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

Sponsored by:	Queen's University
Information provided by:	Queen's University
ClinicalTrials.gov Identifier:	NCT00441636

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)

MedlinePlus related topics: Anxiety Depression Sleep Apnea

U.S. FDA Resources

Study Type:	Interventional
Study Design:	Treatment, Randomized, Single Blind (Outcomes Assessor), Active Control, Parallel Assignment, Efficacy Study
Official Title:	Treatment Resistant Depression and Obstructive Sleep Apnea: Effect of Treatment With CPAP on Mood, Anxiety and Quality of Life

Further study details as provided by Queen's University:

Primary Outcome Measures:

HAM-D [ Time Frame: baseline and 6 weeks ] [ Designated as safety issue: No ]
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 ]

Estimated Enrollment:	120
Study Start Date:	March 2007
Estimated Study Completion Date:	March 2009
Estimated Primary Completion Date:	March 2009 (Final data collection date for primary outcome measure)

Arms	Assigned Interventions
1: Experimental CPAP	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
2: No Intervention
3: No Intervention control

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:

How common is co-morbid OSA in patients with treatment resistant unipolar depression referred to a tertiary Mood Disorders Clinic?
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?
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

Responsible Party:	Queen's University ( Ruzica Jokic )
Study ID Numbers:	PSIY-247-06
Study First Received:	February 27, 2007
Last Updated:	October 31, 2008
ClinicalTrials.gov Identifier:	NCT00441636
Health Authority:	Canada: Health Canada

Keywords provided by Queen's University:

depression
CPAP
obstructive sleep apnea

Study placed in the following topic categories:

Sleep Apnea Syndromes
Depression
Apnea
Sleep Apnea, Obstructive
Respiration Disorders
Quality of Life
Dyssomnias
Sleep Disorders

Depressive Disorder
Sleep Disorders, Intrinsic
Behavioral Symptoms
Signs and Symptoms
Respiratory Tract Diseases
Mental Disorders
Mood Disorders
Signs and Symptoms, Respiratory

Additional relevant MeSH terms:

Nervous System Diseases

ClinicalTrials.gov processed this record on January 14, 2009