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Adjunctive Use of Celecoxib in the Treatment of Bipolar Postpartum Depression

Sponsor
Lawson Health Research Institute (Other)
Overall Status
Terminated
CT.gov ID
NCT02726659
Collaborator
(none)
1
Enrollment
1
Location
2
Arms
32.5
Actual Duration (Months)
0
Patients Per Site Per Month

Study Details

Study Description

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.

Condition or Disease Intervention/Treatment Phase
Phase 3

Study Design

Study Type:
Interventional
Actual Enrollment :
1 participants
Allocation:
Randomized
Intervention Model:
Parallel Assignment
Masking:
Triple (Participant, Care Provider, Investigator)
Primary Purpose:
Treatment
Official Title:
Adjunctive Use of Celecoxib in the Treatment of Bipolar Postpartum Depression: a Randomized, Double-blind, Placebo-controlled Trial
Actual Study Start Date :
May 1, 2016
Actual Primary Completion Date :
Jan 16, 2019
Actual Study Completion Date :
Jan 16, 2019

Arms and Interventions

Arm Intervention/Treatment
Experimental: Celecoxib

Adjunct celecoxib in 6 week treatment

Drug: Celecoxib
Adjunct celecoxib
Other Names:
  • Celebrex

    		•
    Placebo Comparator: Placebo

    Adjunct placebo in 6 week treatment

    Drug: Placebo
    Adjunct placebo

    Outcome Measures

    Primary Outcome Measures

    1. Hamilton Rating Scale for Depression (HAM-D) [6 weeks]

      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.

    Secondary Outcome Measures

    1. Montgomery Asberg Depression Scale [6 weeks]

      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.

    2. Udvalg for Kliniske Undersogelser Scale [6 weeks]

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

    3. Edinburgh Postnatal Depression Scale (EPDS) [6 weeks]

      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.

    4. Clinical Global Impression Scale (CGI) [6 weeks]

      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.

    Eligibility Criteria

    Criteria

    Ages Eligible for Study:
    18 Years to 45 Years
    Sexes Eligible for Study:
    Female
    Accepts Healthy Volunteers:
    No
    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

    Contacts and Locations

    Locations

    Site City State Country Postal Code
    1 Parkwood Institute, Mental Health Care Buildling London Ontario Canada N6C 0A7

    Sponsors and Collaborators

    • Lawson Health Research Institute

    Investigators

    • Principal Investigator: Verinder Sharma, MB BS, Lawson Health Research Institute

    Study Documents (Full-Text)

    None provided.

    More Information

    Publications

    None provided.
    Responsible Party:
    Lawson Health Research Institute
    ClinicalTrials.gov Identifier:
    NCT02726659
    Other Study ID Numbers:
    • 107775
    First Posted:
    Apr 4, 2016
    Last Update Posted:
    Jan 20, 2022
    Last Verified:
    Nov 1, 2018
    Individual Participant Data (IPD) Sharing Statement:
    Yes
    Plan to Share IPD:
    Yes
    Studies a U.S. FDA-regulated Drug Product:
    No
    Studies a U.S. FDA-regulated Device Product:
    No
    Additional relevant MeSH terms:
    Depression, Postpartum
    Depression
    Depressive Disorder
    Bipolar Disorder
    Celecoxib

    Study Results

    No Results Posted as of Jan 20, 2022