Cyclooxygenase-2-Inhibitor Combination Treatment for Bipolar Depression

Study Results

Results available

Outcome measurements, participant flow, baseline characteristics, and adverse events have been published for this study.

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Basic Information

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Recruitment Status

COMPLETED

Clinical Phase

PHASE4

Total Enrollment

100 participants

Study Classification

INTERVENTIONAL

Study Start Date

2011-03-23

Study Completion Date

2018-01-24

Brief Summary

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

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Detailed Description

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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.

Conditions

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Bipolar Depression

Study Design

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Allocation Method

RANDOMIZED

Intervention Model

PARALLEL

Primary Study Purpose

TREATMENT

Blinding Strategy

TRIPLE

Participants Investigators Outcome Assessors

Study Groups

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Intervention cohort

Participants assigned to the intervention cohort receive 10mg escitalopram twice daily plus 200mg celecoxib twice daily.

Group Type EXPERIMENTAL

Escitalopram

Intervention Type DRUG

Escitalopram is a Selective Serotonin Reuptake Inhibitor (SSRI)

Celecoxib

Intervention Type DRUG

Celecoxib is a nonsteroidal anti-inflammatory drug

Control cohort

Participants assigned to the control cohort receive 10mg escitalopram twice daily plus placebo administered twice daily.

Group Type PLACEBO_COMPARATOR

Escitalopram

Intervention Type DRUG

Escitalopram is a Selective Serotonin Reuptake Inhibitor (SSRI)

Placebo

Intervention Type DRUG

Placebo is a manufactured capsule with no active ingredient

Interventions

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Escitalopram

Escitalopram is a Selective Serotonin Reuptake Inhibitor (SSRI)

Intervention Type DRUG

Celecoxib

Celecoxib is a nonsteroidal anti-inflammatory drug

Intervention Type DRUG

Placebo

Placebo is a manufactured capsule with no active ingredient

Intervention Type DRUG

Other Intervention Names

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Lexapro Celebrex Inactive drug

Eligibility Criteria

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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

Minimum Eligible Age

21 Years

Maximum Eligible Age

65 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

No