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India study aims to match depression patients to best therapy or drug

NCT ID NCT05944926

Disease control Sponsor: Harvard Medical School (HMS and HSDM) 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 This study
Running, but no longer taking on new participants.
Completed
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 Results may not be published yet.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This status has not been confirmed recently, so it may be out of date.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 in India tests two common depression treatments—a talk therapy called the Healthy Activity Program and the antidepressant fluoxetine—in 1,500 adults with moderate to severe depression. The goal is to see which treatment works best for different people and to compare costs. Results could help doctors choose the right treatment for each patient.

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

Phase 3

Large-scale testing in a bigger group. Usually the last step before a treatment can be approved.

Participants

About 1,500 people

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

Started

Mar 2024

Expected to finish

Dec 2026

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: * Participants will be adults aged 18 or over of any gender attending one of the selected Primary Health Care Centers with a "diagnosis" of moderate to severe depression based on scores of 10 or above on the Patient Health Questionnaire-9 (PHQ-9). Exclusion Criteria: 1. Women who are pregnant or are breastfeeding or lactating 2. Patients with a history of psychosis, including schizophrenia spectrum disorders or bipolar disorder. 3. Participants planning to permanently move out of the study area during the follow-up period. 4. Patients with evidence of cognitive impairment. 5. Patients who do not speak either English or Hindi. 6. Patients who are undergoing treatment for depression at the time of recruitment or who completed treatment within one month prior to recruitment 7. Patients at imminent risk for suicide 8. Patients from households in which another member has been recruited into the study

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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.

Depression Depressive disorder

Contacts and locations

Locations

  • Sangath

    Bhopal, Madhya Pradesh, 462016, India

More trials for these conditions

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