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

This study is currently recruiting participants.
Verified April 2012 by Queen's University
Sponsor:
Information provided by (Responsible Party):
Queen's University
ClinicalTrials.gov Identifier:
NCT00441636
First received: February 27, 2007
Last updated: April 27, 2012
Last verified: April 2012
History of Changes
  Purpose

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).


Condition Intervention
Depression
Sleep Apnea, Obstructive
 Device: continuous positive airway pressure (CPAP)

Study Type: Interventional
Study Design: Allocation: Randomized
Endpoint Classification: Efficacy Study
Intervention Model: Parallel Assignment
Masking: Single Blind (Outcomes Assessor)
Primary Purpose: Treatment
Official Title: Treatment Resistant Depression and Obstructive Sleep Apnea: Effect of Treatment With CPAP on Mood, Anxiety and Quality of Life

Resource links provided by NLM:

U.S. FDA Resources

Further study details as provided by Queen's University:

Primary Outcome Measures:
  • Montgomery Asberg Depression Rating Scale (MADRS) [ Time Frame: baseline and 6 weeks ] [ Designated as safety issue: No ]

Secondary Outcome Measures:
  • Symbol digit modalities [ Time Frame: baseline and 6 weeks ] [ Designated as safety issue: No ]
  • Stroop Test [ Time Frame: baseline and 6 weeks ] [ Designated as safety issue: No ]
  • Trail-Making test [ Time Frame: baseline and 6 weeks ] [ Designated as safety issue: No ]
  • Pittsburgh Sleep Quality Index (PSQI) [ Time Frame: baseline and 6 weeks ] [ Designated as safety issue: No ]
  • Epworth Sleepiness Score (ESS) [ Time Frame: baseline and 6 weeks ] [ Designated as safety issue: No ]
  • Beck Anxiety Inventory (BAI) [ Time Frame: baseline and 6 weeks ] [ Designated as safety issue: No ]
  • SF-36 questionnaire [ Time Frame: baseline and 6 weeks ] [ Designated as safety issue: No ]
  • Profile of mood state (POMS) [ Time Frame: baseline and 6 weeks ] [ Designated as safety issue: No ]
  • HAM-D21 [ Time Frame: baseline and 6 weeks ] [ Designated as safety issue: No ]
    Hamilton depression inventory


Estimated Enrollment: 120
Study Start Date: March 2007
Estimated Study Completion Date: December 2012
Estimated Primary Completion Date: December 2012 (Final data collection date for primary outcome measure)
Arms Assigned Interventions
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 Name: 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.

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?
  Eligibility

Ages Eligible for Study:   18 Years to 65 Years
Genders Eligible for Study:   Both
Accepts Healthy Volunteers:   Yes
Criteria

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.
  Contacts and Locations
Please refer to this study by its ClinicalTrials.gov identifier: NCT00441636

Contacts
Contact: Ruzica Jokic, MD jokicr@pccchealth.org

Locations
Canada, Ontario
Providence Continuing Care Centre, Mental Health Services Recruiting
Kingston, Ontario, Canada, K7L4X3
Contact: Ruzica Jokic, MD            
Principal Investigator: Ruzica Jokic, MD            
Sponsors and Collaborators
Queen's University
Investigators
Principal Investigator: Ruzica Jokic, MD Queen's University
  More Information

No publications provided

Responsible Party: Queen's University
ClinicalTrials.gov Identifier: NCT00441636     History of Changes
Other Study ID Numbers: PSIY-247-06
Study First Received: February 27, 2007
Last Updated: April 27, 2012
Health Authority: Canada: Health Canada

Keywords provided by Queen's University:
depression
CPAP
obstructive sleep apnea

Additional relevant MeSH terms:
Apnea
Depression
Depressive Disorder
Sleep Apnea Syndromes
Sleep Apnea, Obstructive
Respiration Disorders
Respiratory Tract Diseases
Signs and Symptoms, Respiratory
 Signs and Symptoms
Behavioral Symptoms
Mood Disorders
Mental Disorders
Sleep Disorders, Intrinsic
Dyssomnias
Sleep Disorders
Nervous System Diseases

ClinicalTrials.gov processed this record on May 21, 2013