Adjunctive Use of Celecoxib in the Treatment of Bipolar Postpartum Depression

• Status: Unknown status
• Trial end date: 2019-03-01
• Target enrollment: 0
• Participant gender: Female

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.

• Phase: Phase 3
• Accepts Healthy Volunteers?: No

Details

• Lead Sponsor: Lawson Health Research Institute
• Treatments: Celecoxib

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