CI

At a glance

ClinicalIndex Comparison Record
N/ACompleted· 2,162 enrolled
Drug / intervention
Fluoxetine +1 moredrug
Likely dose
Not stated in record
Structured eligibility isn't available for this trial yet — see the full criteria in the Eligibility tab below.

Standardized by ClinicalIndex from the ClinicalTrials.gov record · verify against the source.

Search/NCT03466346
NCT03466346N/ACompleted

A Sequential, Multiple Assignment Randomized Trial (SMART) for Non-specialist Treatment of Common Mental Disorders in Kenya: Leveraging the Depression And Primary-care Partnership for Effectiveness-implementation Research (DAPPER) Project

University of California, San Francisco·interventional·Posted Mar 15, 2018·Updated Dec 2, 2025

In Brief

A clinical study evaluating Fluoxetine and Interpersonal Psychotherapy for Depression, Unipolar and 2 related conditions. Completed, enrolled 2,162 participants across 3 sites.

Detailed Summary

Despite carrying the vast majority of the global mental disorder burden, 75% of adults with mental disorders in Low and Middle Income Countries have no access to services. This study will test strategies for integrating first and second line evidence-based depression and trauma-related disorder treatments with primary care services at a large public sector hospital and conduct robust cost and cost-benefit analyses of each treatment to produce a "menu" of cost-benefit options for personalized, integrated mental health care with corresponding effectiveness and implementation values.

Study Details

Timeline

N/ACompletedFinished
201820192020202120222023202420252026
First PostedMar 15, 2018
Enrollment StartAug 31, 2020
Primary CompletionMay 6, 2024
TodayJul 2, 2026
Enrollment to primary: 3.7 yearsPosted 8.3 years ago

Interventions

Fluoxetinedrug

Fluoxetine is a selective serotonin reuptake inhibitor that is FDA approved for the treatment of depression. Compared to placebo, fluoxetine is more likely to produce symptom response for MDD. Despite the interim development of many other antidepressants since the development of fluoxetine, it remains a first line treatment for depression.

Interpersonal Psychotherapybehavioral

IPT was developed in the 1980s by Gerald Klerman and Myrna Weissman to address interpersonal issues in depression. IPT is now considered evidence-based, first-line treatment for depression. IPT improves symptoms by addressing problems in social relationships. IPT is traditionally delivered as weekly one-hour sessions over 12 weeks, focused on one interpersonal problem area.