Bipolar Depression and Inflammation
|The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details.|
|ClinicalTrials.gov Identifier: NCT01479829|
Recruitment Status : Completed
First Posted : November 24, 2011
Last Update Posted : March 4, 2019
|Condition or disease||Intervention/treatment||Phase|
|Bipolar Depression||Drug: ESC + CBX Drug: ESC + PBO. Drug: ESC+CBX||Phase 4|
|Study Type :||Interventional (Clinical Trial)|
|Actual Enrollment :||88 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|
|Actual Study Start Date :||March 2011|
|Actual Primary Completion Date :||March 2019|
|Actual Study Completion Date :||March 2019|
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.
• 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.
To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.
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|