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

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

Detailed Description
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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.

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

Conditions
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Major Depressive Disorder

Intervention / Treatment
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* Drug: bupropion hydrobromide
* Drug: Placebo


Participation Criteria
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Eligibility Criteria
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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.

Ages Eligible for Study
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Minimum Age: 7 Years
Maximum Age: 17 Years

Sexes Eligible for Study
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All

Accepts Healthy Volunteers
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No

Study Plan
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How is the study designed?
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Design Details

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


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Experimental: bupropion hydrobromide<br>study drug | Drug: bupropion hydrobromide<br>* study drug<br>* Other names: Aplenzin;|
| Placebo Comparator: placebo<br>placebo | Drug: Placebo<br>* placebo arm<br>|

What is the study measuring?
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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 | 

 Terms related to the study
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Keywords Provided by Centre Hospitalier Valida
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able to swallow medications without difficulty, bupropion hydrobromide