Bupropion for Depression

Overseen By Jessica Ferrigno

Age: < 18

Sex: Any

Trial Phase: Phase 4

Sponsor: Bausch Health Americas, Inc.

Must not be taking: Bupropion

Disqualifiers: Seizures, Pregnancy, Suicide history, others

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

Compensation: Varies

Number of Visits: Unknown

Duration: 2 years

What You Need to Know Before You Apply

What is the purpose of this trial?

This trial aims to evaluate the effectiveness and safety of bupropion hydrobromide for treating depression. Participants will receive either the actual medication or a placebo (a pill with no active medicine) to compare results. In this double-blind trial, neither participants nor researchers know who receives the real treatment. Individuals experiencing a depressive episode for at least four weeks and diagnosed with major depressive disorder might be suitable candidates. As a Phase 4 trial, this research seeks to understand how this FDA-approved and effective treatment benefits a broader range of patients.

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 is the safety track record for Bupropion Hydrobromide?

Research shows that bupropion hydrobromide is usually well-tolerated. Common side effects, such as headache, dry mouth, and nausea, occur at similar rates to other treatments, with differences of less than 5%.

A review of a large database on drug reactions from 2004 to 2023 found that bupropion can sometimes cause mental effects like delusions and hallucinations, though these are less common.

This treatment has undergone safety checks and received FDA approval for other uses, providing some reassurance about its safety in humans. However, if symptoms worsen or thoughts of suicide arise, stopping the medication and seeking medical advice is crucial. ^{1 2 3 4 5}

Why are researchers enthusiastic about this study treatment?

Unlike the standard antidepressants, which often target serotonin or norepinephrine, Bupropion Hydrobromide primarily acts on dopamine and norepinephrine pathways. This unique mechanism can be especially beneficial for individuals who haven't responded well to typical SSRI or SNRI medications. Additionally, Bupropion is known for having a lower risk of sexual side effects, which is a common concern with many other antidepressants. Researchers are excited about its potential to offer a different option for those struggling with depression, particularly for patients seeking alternatives due to side effects or lack of efficacy from existing treatments.

What is the effectiveness track record for Bupropion Hydrobromide in treating depression?

Research has shown that bupropion hydrobromide, which participants in this trial may receive, effectively treats depression. Studies indicate it lowers depression scores in most trials and works as well as other depression treatments. Bupropion has also helped people who haven't improved with other medications, easing their depressive symptoms. With its proven track record, it serves as a reliable option for major depressive disorder. ^{2 5 6 7 8}

Who Is on the Research Team?

Varsha Bhatt

Principal Investigator

Bausch Health

Are You a Good Fit for This Trial?

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.

I am between 7 and 17 years old.

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)

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 for a Trial Participant

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

What Are the Treatments Tested in This Trial?

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.

How Is the Trial Designed?

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

Published Research Related to This Trial

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]

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]

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]

Citations

1.

pmc.ncbi.nlm.nih.gov

pmc.ncbi.nlm.nih.gov/articles/PMC4837968/

Bupropion: a systematic review and meta-analysis of ...

Bupropion was efficacious in reducing depression scores in 24 of the 27 trials, and, where evaluated, showed comparable levels of efficacy to the other classes ...

2.

pubmed.ncbi.nlm.nih.gov

pubmed.ncbi.nlm.nih.gov/18547129/

Spotlight on bupropion in major depressive disorder

Available clinical data suggest that bupropion is an effective and generally well tolerated option in the treatment of MDD.

3.

psychiatryadvisor.com

psychiatryadvisor.com/features/bupropion-for-treatment-resistant-depression/

Bupropion for Treatment-Resistant Depression

There was a significant improvement in depressive symptoms, as shown by a decrease in PHQ-9 scores from a mean (SD) of 15.3 (5.3) prior to the ...

4.

clinicaltrials.gov

clinicaltrials.gov/study/NCT02129751?term=AREA%5BConditionSearch%5D(Depressive%20Disorder,%20Major)%20AND%20AREA%5BBasicSearch%5D(Bupropion)&rank=8

Efficacy and Safety of Bupropion Hydrobromide in ...

Efficacy and Safety of Bupropion Hydrobromide in Adolescents and Children With Major Depressive Disorder. ClinicalTrials.gov ID NCT02129751. Sponsor ...

5.

aplenzin.com

aplenzin.com/hcp/data/

Clinical Experience in MDD & SAD for Healthcare ...

Depressed patients treated with bupropion have had a variety of neuropsychiatric signs and symptoms, including delusions, hallucinations, psychosis, ...

6.

ncbi.nlm.nih.gov

ncbi.nlm.nih.gov/books/NBK470212/

Bupropion - StatPearls - NCBI Bookshelf - NIH

If symptoms worsen or overt suicidality ensues, the clinician should stop therapy.[54] In December 2016, researchers released a safety review; data from a large ...

7.

sciencedirect.com

sciencedirect.com/science/article/pii/S0149291800883010

Safety profile of sustained-release bupropion in depression

Across studies, the most frequently reported adverse events were headache, dry mouth, and nausea. The incidence of adverse events was similar (≤5% difference) ...

8.

sciencedirect.com

sciencedirect.com/science/article/abs/pii/S0165032724005081

A large-scale data analysis from the FAERS database

The study provides an in-depth assessment of Bupropion's adverse reactions, leveraging data from the FAERS database that spans 78 quarters from 2004 to 2023.