Efficacy and Safety of Bupropion Hydrobromide in Adolescents and Children With Major Depressive Disorder

NCT02129751 | Not Yet Recruiting Phase 4 FDA Drug

• 1 other identifier: V01-BUPA-401
• Study Type: interventional
• Target: 246
• Locations: 0 countries
• Sites: N/A

Brief Summary

Double-Blind, Placebo-Controlled, Multicenter Study of Efficacy and Safety

Conditions

Major Depressive Disorder

Keywords

able to swallow medications without difficulty; bupropion hydrobromide

Outcome Measures

Primary Outcomes (1)

• Mean change from Baseline to EOT in total CDRS-R (raw) score

  Change from Baseline to EOT in total Children's Depression Rating Scale - Revised (CDRS-R). A higher score indicates a more profound state of depression. The interviewer rates 17 symptom areas; the symptom scores are summed to generate a total score. The total score ranges from 17 to 108.

  Baseline and 2 years

Study Arms (2)

bupropion hydrobromide

EXPERIMENTAL

study drug

Drug: bupropion hydrobromide

placebo

PLACEBO COMPARATOR

placebo

Drug: Placebo

Interventions

bupropion hydrobromide DRUG

study drug

Also known as: Aplenzin

bupropion hydrobromide

Placebo DRUG

placebo arm

placebo

Eligibility Criteria

• Age: 7 Years - 17 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Child (0-17)

You may qualify if:

• 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).

You may not qualify if:

• 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.

Sponsors & Collaborators

• Bausch Health Americas, Inc.: lead

MeSH Terms

Conditions

Depressive Disorder, Major

Interventions

Bupropion

Condition Hierarchy (Ancestors)

Depressive Disorder; Mood Disorders; Mental Disorders

Intervention Hierarchy (Ancestors)

Propiophenones; Ketones; Organic Chemicals

Study Officials

• Varsha Bhatt

  Bausch Health

  STUDY DIRECTOR

Central Study Contacts

Jessica Ferrigno

CONTACT

520-246-8205; jessica.ferrigno@bauschhealth.com

Study Design

• Study Type: interventional
• Phase: phase 4
• Allocation: RANDOMIZED
• Masking: QUADRUPLE
• Who Masked: PARTICIPANT, CARE PROVIDER, INVESTIGATOR, OUTCOMES ASSESSOR
• Purpose: TREATMENT
• Intervention Model: SINGLE GROUP
• Sponsor Type: INDUSTRY
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: April 30, 2014
• First Posted: May 2, 2014
• Study Start (Estimated): June 1, 2026
• Primary Completion (Estimated): July 1, 2029
• Study Completion (Estimated): December 1, 2029
• Last Updated: September 17, 2025

Record last verified: 2025-09