Clinical Trials Logo

Clinical Trial Details — Status: Completed

Administrative data

NCT number NCT03485287
Other study ID # MP-17
Secondary ID
Status Completed
Phase Phase 2
First received
Last updated
Start date March 13, 2018
Est. completion date June 4, 2019

Study information

Verified date January 2024
Source Lykos Therapeutics
Contact n/a
Is FDA regulated No
Health authority
Study type Interventional

Clinical Trial Summary

This multi-site, open-label, Phase 2, lead-in study assesses the safety and effect of 3,4-methylenedioxymethamphetamine (MDMA)-assisted psychotherapy in participants diagnosed with at least severe posttraumatic stress disorder (PTSD). Therapy teams that have been identified and trained to work on the sponsor's planned Phase 3 studies will treat at least one open-label participant in this study. A flexible dose of MDMA (100 to 125 mg), followed by a supplemental half-dose, unless contraindicated, is administered during the Treatment Period with manualized therapy in three open-label monthly Experimental Sessions. This ~12-week Treatment Period is preceded by three Preparatory Sessions. During the Treatment Period, each Experimental Session is followed by three Integrative Sessions of non-drug psychotherapy. The primary outcome measure is the change in the Clinician Administered PTSD Scale for DSM 5 (CAPS-5) total severity scores from Baseline to Visit 19. The secondary outcome measure is the change in the customized version of the Sheehan Disability Scale (SDS) for PTSD for the MAPS studies total scores from Baseline to Visit 19.


Description:

PTSD is a stress-related psychiatric condition that may occur following a traumatic event such as war, disaster, sexual abuse, violence, terrorism, and accidents. PTSD negatively impacts a person's daily life, resulting in relationship difficulties, difficulty in finding and maintaining a job, reduced cognitive and psychosocial functioning, substance abuse, high-cost healthcare use, and increased depression and suicide risk. Available PTSD treatments, including medications and therapy, effectively treat only a fraction of people who try them for adequate dose and duration. People with PTSD can be treated with psychotherapies and pharmacotherapies. In the past decade, there has been a growing amount of research into medications and other methods that may augment the effectiveness of psychotherapy for PTSD 3,4-methylenedioxymethamphetamine is a drug that releases serotonin, norepinephrine and dopamine in the brain and indirectly increases levels of the neurohormones oxytocin, arginine vasopressin and cortisol. The combined neurobiological effects of MDMA increase compassion, reduce defenses and fear of emotional injury, and enhance communication and introspection. MDMA produces anxiolytic and prosocial effects, which counteract avoidance and hyperarousal in the context of therapy. A combined treatment of MDMA and psychotherapy may be especially useful for treating PTSD. This multi-site, open-label, Phase 2, lead-in study assesses the safety and effect of 3,4-methylenedioxymethamphetamine (MDMA)-assisted psychotherapy in participants diagnosed with at least severe posttraumatic stress disorder (PTSD). Therapy teams that have been identified and trained to work on the sponsor's planned Phase 3 studies will treat at least one open-label participant in this study. A flexible dose of MDMA (100 to 125 mg), followed by a supplemental half-dose, unless contraindicated, is administered during the Treatment Period with manualized therapy in three open-label monthly Experimental Sessions. This ~12-week Treatment Period is preceded by three Preparatory Sessions. During the Treatment Period, each Experimental Session is followed by three Integrative Sessions of non-drug psychotherapy. The primary outcome measure is the change in the Clinician Administered PTSD Scale for DSM 5 (CAPS-5) total severity scores from Baseline to Visit 19. The secondary outcome measure is the change in the customized version of the Sheehan Disability Scale (SDS) for PTSD for the MAPS studies total scores from Baseline to Visit 19.


Recruitment information / eligibility

Status Completed
Enrollment 4
Est. completion date June 4, 2019
Est. primary completion date June 4, 2019
Accepts healthy volunteers No
Gender All
Age group 18 Years and older
Eligibility Inclusion Criteria: - Are at least 18 years old - Are fluent in speaking and reading the predominantly used or recognized language of the study site - 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 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. - Must not be abusing illegal drugs

Study Design


Intervention

Drug:
Midomafetamine
Three sessions of MDMA-assisted therapy with flexible dose of MDMA from 100 to 125 mg and optional supplemental dose half that of initial dose 1.5 to 2 hours later
Behavioral:
Therapy
Non-directive therapy

Locations

Country Name City State
Canada Dr. Simon Amar, LLC Montréal Quebec
Canada British Columbia Centre on Substance Abuse Vancouver British Columbia

Sponsors (1)

