Efficacy and Safety of Bupropion Hydrobromide in Adolescents and Children With Major Depressive Disorder
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|ClinicalTrials.gov Identifier: NCT02129751|
Recruitment Status : Not yet recruiting
First Posted : May 2, 2014
Last Update Posted : January 18, 2019
|Condition or disease||Intervention/treatment||Phase|
|Major Depressive Disorder||Drug: bupropion hydrobromide Drug: Placebo||Phase 4|
- 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 (Clinical Trial)|
|Estimated Enrollment :||200 participants|
|Intervention Model:||Single Group Assignment|
|Masking:||Quadruple (Participant, Care Provider, Investigator, Outcomes Assessor)|
|Official Title:||A Double-Blind, Placebo-Controlled, Multicenter Study of Efficacy and Safety of Bupropion Hydrobromide in Adolescents and Children With Major Depressive Disorder|
|Estimated Study Start Date :||December 2019|
|Estimated Primary Completion Date :||November 2020|
|Estimated Study Completion Date :||March 2021|
Experimental: bupropion hydrobromide
Drug: bupropion hydrobromide
Other Name: Aplenzin
Placebo Comparator: placebo
- Mean change from Baseline to EOT in total CDRS-R (raw) score [ Time Frame: 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.
To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.
Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT02129751
|Contact: Denise Raimondo||908 firstname.lastname@example.org|
|United States, New Jersey|
|Valeant||Not yet recruiting|
|Bridgewater, New Jersey, United States, 08807|
|Principal Investigator: not available not available, MD|
|Study Director:||Johnson Varughese||Bausch Health Americas, Inc.|