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

A Double-Blind, Placebo-Controlled, Multicenter Study of Efficacy and Safety of Bupropion Hydrobromide in Adolescents and Children With Major Depressive Disorder

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

Study Overview

• Status: Not yet recruiting
• Conditions: Major Depressive Disorder
• Intervention / Treatment: Drug: Placebo; Drug: bupropion hydrobromide

Detailed Description

• The primary efficacy endpoint is the mean change from Baseline to EOT in total CDRS-R (raw) score.

• The secondary efficacy endpoints include:

  • Proportion of subjects characterized as responders at EOT (≥40% improvement from Baseline total CDRS-R raw score)
  • Proportion of subjects characterized as in remission at EOT (total CDRS-R raw score <29)
  • Mean change from Baseline to EOT in CGI-C.

Safety endpoints include:

• Incidence of AEs
• Change from Baseline to EOT in vital signs (blood pressure and radial pulse rate), blood and urine laboratory panel, and ECG
• Treatment discontinuation due to AEs
• Suicidality as assessed by the C-SSRS score
• Change from Baseline to EOT in sleep as assessed by the sleep subscale of the CDRS-R.

• Study Type: Interventional
• Enrollment (Estimated): 246
• Phase: Phase 4

Contacts and Locations

• Study Contact: Name: Jessica Ferrigno; Phone Number: 520-246-8205; Email: jessica.ferrigno@bauschhealth.com

Study Locations

• United States
  • New Jersey
    • Bridgewater, New Jersey, United States, 08807
      • Valeant
      • Principal Investigator: not available not available, MD

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 7 years to 17 years (Child)
• Accepts Healthy Volunteers: No

Description

Inclusion Criteria:

• 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).

Exclusion Criteria:

• 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.

Study Plan

How is the study designed?

Design Details

• Primary Purpose: Treatment
• Allocation: Randomized
• Interventional Model: Single Group Assignment
• Masking: Quadruple

Number of Arms

2

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
Placebo Comparator: placebo	Drug: Placebo; placebo arm
Experimental: bupropion hydrobromide; study drug	Drug: bupropion hydrobromide; study drug; Other Names: Aplenzin

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
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

Collaborators and Investigators

• Sponsor: Bausch Health Americas, Inc.
• Investigators: Study Director: Varsha Bhatt, Bausch Health

Study record dates

Study Major Dates

• Study Start (Estimated): June 1, 2026
• Primary Completion (Estimated): July 1, 2029
• Study Completion (Estimated): December 1, 2029

Study Registration Dates

• First Submitted: April 30, 2014
• First Submitted That Met QC Criteria: May 1, 2014
• First Posted (Estimated): May 2, 2014

Study Record Updates

• Last Update Posted (Estimated): September 17, 2025
• Last Update Submitted That Met QC Criteria: September 11, 2025
• Last Verified: September 1, 2025

More Information

Terms related to this study

• Keywords: able to swallow medications without difficulty; bupropion hydrobromide
• Additional Relevant MeSH Terms: Mental Disorders; Mood Disorders; Depressive Disorder; Depressive Disorder, Major; Organic Chemicals; Substandard Drugs; Pharmaceutical Preparations; Ketones; Propiophenones; Bupropion; Counterfeit Drugs
• Other Study ID Numbers: V01-BUPA-401

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: Yes
• Studies a U.S. FDA-regulated device product: No