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Antidepressant

Bupropion for Depression

Phase 4
Waitlist Available
Research Sponsored by Bausch Health Americas, Inc.
Eligibility Criteria Checklist
Specific guidelines that determine who can or cannot participate in a clinical trial
Must have
Current depressive episode of at least 4 weeks' duration as noted in the subject's history (Screening Visit 1)
Be younger than 18 years old
Must not have
Body weight less than the 3rd percentile or greater than the 97th percentile for age
ECG or physical examination abnormality at screening
Timeline
Screening 3 weeks
Treatment Varies
Follow Up baseline and 2 years
Awards & highlights
Pivotal Trial
Drug Has Already Been Approved

Summary

This trial tests a new treatment for children with depression. The effectiveness is measured by changes in depression symptoms. Fluoxetine has been shown to be effective in treating major depressive disorder in children and adolescents.

Who is the study for?
This trial is for boys and girls aged 7 to under 18 with Major Depressive Disorder (MDD), as defined by the DSM IV-TR, experiencing a depressive episode lasting at least 4 weeks. They must have specific scores on depression rating scales and give consent along with their parents. It's not for those who've attempted suicide, have certain medical conditions or abnormal ECGs, are outside the normal weight range for their age, pregnant or breastfeeding, or have seizure disorders.
What is being tested?
The study tests Bupropion Hydrobromide's effectiveness and safety in treating children and adolescents' depression compared to a placebo. Participants won't know which treatment they're getting in this double-blind study conducted across multiple centers.
What are the potential side effects?
Bupropion Hydrobromide may cause headaches, stomach pain, sleep disturbances, agitation or anxiety; more rarely seizures. Side effects can vary widely between individuals.

Eligibility Criteria

Inclusion Criteria

You may be eligible if you check “Yes” for the criteria below
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I have been experiencing a depressive episode for at least 4 weeks.

Exclusion Criteria

You may be eligible for the trial if you check “No” for criteria below:
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My body weight is within the normal range for my age.
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My heart test or physical exam showed something unusual.
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I have trouble swallowing pills.
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I have a history of seizures or head trauma.

Timeline

Screening ~ 3 weeks
Treatment ~ Varies
Follow Up ~baseline and 2 years
This trial's timeline: 3 weeks for screening, Varies for treatment, and baseline and 2 years for reporting.

Treatment Details

Study Objectives

Study objectives can provide a clearer picture of what you can expect from a treatment.
Primary study objectives
Mean change from Baseline to EOT in total CDRS-R (raw) score

Awards & Highlights

Pivotal Trial
The final step before approval, pivotal trials feature drugs that have already shown basic safety & efficacy.
Drug Has Already Been Approved
The FDA has already approved this drug, and is just seeking more data.

Trial Design

2Treatment groups
Experimental Treatment
Placebo Group
Group I: bupropion hydrobromideExperimental Treatment1 Intervention
study drug
Group II: placeboPlacebo Group1 Intervention
placebo

Research Highlights

Information in this section is not a recommendation. We encourage patients to speak with their healthcare team when evaluating any treatment decision.
Mechanism Of Action
Side Effect Profile
Prior Approvals
Other Research
The most common treatments for depression include pharmacotherapy, such as selective serotonin reuptake inhibitors (SSRIs), and psychotherapy, such as cognitive-behavioral therapy (CBT). SSRIs work by increasing the levels of serotonin in the brain, which can help improve mood and emotional stability. CBT helps patients identify and change negative thought patterns and behaviors that contribute to their depression. Exercise is also recommended as it can enhance mood through the release of endorphins and improve overall physical health. Understanding these mechanisms is crucial for patients as it helps them make informed decisions about their treatment options and manage their expectations regarding the outcomes.
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Find a Location

Who is running the clinical trial?

Bausch Health Americas, Inc.Lead Sponsor
262 Previous Clinical Trials
81,716 Total Patients Enrolled
Johnson VarugheseStudy DirectorBausch Health Americas, Inc.
13 Previous Clinical Trials
3,614 Total Patients Enrolled

Media Library

Bupropion Hydrobromide (Antidepressant) Clinical Trial Eligibility Overview. Trial Name: NCT02129751 — Phase 4
Depression Research Study Groups: placebo, bupropion hydrobromide
Depression Clinical Trial 2023: Bupropion Hydrobromide Highlights & Side Effects. Trial Name: NCT02129751 — Phase 4
Bupropion Hydrobromide (Antidepressant) 2023 Treatment Timeline for Medical Study. Trial Name: NCT02129751 — Phase 4
~80 spots leftby Dec 2025
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