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

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ClinicalTrials.gov Identifier: NCT02129751
Recruitment Status : Not yet recruiting
First Posted : May 2, 2014
Last Update Posted : January 18, 2019
Sponsor:
Information provided by (Responsible Party):
Bausch Health Americas, Inc.

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.

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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 : December 2019
Estimated Primary Completion Date : November 2020
Estimated Study Completion Date : March 2021

Resource links provided by the National Library of Medicine


Arm Intervention/treatment
Experimental: bupropion hydrobromide
study drug
Drug: bupropion hydrobromide
study drug
Other Name: Aplenzin

Placebo Comparator: placebo
placebo
Drug: Placebo
placebo arm




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.



Information from the National Library of Medicine

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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.

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT02129751


Contacts
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Contact: Denise Raimondo 908 927-1885 denise.raimondo@valeant.com

Locations
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United States, New Jersey
Valeant Not yet recruiting
Bridgewater, New Jersey, United States, 08807
Principal Investigator: not available not available, MD         
Sponsors and Collaborators
Bausch Health Americas, Inc.
Investigators
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Study Director: Johnson Varughese Bausch Health Americas, Inc.

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Responsible Party: Bausch Health Americas, Inc.
ClinicalTrials.gov Identifier: NCT02129751     History of Changes
Other Study ID Numbers: V01-BUPA-401
First Posted: May 2, 2014    Key Record Dates
Last Update Posted: January 18, 2019
Last Verified: January 2019

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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:
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Disease
Depressive Disorder
Depression
Depressive Disorder, Major
Pathologic Processes
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