Ignite Creation Date:
2024-05-06 @ 1:21 AM
Last Modification Date:
2024-10-26 @ 11:03 AM
Study NCT ID:
NCT01793610
Status:
COMPLETED
Last Update Posted:
2024-01-24
First Post:
2013-02-13
Brief Title:
Dose-Response Study of MDMA-assisted Psychotherapy in People With PTSD
Sponsor:
Lykos Therapeutics
Organization:
Lykos Therapeutics
Study Overview
Official Title:
A Randomized Double-Blind Dose Response Phase 2 Pilot Study of Manualized MDMA-Assisted Psychotherapy in Subjects With Chronic Treatment-Resistant Posttraumatic Stress Disorder PTSD
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:
Posttraumatic stress disorder PTSD is a debilitating psychiatric disorder that can develop after a traumatic life experience that severely reduces quality of life This Phase 2 pilot study examined the safety and efficacy of MDMA-assisted psychotherapy in 23 subjects with chronic treatment-resistant posttraumatic stress disorder PTSD This study is part of a global series of Phase 2 pilot clinical trials This randomized double-blind dose response study assessed two active doses of MDMA 100 mg and 125 mg to a comparator dose of MDMA 40 mg during psychotherapy sessions The initial dose was followed 15 to 25 hours later by an optional supplemental dose of MDMA that was half the size of the first dose MDMA was administered in two experimental sessions lasting up to eight hours and scheduled three to five weeks apart Subjects were prepared for MDMA-assisted psychotherapy prior to the first session in three preparatory sessions and worked with the same pair of therapists throughout the study After each MDMA-assisted psychotherapy session subjects had three integrative sessions with their therapist team to process and understand their experience
This study assessed the change in symptoms of PTSD as measured by the Clinical Administered PTSD Scale CAPS Blake et al 1995 as well as symptoms of depression as measured by the Beck Depression Inventory II BDI-II Beck AT and RA 1984 Beck AT et al 1996 from baseline enrollment to one month after the second MDMA-assisted psychotherapy session primary endpoint
Participants who received the comparator dose of MDMA 40 mg were given the option to enroll in Stage 2 where they underwent three open-label MDMA-assisted psychotherapy sessions with an active dose of MDMA People who received either of the active doses of MDMA in Stage 1 had a third MDMA-assisted psychotherapy session with another active dose of MDMA
This study assessed the change in symptoms of PTSD as measured by the Clinical Administered PTSD Scale CAPS Blake et al 1995 as well as symptoms of depression as measured by the Beck Depression Inventory II BDI-II Beck AT and RA 1984 Beck AT et al 1996 from baseline enrollment to one month after the second MDMA-assisted psychotherapy session primary endpoint
Participants who received the comparator dose of MDMA 40 mg were given the option to enroll in Stage 2 where they underwent three open-label MDMA-assisted psychotherapy sessions with an active dose of MDMA People who received either of the active doses of MDMA in Stage 1 had a third MDMA-assisted psychotherapy session with another active dose of MDMA
Detailed Description:
Posttraumatic stress disorder PTSD is a debilitating psychiatric disorder that can develop after a person experiences a traumatic event such as sexual assault war or any other life-threatening event PTSD is a worldwide health problem that severely reduces a persons quality of life and is associated with high rates of psychiatric and medical comorbidity disability suffering and suicide At least a third of PTSD patients fail to respond to established PTSD psychotherapies A wider array of effective treatments for PTSD are needed
34-methylenedioxymethamphetamine MDMA-assisted psychotherapy may be a potential treatment option for PTSD MDMA is a monoamine releaser that affects serotonin norepinephrine and dopamine MDMA is capable of inducing unique psychopharmacological effects such as decreased feelings of fear increased feelings of wellbeing increased sociability and extroversion increased interpersonal trust and an alert state of consciousness In the US MDMA was used as an adjunct to psychotherapy by a considerable number of psychiatrists and therapists before it was placed in Schedule I in 1985 as a result of non-medical use
This Phase 2 pilot study is a randomized double-blind dose response study to examine the safety and efficacy of MDMA-assisted psychotherapy in 23 subjects with chronic treatment-resistant PTSD of at least six months duration This study is part of a global series of Phase 2 pilot clinical trials This study assessed two active doses of MDMA active dose 1 100 mg and active dose 2 125 mg to a comparator dose of MDMA 40 mg during psychotherapy sessions The initial dose of MDMA was followed 15 to 25 hours later by an optional supplemental dose of MDMA that was half the size of the first dose MDMA was administered orally in two experimental sessions lasting up to eight hours and scheduled three to five weeks apart
