Bipolar Depression and Inflammation

This study is currently recruiting participants. (see Contacts and Locations)
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

September 22, 2011
October 29, 2012
March 2011
March 2014   (final data collection date for primary outcome measure)
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
Same as current
Complete list of historical versions of study NCT01479829 on ClinicalTrials.gov Archive Site
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.
Same as current
Not Provided
Not Provided
 
Bipolar Depression and Inflammation
Cyclooxygenase-2-Inhibitor Combination Treatment for Bipolar Depression: Role of Inflammation and Kynurenine Pathway Biomarkers

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

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.

Interventional
Phase 4
Allocation: Randomized
Endpoint Classification: Safety/Efficacy Study
Intervention Model: Parallel Assignment
Masking: Double Blind (Subject, Investigator, Outcomes Assessor)
Primary Purpose: Treatment
Bipolar Depression
  • Drug: ESC + CBX
    Escitalopram (ESC) 10 mg twice day given orally twice a day plus Celecoxib (CBX) 200 mg twice daily.
  • Drug: ESC + PBO.
    • Escitalopram (ESC) 10 mg twice per day plus Placebo (PBO)administered twice daily.
  • Drug: ESC+CBX
    • Escitalopram 10 mg given twice day plus Celecoxib 200 mg twice daily.
  • Active Comparator: ESC + CBX
    Escitalopram 10 mg twice day plus Celecoxib 200 mg twice daily.
    Interventions:
    • Drug: ESC + CBX
    • Drug: ESC+CBX
  • Placebo Comparator: ESC + PBO.
    Escitalopram 10 mg twice day plus placebo administered twice daily.
    Intervention: Drug: ESC + PBO.
Not Provided

*   Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline.
 
Recruiting
80
September 2014
March 2014   (final data collection date for primary outcome measure)

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
Both
21 Years to 65 Years
No
Contact: Paula Olivieri, MA 708-216-5090 paolivieri@lumc.edu
United States
 
NCT01479829
203368
Yes
Loyola University
Loyola University
Stanley Medical Research Institute
Principal Investigator: Angelo Halaris, M.D., PhD Loyola Univeristy Medical Center
Loyola University
October 2012

ICMJE     Data element required by the International Committee of Medical Journal Editors and the World Health Organization ICTRP