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

Phase 4

Not yet recruiting

• Conditions: Major Depressive Disorder
• Interventions: Drug: bupropion hydrobromide; Drug: Placebo

• Registration Number: NCT02129751
• Lead Sponsor: Bausch Health Americas, Inc.

Brief Summary

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

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 Timeline

• Study First Submitted: 2014-04-30
• Study First Submitted QC: 2014-05-01
• Study First Posted: 2014-05-02
• Status Verified: 2023-02
• Last Update Submitted: 2023-02-06
• Last Update Posted: 2023-02-08
• Study Start: 2023-06
• Primary Completion: 2024-11
• Study Completion: 2024-11

Recruitment & Eligibility

• Status: NOT_YET_RECRUITING
• Sex: All
• Target Recruitment: 200

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 & Design

• Study Type: INTERVENTIONAL
• Study Design: SINGLE_GROUP

Arm && Interventions

Group	Intervention	Description
bupropion hydrobromide	bupropion hydrobromide	study drug
placebo	Placebo	placebo

Primary Outcome Measures

Name	Time	Method
Mean change from Baseline to EOT in total CDRS-R (raw) score	Baseline and 2 years	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.

Trial Locations

Locations (1)

Valeant; 🇺🇸 Bridgewater, New Jersey, United States