Adjunctive Use of Celecoxib in the Treatment of Bipolar Postpartum Depression

NCT ID: NCT02726659

Last Updated: 2022-01-20

Basic Information

• Recruitment Status: TERMINATED
• Clinical Phase: PHASE3
• Total Enrollment: 1 participants
• Study Classification: INTERVENTIONAL
• Study Start Date: 2016-05-31
• Study Completion Date: 2019-01-16

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.

Conditions

Bipolar Disorder; Postpartum Depression

Study Design

• Allocation Method: RANDOMIZED
• Intervention Model: PARALLEL
• Primary Study Purpose: TREATMENT
• Blinding Strategy: TRIPLE

Study Groups

Celecoxib

Adjunct celecoxib in 6 week treatment

Group Type: EXPERIMENTAL

Celecoxib

Intervention Type: DRUG

Adjunct celecoxib

Placebo

Adjunct placebo in 6 week treatment

Group Type: PLACEBO_COMPARATOR

Placebo

Intervention Type: DRUG

Adjunct placebo

Interventions

Celecoxib

Adjunct celecoxib

Intervention Type: DRUG

Placebo

Adjunct placebo

Intervention Type: DRUG

Other Intervention Names

Celebrex

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

• Minimum Eligible Age: 18 Years
• Maximum Eligible Age: 45 Years
• Eligible Sex: FEMALE
• Accepts Healthy Volunteers: No

Sponsors

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

OTHER

Sponsor Role: lead

Responsible Party

Responsibility Role: SPONSOR

Principal Investigators

Verinder Sharma, MB BS

Role: PRINCIPAL_INVESTIGATOR

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

Locations

Parkwood Institute, Mental Health Care Buildling

London, Ontario, Canada

Countries

Canada

Other Identifiers

107775

Identifier Type: -

Identifier Source: org_study_id