Adjunctive Use of Celecoxib in the Treatment of Bipolar Postpartum Depression

NCT02726659 | Terminated Phase 3

• 1 other identifier: 107775
• Study Type: interventional
• Target: 1
• Locations: 1 country
• Sites: 1

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.

Conditions

Bipolar Disorder; Postpartum Depression

Outcome Measures

Primary Outcomes (1)

• 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 Outcomes (4)

• Montgomery Asberg Depression Scale

  6 weeks

• Udvalg for Kliniske Undersogelser Scale

  6 weeks

• Edinburgh Postnatal Depression Scale (EPDS)

  6 weeks

• Clinical Global Impression Scale (CGI)

  6 weeks

Study Arms (2)

Celecoxib

EXPERIMENTAL

Adjunct celecoxib in 6 week treatment

Drug: Celecoxib

Placebo

PLACEBO COMPARATOR

Adjunct placebo in 6 week treatment

Drug: Placebo

Interventions

Celecoxib DRUG

Adjunct celecoxib

Also known as: Celebrex

Celecoxib

Placebo DRUG

Adjunct placebo

Placebo

Eligibility Criteria

• Age: 18 Years - 45 Years
• Sex: female
• Healthy Volunteers: No
• Age Groups: Adult (18-64)

You may qualify if:

• 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

You may not qualify if:

• 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

Sponsors & Collaborators

• London Health Sciences Centre Research Institute OR Lawson Research Institute of St. Joseph's: lead

Study Sites (1)

Parkwood Institute, Mental Health Care Buildling

London, Ontario, N6C 0A7, Canada

Location

MeSH Terms

Conditions

Bipolar Disorder; Depression, Postpartum

Interventions

Celecoxib

Condition Hierarchy (Ancestors)

Bipolar and Related Disorders; Mood Disorders; Mental Disorders; Puerperal Disorders; Pregnancy Complications; Female Urogenital Diseases and Pregnancy Complications; Urogenital Diseases; Depressive Disorder

Intervention Hierarchy (Ancestors)

Benzenesulfonamides; Sulfonamides; Amides; Organic Chemicals; Benzene Derivatives; Hydrocarbons, Aromatic; Hydrocarbons, Cyclic; Hydrocarbons; Sulfones; Sulfur Compounds; Pyrazoles; Azoles; Heterocyclic Compounds, 1-Ring; Heterocyclic Compounds

Study Officials

• Verinder Sharma, MB BS

  London Health Sciences Centre Research Institute OR Lawson Research Institute of St. Joseph's

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: interventional
• Phase: phase 3
• Allocation: RANDOMIZED
• Masking: TRIPLE
• Who Masked: PARTICIPANT, CARE PROVIDER, INVESTIGATOR
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: March 15, 2016
• First Posted: April 4, 2016
• Study Start: May 1, 2016
• Primary Completion: January 16, 2019
• Study Completion: January 16, 2019
• Last Updated: January 20, 2022

Record last verified: 2018-11

Data Sharing

• IPD Sharing: Will share

Locations

CA (1)