Ignite Creation Date:
2025-12-24 @ 2:51 PM
Ignite Modification Date:
2026-04-19 @ 4:50 AM
Study NCT ID:
NCT02726659
Status:
TERMINATED
Last Update Posted:
2022-01-20
First Post:
2016-03-15
Is NOT Gene Therapy:
True
Has Adverse Events:
False
Brief Title:
Adjunctive Use of Celecoxib in the Treatment of Bipolar Postpartum Depression
Sponsor:
Organization:
Raw JSON
{'hasResults': False, 'derivedSection': {'miscInfoModule': {'versionHolder': '2025-12-24'}, 'conditionBrowseModule': {'meshes': [{'id': 'D001714', 'term': 'Bipolar Disorder'}, {'id': 'D019052', 'term': 'Depression, Postpartum'}], 'ancestors': [{'id': 'D000068105', 'term': 'Bipolar and Related Disorders'}, {'id': 'D019964', 'term': 'Mood Disorders'}, {'id': 'D001523', 'term': 'Mental Disorders'}, {'id': 'D011644', 'term': 'Puerperal Disorders'}, {'id': 'D011248', 'term': 'Pregnancy Complications'}, {'id': 'D005261', 'term': 'Female Urogenital Diseases and Pregnancy Complications'}, {'id': 'D000091642', 'term': 'Urogenital Diseases'}, {'id': 'D003866', 'term': 'Depressive Disorder'}]}, 'interventionBrowseModule': {'meshes': [{'id': 'D000068579', 'term': 'Celecoxib'}], 'ancestors': [{'id': 'D000096926', 'term': 'Benzenesulfonamides'}, {'id': 'D013449', 'term': 'Sulfonamides'}, {'id': 'D000577', 'term': 'Amides'}, {'id': 'D009930', 'term': 'Organic Chemicals'}, {'id': 'D001555', 'term': 'Benzene Derivatives'}, {'id': 'D006841', 'term': 'Hydrocarbons, Aromatic'}, {'id': 'D006844', 'term': 'Hydrocarbons, Cyclic'}, {'id': 'D006838', 'term': 'Hydrocarbons'}, {'id': 'D013450', 'term': 'Sulfones'}, {'id': 'D013457', 'term': 'Sulfur Compounds'}, {'id': 'D011720', 'term': 'Pyrazoles'}, {'id': 'D001393', 'term': 'Azoles'}, {'id': 'D006573', 'term': 'Heterocyclic Compounds, 1-Ring'}, {'id': 'D006571', 'term': 'Heterocyclic Compounds'}]}}, 'protocolSection': {'designModule': {'phases': ['PHASE3'], 'studyType': 'INTERVENTIONAL', 'designInfo': {'allocation': 'RANDOMIZED', 'maskingInfo': {'masking': 'TRIPLE', 'whoMasked': ['PARTICIPANT', 'CARE_PROVIDER', 'INVESTIGATOR']}, 'primaryPurpose': 'TREATMENT', 'interventionModel': 'PARALLEL'}, 'enrollmentInfo': {'type': 'ACTUAL', 'count': 1}}, 'statusModule': {'whyStopped': 'Difficulty recruiting participants because principal investigator noticed that the participants in the population were responding well to low doses of mood stabilizers and therefor would not be recruited into the study.', 'overallStatus': 'TERMINATED', 'startDateStruct': {'date': '2016-05', 'type': 'ACTUAL'}, 'expandedAccessInfo': {'hasExpandedAccess': False}, 'statusVerifiedDate': '2018-11', 'completionDateStruct': {'date': '2019-01-16', 'type': 'ACTUAL'}, 'lastUpdateSubmitDate': '2022-01-04', 'studyFirstSubmitDate': '2016-03-15', 'studyFirstSubmitQcDate': '2016-03-29', 'lastUpdatePostDateStruct': {'date': '2022-01-20', 'type': 'ACTUAL'}, 'studyFirstPostDateStruct': {'date': '2016-04-04', 'type': 'ESTIMATED'}, 'primaryCompletionDateStruct': {'date': '2019-01-16', 'type': 'ACTUAL'}}, 'outcomesModule': {'primaryOutcomes': [{'measure': 'Hamilton Rating Scale for Depression (HAM-D)', 'timeFrame': '6 weeks', 'description': 'To assess the effectiveness of the addition of celecoxib in the treatment of bipolar postpartum depression by the change in mean scores on the HAM-D between baseline and the 6 weeks endpoint. Response will be a \\> 50% reduction in HAM-D score and remission will be a \\< 7 HAM-D score from baseline to week 6.'}], 'secondaryOutcomes': [{'measure': 'Montgomery Asberg Depression Scale', 'timeFrame': '6 weeks', 'description': 'To assess the effectiveness of the addition of celecoxib in the treatment of bipolar postpartum depression as measured by the change in the mean scores on the Montgomery Asberg Depression Rating Scale between baseline and the study termination endpoint.'}, {'measure': 'Udvalg for Kliniske Undersogelser Scale', 'timeFrame': '6 weeks', 'description': 'To assess the tolerability of celecoxib in women with bipolar postpartum depression as assessed by the Udvalg for Kliniske Undersogelser Scale.'}, {'measure': 'Edinburgh Postnatal Depression Scale (EPDS)', 'timeFrame': '6 weeks', 'description': 'To assess the effectiveness of the addition of celecoxib in the treatment of bipolar postpartum depression as measured by the mean change in scores on the EPDS between baseline and the study termination endpoint.'