Back to resultsBipolar Depression and Inflammation
Primary Purpose
Bipolar Depression
Status
Completed
Phase
Phase 4
Locations
United States
Study Type
Interventional
Intervention
ESC + CBX
ESC + PBO.
ESC+CBX
Sponsored by
About this trial
This is an interventional treatment trial for Bipolar Depression focused on measuring Bipolar depression, Celecoxib, Escitalopram, Inflammation
Eligibility 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
Sites / Locations
- Loyola University Medical Center
Arms of the Study
Arm 1
Arm 2
Arm Type
Active Comparator
Placebo Comparator
Arm Label
ESC + CBX
ESC + PBO.
Arm Description
Escitalopram 10 mg twice day plus Celecoxib 200 mg twice daily.
Escitalopram 10 mg twice day plus placebo administered twice daily.
Outcomes
Primary Outcome Measures
Improved affective responses
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
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.
Full Information
NCT ID
NCT01479829
First Posted
September 22, 2011
Last Updated
March 1, 2019
Sponsor
Loyola University
Collaborators
Stanley Medical Research Institute
1. Study Identification
Unique Protocol Identification Number
NCT01479829
Brief Title
Bipolar Depression and Inflammation
Official Title
Cyclooxygenase-2-Inhibitor Combination Treatment for Bipolar Depression: Role of Inflammation and Kynurenine Pathway Biomarkers
Study Type
Interventional
2. Study Status
Record Verification Date
March 2019
Overall Recruitment Status
Completed
Study Start Date
March 2011 (Actual)
Primary Completion Date
March 2019 (Actual)
Study Completion Date
March 2019 (Actual)
3. Sponsor/Collaborators
Responsible Party, by Official Title
Principal Investigator
Name of the Sponsor
Loyola University
Collaborators
Stanley Medical Research Institute
4. Oversight
Data Monitoring Committee
Yes
5. Study Description
Brief Summary
This project will attempt to enhance and augment the antidepressant efficacy of a commonly used antidepressant in poorly responding bipolar depressed patients.
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.
6. Conditions and Keywords
Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Bipolar Depression
Keywords
Bipolar depression, Celecoxib, Escitalopram, Inflammation
7. Study Design
Primary Purpose
Treatment
Study Phase
Phase 4
Interventional Study Model
Parallel Assignment
Masking
ParticipantInvestigatorOutcomes Assessor
Allocation
Randomized
Enrollment
88 (Actual)
8. Arms, Groups, and Interventions
Arm Title
ESC + CBX
Arm Type
Active Comparator
Arm Description
Escitalopram 10 mg twice day plus Celecoxib 200 mg twice daily.
Arm Title
ESC + PBO.
Arm Type
Placebo Comparator
Arm Description
Escitalopram 10 mg twice day plus placebo administered twice daily.
Intervention Type
Drug
Intervention Name(s)
ESC + CBX
Intervention Description
Escitalopram (ESC) 10 mg twice day given orally twice a day plus Celecoxib (CBX) 200 mg twice daily.
Intervention Type
Drug
Intervention Name(s)
ESC + PBO.
Intervention Description
• Escitalopram (ESC) 10 mg twice per day plus Placebo (PBO)administered twice daily.
Intervention Type
Drug
Intervention Name(s)
ESC+CBX
Intervention Description
• Escitalopram 10 mg given twice day plus Celecoxib 200 mg twice daily.
Primary Outcome Measure Information:
Title
Improved affective responses
Description
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
Time Frame
8 weeks
Secondary Outcome Measure Information:
Title
Safety profile of combined ESC/CBX therapy
Description
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.
Time Frame
8 weeks
10. Eligibility
Sex
All
Minimum Age & Unit of Time
21 Years
Maximum Age & Unit of Time
65 Years
Accepts Healthy Volunteers
No
Eligibility 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
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Angelo Halaris, M.D., PhD
Organizational Affiliation
Loyola Univeristy Medical Center
Official's Role
Principal Investigator
Facility Information:
Facility Name
Loyola University Medical Center
City
Maywood
State/Province
Illinois
ZIP/Postal Code
60153
Country
United States
12. IPD Sharing Statement
Citations:
PubMed Identifier
31923551
Citation
Murata S, Murphy M, Hoppensteadt D, Fareed J, Welborn A, Halaris A. Effects of adjunctive inflammatory modulation on IL-1beta in treatment resistant bipolar depression. Brain Behav Immun. 2020 Jul;87:369-376. doi: 10.1016/j.bbi.2020.01.004. Epub 2020 Jan 7.
Results Reference
derived
PubMed Identifier
31630035
Citation
Halaris A, Cantos A, Johnson K, Hakimi M, Sinacore J. Modulation of the inflammatory response benefits treatment-resistant bipolar depression: A randomized clinical trial. J Affect Disord. 2020 Jan 15;261:145-152. doi: 10.1016/j.jad.2019.10.021. Epub 2019 Oct 13.
Results Reference
derived
Learn more about this trial
Bipolar Depression and Inflammation
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