drugset / Trial / NCT05487885

Anhedonia, Development, and Emotions: Phenotyping and Therapeutics

NCT05487885 ↗

Phase 4 Completed 123 enrolled Erika Forbes
Non-randomizedSequentialOpen-labelTreatment

Summary

The goal of the ADEPT Study is to understand anhedonia in young people and how it changes based on treatments targeting the brain circuit underlying it. Anhedonia is a challenging mental health symptom that involves difficulty with motivation to experience pleasant events. This study could help develop treatments for people whose depression does not improve with traditional treatments. The ADEPT Study includes two phases. In Phase 1, participants are asked to go through a series of activities to measure anhedonia, including MRI scans, blood draws, behavioral tasks, clinical interviews, questionnaires, and app-based assessments of experiences and behaviors. Phase 2 involves therapeutic activities, such as transcranial magnetic stimulation (TMS), positive affect training, and, for some people, ketamine administration. If the participant qualifies and is interested, they may choose to do Phase 2 activities in addition to Phase 1.

Timeline

Start
2022-07-22
Primary completion
2024-12-19
Completion
2025-06-01

Outcome

Met primary endpoint

registry analysis (other test); Phase 2: TMS and PAT; p <0.001; Mean Difference (Final Values) 7.5; ANOVA; note: a priori threshold was p\<.05 NCT05487885 ↗

registry analysis (other test); Phase 2: Ketamine; p <0.005; Median Difference (Final Values) 4.2; ANOVA NCT05487885 ↗

Publications

Drugs

EvaluationDrugModalityDoseRoute
Subject Ketamine Small molecule 0.5 mg/kg Intravenous