Status:
COMPLETED
Cyclooxygenase-2-Inhibitor Combination Treatment for Bipolar Depression
Lead Sponsor:
Loyola University
Collaborating Sponsors:
Stanley Medical Research Institute
Conditions:
Bipolar Depression
Eligibility:
All Genders
21-65 years
Phase:
PHASE4
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)...
Eligibility Criteria
Inclusion
- 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
- 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
Key Trial Info
Start Date :
March 23 2011
Trial Type :
INTERVENTIONAL
Allocation :
ACTUAL
End Date :
January 24 2018
Estimated Enrollment :
100 Patients enrolled
Trial Details
Trial ID
NCT01479829
Start Date
March 23 2011
End Date
January 24 2018
Last Update
April 29 2024
Active Locations (1)
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1
Loyola University Medical Center
Maywood, Illinois, United States, 60153