Cyclooxygenase-2-Inhibitor Combination Treatment for Bipolar Depression

Phase 4 Completed 100 enrolled Loyola University Stanley Medical Research Institute · collab

RandomizedParallel-groupTriple-blindTreatment

Summary

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

Timeline

Start: 2011-03-23
Primary completion: 2017-12-28
Completion: 2018-01-24

Outcome

Met primary endpoint

registry analysis (superiority test); Intervention Cohort vs Control Cohort; p = .02; Chi-square value 5.3466; Chi-squared NCT01479829 ↗

registry analysis (superiority test); Intervention Cohort vs Control Cohort; p <.001; Chi-square value 13.3821; Chi-squared NCT01479829 ↗

Publications

Murata S, Murphy M, Hoppensteadt D, Fareed J, Welborn A, Halaris A. Effects of adjunctive inflammatory modulation on IL-1beta in treatment resistant bipolar depression. Brain Behav Immun. 2020 Jul;87:369-376. doi: 10.1016/j.bbi.2020.01.004. Epub 2020 Jan 7.
Halaris A, Cantos A, Johnson K, Hakimi M, Sinacore J. Modulation of the inflammatory response benefits treatment-resistant bipolar depression: A randomized clinical trial. J Affect Disord. 2020 Jan 15;261:145-152. doi: 10.1016/j.jad.2019.10.021. Epub 2019 Oct 13.

Drugs

Evaluation	Drug	Modality	Dose	Route
Subject	Celecoxib	Other / unclassified	200 mg	—
Background	Escitalopram	Small molecule	10 mg	—