- ICH GCP
- US Clinical Trials Registry
- Clinical Trial NCT02129751
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
Conditions
Intervention / Treatment
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
- Name: Tendai Merriweather
- Phone Number: 908-541-2720
- Email: tendai.merriweather@bauschhealth.com
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:
|
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.
Sponsor
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
Terms related to this study
Additional Relevant MeSH Terms
- Behavioral Symptoms
- Mental Disorders
- Mood Disorders
- Depression
- Depressive Disorder
- Depressive Disorder, Major
- Physiological Effects of Drugs
- Neurotransmitter Agents
- Molecular Mechanisms of Pharmacological Action
- Enzyme Inhibitors
- Psychotropic Drugs
- Neurotransmitter Uptake Inhibitors
- Membrane Transport Modulators
- Antidepressive Agents
- Dopamine Agents
- Cytochrome P-450 Enzyme Inhibitors
- Antidepressive Agents, Second-Generation
- Cytochrome P-450 CYP2D6 Inhibitors
- Dopamine Uptake Inhibitors
- Bupropion
Other Study ID Numbers
- V01-BUPA-401
Drug and device information, study documents
Studies a U.S. FDA-regulated drug product
Yes
Studies a U.S. FDA-regulated device product
No
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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