Adjunctive Use of Celecoxib in the Treatment of Bipolar P... | NCT02726659

Studies
Adjunctive Use of Celecoxib in the Treatment of Bipolar Postpartum Depression

NCT02726659

Sponsor

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

Status

Terminated

Last Update Posted

Jan 20, 2022Actual

Enrollment

1Actual

Phase

Phase 3

Conditions

Bipolar Disorder
Postpartum Depression

Interventions

Celecoxib
Placebo

Countries

Canada

Protocol Section

Identification Module Status Module Sponsor/Collaborators Module Oversight Module Description Module Conditions Module Design Module Arms/Interventions Module Outcomes Module Eligibility Module Contacts/Locations Module References Module IPD Sharing Statement Module

Results Section

Participant Flow Module Baseline Characteristics Module Outcome Measures Module Adverse Events Module More Info Module

Annotation Section

Annotation Module

Document Section

Large Document Module

Derived Section

Miscellaneous Info Module Condition Browse Module Intervention Browse Module

Protocol Section

Identification Module

NCT ID

Results Section

No data available

No data is available for this block.

Annotation Section

No data available

No data is available for this block.

Document Section

No data available

No data is available for this block.

Derived Section

Miscellaneous Info Module

Version Holder

Status Module

Record Verification Date

Nov 2018

Overall Recruitment Status or Expanded Access Status

Terminated

Last Known Status

Not provided

Delayed Posting

Not provided

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.

Expanded Access Info

Start Date

May 2016Actual

Primary Completion Date

Jan 16, 2019Actual

Completion Date

Jan 16, 2019Actual

First Submitted Date

Mar 15, 2016

First Submission Date that Met QC Criteria

Mar 29, 2016

First Posted Date

Apr 4, 2016Estimated

Results Waived

Not provided

Results First Submitted Date

Not provided

Results First Submitted that Met QC Criteria

Not provided

Results First Posted Date

Not provided

Certification/Extension (aka Delayed Results) First Submitted Date

Not provided

Certification/Extension First Submitted that Passed QC Review

Not provided

Certification/Extension First Posted Date

Not provided

Last Update Submitted Date

Jan 4, 2022

Last Update Posted Date

Jan 20, 2022Actual

Oversight Module

Has Data Monitoring Committee (DMC)

Is FDA Regulated Drug

Is FDA Regulated Device

Is Unapproved Device

Not provided

Pediatric Postmarket Surveillance of a Device Product

Not provided

Product Exported from US

Not provided

FDAAA801 Violation

Not provided

Description Module

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.

Detailed Description

Not provided

Design Module

Study Type

Interventional

Number of References to an Expanded Access Study

Not provided

Expanded Access Types

Not provided

Patient Registry

Not provided

Target Follow-Up Duration

Not provided

Phases

Phase 3

Interventional Study Design

Allocation

Biospecimen

No data available

No data is available for this block.

Enrollment

1Actual

Arms/Interventions Module

Arm Groups

Label	Type	Description	Intervention Names
Celecoxib	Experimental	Adjunct celecoxib in 6 week treatment	Drug: Celecoxib
Placebo	Placebo Comparator	Adjunct placebo in 6 week treatment	Drug: Placebo

Interventions

Name	Type	Description	Arm Group Labels	Other Names
Celecoxib	Drug	Adjunct celecoxib	Celecoxib	Celebrex

Outcomes Module

Primary Outcomes

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 Outcomes

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

Other Outcomes

Not provided

Eligibility Module

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

Accepts Healthy Volunteers

Sex

Female

Sex/Gender Based

Not provided

Sex/Gender Description

Not provided

Minimum Age

18 Years

Maximum Age

45 Years

Standard Ages

Adult

Study Population

Not provided

Sampling Method

Not provided

Contacts/Locations Module

Central Contacts

Not provided

Overall Officials

Name	Affiliation	Role
Verinder Sharma, MB BS	London Health Sciences Centre Research Institute OR Lawson Research Institute of St. Joseph's	Principal Investigator

Locations

Facility	Status	City	State	ZIP	Country	Contacts
Parkwood Institute, Mental Health Care Buildling		London	Ontario	N6C 0A7	Canada

IPD Sharing Statement Module

Plan to Share IPD

Yes

Description

A data sharing agreement will be in place between Lawson Health Research Institute and The National Institute for Mental Health Research.

Types

Not provided

Time Frame

Not provided

Access Criteria

Not provided

URL

Not provided

Condition Browse Module

MeSH Terms

ID	Term
D001714	Bipolar Disorder
D019052	Depression, Postpartum

Ancestor Terms

ID	Term
D000068105	Bipolar and Related Disorders
D019964	Mood Disorders
D001523	Mental Disorders
D011644	Puerperal Disorders

Browse Leaves

Not provided

Browse Branches

Not provided

Intervention Browse Module

MeSH Terms

ID	Term
D000068579	Celecoxib

Ancestor Terms

ID	Term
D000096926	Benzenesulfonamides
D013449	Sulfonamides
D000577	Amides
D009930	Organic Chemicals

Browse Leaves

Not provided

Browse Branches

Not provided