Bipolar Depression and Inflammation

• Status: Completed
• Trial end date: 2019-03-01
• Target enrollment: 0
• Participant gender: All

Summary

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

• Phase: Phase 4
• Accepts Healthy Volunteers?: No

Details

• Lead Sponsor: Loyola University
• Collaborator: Stanley Medical Research Institute
• Treatments: Celecoxib; Citalopram; Cyclooxygenase 2 Inhibitors; Dexetimide

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 (mor 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 MDD

• Inability to commit to the follow-up visits between 8 and 11 am