders.
• Have symptomatic liver disease.
• Have history of hyponatremia or hyperthermia.
• Weigh less than 48 kilograms (kg).
• Are pregnant or nursing, or are of childbearing potential and are not practicing an effective means of birth control.
• Are abusing illegal drugs.
Posttraumatic Stress Disorder, Post-traumatic stress disorder, Mental & Behavioral Health
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A Study of Psilocybin for Major Depressive Disorder (MDD)

Eighty participants, ages 21 to 65, who meet Diagnostic and Statistical Manual of Mental Disorders (DSM-5) criteria for major depressive disorder (MDD) will be stratified by study site and randomized with a 1-to-1 allocation under double-blind conditions to receive a single 25 mg oral dose of psilocybin or a single 100 mg oral dose of niacin. Niacin will serve as an active placebo. The purpose of this study is to evaluate the potential efficacy of a single 25 mg oral dose of psilocybin for MDD compared to the active placebo in otherwise medically-healthy participants, assessed as the difference between groups in changes in depressive symptoms from Baseline to Day 8 post-dose.
Randall Brown, MD
21 Years to 65 Years old
Phase 2
This study is also accepting healthy volunteers
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Inclusion Criteria:

• 21 to 65 years old
• Able to swallow capsules
• If of childbearing potential, agree to practice an effective means of birth control throughout the duration of the study
• Have an identified support person and agree to be accompanied home by that person following dosing
• Have sustained moderate-severe depression symptoms at Screening and Baseline
• Meet DSM-5 criteria for a diagnosis of major depressive disorder and are currently experiencing a major depressive episode of at least a 60-day duration at the time of screening
Exclusion Criteria:

• Women who are pregnant or who intend to become pregnant during the study or who are currently nursing
• Have any of the following cardiovascular conditions: uncontrolled hypertension, coronary artery disease, congenital long QT syndrome, cardiac hypertrophy, cardiac ischemia, congestive heart failure, myocardial infarction, tachycardia, artificial heart valve, a clinically significant screening ECG abnormality, or any other significant cardiovascular condition
• Have a history of stroke or Transient Ischemic Attack (TIA)
• Have moderate to severe hepatic impairment
• Have epilepsy
• Have insulin-dependent diabetes
• Have a positive urine drug test
• Nicotine dependence that would disallow an individual to be nicotine free for the 7-10 hours during the dosing period
• Meet DSM-5 criteria for schizophrenia spectrum or other psychotic disorders, including major depressive disorder with psychotic features, or Bipolar I or Bipolar II Disorder
• Meet DSM-5 criteria for antisocial personality disorder
• Meet DSM-5 criteria for a moderate or severe alcohol or drug use disorder
Major depressive disorder, recurrent, Mental & Behavioral Health, Depressive Disorder, Major
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Pilot RECAP Study in Healthy Normal Volunteers (RECAP)

The primary objective of the RECAP Study Program is to investigate the role played by conscious experience in the antidepressant effects of the psychedelic agent psilocybin. This pilot dosing study (PILOT RECAP) is designed to determine the optimal dose of midazolam that allows a psychedelic experience to occur while inducing amnesia for the experience. This is an essential step required for subsequent evaluation of the role of memory for the psychedelic experience in the antidepressant effects of psilocybin in the full RECAP study.
Christopher Nicholas, PhD
21 Years to 60 Years old
Phase 1
This study is also accepting healthy volunteers
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Inclusion Criteria:

• Age 21 to 60 years at screening
• Medically healthy (does not meet criteria for an exclusionary medical condition)
• No current DSM-5 psychiatric diagnosis
• No current use of psychotropic medications
• Ability/willingness to complete all study activities
• Use of acceptable contraceptive methods (sexually active males and women of childbearing potential)
• Speaks and reads English
• No use of psychedelic drugs within prior 3 months
• Able to swallow oral medications
Exclusion Criteria:

• Pregnancy
• Current exclusionary medical illness
• Current DSM-5 psychiatric diagnosis and/or suicidal thoughts/behavior within prior 12 months
• Clinically significant safety lab abnormalities (i.e., Complete Blood Count with Differential, Comprehensive Metabolic Panel, and urinalysis)
• Clinically significant electrocardiogram (ECG)
• Hypertension or tachycardia
• First degree relative(s) with a history of schizophrenia, schizophreniform disorder, bipolar I disorder, bipolar II disorder, major depressive disorder with psychotic features
Psychedelic Experiences, Amnesia, Major depressive disorder, recurrent, Persistent mood [affective] disorders, Healthy Volunteers, Mental & Behavioral Health
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