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Psilocybin-assisted Cognitive Behavioral Therapy for Major Depressive Disorder

Award Number: R34AT013077
ORGANIZATION: CENTER FOR DRUG EVALUATION AND RESEARCH, NIH
OPDIV: NIH
AWARD CLASS: DISCRETIONARY
AWARD ACTIVITY TYPE: SCIENTIFIC/HEALTH RESEARCH (INCLUDES SURVEYS)
PERIOD OF PERFORMANCE START DATE: 12/17/2024
PERIOD OF PERFORMANCE END DATE: 11/30/2027

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Psilocybin-assisted Cognitive Behavioral Therapy for Major Depressive Disorder - PROJECT SUMMARY This study will provide data and a well-manualized treatment that are critical for the planning and design of a subsequent clinical efficacy trial to elucidate the effects of combining psilocybin with an evidence-based psychotherapy for major depressive disorder. Background. Psilocybin has emerged as a therapeutic agent for a range of mental disorders, including major depressive disorder; however, more recent data suggest its antidepressant effect may not be as powerful as initially reported. While the drug has received the bulk of attention, its use within the scientific literature is always complemented by some amount of psychotherapy. In fact, some psychedelic experts hypothesize that it is the therapy enhanced by the drug (rather than the drug itself) that leads to therapeutic benefits. It is critical we identify the necessary psychotherapeutic components that lead to safe and effective psilocybin treatment. Specifically, there is a significant need for a protocolized psychosocial treatment that can be tested and optimized to adjoin psilocybin treatment for major depression. We have preliminarily protocolized and, for this application, collected initial supporting data for a psilocybin- assisted cognitive behavioral therapy (PA-CBT) for adults with major depressive disorder. PA-CBT includes the core safety elements of standard psilocybin treatment, two psilocybin sessions (10mg & 25mg), and 12 sessions of CBT. Specific Aims. We seek to conduct a feasibility clinical trial of PA-CBT in two phases. Phase I will involve refining and optimizing PA-CBT using participant and clinician feedback through an open trial of PA-CBT. Phase II will be a randomized, two-arm, fixed dose trial that will test the feasibility, acceptability, and adherence to PA-CBT. Both conditions will receive two doses of psilocybin (10mg then 25mg, separated by one month). Participants will be randomized (1:1) to either a 12-session PA-CBT or a 6-session standard psilocybin-assisted therapy (PAT) condition that involves supportive therapy and contains no elements of CBT. Primary outcomes include feasibility (recruitment and retention of participants), quantitative measures of patient and therapist acceptability and treatment adherence (i.e., therapist fidelity to the study’s treatment manuals and, in the PA-CBT condition, participant’s adherence to CBT skill practices). Feasibility. We have received the regulatory approvals for the Phase I portion of this award. Our team consists of experts in psychosocial clinical trials for depression and psychedelic medicine. We have trained our core study personnel and collected supporting data on five initial participants. Impact. In line with NCCIH funding priorities, the proposed research will answer critical questions about the acceptability and feasibility of combining standard psilocybin treatment with one of the gold-standard psychotherapies (CBT) for major depressive disorder and begin to uncover the initial effects by which CBT can influence participants’ depressive severity and psychosocial functioning. This work will lead to the development of a manualized, evidence-based psilocybin- assisted therapy that can be further studied, optimized, and broadly disseminated to clinicians.


Issue Date FY	Funding FY	Legal Entity Name	Legal Entity Address	Legal Entity City	Legal Entity State	Legal Entity Zip Code	Legal Entity COUNTY	Legal Entity COUNTRY	Assistance Listing	Award Code	Budget Year	Action Date	Action Type	Action Amount

Issue Date FY: 2025 ( Subtotal = $236,250 )
2025	2025	UNIVERSITY OF CALIFORNIA, LOS ANGELES	10889 WILSHIRE BLVD STE 700	LOS ANGELES	CA	90024	LOS ANGELES	USA	Research and Training in Complementary and Integrative Health	000	1	12/17/2024	NEW	$236,250
														Subtotal = $236,250

Grand Total All Awards = $236,250

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Psilocybin-assisted Cognitive Behavioral Therapy for Major Depressive Disorder

Award Number: R34AT013077

ORGANIZATION: CENTER FOR DRUG EVALUATION AND RESEARCH, NIH

OPDIV: NIH

AWARD CLASS: DISCRETIONARY

AWARD ACTIVITY TYPE: SCIENTIFIC/HEALTH RESEARCH (INCLUDES SURVEYS)

PERIOD OF PERFORMANCE START DATE: 12/17/2024

PERIOD OF PERFORMANCE END DATE: 11/30/2027

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