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

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Know the risks and potential benefits of clinical studies and talk to your health care provider before participating. Read our disclaimer for details. Identifier: NCT00441636
Recruitment Status : Recruiting
First Posted : March 1, 2007
Last Update Posted : April 30, 2018
Information provided by (Responsible Party):
Dr. Ruzica Jokic, Queen's University

Brief Summary:
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 or disease Intervention/treatment Phase
Depression Sleep Apnea, Obstructive Device: continuous positive airway pressure (CPAP) Not Applicable

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  (Clinical Trial)
Estimated Enrollment : 120 participants
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Single (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
Study Start Date : March 2007
Estimated Primary Completion Date : December 2019
Estimated Study Completion Date : December 2019

Resource links provided by the National Library of Medicine

MedlinePlus related topics: Anxiety Sleep Apnea

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 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.

Primary Outcome Measures :
  1. Montgomery Asberg Depression Rating Scale (MADRS) [ Time Frame: baseline and 6 weeks ]

Secondary Outcome Measures :
  1. Symbol digit modalities [ Time Frame: baseline and 6 weeks ]
  2. Stroop Test [ Time Frame: baseline and 6 weeks ]
  3. Trail-Making test [ Time Frame: baseline and 6 weeks ]
  4. Pittsburgh Sleep Quality Index (PSQI) [ Time Frame: baseline and 6 weeks ]
  5. Epworth Sleepiness Score (ESS) [ Time Frame: baseline and 6 weeks ]
  6. Beck Anxiety Inventory (BAI) [ Time Frame: baseline and 6 weeks ]
  7. SF-36 questionnaire [ Time Frame: baseline and 6 weeks ]
  8. Profile of mood state (POMS) [ Time Frame: baseline and 6 weeks ]
  9. HAM-D21 [ Time Frame: baseline and 6 weeks ]
    Hamilton depression inventory

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Ages Eligible for Study:   18 Years to 65 Years   (Adult, Older Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   Yes

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.

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its identifier (NCT number): NCT00441636

Contact: Ruzica Jokic, MD
Contact: Gisele Berube

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
Principal Investigator: Ruzica Jokic, MD Queen's University

Responsible Party: Dr. Ruzica Jokic, Principal Investigator, Queen's University Identifier: NCT00441636     History of Changes
Other Study ID Numbers: PSIY-247-06
First Posted: March 1, 2007    Key Record Dates
Last Update Posted: April 30, 2018
Last Verified: April 2018

Keywords provided by Dr. Ruzica Jokic, Queen's University:
obstructive sleep apnea

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