Adjunctive Use of Celecoxib in the Treatment of Bipolar Postpartum Depression

Study Overview
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Brief Summary
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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.

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

Conditions
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Bipolar Disorder, Postpartum Depression

Intervention / Treatment
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* Drug: Celecoxib
* Drug: Placebo


Participation Criteria
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Eligibility Criteria
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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

Ages Eligible for Study
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Minimum Age: 18 Years
Maximum Age: 45 Years

Sexes Eligible for Study
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Female

Accepts Healthy Volunteers
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No

Study Plan
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How is the study designed?
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Design Details

Primary Purpose: Treatment
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Triple


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Experimental: Celecoxib<br>Adjunct celecoxib in 6 week treatment | Drug: Celecoxib<br>* Adjunct celecoxib<br>* Other names: Celebrex;|
| Placebo Comparator: Placebo<br>Adjunct placebo in 6 week treatment | Drug: Placebo<br>* Adjunct placebo<br>|

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| 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 Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| 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 | 
| 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 | 
| 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 | 
| 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 |