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Bipolar Depression and Inflammation

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details. Identifier: NCT01479829
Recruitment Status : Completed
First Posted : November 24, 2011
Last Update Posted : March 4, 2019
Stanley Medical Research Institute
Information provided by (Responsible Party):
Angelos Halaris, Loyola University

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

Condition or disease Intervention/treatment Phase
Bipolar Depression Drug: ESC + CBX Drug: ESC + PBO. Drug: ESC+CBX Phase 4

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.

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Study Type : Interventional  (Clinical Trial)
Actual Enrollment : 88 participants
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Triple (Participant, Investigator, Outcomes Assessor)
Primary Purpose: Treatment
Official Title: Cyclooxygenase-2-Inhibitor Combination Treatment for Bipolar Depression: Role of Inflammation and Kynurenine Pathway Biomarkers
Actual Study Start Date : March 2011
Actual Primary Completion Date : March 2019
Actual Study Completion Date : March 2019

Resource links provided by the National Library of Medicine

Arm Intervention/treatment
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.

Primary Outcome Measures :
  1. 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 :
  1. 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.

Information from the National Library of Medicine

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Ages Eligible for Study:   21 Years to 65 Years   (Adult, Older 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

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its identifier (NCT number): NCT01479829

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

Publications automatically indexed to this study by Identifier (NCT Number):
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Responsible Party: Angelos Halaris, Professor, Loyola University Identifier: NCT01479829    
Other Study ID Numbers: 203368
First Posted: November 24, 2011    Key Record Dates
Last Update Posted: March 4, 2019
Last Verified: March 2019
Keywords provided by Angelos Halaris, Loyola University:
Bipolar depression
Additional relevant MeSH terms:
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Depressive Disorder
Bipolar Disorder
Behavioral Symptoms
Mood Disorders
Mental Disorders
Pathologic Processes
Bipolar and Related Disorders
Anti-Inflammatory Agents, Non-Steroidal
Analgesics, Non-Narcotic
Sensory System Agents
Peripheral Nervous System Agents
Physiological Effects of Drugs
Anti-Inflammatory Agents
Antirheumatic Agents
Cyclooxygenase 2 Inhibitors
Cyclooxygenase Inhibitors
Enzyme Inhibitors
Molecular Mechanisms of Pharmacological Action
Serotonin Uptake Inhibitors
Neurotransmitter Uptake Inhibitors
Membrane Transport Modulators
Neurotransmitter Agents
Serotonin Agents
Antidepressive Agents, Second-Generation