Adjunctive Use of Celecoxib in the Treatment of Bipolar Postpartum Depression

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

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.

Study Overview

• Status: Terminated
• Conditions: Postpartum Depression; Bipolar Disorder
• Intervention / Treatment: Drug: Celecoxib; Drug: Placebo

• Study Type: Interventional
• Enrollment (Actual): 1
• Phase: Phase 3

Contacts and Locations

Study Locations

• Canada
  • Ontario
    • London, Ontario, Canada, N6C 0A7
      • Parkwood Institute, Mental Health Care Buildling

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 18 years to 45 years (ADULT)
• Accepts Healthy Volunteers: No
• Genders Eligible for Study: Female

Description

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

Study Plan

How is the study designed?

Design Details

• Primary Purpose: TREATMENT
• Allocation: RANDOMIZED
• Interventional Model: PARALLEL
• Masking: TRIPLE

Number of Arms

2

Arms and Interventions

Participant Group / 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

What is the study measuring?

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

Collaborators and Investigators

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

Study record dates

Study Major Dates

• Study Start (ACTUAL): May 1, 2016
• Primary Completion (ACTUAL): January 16, 2019
• Study Completion (ACTUAL): January 16, 2019

Study Registration Dates

• First Submitted: March 15, 2016
• First Submitted That Met QC Criteria: March 29, 2016
• First Posted (ESTIMATE): April 4, 2016

Study Record Updates

• Last Update Posted (ACTUAL): January 20, 2022
• Last Update Submitted That Met QC Criteria: January 4, 2022
• Last Verified: November 1, 2018

More Information

Terms related to this study

• Additional Relevant MeSH Terms: Behavioral Symptoms; Mental Disorders; Mood Disorders; Pregnancy Complications; Puerperal Disorders; Bipolar and Related Disorders; Depression; Depressive Disorder; Depression, Postpartum; Bipolar Disorder; Physiological Effects of Drugs; Molecular Mechanisms of Pharmacological Action; Peripheral Nervous System Agents; Enzyme Inhibitors; Analgesics; Sensory System Agents; Anti-Inflammatory Agents, Non-Steroidal; Analgesics, Non-Narcotic; Anti-Inflammatory Agents; Antirheumatic Agents; Cyclooxygenase Inhibitors; Cyclooxygenase 2 Inhibitors; Celecoxib
• Other Study ID Numbers: 107775

Plan for Individual participant data (IPD)

• Plan to Share Individual Participant Data (IPD)?: YES
• IPD Plan Description: A data sharing agreement will be in place between Lawson Health Research Institute and The National Institute for Mental Health Research.

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: No