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Bipolar Depression and Inflammation

This study is ongoing, but not recruiting participants.
Stanley Medical Research Institute
Information provided by (Responsible Party):
Angelos Halaris, Loyola University Identifier:
First received: September 22, 2011
Last updated: March 13, 2017
Last verified: March 2017
This project will attempt to enhance and augment the antidepressant efficacy of a commonly used antidepressant in poorly responding bipolar depressed patients.

Condition Intervention Phase
Bipolar Depression
Drug: ESC + CBX
Drug: ESC + PBO.
Phase 4

Study Type: Interventional
Study Design: Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Participant, Investigator, Outcomes Assessor
Primary Purpose: Treatment
Official Title: Cyclooxygenase-2-Inhibitor Combination Treatment for Bipolar Depression: Role of Inflammation and Kynurenine Pathway Biomarkers

Further study details as provided by Loyola University:

Primary Outcome Measures:
  • Improved affective responses [ Time Frame: 8 weeks ]
    combined pharmacotherapy of ESC + CBX will result in earlier and/or improved affective responses compared to ESC + placebo measured by rating three levels of assessment of clinical improvement: (a) time of onset of mood response, (b) magnitude of mood response, and (c) prevalence and time point of symptom remission

Secondary Outcome Measures:
  • Safety profile of combined ESC/CBX therapy [ Time Frame: 8 weeks ]
    Determine whether combined pharmacotherapy of ESC + CBX poses safety or tolerability issues, particularly in terms of gastrointestinal bleeding or cardiovascular health over a 8-week course of treatment.

Estimated Enrollment: 80
Study Start Date: March 2011
Estimated Study Completion Date: December 2017
Estimated Primary Completion Date: June 2017 (Final data collection date for primary outcome measure)
Arms Assigned Interventions
Active Comparator: ESC + CBX
Escitalopram 10 mg twice day plus Celecoxib 200 mg twice daily.
Drug: ESC + CBX
Escitalopram (ESC) 10 mg twice day given orally twice a day plus Celecoxib (CBX) 200 mg twice daily.
• Escitalopram 10 mg given twice day plus Celecoxib 200 mg twice daily.
Placebo Comparator: ESC + PBO.
Escitalopram 10 mg twice day plus placebo administered twice daily.
Drug: ESC + PBO.
• Escitalopram (ESC) 10 mg twice per day plus Placebo (PBO)administered twice daily.

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). 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.

Ages Eligible for Study:   21 Years to 65 Years   (Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No

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
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Please refer to this study by its identifier: NCT01479829

United States, Illinois
Loyola University Medical Center
Maywood, Illinois, United States, 60153
Sponsors and Collaborators
Loyola University
Stanley Medical Research Institute
Principal Investigator: Angelo Halaris, M.D., PhD Loyola Univeristy Medical Center
  More Information

Responsible Party: Angelos Halaris, Professor, Loyola University Identifier: NCT01479829     History of Changes
Other Study ID Numbers: 203368
Study First Received: September 22, 2011
Last Updated: March 13, 2017

Keywords provided by Loyola University:
Bipolar depression

Additional relevant MeSH terms:
Depressive Disorder
Bipolar Disorder
Behavioral Symptoms
Mood Disorders
Mental Disorders
Pathologic Processes
Bipolar and Related Disorders
Cyclooxygenase 2 Inhibitors
Serotonin Uptake Inhibitors
Neurotransmitter Uptake Inhibitors
Membrane Transport Modulators
Molecular Mechanisms of Pharmacological Action
Neurotransmitter Agents
Serotonin Agents
Physiological Effects of Drugs
Antidepressive Agents, Second-Generation
Antidepressive Agents
Psychotropic Drugs
Antiparkinson Agents
Anti-Dyskinesia Agents
Autonomic Agents
Peripheral Nervous System Agents
Muscarinic Antagonists
Cholinergic Antagonists processed this record on April 25, 2017