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New study aims to bring depression and PTSD treatment to millions in kenya

NCT ID NCT03466346

Disease control Sponsor: University of California, San Francisco Source: ClinicalTrials.gov ↗

What the study statuses mean

This study's is highlighted.

Recruitment status, easiest to join first

Recruiting now
This trial is taking on new participants right now.
Not yet recruiting
Registered, but not yet taking participants.
By invitation only
Not open to general applications. Only people the study team invites can take part.
Paused
Paused for now. It may or may not start again.
Ongoing
Running, but no longer taking on new participants.
Completed This study
The trial has finished. Results may not be published yet.
Stopped early
Stopped early, before it reached the end. That can be for many reasons, including safety.
Cancelled
Cancelled before anyone took part.

Expanded access (not trials)

Expanded access
Not a trial. This treatment can be requested outside a study, case by case, for people who qualify.
Expanded access (paused)
Not a trial. The treatment can normally be requested outside a study, but is unavailable right now.
Expanded access (ended)
Not a trial. The treatment could once be requested outside a study, but no longer can.
Approved
The treatment has been approved, so it is available normally rather than through this programme.

When the status isn't known

Details not published
The full record has not been published yet, so there is little to show here.
Status unknown
This status has not been confirmed recently, so it may be out of date.

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

Summary

This study tested two common treatments for depression and PTSD—talk therapy (IPT) and an antidepressant (fluoxetine)—in a large public hospital in Kenya. Over 2,100 adults participated to see if these treatments could be effectively delivered by non-specialists in primary care. The goal was to find affordable, practical ways to help people with mental health issues in low-resource settings.

What this could mean

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

Active substance
Fluoxetine (antidepressant medication) and Interpersonal Psychotherapy (talk therapy)
What this could lead to
If successful, this could show that combining simple treatments like therapy and medication works well for depression and PTSD in places with few mental health specialists.
What could go wrong
This study is already completed, so results are known. However, the treatments may not work for everyone, and access to ongoing care could still be a challenge in real-world settings.

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

2,162 people

The number who actually took part.

Started

Aug 2020

Finished

May 2024

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: 1. Kisumu County Hospital (KCH) adult primary care outpatient clinic attendees who screen positive for depression and/or PTSD 2. Ability to attend weekly IPT sessions/fluoxetine monitoring; (3) 18 years or older Exclusion Criteria: 1. Cognitive dysfunction compromising ability to participate in IPT or accurately take fluoxetine (lack of orientation to person, place, time and situation) 2. acute suicidality requiring higher level of care 3. drug/alcohol use disorders requiring substance use treatment (AUDIT score of 8 or higher, DAST score of 3 or higher) 4. history of mania or requiring treatment for hypomania 5. Outside mental health treatment during the study treatment phases (any mental health treatment is allowed during follow-up phases and is recorded by study team).

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Conditions

The condition(s) this trial relates to.

depressive disorder injury major depressive disorder post-traumatic stress disorder

As listed by the trial registrant

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

Depression, unipolar Posttraumatic stress disorder Trauma

Contacts and locations

Locations

  • Jaramogi Oginga Odinga Teaching and Referral Hospital (JOOTRH)

    Kisumu, Kenya

  • Kisumu County Hospital

    Kisumu, Kenya

  • Lumumba Health Center

    Kisumu, Kenya

More trials for these conditions

Other studies related to the condition(s) this trial covers.