Ignite Creation Date:
2025-12-24 @ 11:38 PM
Ignite Modification Date:
2026-01-01 @ 12:15 PM
Study NCT ID:
NCT02129751
Status:
NOT_YET_RECRUITING
Last Update Posted:
2025-09-17
First Post:
2014-04-30
Is NOT Gene Therapy:
True
Has Adverse Events:
False
Brief Title:
Efficacy and Safety of Bupropion Hydrobromide in Adolescents and Children With Major Depressive Disorder
Sponsor:
Organization:
Raw JSON
{'hasResults': False, 'derivedSection': {'miscInfoModule': {'versionHolder': '2025-12-24', 'removedCountries': ['United States']}, 'conditionBrowseModule': {'meshes': [{'id': 'D003865', 'term': 'Depressive Disorder, Major'}], 'ancestors': [{'id': 'D003866', 'term': 'Depressive Disorder'}, {'id': 'D019964', 'term': 'Mood Disorders'}, {'id': 'D001523', 'term': 'Mental Disorders'}]}, 'interventionBrowseModule': {'meshes': [{'id': 'D016642', 'term': 'Bupropion'}], 'ancestors': [{'id': 'D011427', 'term': 'Propiophenones'}, {'id': 'D007659', 'term': 'Ketones'}, {'id': 'D009930', 'term': 'Organic Chemicals'}]}}, 'protocolSection': {'designModule': {'phases': ['PHASE4'], 'studyType': 'INTERVENTIONAL', 'designInfo': {'allocation': 'RANDOMIZED', 'maskingInfo': {'masking': 'QUADRUPLE', 'whoMasked': ['PARTICIPANT', 'CARE_PROVIDER', 'INVESTIGATOR', 'OUTCOMES_ASSESSOR']}, 'primaryPurpose': 'TREATMENT', 'interventionModel': 'SINGLE_GROUP'}, 'enrollmentInfo': {'type': 'ESTIMATED', 'count': 246}}, 'statusModule': {'overallStatus': 'NOT_YET_RECRUITING', 'startDateStruct': {'date': '2026-06', 'type': 'ESTIMATED'}, 'expandedAccessInfo': {'hasExpandedAccess': False}, 'statusVerifiedDate': '2025-09', 'completionDateStruct': {'date': '2029-12', 'type': 'ESTIMATED'}, 'lastUpdateSubmitDate': '2025-09-11', 'studyFirstSubmitDate': '2014-04-30', 'studyFirstSubmitQcDate': '2014-05-01', 'lastUpdatePostDateStruct': {'date': '2025-09-17', 'type': 'ESTIMATED'}, 'studyFirstPostDateStruct': {'date': '2014-05-02', 'type': 'ESTIMATED'}, 'primaryCompletionDateStruct': {'date': '2029-07', 'type': 'ESTIMATED'}}, 'outcomesModule': {'primaryOutcomes': [{'measure': 'Mean change from Baseline to EOT in total CDRS-R (raw) score', 'timeFrame': 'Baseline and 2 years', 'description': "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."}]}, 'oversightModule': {'oversightHasDmc': False, 'isFdaRegulatedDrug': True, 'isFdaRegulatedDevice': False}, 'conditionsModule': {'keywords': ['able to swallow medications without difficulty', 'bupropion hydrobromide'], 'conditions': ['Major Depressive Disorder']}, 'descriptionModule': {'briefSummary': 'Double-Blind, Placebo-Controlled, Multicenter Study of Efficacy and Safety', 'detailedDescription': '* The primary efficacy endpoint is the mean change from Baseline to EOT in total CDRS-R (raw) score.\n* The secondary efficacy endpoints include:\n\n * Proportion of subjects characterized as responders at EOT (≥40% improvement from Baseline total CDRS-R raw score)\n * Proportion of subjects characterized as in remission at EOT (total CDRS-R raw score \\<29)\n * Mean change from Baseline to EOT in CGI-C.\n\nSafety endpoints include:\n\n* Incidence of AEs\n* Change from Baseline to EOT in vital signs (blood pressure and radial pulse rate), blood and urine laboratory panel, and ECG\n* Treatment discontinuation due to AEs\n* Suicidality as assessed by the C-SSRS score\n* Change from Baseline to EOT in sleep as assessed by the sleep subscale of the CDRS-R.'}, 'eligibilityModule': {'sex': 'ALL', 'stdAges': ['CHILD'], 'maximumAge': '17 Years', 'minimumAge': '7 Years', 'healthyVolunteers': False, 'eligibilityCriteria': "Inclusion Criteria:\n\n* Male or female outpatients aged ≥7 to \\<18 years (at Screening Visit 1).\n* 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).\n* 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).\n* Current depressive episode of at least 4 weeks' duration as noted in the subject's history (Screening Visit 1).\n* Total CDRS-R raw score ≥45 at both the Screening and Baseline Visits (Visits 1 and 2) (see Appendix 17.3).\n* CGI-S score of ≥4 at the Baseline Visit (Visit 2) (see Appendix 17.4).\n\nExclusion Criteria:\n\n* are unable to swallow medications without difficulty\n* have known hypersensitivity to bupropion hydrobromide\n* are pregnant or planning to get pregnant or are lactating\n* Women of childbearing age unable to use at least one method of effective contraception for the duration of the study\n* Previous history of attempted suicide\n* are unable to understand and communicate effectively with parent, Investigator, and study coordinator\n* are at immediate risk of requiring hospitalization, in the Investigator's opinion\n* have current seizure disorder or history of seizures or head trauma\n* have history or presence of clinically significant medical conditions or clinically important laboratory abnormalities\n* have ECG or physical examination abnormality at screening\n* have body weight less than the 3rd percentile or greater than the 97th percentile for age."}, 'identificationModule': {'nctId': 'NCT02129751', 'briefTitle': 'Efficacy and Safety of Bupropion Hydrobromide in Adolescents and Children With Major Depressive Disorder', 'organization': {'class': 'INDUSTRY', 'fullName': 'Bausch Health Americas, Inc.'}, 'officialTitle': 'A Double-Blind, Placebo-Controlled, Multicenter Study of Efficacy and Safety of Bupropion Hydrobromide in Adolescents and Children With Major Depressive Disorder', 'orgStudyIdInfo': {'id': 'V01-BUPA-401'}}, 'armsInterventionsModule': {'armGroups': [{'type': 'EXPERIMENTAL', 'label': 'bupropion hydrobromide', 'description': 'study drug', 'interventionNames': ['Drug: bupropion hydrobromide']}, {'type': 'PLACEBO_COMPARATOR', 'label': 'placebo', 'description': 'placebo', 'interventionNames': ['Drug: Placebo']}], 'interventions': [{'name': 'bupropion hydrobromide', 'type': 'DRUG', 'otherNames': ['Aplenzin'], 'description': 'study drug', 'armGroupLabels': ['bupropion hydrobromide']}, {'name': 'Placebo', 'type': 'DRUG', 'description': 'placebo arm', 'armGroupLabels': ['placebo']}]}, 'contactsLocationsModule': {'centralContacts': [{'name': 'Jessica Ferrigno', 'role': 'CONTACT', 'email': 'jessica.ferrigno@bauschhealth.com', 'phone': '520-246-8205'}], 'overallOfficials': [{'name': 'Varsha Bhatt', 'role': 'STUDY_DIRECTOR', 'affiliation': 'Bausch Health'}]}, 'sponsorCollaboratorsModule': {'leadSponsor': {'name': 'Bausch Health Americas, Inc.', 'class': 'INDUSTRY'}, 'responsibleParty': {'type': 'SPONSOR'}}}}