Adjunctive Use of Celecoxib in the Treatment of Bipolar Postpartum Depression

Bipolar Disorder Clinical Trial

Official title:

Adjunctive Use of Celecoxib in the Treatment of Bipolar Postpartum Depression: a Randomized, Double-blind, Placebo-controlled Trial

Clinical Trial Details — Status: Terminated

Administrative data

• NCT number: NCT02726659
• Other study ID #: 107775
• Status: Terminated
• Phase: Phase 3
• Start date: May 2016
• Est. completion date: January 16, 2019

Study information

• Verified date: November 2018
• Source: Lawson Health Research Institute
• Contact: n/a
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial 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.

Recruitment information / eligibility

• Status: Terminated
• Enrollment: 1
• Est. completion date: January 16, 2019
• Est. primary completion date: January 16, 2019
• Accepts healthy volunteers: No
• Gender: Female
• Age group: 18 Years to 45 Years

Eligibility

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

Related Conditions & MeSH terms

• Bipolar Disorder
• Depression
• Depression, Postpartum
• Depressive Disorder
• Postpartum Depression

Intervention

Drug:
• Celecoxib
Adjunct celecoxib
• Placebo
Adjunct placebo

Locations

Country	Name	City	State
Canada	Parkwood Institute, Mental Health Care Buildling	London	Ontario

Sponsors (1)

Lead Sponsor	Collaborator
Lawson Health Research Institute

Country where clinical trial is conducted

Canada, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	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.	6 weeks
Secondary	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.	6 weeks
Secondary	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.	6 weeks
Secondary	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.	6 weeks
Secondary	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.	6 weeks