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Bipolar Depression and Inflammation

This study is currently recruiting participants.
Verified October 2012 by Loyola University
Sponsor:
Collaborator:
Stanley Medical Research Institute
Information provided by (Responsible Party):
Loyola University
ClinicalTrials.gov Identifier:
NCT01479829
First received: September 22, 2011
Last updated: October 29, 2012
Last verified: October 2012
History of Changes
  Purpose

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.
Drug: ESC+CBX
 Phase 4

Study Type: Interventional
Study Design: Allocation: Randomized
Endpoint Classification: Safety/Efficacy Study
Intervention Model: Parallel Assignment
Masking: Double Blind (Subject, Investigator, Outcomes Assessor)
Primary Purpose: Treatment
Official Title: Cyclooxygenase-2-Inhibitor Combination Treatment for Bipolar Depression: Role of Inflammation and Kynurenine Pathway Biomarkers

Resource links provided by NLM:

U.S. FDA Resources

Further study details as provided by Loyola University:

Primary Outcome Measures:
  • Improved affective responses [ Time Frame: 8 weeks ] [ Designated as safety issue: No ]
    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 ] [ Designated as safety issue: Yes ]
    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: September 2014
Estimated Primary Completion Date: March 2014 (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.
Drug: ESC+CBX
• 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.

  Eligibility

Ages Eligible for Study:   21 Years to 65 Years
Genders Eligible for Study:   Both
Accepts Healthy Volunteers:   No
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
  Contacts and Locations
Please refer to this study by its ClinicalTrials.gov identifier: NCT01479829

Contacts
Contact: Paula Olivieri, MA 708-216-5090 paolivieri@lumc.edu

Locations
United States, Illinois
Loyola University Medical Center Recruiting
Maywood, Illinois, United States, 60153
Contact: Elaine Fluder, MSN     708-216-4608     efluder@lumc.edu    
Sub-Investigator: Edwin Meresh, M.D.            
Sub-Investigator: Jawed Fareed, PhD            
Principal Investigator: Angelo Halaris, M.D., PhD            
Sponsors and Collaborators
Loyola University
Stanley Medical Research Institute
Investigators
Principal Investigator: Angelo Halaris, M.D., PhD Loyola Univeristy Medical Center
  More Information

No publications provided

Responsible Party: Loyola University
ClinicalTrials.gov Identifier: NCT01479829     History of Changes
Other Study ID Numbers: 203368
Study First Received: September 22, 2011
Last Updated: October 29, 2012
Health Authority: United States: Institutional Review Board

Keywords provided by Loyola University:
Bipolar depression
Celecoxib
Escitalopram
Inflammation

Additional relevant MeSH terms:
Bipolar Disorder
Depression
Depressive Disorder
Inflammation
Affective Disorders, Psychotic
Mood Disorders
Mental Disorders
Behavioral Symptoms
Pathologic Processes
Dexetimide
Citalopram
Celecoxib
Cyclooxygenase 2 Inhibitors
Antiparkinson Agents
Anti-Dyskinesia Agents
 Central Nervous System Agents
Therapeutic Uses
Pharmacologic Actions
Parasympatholytics
Autonomic Agents
Peripheral Nervous System Agents
Physiological Effects of Drugs
Muscarinic Antagonists
Cholinergic Antagonists
Cholinergic Agents
Neurotransmitter Agents
Molecular Mechanisms of Pharmacological Action
Antidepressive Agents, Second-Generation
Antidepressive Agents
Psychotropic Drugs

ClinicalTrials.gov processed this record on June 18, 2013