drugset / Trial / NCT06153004
OptimizeD Pilot Study
Phase 3
Completed
76 enrolled
Harvard Medical School (HMS and HSDM)
All India Institute of Medical Sciences, Bhopal · collabBrigham and Women's Hospital · collabCentre for Addiction and Mental Health · collabHarvard School of Public Health (HSPH) · collabMassachusetts General Hospital · collabNational Institute of Mental Health (NIMH) · collabSangath · collabVanderbilt University · collab
RandomizedParallel-groupSingle-blindTreatment
Summary
This pilot study aims to explore and refine the trial procedures that will be implemented in a larger-scale clinical trial scheduled to commence in March 2024 (NCT05944926). As part of this study, 60 patients with moderate to severe depression will be randomized to either psychotherapy based on behavioral activation called the Healthy Activity Program (HAP) or antidepressant medication. The pilot study has two primary objectives: 1. Evaluate the feasibility and acceptability of the study 2. Collect essential outcome data in preparation for the larger trial
Timeline
- Start
- 2023-08-01
- Primary completion
- 2024-03-10
- Completion
- 2024-03-31
Drugs
| Evaluation | Drug | Modality | Dose | Route |
|---|---|---|---|---|
| Subject | Escitalopram | Small molecule | — | — |
| Subject | Fluoxetine | Small molecule | 20 mg | — |
| Subject | Fluoxetine | Small molecule | 40 mg | — |