Bupropion for Depression

Overseen By Tendai Merriweather

Age: < 18

Sex: Any

Trial Phase: Phase 4

Sponsor: Bausch Health Americas, Inc.

Prior Safety Data This treatment has passed at least one previous human trial

Compensation: Varies

Number of Visits: Unknown

Duration: 2 years

200 Participants Needed

Trial Summary

What is the purpose of this trial?

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.

Will I have to stop taking my current medications?

The trial information does not specify whether you need to stop taking your current medications. It's best to discuss this with the study coordinator or your doctor.

What data supports the effectiveness of the drug Bupropion Hydrobromide for depression?

Research shows that Bupropion is significantly more effective than a placebo in reducing symptoms of depression, with improvements seen as early as 5 days into treatment. It is also well-tolerated, with side effects similar to those of a placebo. ^{1 2 3 4 5}

Is bupropion safe for humans?

Bupropion has been shown to be generally safe in humans, with side effects similar to a placebo in several studies. The most common mild side effect reported was dry mouth, and the only significant adverse reaction noted was the potential for seizures, which is comparable to other antidepressants. ^{2 3 6 7 8}

How does the drug Bupropion Hydrobromide differ from other depression treatments?

Bupropion Hydrobromide is unique because it works by inhibiting the reuptake of norepinephrine and dopamine, which are chemicals in the brain that affect mood, unlike many other antidepressants that primarily target serotonin. It is also associated with fewer side effects like weight gain and sexual dysfunction compared to some other antidepressants. ^{1 2 6 9 10}

Research Team

Johnson Varughese

Principal Investigator

Bausch Health Americas, Inc.

Eligibility Criteria

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.

Inclusion Criteria

I have been experiencing a depressive episode for at least 4 weeks.

Total CDRS-R raw score ≥45 at both the Screening and Baseline Visits (Visits 1 and 2)

CGI-S score of ≥4 at the Baseline Visit (Visit 2)

Exclusion Criteria

My body weight is within the normal range for my age.

My heart test or physical exam showed something unusual.

Unable to understand and communicate effectively with parent, Investigator, and study coordinator

Timeline

Screening

Participants are screened for eligibility to participate in the trial

2-4 weeks

Treatment

Participants receive either bupropion hydrobromide or placebo in a double-blind manner

2 years

Follow-up

Participants are monitored for safety and effectiveness after treatment

4-8 weeks

Treatment Details

Interventions

• Bupropion Hydrobromide
• Placebo

Trial Overview 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.

Participant Groups

Group I: bupropion hydrobromide Experimental Treatment 1 Intervention

study drug

Group II: placebo Placebo Group 1 Intervention

placebo

Who Is Running the Clinical Trial?

Bausch Health Americas, Inc.

Lead Sponsor

Trials

265

Recruited

82,000+

Dr. Jonathan Sadeh

Bausch Health Americas, Inc.

Chief Medical Officer

MD from Mount Sinai School of Medicine, MSc in Clinical Research from Harvard Medical School

Thomas J. Appio

Bausch Health Americas, Inc.

Chief Executive Officer since 2021

Bachelor's degree in Biology from Rutgers University

Findings from Research

Bupropion is an effective antidepressant that is well-tolerated, showing superior efficacy compared to placebo in clinical trials involving doses of 300-750 mg/d.

It has a safety profile that is favorable compared to traditional antidepressants like amitriptyline and imipramine, with the main risk being seizure induction, which occurs at a frequency similar to imipramine.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Bupropion hydrochloride. Dufresne, RL., Weber, SS., Becker, RE.[2019]

Bupropion (Wellbutrin) was evaluated in four double-blind, placebo-controlled trials involving 360 participants, demonstrating minimal adverse events associated with its use.

The adverse events correlated well with the known pharmacological properties of bupropion, indicating a favorable safety profile for this novel antidepressant.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Methodologic approach to adverse events applied to bupropion clinical trials. Cato, AE., Cook, L., Starbuck, R., et al.[2013]

Wellbutrin (bupropion) shows potential genotoxic effects in cultured human peripheral blood lymphocytes, indicating it may cause chromosomal damage in vitro.

Despite these findings, the study suggests that the cytogenetic effects of Wellbutrin are unlikely to occur in actual patients, implying a safety margin when used as an antidepressant.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Assessment of Potential In vitro Genotoxic and Cytotoxic Effects of Bupropion Hydrochloride (Wellbutrin) in Human Peripheral Lymphocytes and Human Cortical Neuron. Bhattacharya, SK., Nathawat, LS., Damani, P., et al.[2021]

References

1. United States pubmed.ncbi.nlm.nih.gov

The use of bupropion in hospitalized depressed patients. [2013]

2. United States pubmed.ncbi.nlm.nih.gov

Bupropion in depression: a tri-center placebo-controlled study. [2013]

3. United States pubmed.ncbi.nlm.nih.gov

Review of placebo-controlled trials with bupropion. [2013]

4. Australia pubmed.ncbi.nlm.nih.gov

Bupropion for adults with attention-deficit hyperactivity disorder: meta-analysis of randomized, placebo-controlled trials. [2022]

5. United States pubmed.ncbi.nlm.nih.gov

A fixed-dose (300 mg) efficacy study of bupropion and placebo in depressed outpatients. [2013]

6. United States pubmed.ncbi.nlm.nih.gov

Bupropion hydrochloride. [2019]

7. United States pubmed.ncbi.nlm.nih.gov

Methodologic approach to adverse events applied to bupropion clinical trials. [2013]

8. United States pubmed.ncbi.nlm.nih.gov

A multicenter evaluation of the efficacy and safety of 150 and 300 mg/d sustained-release bupropion tablets versus placebo in depressed outpatients. [2019]

9. India pubmed.ncbi.nlm.nih.gov

Assessment of Potential In vitro Genotoxic and Cytotoxic Effects of Bupropion Hydrochloride (Wellbutrin) in Human Peripheral Lymphocytes and Human Cortical Neuron. [2021]

10. New Zealand pubmed.ncbi.nlm.nih.gov

Bupropion: a review of its use in the management of major depressive disorder. [2022]