Bipolar Depression and Inflammation

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.

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