Adjunctive Use of Celecoxib in the Treatment of Bipolar Postpartum Depression

Phase 3TerminatedNCT02726659

London Health Sciences Centre Research Institute OR Lawson Research Institute of St. Joseph's1 enrolled

Overview

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.

Study Type

INTERVENTIONAL

Allocation

RANDOMIZED

Purpose

TREATMENT

Masking

TRIPLE

Enrollment

Conditions

Bipolar Disorder Postpartum Depression

Interventions

Eligibility

Sex: FEMALEMin age: 18 YearsMax age: 45 Years

Medical Language ↔ Plain English

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

Outcomes

Primary Outcomes

Hamilton Rating Scale for Depression (HAM-D)

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.

Time frame: 6 weeks

Secondary Outcomes

Montgomery Asberg Depression Scale

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.

Time frame: 6 weeks

Udvalg for Kliniske Undersogelser Scale

To assess the tolerability of celecoxib in women with bipolar postpartum depression as assessed by the Udvalg for Kliniske Undersogelser Scale.

Time frame: 6 weeks

Edinburgh Postnatal Depression Scale (EPDS)

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.

Time frame: 6 weeks

Clinical Global Impression Scale (CGI)

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.

Time frame: 6 weeks

Adjunctive Use of Celecoxib in the Treatment of Bipolar Postpartum Depression

Overview

Conditions

Interventions

Eligibility

Locations (1)

Outcomes

Primary Outcomes

Secondary Outcomes