Bipolar Depression and Inflammation
|ClinicalTrials.gov Identifier: NCT01479829|
Recruitment Status : Active, not recruiting
First Posted : November 24, 2011
Last Update Posted : February 1, 2018
|Condition or disease||Intervention/treatment||Phase|
|Bipolar Depression||Drug: ESC + CBX Drug: ESC + PBO. Drug: ESC+CBX||Phase 4|
|Study Type :||Interventional (Clinical Trial)|
|Estimated Enrollment :||80 participants|
|Intervention Model:||Parallel Assignment|
|Masking:||Triple (Participant, Investigator, Outcomes Assessor)|
|Official Title:||Cyclooxygenase-2-Inhibitor Combination Treatment for Bipolar Depression: Role of Inflammation and Kynurenine Pathway Biomarkers|
|Study Start Date :||March 2011|
|Estimated Primary Completion Date :||December 2018|
|Estimated Study Completion Date :||December 2018|
Active Comparator: ESC + CBX
Escitalopram 10 mg twice day plus Celecoxib 200 mg twice daily.
Drug: ESC + CBX
Escitalopram (ESC) 10 mg twice day given orally twice a day plus Celecoxib (CBX) 200 mg twice daily.Drug: ESC+CBX
• Escitalopram 10 mg given twice day plus Celecoxib 200 mg twice daily.
Placebo Comparator: ESC + PBO.
Escitalopram 10 mg twice day plus placebo administered twice daily.
Drug: ESC + PBO.
• Escitalopram (ESC) 10 mg twice per day plus Placebo (PBO)administered twice daily.
- Improved affective responses [ Time Frame: 8 weeks ]combined pharmacotherapy of ESC + CBX will result in earlier and/or improved affective responses compared to ESC + placebo measured by rating three levels of assessment of clinical improvement: (a) time of onset of mood response, (b) magnitude of mood response, and (c) prevalence and time point of symptom remission
- Safety profile of combined ESC/CBX therapy [ Time Frame: 8 weeks ]Determine whether combined pharmacotherapy of ESC + CBX poses safety or tolerability issues, particularly in terms of gastrointestinal bleeding or cardiovascular health over a 8-week course of treatment.
Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT01479829
|United States, Illinois|
|Loyola University Medical Center|
|Maywood, Illinois, United States, 60153|
|Principal Investigator:||Angelo Halaris, M.D., PhD||Loyola Univeristy Medical Center|