Clinical trial NCT01479829: Cyclooxygenase-2-Inhibitor Combination Treatment for Bipolar Depression
Official title: Cyclooxygenase-2-Inhibitor Combination Treatment for Bipolar Depression: Role of Inflammation and Kynurenine Pathway Biomarkers
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: PHASE4
Conditions: Bipolar Depression
Keywords: Bipolar depression
Celecoxib
Escitalopram
Inflammation
Lead sponsor: Loyola University
Sponsor class: OTHER
Collaborators: name: Stanley Medical Research Institute
First posted: 2011-11-24
Enrollment: 100
Sex: ALL
Minimum age (years): 21
Maximum age (years): 65
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: TREATMENT

Brief 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.

Eligibility criteria: Inclusion Criteria:

* Ages 21 - 65 years old at time of screening visit. Both genders and any race will be accepted.
* Diagnosis of BPD I or II without significant co-morbid secondary medical or psychiatric diagnoses; no substance abuse or dependence during preceding 12 months
* A minimum score of 18 on the first 17 items of the 21-item Hamilton Depression Scale
* Willingness to washout for a reasonable time (depending on the substance) from: Vitamin E and fish oils (\>600 IU/day), non-aspirin NSAIDs or aspirin (\>81 mg/day, H2 receptor antagonists, Ginko biloba, caffeine on morning of blood drawing, and to institute lights-out at 23:00 hours on the nights before blood drawings

Exclusion Criteria:

* Any abnormal findings on the physical exam, ECG, blood/urine or minor infections
* Any pre-existing physical pain condition, including fibromyalgia
* History of peptic ulcer complicated by perforation, hemorrhage, or obstruction; symptoms of peptic ulcer within 4 weeks of enrollment date
* Any substance abuse or dependence during the preceding 12 months
* Clinically significant hypertension, anemia, liver disease, kidney disease, arthritis, diabetes, recurrent migraines, epilepsy, stroke, gum disease, autoimmune disease
* Current use of lithium
* Current use of a stimulant
* Certain steroids including use of hormonal birth control and any systemic or topical corticosteroids (hormone replacement therapy will be allowed)
* Unwillingness to refrain from H2 receptor antagonists, non-aspirin NSAIDs, or aspirin (more than 1 mg/day).
* Use of any anticoagulant agents
* Use of nicotine-containing substances. Subjects who quit smoking more than 3 months prior to assessment may be considered for the study
* Known sensitivity or allergy to the study medications or a need to receive agents that are contra-indicated in combination with CBX or ESC
* Unwillingness to fast and abstain from caffeine on mornings of blood drawings
* A sleep disorder other than insomnia or hypersomnia as a distinct symptom of major depressive disorder (MDD)
* Inability to commit to the follow-up visits between 8 and 11 am

Primary outcomes:
measure: Response to Treatment
timeFrame: 8 weeks
measure: Disease Remission
timeFrame: 8 weeks
Secondary outcomes:
Other outcomes:
Locations:
city: Maywood
country: United States
facility: Loyola University Medical Center
state: Illinois
Study officials:
affiliation: Loyola Univeristy Medical Center
name: Angelo Halaris, MD, PhD
role: PRINCIPAL_INVESTIGATOR
References:
citation: 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.
citation: 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.