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Adjunctive Use of Celecoxib in the Treatment of Bipolar Postpartum Depression

Primary Purpose

Bipolar Disorder, Postpartum Depression

Status
Terminated
Phase
Phase 3
Locations
Canada
Study Type
Interventional
Intervention
Celecoxib
Placebo
Sponsored by
Lawson Health Research Institute
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional treatment trial for Bipolar Disorder

Eligibility Criteria

18 Years - 45 Years (Adult)FemaleDoes not accept healthy volunteers

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

Sites / Locations

  • Parkwood Institute, Mental Health Care Buildling

Arms of the Study

Arm 1

Arm 2

Arm Type

Experimental

Placebo Comparator

Arm Label

Celecoxib

Placebo

Arm Description

Adjunct celecoxib in 6 week treatment

Adjunct placebo in 6 week treatment

Outcomes

Primary Outcome Measures

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.

Secondary Outcome Measures

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.
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.
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.
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.

Full Information

First Posted
March 15, 2016
Last Updated
January 4, 2022
Sponsor
Lawson Health Research Institute
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1. Study Identification

Unique Protocol Identification Number
NCT02726659
Brief Title
Adjunctive Use of Celecoxib in the Treatment of Bipolar Postpartum Depression
Official Title
Adjunctive Use of Celecoxib in the Treatment of Bipolar Postpartum Depression: a Randomized, Double-blind, Placebo-controlled Trial
Study Type
Interventional

2. Study Status

Record Verification Date
November 2018
Overall Recruitment Status
Terminated
Why Stopped
Difficulty recruiting participants because principal investigator noticed that the participants in the population were responding well to low doses of mood stabilizers and therefor would not be recruited into the study.
Study Start Date
May 2016 (Actual)
Primary Completion Date
January 16, 2019 (Actual)
Study Completion Date
January 16, 2019 (Actual)

3. Sponsor/Collaborators

Responsible Party, by Official Title
Sponsor
Name of the Sponsor
Lawson Health Research Institute

4. Oversight

Studies a U.S. FDA-regulated Drug Product
No
Studies a U.S. FDA-regulated Device Product
No
Data Monitoring Committee
No

5. 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.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Bipolar Disorder, Postpartum Depression

7. Study Design

Primary Purpose
Treatment
Study Phase
Phase 3
Interventional Study Model
Parallel Assignment
Masking
ParticipantCare ProviderInvestigator
Allocation
Randomized
Enrollment
1 (Actual)

8. Arms, Groups, and Interventions

Arm Title
Celecoxib
Arm Type
Experimental
Arm Description
Adjunct celecoxib in 6 week treatment
Arm Title
Placebo
Arm Type
Placebo Comparator
Arm Description
Adjunct placebo in 6 week treatment
Intervention Type
Drug
Intervention Name(s)
Celecoxib
Other Intervention Name(s)
Celebrex
Intervention Description
Adjunct celecoxib
Intervention Type
Drug
Intervention Name(s)
Placebo
Intervention Description
Adjunct placebo
Primary Outcome Measure Information:
Title
Hamilton Rating Scale for Depression (HAM-D)
Description
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 Outcome Measure Information:
Title
Montgomery Asberg Depression Scale
Description
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
Title
Udvalg for Kliniske Undersogelser Scale
Description
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
Title
Edinburgh Postnatal Depression Scale (EPDS)
Description
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
Title
Clinical Global Impression Scale (CGI)
Description
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

10. Eligibility

Sex
Female
Minimum Age & Unit of Time
18 Years
Maximum Age & Unit of Time
45 Years
Accepts Healthy Volunteers
No
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
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Verinder Sharma, MB BS
Organizational Affiliation
Lawson Health Research Institute
Official's Role
Principal Investigator
Facility Information:
Facility Name
Parkwood Institute, Mental Health Care Buildling
City
London
State/Province
Ontario
ZIP/Postal Code
N6C 0A7
Country
Canada

12. IPD Sharing Statement

Plan to Share IPD
Yes
IPD Sharing Plan Description
A data sharing agreement will be in place between Lawson Health Research Institute and The National Institute for Mental Health Research.

Learn more about this trial

Adjunctive Use of Celecoxib in the Treatment of Bipolar Postpartum Depression

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