}, {'measure': 'Clinical Global Impression Scale (CGI)', 'timeFrame': '6 weeks', 'description': 'To assess the effectiveness of the addition of celecoxib in the treatment of bipolar postpartum depression as measured by the change in scores on the CGI between baseline and the study termination endpoint.'}]}, 'oversightModule': {'oversightHasDmc': False, 'isFdaRegulatedDrug': False, 'isFdaRegulatedDevice': False}, 'conditionsModule': {'conditions': ['Bipolar Disorder', 'Postpartum Depression']}, 'descriptionModule': {'briefSummary': 'The investigators will conduct a 6-week, randomized, double-blind, placebo-controlled trial of celecoxib as an add-on treatment to the mood stabilizer among women with bipolar I or II postpartum depression. Women who are taking a mood stabilizer for treatment of bipolar disorder in the postpartum treatment will receive either a placebo or celecoxib add-on treatment. Patients will be monitored regularly to assess psychiatric symptoms and side effects. The investigators aim to evaluate the potential antidepressant effect of celecoxib in bipolar postpartum depression.'}, 'eligibilityModule': {'sex': 'FEMALE', 'stdAges': ['ADULT'], 'maximumAge': '45 Years', 'minimumAge': '18 Years', 'healthyVolunteers': False, 'eligibilityCriteria': 'Inclusion Criteria:\n\n* women aged 18-45 who are within 3 months of delivering a healthy, term (37 to 40 weeks) singleton\n* diagnosis of bipolar postpartum depression - depressed with peripartum onset\n* have a 17-item Hamilton Rating Scale for Depression score of \\>18\n* have failed to respond to an adequate trial of the mood stabilizer\n* are currently not on any psychotropic drug except a mood stabilizer (lithium, lamotrigine or quetiapine)\n* are able to communicate (written and oral) in English and capable of giving consent\n\nExclusion Criteria:\n\n* current major depressive episode of more than 6 months duration\n* a current comorbid psychiatric disorder\n* history of alcohol or substance abuse within the 12 months before screening\n* concurrent psychotherapy\n* high risk for suicide (actively suicidal or a score of = 3 on item #3 on HAM-D)\n* current hepatic, renal, or cardiac disease, chronic pain, coagulation disorders, esophageal or gastro duodenal ulceration within the previous 30 days\n* known immediate-type hypersensitivity to COX-2 inhibitors, sulfonamides, ibuprofen, or diclofenac\n* breastfeeding mothers'}, 'identificationModule': {'nctId': 'NCT02726659', 'briefTitle': 'Adjunctive Use of Celecoxib in the Treatment of Bipolar Postpartum Depression', 'organization': {'class': 'OTHER', 'fullName': "London Health Sciences Centre Research Institute OR Lawson Research Institute of St. Joseph's"}, 'officialTitle': 'Adjunctive Use of Celecoxib in the Treatment of Bipolar Postpartum Depression: a Randomized, Double-blind, Placebo-controlled Trial', 'orgStudyIdInfo': {'id': '107775'}}, 'armsInterventionsModule': {'armGroups': [{'type': 'EXPERIMENTAL', 'label': 'Celecoxib', 'description': 'Adjunct celecoxib in 6 week treatment', 'interventionNames': ['Drug: Celecoxib']}, {'type': 'PLACEBO_COMPARATOR', 'label': 'Placebo', 'description': 'Adjunct placebo in 6 week treatment', 'interventionNames': ['Drug: Placebo']}], 'interventions': [{'name': 'Celecoxib', 'type': 'DRUG', 'otherNames': ['Celebrex'], 'description': 'Adjunct celecoxib', 'armGroupLabels': ['Celecoxib']}, {'name': 'Placebo', 'type': 'DRUG', 'description': 'Adjunct placebo', 'armGroupLabels': ['Placebo']}]}, 'contactsLocationsModule': {'locations': [{'zip': 'N6C 0A7', 'city': 'London', 'state': 'Ontario', 'country': 'Canada', 'facility': 'Parkwood Institute, Mental Health Care Buildling', 'geoPoint': {'lat': 42.98339, 'lon': -81.23304}}], 'overallOfficials': [{'name': 'Verinder Sharma, MB BS', 'role': 'PRINCIPAL_INVESTIGATOR', 'affiliation': "London Health Sciences Centre Research Institute OR Lawson Research Institute of St. Joseph's"}]}, 'ipdSharingStatementModule': {'ipdSharing': 'YES', 'description': 'A data sharing agreement will be in place between Lawson Health Research Institute and The National Institute for Mental Health Research.'}, 'sponsorCollaboratorsModule': {'leadSponsor': {'name': "London Health Sciences Centre Research Institute OR Lawson Research Institute of St. Joseph's", 'class': 'OTHER'}, 'responsibleParty': {'type': 'SPONSOR'}}}}