Ignite Creation Date:
2024-05-06 @ 10:33 AM
Last Modification Date:
2024-10-26 @ 12:31 PM
Study NCT ID:
NCT03282123
Status:
COMPLETED
Last Update Posted:
2024-01-24
First Post:
2017-09-11
Brief Title:
Open Label Multi-Site Study of Safety and Effects of MDMA-assisted Therapy for Treatment of PTSD
Sponsor:
Lykos Therapeutics
Organization:
Lykos Therapeutics
Study Overview
Official Title:
An Open-Label Multi-Site Phase 2 Study of the Safety and Effect of Manualized MDMA-Assisted Therapy for the Treatment of Severe Posttraumatic Stress Disorder
Status:
COMPLETED
Status Verified Date:
2024-01
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:
None
Brief Summary:
This multi-site open-label Phase 2 lead-in study assesses the safety and effect of 34-methylenedioxymethamphetamine MDMA-assisted therapy in participants diagnosed with at least severe posttraumatic stress disorder PTSD Therapy teams that have been identified and trained to work on the sponsors planned Phase 3 studies will treat at least one open-label participant in this study
This study will compare the effects of three open-label manualized Experimental Sessions of therapy assisted by flexible doses of MDMA Initial doses per Experimental Session include 80 mg or 120 mg of MDMA compounded with lactose followed 15 to 2 hours later by a supplemental half-dose 40 mg or 60 mg Total amounts of MDMA to be administered per Experimental Session range from 80 mg to 180 mg 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 Clinician Administered PTSD Scale for DSM 5 CAPS-5 total severity scores from Baseline to Primary Endpoint Visit 19
This study will compare the effects of three open-label manualized Experimental Sessions of therapy assisted by flexible doses of MDMA Initial doses per Experimental Session include 80 mg or 120 mg of MDMA compounded with lactose followed 15 to 2 hours later by a supplemental half-dose 40 mg or 60 mg Total amounts of MDMA to be administered per Experimental Session range from 80 mg to 180 mg 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 Clinician Administered PTSD Scale for DSM 5 CAPS-5 total severity scores from Baseline to Primary Endpoint Visit 19
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 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 therapy may be especially useful for treating PTSD
This multi-site open-label Phase 2 lead-in study assesses the safety and effect of 34-methylenedioxymethamphetamine MDMA-assisted therapy in participants diagnosed with at least severe posttraumatic stress disorder PTSD Therapy teams that have been identified and trained to work on the sponsors planned Phase 3 studies will treat at least one open-label participant in this study
This study will compare the effects of three open-label 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 lactose followed 15 to 2 hours later by a supplemental half-dose 40 mg or 60 mg Total amounts of MDMA to be administered per Experimental Session range from 80 mg to 180 mg 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 Clinician Administered PTSD Scale for DSM 5 CAPS-5 from Baseline to Primary Endpoint Visit 19
34-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 therapy may be especially useful for treating PTSD
This multi-site open-label Phase 2 lead-in study assesses the safety and effect of 34-methylenedioxymethamphetamine MDMA-assisted therapy in participants diagnosed with at least severe posttraumatic stress disorder PTSD Therapy teams that have been identified and trained to work on the sponsors planned Phase 3 studies will treat at least one open-label participant in this study
This study will compare the effects of three open-label 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 lactose followed 15 to 2 hours later by a supplemental half-dose 40 mg or 60 mg Total amounts of MDMA to be administered per Experimental Session range from 80 mg to 180 mg 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 Clinician Administered PTSD Scale for DSM 5 CAPS-5 from Baseline to Primary Endpoint Visit 19
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