NCT01479829

Cyclooxygenase-2-Inhibitor Combination Treatment for Bipolar Depression

Cyclooxygenase-2-Inhibitor Combination Treatment for Bipolar Depression: Role of Inflammation and Kynurenine Pathway Biomarkers

• Status: Completed
• Phase: Phase 4
• Study type: Interventional
• Enrollment: 100 (actual)
• Sponsor: Loyola University · Academic / Other
• Sex: All
• Age: 21 Years – 65 Years
• Healthy volunteers: Not accepted

Summary

This project will attempt to enhance and augment the antidepressant efficacy of a commonly used antidepressant in poorly responding bipolar depressed patients.

Detailed description

This is a placebo-controlled study of patients with bipolar I disorder (BPD) utilizing a well-known antidepressant, escitalopram (ESC), in combination with the anti-inflammatory agent, celecoxib (CBX). The investigators hypothesize that combination treatment will lead to a qualitatively and quantitatively augmented response and will result in greater numbers of remitters compared to ESC monotherapy.

Conditions

• Bipolar Depression

Interventions

Type	Name	Description
DRUG	Escitalopram	Escitalopram is a Selective Serotonin Reuptake Inhibitor (SSRI)
DRUG	Celecoxib	Celecoxib is a nonsteroidal anti-inflammatory drug
DRUG	Placebo	Placebo is a manufactured capsule with no active ingredient

Timeline

• Start date: 2011-03-23
• Primary completion: 2017-12-28
• Completion: 2018-01-24
• First posted: 2011-11-24
• Last updated: 2024-04-29
• Results posted: 2024-04-09

Locations

1 site across 1 country: United States

Regulatory

• FDA-regulated drug study