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

• ClinicalTrials.gov Identifier: NCT02129751
• Recruitment Status: Not yet recruiting
• First Posted: May 2, 2014
• Last Update Posted: February 8, 2023
• Sponsor: Bausch Health Americas, Inc.
• Information provided by (Responsible Party): Bausch Health Americas, Inc.

Study Description

Brief Summary:

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

Condition or disease	Intervention/treatment	Phase
Major Depressive Disorder	Drug: bupropion hydrobromide; Drug: Placebo	Phase 4

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 Design

• Study Type: Interventional (Clinical Trial)
• Estimated Enrollment: 200 participants
• Allocation: Randomized
• Intervention Model: Single Group Assignment
• Masking: Quadruple (Participant, Care Provider, Investigator, Outcomes Assessor)
• Primary Purpose: Treatment
• Official Title: A Double-Blind, Placebo-Controlled, Multicenter Study of Efficacy and Safety of Bupropion Hydrobromide in Adolescents and Children With Major Depressive Disorder
• Estimated Study Start Date: June 2023
• Estimated Primary Completion Date: November 2024
• Estimated Study Completion Date: November 2024

Arms and Interventions

Arm	Intervention/treatment
Experimental: bupropion hydrobromide; study drug	Drug: bupropion hydrobromide; study drug; Other Name: Aplenzin
Placebo Comparator: placebo; placebo	Drug: Placebo; placebo arm

Outcome Measures

Primary Outcome Measures :

1. 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.

Eligibility Criteria

• Ages Eligible for Study: 7 Years to 17 Years (Child)
• Sexes Eligible for Study: All
• Accepts Healthy Volunteers: No

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.

Contacts and Locations

Contacts

Contact: Tendai Merriweather; 908-541-2720; tendai.merriweather@bauschhealth.com

Locations

United States, New Jersey

Valeant

Bridgewater, New Jersey, United States, 08807

Principal Investigator: not available not available, MD

Sponsors and Collaborators

Bausch Health Americas, Inc.

Investigators

• Study Director: Johnson Varughese; Bausch Health Americas, Inc.

More Information

• Responsible Party: Bausch Health Americas, Inc.
• ClinicalTrials.gov Identifier: NCT02129751
• Other Study ID Numbers: V01-BUPA-401
• First Posted: May 2, 2014
• Last Update Posted: February 8, 2023
• Last Verified: February 2023

• Studies a U.S. FDA-regulated Drug Product: Yes
• Studies a U.S. FDA-regulated Device Product: No

Keywords provided by Bausch Health Americas, Inc.:

able to swallow medications without difficulty; bupropion hydrobromide

Additional relevant MeSH terms:

Depressive Disorder; Depression; Depressive Disorder, Major; Mood Disorders; Mental Disorders; Behavioral Symptoms; Bupropion; Antidepressive Agents, Second-Generation; Antidepressive Agents; Psychotropic Drugs; Dopamine Uptake Inhibitors; Neurotransmitter Uptake Inhibitors; Membrane Transport Modulators; Molecular Mechanisms of Pharmacological Action; Dopamine Agents; Neurotransmitter Agents; Physiological Effects of Drugs; Cytochrome P-450 CYP2D6 Inhibitors; Cytochrome P-450 Enzyme Inhibitors; Enzyme Inhibitors