Adjunctive Use of Celecoxib in the Treatment of Bipolar Postpartum Depression

Lawson Health Research Institute

Status and phase: Terminated; Phase 3

Conditions: Bipolar Disorder; Postpartum Depression

Treatments: Drug: Placebo; Drug: Celecoxib

Study type: Interventional

Funder types: Other

Identifiers

NCT02726659

107775

Details and patient eligibility

About

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.

Enrollment: 1 patient

Sex: Female

Ages: 18 to 45 years old

Volunteers: No Healthy Volunteers

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

Trial design

Primary purpose: Treatment

Allocation: Randomized

Interventional model: Parallel Assignment

Masking: Triple Blind

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1 participants in 2 patient groups, including a placebo group

Celecoxib

Experimental group

Description:

Adjunct celecoxib in 6 week treatment

Treatment:

Drug: Celecoxib

Placebo

Placebo Comparator group

Description:

Adjunct placebo in 6 week treatment

Treatment:

Drug: Placebo