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

Bausch Health

Status and phase: Not yet enrolling; Phase 4

Conditions: Major Depressive Disorder

Treatments: Drug: Placebo; Drug: bupropion hydrobromide

Study type: Interventional

Funder types: Industry

Identifiers

NCT02129751

V01-BUPA-401

Details and patient eligibility

About

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

Full 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.

Enrollment: 200 estimated patients

Sex: All

Ages: 7 to 17 years old

Volunteers: No Healthy Volunteers

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.

Trial design

Primary purpose: Treatment

Allocation: Randomized

Interventional model: Single Group Assignment

Masking: Quadruple Blind

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200 participants in 2 patient groups, including a placebo group

bupropion hydrobromide

Experimental group

Description:

study drug

Treatment:

Drug: bupropion hydrobromide

placebo

Placebo Comparator group

Description:

placebo

Treatment:

Drug: Placebo