Adjunctive Use of Celecoxib in the Treatment of Bipolar Postpartum Depression: a Randomized, Double-blind, Placebo-controlled Trial
Overview
- Phase
- Phase 3
- Intervention
- Celecoxib
- Conditions
- Bipolar Disorder
- Sponsor
- Lawson Health Research Institute
- Enrollment
- 1
- Locations
- 1
- Primary Endpoint
- Hamilton Rating Scale for Depression (HAM-D)
- Status
- Terminated
- Last Updated
- 4 years ago
Overview
Brief Summary
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.
Investigators
Eligibility Criteria
Inclusion Criteria
- •women aged 18-45 who are within 3 months of delivering a healthy, term (37 to 40 weeks) singleton
- •diagnosis of bipolar postpartum depression - depressed with peripartum onset
- •have a 17-item Hamilton Rating Scale for Depression score of \>18
- •have failed to respond to an adequate trial of the mood stabilizer
- •are currently not on any psychotropic drug except a mood stabilizer (lithium, lamotrigine or quetiapine)
- •are able to communicate (written and oral) in English and capable of giving consent
Exclusion Criteria
- •current major depressive episode of more than 6 months duration
- •a current comorbid psychiatric disorder
- •history of alcohol or substance abuse within the 12 months before screening
- •concurrent psychotherapy
- •high risk for suicide (actively suicidal or a score of = 3 on item #3 on HAM-D)
- •current hepatic, renal, or cardiac disease, chronic pain, coagulation disorders, esophageal or gastro duodenal ulceration within the previous 30 days
- •known immediate-type hypersensitivity to COX-2 inhibitors, sulfonamides, ibuprofen, or diclofenac
- •breastfeeding mothers
Arms & Interventions
Celecoxib
Adjunct celecoxib in 6 week treatment
Intervention: Celecoxib
Placebo
Adjunct placebo in 6 week treatment
Intervention: Placebo
Outcomes
Primary Outcomes
Hamilton Rating Scale for Depression (HAM-D)
Time Frame: 6 weeks
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.
Secondary Outcomes
- Edinburgh Postnatal Depression Scale (EPDS)(6 weeks)
- Montgomery Asberg Depression Scale(6 weeks)
- Udvalg for Kliniske Undersogelser Scale(6 weeks)
- Clinical Global Impression Scale (CGI)(6 weeks)