Treatment Resistant Depression and Obstructive Sleep Apnea, Effect of Continuous Positive Airway Pressure (CPAP)

April 27, 2018 updated by: Dr. Ruzica Jokic, Queen's University

Treatment Resistant Depression and Obstructive Sleep Apnea: Effect of Treatment With CPAP on Mood, Anxiety and Quality of Life

The purpose of the study is to determine the effect on mood and anxiety symptoms of adding CPAP to the psychiatric treatment of patients with TRD (treatment resistant depression) and associated OSA (obstructive sleep apnea).

Study Overview

Status

Unknown

Conditions

Intervention / Treatment

Detailed Description

Primary objective:

What is the effect on mood and anxiety symptoms of adding CPAP to the psychiatric treatment of patients with TRD and associated OSA?

Secondary objectives:

  1. How common is co-morbid OSA in patients with treatment resistant unipolar depression referred to a tertiary Mood Disorders Clinic?
  2. Is there a difference in daytime functioning (severity of depressive and anxiety symptoms, cognitive function, daytime sleepiness) and sleep quality between patients with TRD diagnosed with OSA compared with patients with TRD who have no OSA?
  3. What is the association between sleep fragmentation and hypoxemia and the severity of depression in patients with TRD?

Study Type

Interventional

Enrollment (Anticipated)

120

Phase

  • Not Applicable

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Contact

Study Contact Backup

Study Locations

  • Canada
    • Ontario
      • Kingston, Ontario, Canada, K7L4X3
        • Recruiting
        • Providence Continuing Care Centre, Mental Health Services
        • Contact:
          • Ruzica Jokic, MD
        • Principal Investigator:
          • Ruzica Jokic, MD

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

18 years to 65 years (ADULT, OLDER_ADULT)

Accepts Healthy Volunteers

Yes

Genders Eligible for Study

All

Description

Inclusion Criteria:

  • Patients with TRD.
  • Males and females between the ages of 18 and 65 years who agree to take part and sign the Informed Consent will be invited to participate in the study.
  • Patients with co-morbid Dysthymic Disorder, Generalized Anxiety Disorder or Social Anxiety Disorder may be included in the study.

Exclusion Criteria:

  • Patients with uncontrolled medical illnesses will not be permitted to participate.
  • Patients with a history of current or Bipolar Disorder, Schizophrenia, Panic Disorder, Obsessive-Compulsive Disorder or Anorexia Nervosa.
  • Head injury patients resulting in loss of consciousness for more than 10 minutes.
  • Patients with epilepsy or severe personality disorders who, at the judgment of the investigators, are not appropriate candidates for the study, will be excluded.
  • Patients who do not have the mental or physical capacity to apply the CPAP interface and to plug in and switch on an auto CPAP unit at home will be excluded.
  • Blind and/or deaf patients will be excluded.
  • Patients who initially decline an offer of CPAP treatment for OSA, and those who prefer conservative treatment options (weight loss, avoidance of alcohol and sedatives) will be excluded.
  • Patients with severe claustrophobia, who cannot tolerate any CPAP interface, will be excluded.

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Primary Purpose: TREATMENT
  • Allocation: RANDOMIZED
  • Interventional Model: PARALLEL
  • Masking: SINGLE

Arms and Interventions

Participant Group / Arm
Intervention / Treatment
EXPERIMENTAL: CPAP treatment
Continuous Positive Airway Pressure (CPAP)for 4 weeks
Device: continuous positive airway pressure (CPAP)
CPAP (Respironics: RemStar plus M-series) machines for treatment of obstructive sleep apnea training for participant required by registered sleep technologist
Other Names:
  • CPAP - Respironics: RemStar plus M-series
NO_INTERVENTION: No CPAP
routine psychiatric care for 4 weeks followed by CPAP titration and initiation after followup measures.
NO_INTERVENTION: Control group
No obstructive sleep apnea detected.

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Time Frame
Montgomery Asberg Depression Rating Scale (MADRS)
Time Frame: baseline and 6 weeks
baseline and 6 weeks

Secondary Outcome Measures

Outcome Measure
Measure Description
Time Frame
Symbol digit modalities
Time Frame: baseline and 6 weeks
baseline and 6 weeks
Stroop Test
Time Frame: baseline and 6 weeks
baseline and 6 weeks
Trail-Making test
Time Frame: baseline and 6 weeks
baseline and 6 weeks
Pittsburgh Sleep Quality Index (PSQI)
Time Frame: baseline and 6 weeks
baseline and 6 weeks
Epworth Sleepiness Score (ESS)
Time Frame: baseline and 6 weeks
baseline and 6 weeks
Beck Anxiety Inventory (BAI)
Time Frame: baseline and 6 weeks
baseline and 6 weeks
SF-36 questionnaire
Time Frame: baseline and 6 weeks
baseline and 6 weeks
Profile of mood state (POMS)
Time Frame: baseline and 6 weeks
baseline and 6 weeks
HAM-D21
Time Frame: baseline and 6 weeks
Hamilton depression inventory
baseline and 6 weeks

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Queen's University

Investigators

  • Principal Investigator: Ruzica Jokic, MD, Queen's University

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start

March 1, 2007

Primary Completion (ANTICIPATED)

December 1, 2019

Study Completion (ANTICIPATED)

December 1, 2019

Study Registration Dates

First Submitted

February 27, 2007

First Submitted That Met QC Criteria

February 28, 2007

First Posted (ESTIMATE)

March 1, 2007

Study Record Updates

Last Update Posted (ACTUAL)

April 30, 2018

Last Update Submitted That Met QC Criteria

April 27, 2018

Last Verified

April 1, 2018

More Information

Terms related to this study

Keywords

Additional Relevant MeSH Terms

Other Study ID Numbers

  • PSIY-247-06

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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