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Trial record 11 of 543 for:    Celecoxib

Adjunctive Use of Celecoxib in the Treatment of Bipolar Postpartum Depression

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ClinicalTrials.gov Identifier: NCT02726659
Recruitment Status : Recruiting
First Posted : April 4, 2016
Last Update Posted : November 27, 2018
Sponsor:
Information provided by (Responsible Party):
Lawson Health Research Institute

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
Bipolar Disorder Postpartum Depression Drug: Celecoxib Drug: Placebo Phase 3

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Study Type : Interventional  (Clinical Trial)
Estimated Enrollment : 56 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 2016
Estimated Primary Completion Date : March 2019
Estimated Study Completion Date : March 2019

Resource links provided by the National Library of Medicine

Drug Information available for: Celecoxib

Arm Intervention/treatment
Experimental: Celecoxib
Adjunct celecoxib in 6 week treatment
Drug: Celecoxib
Adjunct celecoxib
Other Name: Celebrex

Placebo Comparator: Placebo
Adjunct placebo in 6 week treatment
Drug: Placebo
Adjunct placebo




Primary Outcome Measures :
  1. Hamilton Rating Scale for Depression (HAM-D) [ Time Frame: 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 [ Time Frame: 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 [ Time Frame: 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) [ Time Frame: 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) [ Time Frame: 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.



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

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT02726659


Contacts
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Contact: Verinder Sharma, MB BS 519-455-5110 ext 47392 vsharma@uwo.ca

Locations
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Canada, Ontario
Parkwood Institute, Mental Health Care Buildling Recruiting
London, Ontario, Canada, N6C 0A7
Contact: Verinder Sharma, MBBS    519-455-5110 ext 47600    vsharma@uwo.ca   
Principal Investigator: Verinder Sharma, MBBS         
Sponsors and Collaborators
Lawson Health Research Institute
Investigators
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Principal Investigator: Verinder Sharma, MB BS Lawson Health Research Institute

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Responsible Party: Lawson Health Research Institute
ClinicalTrials.gov Identifier: NCT02726659     History of Changes
Other Study ID Numbers: 107775
First Posted: April 4, 2016    Key Record Dates
Last Update Posted: November 27, 2018
Last Verified: November 2018
Individual Participant Data (IPD) Sharing Statement:
Plan to Share IPD: Yes
Plan Description: A data sharing agreement will be in place between Lawson Health Research Institute and The National Institute for Mental Health Research.

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Studies a U.S. FDA-regulated Drug Product: No
Studies a U.S. FDA-regulated Device Product: No
Additional relevant MeSH terms:
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Celecoxib
Depression, Postpartum
Depression
Depressive Disorder
Bipolar Disorder
Behavioral Symptoms
Mood Disorders
Mental Disorders
Bipolar and Related Disorders
Puerperal Disorders
Pregnancy Complications
Anti-Inflammatory Agents, Non-Steroidal
Analgesics, Non-Narcotic
Analgesics
Sensory System Agents
Peripheral Nervous System Agents
Physiological Effects of Drugs
Anti-Inflammatory Agents
Antirheumatic Agents
Cyclooxygenase 2 Inhibitors
Cyclooxygenase Inhibitors
Enzyme Inhibitors
Molecular Mechanisms of Pharmacological Action