Depression breakthrough? zimbabwe trial combines therapy and pills

NCT ID NCT06384209

Disease control Sponsor: University of Bern Source: ClinicalTrials.gov ↗

First seen Jun 27, 2026 · Last updated Jun 27, 2026

Summary

This study in Zimbabwe tests whether adding antidepressants (fluoxetine or sertraline) to a proven talk therapy program (Friendship Bench) works better than talk therapy alone for adults with moderate to severe depression. About 296 participants will be randomly assigned to one of the two groups. The goal is to see if the combination leads to greater improvement in depression scores and to understand how nurses can prescribe these medications in primary care.

What this could mean

Our plain-language read of the trial. This is informational only, not medical advice or a prediction.

Active substance: Fluoxetine (or Sertraline for breastfeeding women)
What this could lead to: If it works, this could provide a more effective, scalable treatment for depression in low-resource settings by combining talk therapy with medication.
What could go wrong: This is a relatively small trial (296 people) in one country, so results may not apply everywhere. Adding medication also brings risks like side effects and the need for ongoing management.

This is an AI summary of the original study and may miss details. Read our disclaimer.

Study facts

What this study's own registry entry says, in plain language.

Phase

Not a phased trial

Phase numbers describe drug development. The registry uses this when they do not apply, as it does for trials of devices, procedures or behaviour changes, and for observational studies.

Participants

About 296 people

The number the study aims to enrol. It can still change while the study runs.

Started

Jun 2025

Expected to finish

Feb 2028

An estimate. End dates often move.

Lead sponsor

Other sponsor

The registry's catch-all category, for sponsors it does not file as a company, a government agency, or a research network.

Who can take part

This study's own entry requirements. Only the study team can say for certain whether you qualify.

Ages

18 years and older

Sex

Anyone

Healthy volunteers

Not accepted

This study is not open to healthy volunteers. The entry requirements below say who it is open to.

Show the full entry requirements

Copied word for word from the study's registry entry, so the wording is the study team's rather than ours.

Inclusion Criteria: * Adults ≥18 years * Moderate to severe depression defined as PHQ-9 ≥ 11 * Treatment naïve to the Friendship Bench intervention at the time of recruitment * Speaks English or Shona (local language) * Written informed consent Exclusion Criteria: * Mild depression defined as PHQ-9 \<11 * Psychotic symptoms (SSQ-14 probing question 5 positive and confirmation by study coordinator) * High risk of suicide according to P4 screener * Patient has received FB in the past 12 months * Patient is currently under treatment (counselling, antidepressants, followed up by a psychiatrist) * History of or presenting with end-stage AIDS * History of or presenting with kidney failure * History of or presenting with liver failure * History of or presenting with serious cardio-vascular disease (including previous heart attack, stroke or arrhythmias) * History of or presenting with cancer * Positive urine pregnancy test * Clear intention of pregnancy during the study period * Not willing to use effective contraception during study period * Unable to comprehend the nature of the study in either English or Shona (local language)

Get updates

Get notified about this study

Sign up to get updates when this study changes or when new studies for Major depressive disorder are added.

Vår säkerhetsrekommendation!

Genom att skicka in godkänner du våra Användarvillkor

Conditions

The condition(s) this trial relates to.

Depression depressive disorder major depressive disorder

As listed by the trial registrant

The condition terms exactly as the trial's registrant entered them.

Major depressive disorder Severe depressive episode without psychotic symptoms

How to take part

Only the study team decides who joins. These are the ways to reach them.

The places running it

1 site. The list below names each one and where it is.
The official record

ClinicalTrials.gov lists the study team's own contact details, including names and phone numbers. We don't republish those.

Open the record ↗
A doctor treating you

A doctor who knows your case can contact a study site on your behalf, and can tell you whether this study is worth pursuing at all.

Depression breakthrough? zimbabwe trial combines therapy and pills

What the study statuses mean