Cyclooxygenase-2-Inhibitor Combination Treatment for Bipolar Depression

NCT01479829 | Completed Phase 4 Results DMC FDA Drug

• 1 other identifier: 203368
• Study Type: interventional
• Target: 100
• Locations: 1 country
• Sites: 1

Brief Summary

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

Conditions

Bipolar Depression

Keywords

Bipolar depression; Celecoxib; Escitalopram; Inflammation

Outcome Measures

Primary Outcomes (2)

• Response to Treatment

  Participants complete the Hamilton Depression Rating Scale (HDRS-17). The HDRS-17 is a clinician-administered assessment scale measuring the melancholic and physical symptoms of depression. Possible scores range from 0 to 54 (i.e., where higher scores indicate worse depression). In this study, response to treatment is defined as a reduction in the HDRS-17 score of at least 50% after 8 weeks of treatment.

  8 weeks

• Disease Remission

  Participants complete the Hamilton Depression Rating Scale (HDRS-17). The HDRS-17 is a clinician-administered assessment scale measuring the melancholic and physical symptoms of depression. Possible scores range from 0 to 54 (i.e., where higher scores indicate worse depression). In this study, diisease remission is defined as an HDRS-17 score less than 8 points after 8 weeks of treatment.

  8 weeks

Study Arms (2)

Intervention cohort

EXPERIMENTAL

Participants assigned to the intervention cohort receive 10mg escitalopram twice daily plus 200mg celecoxib twice daily.

Drug: Escitalopram; Drug: Celecoxib

Control cohort

PLACEBO COMPARATOR

Participants assigned to the control cohort receive 10mg escitalopram twice daily plus placebo administered twice daily.

Drug: Escitalopram; Drug: Placebo

Interventions

Escitalopram DRUG

Escitalopram is a Selective Serotonin Reuptake Inhibitor (SSRI)

Also known as: Lexapro

Control cohort; Intervention cohort

Celecoxib DRUG

Celecoxib is a nonsteroidal anti-inflammatory drug

Also known as: Celebrex

Intervention cohort

Placebo DRUG

Placebo is a manufactured capsule with no active ingredient

Also known as: Inactive drug

Control cohort

Eligibility Criteria

• Age: 21 Years - 65 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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

You may not qualify if:

• 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 (more 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 major depressive disorder (MDD)
• Inability to commit to the follow-up visits between 8 and 11 am

Sponsors & Collaborators

• Loyola University: lead
• Stanley Medical Research Institute: collaborator

Study Sites (1)

Loyola University Medical Center

Maywood, Illinois, 60153, United States

Location

Related Publications (2)

• 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.

  PMID: 31923551 DERIVED

• 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.

  PMID: 31630035 DERIVED

MeSH Terms

Conditions

Bipolar Disorder; Inflammation

Interventions

Escitalopram; Celecoxib

Condition Hierarchy (Ancestors)

Bipolar and Related Disorders; Mood Disorders; Mental Disorders; Pathologic Processes; Pathological Conditions, Signs and Symptoms

Intervention Hierarchy (Ancestors)

Propylamines; Amines; Organic Chemicals; Nitriles; Benzofurans; Heterocyclic Compounds, 2-Ring; Heterocyclic Compounds, Fused-Ring; Heterocyclic Compounds; Benzenesulfonamides; Sulfonamides; Amides; Benzene Derivatives; Hydrocarbons, Aromatic; Hydrocarbons, Cyclic; Hydrocarbons; Sulfones; Sulfur Compounds; Pyrazoles; Azoles; Heterocyclic Compounds, 1-Ring

Results Point of Contact

• Title: Dr. Angelos Halaris
• Organization: Loyola University Medical Center

ahalaris@luc.edu

708-216-3272

Study Officials

• Angelo Halaris, MD, PhD

  Loyola Univeristy Medical Center

  PRINCIPAL INVESTIGATOR

Publication Agreements

• PI is Sponsor Employee: Yes

Study Design

• Study Type: interventional
• Phase: phase 4
• Allocation: RANDOMIZED
• Masking: TRIPLE
• Who Masked: PARTICIPANT, INVESTIGATOR, OUTCOMES ASSESSOR
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Professor

Study Record Dates

• First Submitted: September 22, 2011
• First Posted: November 24, 2011
• Study Start: March 23, 2011
• Primary Completion: December 28, 2017
• Study Completion: January 24, 2018
• Last Updated: April 29, 2024
• Results First Posted: April 9, 2024

Record last verified: 2024-04

Data Sharing

• IPD Sharing: Will not share

Locations

US (1)