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

February 6, 2023 updated by: Bausch Health Americas, Inc.

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

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

Study Overview

Status

Not yet recruiting

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.

Study Type

Interventional

Enrollment (Anticipated)

200

Phase

  • Phase 4

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Contact

Study Locations

    • New Jersey
      • Bridgewater, New Jersey, United States, 08807
        • Valeant
        • Principal Investigator:
          • not available not available, MD

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

7 years to 17 years (CHILD)

Accepts Healthy Volunteers

No

Genders Eligible for Study

All

Description

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.

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Primary Purpose: TREATMENT
  • Allocation: RANDOMIZED
  • Interventional Model: SINGLE_GROUP
  • Masking: QUADRUPLE

Arms and Interventions

Participant Group / Arm
Intervention / Treatment
PLACEBO_COMPARATOR: placebo
placebo arm
EXPERIMENTAL: bupropion hydrobromide
study drug
study drug
Other Names:
  • Aplenzin

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Measure Description
Time Frame
Mean change from Baseline to EOT in total CDRS-R (raw) score
Time Frame: 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.
Baseline and 2 years

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start (ANTICIPATED)

June 1, 2023

Primary Completion (ANTICIPATED)

November 1, 2024

Study Completion (ANTICIPATED)

November 1, 2024

Study Registration Dates

First Submitted

April 30, 2014

First Submitted That Met QC Criteria

May 1, 2014

First Posted (ESTIMATE)

May 2, 2014

Study Record Updates

Last Update Posted (ACTUAL)

February 8, 2023

Last Update Submitted That Met QC Criteria

February 6, 2023

Last Verified

February 1, 2023

More Information

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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