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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
Timeline
Screening 3 weeks
Treatment Varies
Follow Up baseline and 2 years
Awards & highlights

Study Summary

This trial is designed to test the safety and effectiveness of a new medication by comparing it to a placebo. The trial will involve multiple centers and neither the participants nor the researchers will know who is receiving the new medication or the placebo.

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.Check my eligibility
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.See study design
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
Select...
I have been experiencing a depressive episode for at least 4 weeks.

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

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

Trial Design

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

Find a Location

Who is running the clinical trial?

Bausch Health Americas, Inc.Lead Sponsor
262 Previous Clinical Trials
81,828 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

Frequently Asked Questions

These questions and answers are submitted by anonymous patients, and have not been verified by our internal team.

Does this clinical experiment accept new participants?

"As indicated on clinicaltrials.gov, this medical experiment is no longer actively recruiting patients as it was last updated in February of 2022. However, a plethora of other studies are currently looking for participants to join their trial with 1326 opportunities available at present."

Answered by AI

Has bupropion hydrobromide been ratified by the FDA?

"Our assessment of bupropion hydrobromide's safety has resulted in a score of 3; this is because Phase 4 trials are usually conducted to confirm the efficacy and safety of medications that have already been approved by regulatory bodies."

Answered by AI

Are there any specific qualifications for a person to join this clinical study?

"This medical study is seeking 200 adolescents aged 7 to 17 years old with melancholia. To be eligible, candidates must be male or female outpatients with a minimum 4-week history of depression (as determined by CDRS-R raw score ≥45 at Screening and Baseline Visits), plus a CGI-S score of ≥4 at the Baseline Visit."

Answered by AI

Does this investigation accept participation from those over the age of seventy?

"As indicated by the stipulations of this clinical trial, only those aged between 7 and 17 are eligible to participate. Moreover, there exist 193 studies for minors and 994 for seniors."

Answered by AI

Have there been any other investigations pertaining to bupropion hydrobromide?

"At present, 31 trials are researching bupropion hydrobromide. 10 of these studies have progressed to Phase 3. Although most of the research is undertaken in New Haven, Connecticut, there are 283 sites actively running these clinical tests for this pharmaceutical treatment."

Answered by AI

What conditions can bupropion hydrobromide be used to treat?

"Bupropion hydrobromide is regularly prescribed to treat seasonal affective disorder. In addition, it can prove efficacious in managing smoking cessation and the associated symptoms of smoke-related diseases."

Answered by AI

How many individuals are enrolled in the current clinical trial?

"Recruitment for this clinical trial has concluded. The study was initially posted on October 1st 2022 and the latest update happened February 23rd of that same year. If you're in search of an alternate medical research opportunity, 1295 trials related to melancholia and 31 studies involving bupropion hydrobromide are actively enrolling participants."

Answered by AI

Who else is applying?

What site did they apply to?
Valeant
What portion of applicants met pre-screening criteria?
Met criteria
Recent research and studies
clinicaltrials.govStudy
Efficacy and Safety of Bupropion Hydrobromide in Adolescents and Children With Major Depressive Disorder
2023. "Efficacy and Safety of Bupropion Hydrobromide in Adolescents and Children With Major Depressive Disorder". ClinicalTrials.gov. https://clinicaltrials.gov/ct2/show/NCT02129751.
All > Mdd > Wellbutrin
~71 spots leftby Nov 2024
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