Efficacy and Safety of Bupropion Hydrobromide in Adolescents and Children With Major Depressive Disorder
Last updated on July 2021Recruitment
- Recruitment Status
- Not yet recruiting
- Estimated Enrollment
- Same as current
Summary
- Conditions
- Major Depressive Disorder
- Type
- Interventional
- Phase
- Phase 4
- Design
- Allocation: RandomizedIntervention Model: Single Group AssignmentMasking: Quadruple (Participant, Care Provider, Investigator, Outcomes Assessor)Primary Purpose: Treatment
Participation Requirements
- Age
- Between 7 years and 17 years
- Gender
- Both males and females
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 re...
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.
Tracking Information
- NCT #
- NCT02129751
- Collaborators
- Not Provided
- Investigators
- Study Director: Johnson Varughese Bausch Health Americas, Inc.
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