Efficacy and Safety of Bupropion Hydrobromide in Adolescents and Children With Major Depressive Disorder
For patients and families
In plain language
An automatic summary of structured registry data. It is an orientation aid, not a substitute for the official protocol or a physician assessment.
- What is being studied
- The protocol lists: bupropion hydrobromide, Placebo.
- Who it may be relevant to
- Registry conditions: Major Depressive Disorder. Basic parameters: 7 years — 17 years · All.
- What needs checking
- Age, condition and sex are only basic indicators. Prior treatment, laboratory values and other mandatory requirements appear in the eligibility criteria below.
- Where it takes place
- Center list to be confirmed — check the primary protocol.
- Next step
- Save the trial, show it to the treating physician, and confirm current recruitment with the study center. Costs, documents and travel →
Unsure about the terms? Read our patient guide →
Official title
A Double-Blind, Placebo-Controlled, Multicenter Study of Efficacy and Safety of Bupropion Hydrobromide in Adolescents and Children With Major Depressive Disorder
Overview
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
- Drug bupropion hydrobromide
study drug - Drug Placebo
placebo arm
Primary outcome measures
- Mean change from Baseline to EOT in total CDRS-R (raw) score [Time frame: Baseline and 2 years]
Eligibility criteria
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.
Criteria are shown verbatim from the registry (in English). Final eligibility is always assessed by the study center.
Healthy volunteers: No
Study design
- Allocation
- Randomized
- Model
- Single group
- Masking
- Quadruple blind
- Primary purpose
- Treatment
Study locations
Center list to be confirmed — check the primary protocol.
Identifiers
NCT: NCT02129751 · V01-BUPA-401