Cyclooxygenase-2-Inhibitor Combination Treatment for Bipolar Depression

Bipolar Depression Clinical Trial

Official title:

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

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT01479829
• Other study ID #: 203368
• Status: Completed
• Phase: Phase 4
• Start date: March 23, 2011
• Est. completion date: January 24, 2018

Study information

• Verified date: April 2024
• Source: Loyola University
• Contact: n/a
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial Summary

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

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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 100
• Est. completion date: January 24, 2018
• Est. primary completion date: December 28, 2017
• Accepts healthy volunteers: No
• Gender: All
• Age group: 21 Years to 65 Years

Eligibility

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

Related Conditions & MeSH terms

• Bipolar Depression
• Bipolar Disorder
• Depression
• Depressive Disorder

Intervention

Drug:
• Escitalopram
Escitalopram is a Selective Serotonin Reuptake Inhibitor (SSRI)
• Celecoxib
Celecoxib is a nonsteroidal anti-inflammatory drug
• Placebo
Placebo is a manufactured capsule with no active ingredient

Locations

Country	Name	City	State
United States	Loyola University Medical Center	Maywood	Illinois

Sponsors (2)

Lead Sponsor	Collaborator
Loyola University	Stanley Medical Research Institute

Country where clinical trial is conducted

United States, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Response to Treatment	Participants complete the Hamilton Depression Rating Scale (HDRS-17). The HDRS-17 is a clinician-administered assessment scale measuring the melancholic and physical symptoms of depression. Possible scores range from 0 to 54 (i.e., where higher scores indicate worse depression). In this study, response to treatment is defined as a reduction in the HDRS-17 score of at least 50% after 8 weeks of treatment.	8 weeks
Primary	Disease Remission	Participants complete the Hamilton Depression Rating Scale (HDRS-17). The HDRS-17 is a clinician-administered assessment scale measuring the melancholic and physical symptoms of depression. Possible scores range from 0 to 54 (i.e., where higher scores indicate worse depression). In this study, diisease remission is defined as an HDRS-17 score less than 8 points after 8 weeks of treatment.	8 weeks