Major Depressive Disorder
Conditions
Keywords
able to swallow medications without difficulty, bupropion hydrobromide
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.
Interventions
DRUGbupropion hydrobromide
study drug
DRUGPlacebo
placebo arm
Sponsors
Bausch Health Americas, Inc.
Study design
Allocation
RANDOMIZED
Intervention model
SINGLE_GROUP
Primary purpose
TREATMENT
Masking
QUADRUPLE (Subject, Caregiver, Investigator, Outcomes Assessor)
Eligibility
Sex/Gender
ALL
Age
7 Years to 17 Years
Healthy volunteers
No
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.
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| 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. |
Contacts
Primary ContactJessica Ferrigno
Outcome results
None listed