Lead Sponsor Collaborator
Lykos Therapeutics

Country where clinical trial is conducted

Canada, 

Outcome

Type Measure Description Time frame Safety issue
Primary Change From Baseline to Primary Endpoint in Clinician-Administered PTSD Scale for DSM-5 (CAPS-5) Total Severity Score The Clinician-Administered PTSD Scale for DSM-5 (CAPS-5) is a clinician administered and scored assessment of PTSD symptoms via structured interview based upon PTSD diagnosis in DSM-5. It contains symptom subscales, a CAPS-5 total severity score, and a diagnostic score. The total severity score is a sum of symptom frequency and intensity scores for the subscales B (re-experiencing), C (avoidance) and D (hypervigilance) and ranges from 0 to 136, with higher scores indicating greater severity of PTSD symptoms. Baseline (Visit 3) to Primary Endpoint (Visit 19,18 weeks post enrollment)
Primary Baseline Clinician-Administered PTSD Scale for DSM-5 (CAPS-5) Total Severity Scores The Clinician-Administered PTSD Scale for DSM-5 (CAPS-5) is a clinician administered and scored assessment of PTSD symptoms via structured interview based upon PTSD diagnosis in DSM-5. It contains symptom subscales, a CAPS-5 total severity score, and a diagnostic score. The total severity score is a sum of symptom frequency and intensity scores for the subscales B (re-experiencing), C (avoidance) and D (hypervigilance) and ranges from 0 to 136, with higher scores indicating greater severity of PTSD symptoms. Baseline (Visit 3)
Primary Primary Endpoint Clinician-Administered PTSD Scale for DSM-5 (CAPS-5) Total Severity Score The Clinician-Administered PTSD Scale for DSM-5 (CAPS-5) is a clinician administered and scored assessment of PTSD symptoms via structured interview based upon PTSD diagnosis in DSM-5. It contains symptom subscales, a CAPS-5 total severity score, and a diagnostic score. The total severity score is a sum of symptom frequency and intensity scores for the subscales B (re-experiencing), C (avoidance) and D (hypervigilance) and ranges from 0 to 136, with higher scores indicating greater severity of PTSD symptoms. Visit 19 (18 weeks post-enrollment)
Secondary Change From Baseline to Primary Endpoint in Sheehan Disability Scale (SDS for PTSD for MAPS) Total Score The Sheehan Disability Scale (SDS for PTSD for MAPS) is a self-report assessment of functional impairment. The reporting period for the adapted SDS refers to the past month. The items indicate degree of impairment in the domains of work/school, social life, and home life, with response options based on an eleven-point scale (0=not at all to 10=extremely), with higher scores indicating greater functional impairment. Baseline (Visit 3) to Primary Endpoint (Visit 19, 18 weeks post-enrollment)
Secondary Baseline Sheehan Disability Scale (SDS for PTSD for MAPS) Total Score The Sheehan Disability Scale (SDS for PTSD for MAPS) is a self-report assessment of functional impairment. The reporting period for the adapted SDS refers to the past month. The items indicate degree of impairment in the domains of work/school, social life, and home life, with response options based on an eleven-point scale (0=not at all to 10=extremely), with higher scores indicating greater functional impairment. Baseline (Visit 3)
Secondary Primary Endpoint Sheehan Disability Scale (SDS for PTSD for MAPS) Total Score The Sheehan Disability Scale (SDS for PTSD for MAPS) is a self-report assessment of functional impairment. The reporting period for the adapted SDS refers to the past month. The items indicate degree of impairment in the domains of work/school, social life, and home life, with response options based on an eleven-point scale (0=not at all to 10=extremely), with higher scores indicating greater functional impairment. Visit 19 (18 weeks post-enrollment)
See also
  Status Clinical Trial Phase
Completed NCT03384706 - A Comparison of CPT Versus ART Versus WL N/A
Completed NCT03418129 - Neuromodulatory Treatments for Pain Management in TBI N/A
Completed NCT03129204 - Sensation Awareness Focused Training for Spouses N/A
Recruiting NCT05651295 - A Precision Medicine Approach to Target Engagement for Emotion Regulation N/A
Completed NCT05113277 - Development and Evaluation of a Tonic Immobility Focused Psychoeducational Intervention N/A
Recruiting NCT05327504 - Written Exposure Therapy for Veterans With SUD and PTSD N/A
Recruiting NCT05843695 - Enhancing Psychotherapy for Veterans and Service Members With PTSD and Anxiety N/A
Active, not recruiting NCT05530642 - An Augmented Training Program for Preventing Post-Traumatic Stress Injuries Among Diverse Public Safety Personnel N/A
Completed NCT00644423 - Omega-3 Fatty Acids and Post Traumatic Stress Disorder (PTSD) N/A
Completed NCT02989987 - NET for SGBV Survivors in Eastern DR Congo N/A
Completed NCT02320799 - Randomized Controlled Trial of Interpersonal Psychotherapy for Depression and PTSD Among HIV+ Women in Kenya N/A
Recruiting NCT02293291 - Thermal Clinic Treatment in Gulf War Illness Phase 1/Phase 2
Completed NCT02242136 - Treatment of Posttraumatic Stress Disorder and Aggressive Behavior in Soldiers and Ex-combatants N/A
Completed NCT01911585 - Efficacy of 60-minute Versus 90-minute Sessions in Treating PTSD Using Prolonged Exposure N/A
Completed NCT02720497 - The Efficacy of 90-Minute Versus 60-Minute Sessions of Prolonged Exposure for PTSD N/A
Completed NCT01693978 - Contingency Outcomes in Prolonged Exposure N/A
Terminated NCT01408641 - Topiramate for Alcohol Use in Posttraumatic Stress Disorder N/A
Completed NCT01469754 - Longitudinal Survey Analysis in Lymphoma Survivors N/A
Completed NCT02362477 - Telemental Health and Cognitive Processing Therapy for Female Veterans With Military-related PTSD Phase 3
Terminated NCT01239173 - Emotional Memory Reactivation in Posttraumatic Stress Disorder Phase 3