Ignite Creation Date:
2024-05-06 @ 3:40 PM
Last Modification Date:
2024-10-26 @ 1:54 PM
Study NCT ID:
NCT04714359
Status:
COMPLETED
Last Update Posted:
2024-04-29
First Post:
2021-01-14
Brief Title:
A Multi-Site Open-Label Extension Study of MDMA-Assisted Psychotherapy for PTSD
Sponsor:
Lykos Therapeutics
Organization:
Lykos Therapeutics
Study Overview
Official Title:
A Multi-Site Open-Label Safety Extension Study of Manualized MDMA-Assisted Psychotherapy for the Treatment of Participants With Posttraumatic Stress Disorder
Status:
COMPLETED
Status Verified Date:
2024-04
Last Known Status:
None
Delayed Posting:
No
If Stopped, Why?:
Not Stopped
Has Expanded Access:
False
If Expanded Access, NCT#:
N/A
Has Expanded Access, NCT# Status:
N/A
Acronym:
MAPPUSX
Brief Summary:
This multi-site open-label study assesses the efficacy and safety of 34-methylenedioxymethamphetamine MDMA-assisted psychotherapy in participants who were enrolled in a parent study for treatment of posttraumatic stress disorder PTSD The study will be conducted in up to N 100 participants Participants will receive a flexible dose of MDMA followed by a supplemental dose unless contraindicated during the Treatment Period with manualized psychotherapy in three 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 PTSD Checklist PCL-5 for the Diagnostic and Statistical Manual of Mental Disorders 5th Edition DSM-5 from Visit 3 is assessed at Visit 16 This study will compare the effects of three manualized Experimental Sessions of psychotherapy assisted by flexible doses of MDMA Initial doses per Experimental Session include 80 mg or 120 mg of MDMA compounded with mannitol and magnesium stearate alone mannitol and magnesium stearate followed 15 to 2 hours later by a supplemental dose 40 or 60 mg Total amounts of MDMA to be administered per Experimental Session range from 80 mg to 180 mg
Detailed Description:
PTSD is a serious debilitating disorder that negatively impacts a persons daily life 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 persons 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
34-methylenedioxymethamphetamine MDMA 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 safety extension study assesses the efficacy and safety of MDMA-assisted psychotherapy versus psychotherapy in participants diagnosed with PTSD The study will be conducted in N 100 participants Participants who were randomized to the placebo arm in the two parent Phase 3 trials of MDMA-assisted psychotherapy and who meet all other entry criteria will be eligible and invited to participate in this open-label safety extension study In addition participants in the parent Phase 3 trials whose study participation was affected by COVID-19 pandemic or other unforeseen circumstances and were unable to complete the study may participate in this open-label study
The treatment consists of a flexible dose of MDMA 80 or 120 mg followed by a supplemental dose 40 or 60 mg unless contraindicated administered with manualized psychotherapy in three open-label approximately monthly Experimental Sessions During Experimental Session 1 participants will receive an initial dose of 80 mg of MDMA followed by a supplemental dose of 40 mg During Experimental Sessions 2 and 3 participants will receive an initial dose of 80 or 120 mg of MDMA followed by a supplemental dose of 40 or 60 mg
This 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 Experimental Sessions are followed by an overnight stay The Primary Outcome measure the change in PCL-5 PTSD Checklist for DSM-5 from Visit 3 is assessed at Visit 16
34-methylenedioxymethamphetamine MDMA 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 safety extension study assesses the efficacy and safety of MDMA-assisted psychotherapy versus psychotherapy in participants diagnosed with PTSD The study will be conducted in N 100 participants Participants who were randomized to the placebo arm in the two parent Phase 3 trials of MDMA-assisted psychotherapy and who meet all other entry criteria will be eligible and invited to participate in this open-label safety extension study In addition participants in the parent Phase 3 trials whose study participation was affected by COVID-19 pandemic or other unforeseen circumstances and were unable to complete the study may participate in this open-label study
The treatment consists of a flexible dose of MDMA 80 or 120 mg followed by a supplemental dose 40 or 60 mg unless contraindicated administered with manualized psychotherapy in three open-label approximately monthly Experimental Sessions During Experimental Session 1 participants will receive an initial dose of 80 mg of MDMA followed by a supplemental dose of 40 mg During Experimental Sessions 2 and 3 participants will receive an initial dose of 80 or 120 mg of MDMA followed by a supplemental dose of 40 or 60 mg
This 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 Experimental Sessions are followed by an overnight stay The Primary Outcome measure the change in PCL-5 PTSD Checklist for DSM-5 from Visit 3 is assessed at Visit 16
Study Oversight
Has Oversight DMC:
None
Is a FDA Regulated Drug?:
True
Is a FDA Regulated Device?:
False
Is an Unapproved Device?:
None
Is a PPSD?:
None
Is a US Export?:
None
Is an FDA AA801 Violation?:
None