A Phase 3 interventional study of Celecoxib and Placebo in Bipolar Disorder and Postpartum Depression, sponsored by London Health Sciences Centre Research Institute OR Lawson Research Institute of St. Joseph's. Terminated at 1 site in Canada. Open to female participants aged 18 Years to 45 Years. Per ClinicalTrials.gov, last updated 2022-01-20.
Sponsored by London Health Sciences Centre Research Institute OR Lawson Research Institute of St. Joseph's · Phase 3, Interventional, and Treatment
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.
528 studies on the registry are indexed under Depression, Postpartum; 124 are open to participants now.
This study's enrollment of 1 is below the median of 105 across 425 interventional studies indexed under Depression, Postpartum.
Browse Depression, Postpartum studies →London Health Sciences Centre Research Institute OR Lawson Research Institute of St. Joseph's is the lead sponsor of 309 studies on the registry; 126 are open to participants now.
Counted across the registry records on this site, refreshed daily.
Exclusion Criteria:
Adjunct celecoxib in 6 week treatment
Drug: Celecoxib
Adjunct placebo in 6 week treatment
Drug: Placebo
Adjunct celecoxib
Also known as: Celebrex
Adjunct placebo
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.
Time frame: 6 weeks
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.
Time frame: 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.
Time frame: 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.
Time frame: 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.
Time frame: 6 weeks
Plan to share: Yes — 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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This study is terminated, as verified in Nov 2018. You cannot join it, but the record below documents what was studied.
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London Health Sciences Centre Research Institute OR Lawson Research Institute of St. Joseph's