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Clinical Trial Details — Status: Not yet recruiting

Administrative data

NCT number NCT02129751
Other study ID # V01-BUPA-401
Secondary ID
Status Not yet recruiting
Phase Phase 4
First received
Last updated
Start date June 2023
Est. completion date November 2024

Study information

Verified date February 2023
Source Bausch Health Americas, Inc.
Contact Tendai Merriweather
Phone 908-541-2720
Email tendai.merriweather@bauschhealth.com
Is FDA regulated No
Health authority
Study type Interventional

Clinical Trial Summary

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


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.


Recruitment information / eligibility

Status Not yet recruiting
Enrollment 200
Est. completion date November 2024
Est. primary completion date November 2024
Accepts healthy volunteers No
Gender All
Age group 7 Years to 17 Years
Eligibility 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


Intervention

Drug:
bupropion hydrobromide
study drug
Placebo
placebo arm

Locations

Country Name City State
United States Valeant Bridgewater New Jersey

Sponsors (1)

Lead Sponsor Collaborator
Bausch Health Americas, Inc.

Country where clinical trial is conducted

United States, 

Outcome

Type Measure Description Time frame Safety issue
Primary 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
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