Major Depressive DisorderPhase 4NCT02129751
Efficacy and Safety of Bupropion Hydrobromide in Adolescents and Children With Major Depressive Disorder
A Phase 4 study testing bupropion hydrobromide in people with Major Depressive Disorder, run by Bausch Health Americas, Inc..
Trial summary
Double-Blind, Placebo-Controlled, Multicenter Study of Efficacy and Safety Read more about this study
- Who is it for?
- Ages 7 to 17 years
- Conditions the study is for
- Major Depressive Disorder
- What is being tested?
- bupropion hydrobromide
- Could I receive a placebo?
- Yes, some participants may receive a placebo
- How many people
- 246 participants
- Where
- No sites listed yet
- Study dates
- 1 Jul 2027to Dec 2030
- Phase
- Phase 4
- Are there results?
- Not yet: the study is under way
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 7 to 17 years
- All sexes
- No healthy volunteers
- Child
Who may be able to join
- 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).
Who cannot join
- 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
Show all 11Show fewer
- 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 locations and contacts
No sites are listed yet. Contact the study team or a site near you to ask about taking part.
About this study
Official title: 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
Read the 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.
- Conditions
- Major Depressive Disorder
- Being tested
- bupropion hydrobromide, Placebo
- Keywords
- able to swallow medications without difficulty, bupropion hydrobromide
- Medical subject headings
- Depressive Disorder, Major
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
bupropion hydrobromideDrug
Also called Aplenzin
study drug
PlaceboDrug
placebo arm
| Study group | Role | What they receive |
|---|---|---|
| bupropion hydrobromide | Experimental | study drug Receives: Drug: bupropion hydrobromide |
| placebo | Placebo comparator | placebo Receives: Drug: Placebo |
What is being measured
The primary outcome is the main question the study is designed to answer.
Mean change from Baseline to EOT in total CDRS-R (raw) score
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.
Measured: Baseline and 2 years
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted2 May 2014 (estimated)
- Study start1 Jul 2027 (estimated)
- Primary completionJul 2030 (estimated)
- Study completionDec 2030 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Major Depressive DisorderStudies of the same condition, open and under way.
- More trials run by Bausch Health Americas, Inc.The sponsor's other registered studies.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase 4
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Single group
- Masking
- Quadruple blind
- Who is masked
- Participant, Care provider, Investigator, Outcomes assessor
- Enrolment
- 246 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Bausch Health Americas, Inc.
- Sponsor type
- Industry (pharma, biotech, devices)
- Responsible party
- Sponsor
- Investigators
- Angela Moore, Study director, Bausch Health US, LLC
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT02129751
- Sponsor's protocol ID
- V01-BUPA-401
- Status last verified
- Sep 2026
- First submitted
- 30 Apr 2014
- Last updated
- 29 Sep 2026
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- Yes
- FDA-regulated device
- No
Study at a glance
From the registry record, last updated by the sponsor on 29 Sep 2026. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- A Double-Blind, Placebo-Controlled, Multicenter Study of Efficacy and Safety of Bupropion Hydrobromide in Adolescents and Children With Major Depressive Disorder
- ClinicalTrials.gov ID
- NCT02129751
- Acronym / sponsor ID
- V01-BUPA-401
- Conditions
- Major Depressive Disorder
- Keywords
- able to swallow medications without difficulty, bupropion hydrobromide
- Phase
- Phase 4
- Study type
- Interventional
- Recruitment status
- Not yet recruiting
- Enrolment
- 246 participants (estimated)
- Lead sponsor
- Bausch Health Americas, Inc.Industry (pharma, biotech, devices)
- Study start
- 1 Jul 2027 (estimated)
- Primary completion
- Jul 2030 (estimated)
- Study completion
- Dec 2030 (estimated)
- First posted
- 2 May 2014 (estimated)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
Double-Blind, Placebo-Controlled, Multicenter Study of Efficacy and Safety
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
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Single group
- Masking
- Quadruple blind (participant, care provider, investigator, outcomes assessor)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| bupropion hydrobromide | Experimental | Drug: bupropion hydrobromidestudy drug |
| placebo | Placebo comparator | Drug: Placeboplacebo |
Who may qualify
- Ages
- 7 to 17 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Child
Key inclusion criteria (6 listed)
- 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).
Key exclusion criteria (11 listed)
- 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
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| bupropion hydrobromideAlso: Aplenzinstudy drug | Drug | bupropion hydrobromide |
| Placeboplacebo arm | Drug | placebo |
Primary outcome
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.
Results and safety
This study is still under way. Results are not available in the source record yet.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 29 Sep 2026.
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part.
Angela Moore study director
Bausch Health US, LLC
Questions about this trial
What is this clinical trial studying?
A Phase 4 study testing bupropion hydrobromide in people with Major Depressive Disorder, run by Bausch Health Americas, Inc..
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 6 inclusion and 11 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: opening soon, as of the sponsor's last update on 29 Sep 2026. Status can change between updates, so confirm with the study contact before making plans.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. Some participants in this study may receive a placebo. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
What does this phase mean?
Phase 4 studies take place after a treatment is approved, to learn more about its long-term benefits and risks in everyday use.
Not every study follows the same path, and some studies (observational studies, device studies) have no phase.
Are results available for this study?
This study is still under way. Results are not available in the source record yet.
How can a doctor refer a patient or contact the research team?
Contact Wendy Walton (505-917-8552, wendy.walton@bauschhealth.com), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Mean change from Baseline to EOT in total CDRS-R (raw) score (time frame: Baseline and 2 years). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 29 Sep 2026; AzTrials last refreshed its copy on 8 Nov 2026.