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New hope for young minds: depression drug trial for children

NCT ID NCT02129751

Symptom relief Sponsor: Bausch Health Americas, Inc. 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 This study
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
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 Results may not be published yet.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This status has not been confirmed recently, so it may be out of date.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 25, 2026 · Last updated Jun 26, 2026 · Updated 1 time

Summary

This study tests whether bupropion hydrobromide (Aplenzin) can safely ease depression symptoms in children and adolescents aged 7 to 17. About 246 participants will receive either the drug or a placebo. The main goal is to see if depression scores improve by the end of treatment.

What this could mean

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

Active substance
bupropion hydrobromide (Aplenzin)
What this could lead to
If successful, this could provide a new treatment option for depression in children and adolescents.
What could go wrong
This is a Phase 4 trial, but results may not apply to all ages or severities. Side effects like seizures or mood changes are possible.

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 4

Runs after approval, following long-term safety and how well the treatment works in everyday use.

Participants

About 246 people

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

Expected to start

Jun 2026

An estimate. Start dates often move.

Expected to finish

Dec 2029

An estimate. End dates often move.

Lead sponsor

A company

The lead sponsor is a pharmaceutical, biotech, or medical-device company.

Who can take part

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

Ages

7 to 17 years

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: * Male or female outpatients aged ≥7 to \<18 years (at Screening Visit 1). * Provide assent (subject) and written informed consent (parent/legal representative) and Health Insurance Portability and Accountability Act (HIPAA) for study participation (at Screening Visit 1). * Meet diagnostic criteria for MDD as defined in the DSM IV-TR5 at Screening Visits 1 and 1a (K-SADS-PL; see Appendix 17.2). * Current depressive episode of at least 4 weeks' duration as noted in the subject's history (Screening Visit 1). * Total CDRS-R raw score ≥45 at both the Screening and Baseline Visits (Visits 1 and 2) (see Appendix 17.3). * CGI-S score of ≥4 at the Baseline Visit (Visit 2) (see Appendix 17.4). Exclusion Criteria: * are unable to swallow medications without difficulty * have known hypersensitivity to bupropion hydrobromide * are pregnant or planning to get pregnant or are lactating * Women of childbearing age unable to use at least one method of effective contraception for the duration of the study * Previous history of attempted suicide * are unable to understand and communicate effectively with parent, Investigator, and study coordinator * are at immediate risk of requiring hospitalization, in the Investigator's opinion * have current seizure disorder or history of seizures or head trauma * have history or presence of clinically significant medical conditions or clinically important laboratory abnormalities * have ECG or physical examination abnormality at screening * have body weight less than the 3rd percentile or greater than the 97th percentile for age.

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Conditions

The condition(s) this trial relates to.

major depressive disorder

As listed by the trial registrant

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

Major depressive disorder

How to take part

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

  1. 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 ↗

  2. 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.

More trials for these conditions

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