Subjects were prepared for MDMA-assisted psychotherapy in three preparatory sessions prior to the first experimental session and worked with the same pair of therapists throughout the study After each experimental session three integrative sessions were scheduled with the subject including one integrative session the morning after the experimental session During integrative sessions subjects processed and connected their thoughts and feelings about the experience with their therapist team
Subjects who received the comparator dose 40 mg were given the option to enroll in Stage 2 where they underwent three open-label MDMA-assisted psychotherapy sessions 100 mg of MDMA was administered in the first session and therapists determined whether to increase to 125 mg of MDMA for the second and third experimental sessions People who received 125 mg of MDMA during the first two experimental sessions received the same dose during an open-label third experimental session People who received 100 mg of MDMA during the first two sessions were able to choose in consultation with their therapist to either continue to receive 100 mg in a third session or to increase their dose to 125 mg
A blinded independent rater IR assessed the severity of PTSD symptoms at baseline one month after the second experimental session the primary endpoint two months after the third open-label experimental session and at equivalent points in Stage 2
34-methylenedioxymethamphetamine MDMA-assisted psychotherapy may be a potential treatment option for PTSD MDMA is a monoamine releaser that affects serotonin norepinephrine and dopamine MDMA is capable of inducing unique psychopharmacological effects such as decreased feelings of fear increased feelings of wellbeing increased sociability and extroversion increased interpersonal trust and an alert state of consciousness In the US MDMA was used as an adjunct to psychotherapy by a considerable number of psychiatrists and therapists before it was placed in Schedule I in 1985 as a result of non-medical use
This Phase 2 pilot study is a randomized double-blind dose response study to examine the safety and efficacy of MDMA-assisted psychotherapy in 23 subjects with chronic treatment-resistant PTSD of at least six months duration This study is part of a global series of Phase 2 pilot clinical trials This study assessed two active doses of MDMA active dose 1 100 mg and active dose 2 125 mg to a comparator dose of MDMA 40 mg during psychotherapy sessions The initial dose of MDMA was followed 15 to 25 hours later by an optional supplemental dose of MDMA that was half the size of the first dose MDMA was administered orally in two experimental sessions lasting up to eight hours and scheduled three to five weeks apart
Subjects were prepared for MDMA-assisted psychotherapy in three preparatory sessions prior to the first experimental session and worked with the same pair of therapists throughout the study After each experimental session three integrative sessions were scheduled with the subject including one integrative session the morning after the experimental session During integrative sessions subjects processed and connected their thoughts and feelings about the experience with their therapist team
Subjects who received the comparator dose 40 mg were given the option to enroll in Stage 2 where they underwent three open-label MDMA-assisted psychotherapy sessions 100 mg of MDMA was administered in the first session and therapists determined whether to increase to 125 mg of MDMA for the second and third experimental sessions People who received 125 mg of MDMA during the first two experimental sessions received the same dose during an open-label third experimental session People who received 100 mg of MDMA during the first two sessions were able to choose in consultation with their therapist to either continue to receive 100 mg in a third session or to increase their dose to 125 mg
A blinded independent rater IR assessed the severity of PTSD symptoms at baseline one month after the second experimental session the primary endpoint two months after the third open-label experimental session and at equivalent points in Stage 2
Study Oversight
Has Oversight DMC:
None
Is a FDA Regulated Drug?:
None
Is a FDA Regulated Device?:
None
Is an Unapproved Device?:
None
Is a PPSD?:
None
Is a US Export?:
None
Is an FDA AA801 Violation?:
None