Clinical trial NCT02129751: Efficacy and Safety of Bupropion Hydrobromide in Adolescents and Children With Major Depressive Disorder
Official title: A Double-Blind, Placebo-Controlled, Multicenter Study of Efficacy and Safety of Bupropion Hydrobromide in Adolescents and Children With Major Depressive Disorder
Study type: INTERVENTIONAL
Overall status: UNKNOWN
Phase: PHASE4
Conditions: Major Depressive Disorder
Keywords: able to swallow medications without difficulty
bupropion hydrobromide
Lead sponsor: Bausch Health Americas, Inc.
Sponsor class: INDUSTRY
First posted: 2014-05-02
Enrollment: 200
Sex: ALL
Minimum age (years): 7
Maximum age (years): 17
Standard ages: CHILD
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: SINGLE_GROUP
Primary purpose: TREATMENT

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.

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.

Primary outcomes:
measure: Mean change from Baseline to EOT in total CDRS-R (raw) score
timeFrame: Baseline and 2 years
Secondary outcomes:
Other outcomes:
Locations:
city: Bridgewater
country: United States
facility: Valeant
state: New Jersey
Study officials:
affiliation: Bausch Health Americas, Inc.
name: Johnson Varughese
role: STUDY_DIRECTOR
References: