Clinical trial NCT00441636: Treatment Resistant Depression and Obstructive Sleep Apnea, Effect of Continuous Positive Airway Pressure (CPAP)
Official title: Treatment Resistant Depression and Obstructive Sleep Apnea: Effect of Treatment With CPAP on Mood, Anxiety and Quality of Life
Study type: INTERVENTIONAL
Overall status: UNKNOWN
Phase: NA
Conditions: Depression
Sleep Apnea, Obstructive
Keywords: depression
CPAP
obstructive sleep apnea
Lead sponsor: Queen's University
Sponsor class: OTHER
First posted: 2007-03-01
Enrollment: 120
Sex: ALL
Minimum age (years): 18
Maximum age (years): 65
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: yes
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: TREATMENT

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).

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 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.

Primary outcomes:
measure: Montgomery Asberg Depression Rating Scale (MADRS)
timeFrame: baseline and 6 weeks
Secondary outcomes:
measure: Symbol digit modalities
timeFrame: baseline and 6 weeks
measure: Stroop Test
timeFrame: baseline and 6 weeks
measure: Trail-Making test
timeFrame: baseline and 6 weeks
measure: Pittsburgh Sleep Quality Index (PSQI)
timeFrame: baseline and 6 weeks
measure: Epworth Sleepiness Score (ESS)
timeFrame: baseline and 6 weeks
measure: Beck Anxiety Inventory (BAI)
timeFrame: baseline and 6 weeks
measure: SF-36 questionnaire
timeFrame: baseline and 6 weeks
measure: Profile of mood state (POMS)
timeFrame: baseline and 6 weeks
measure: HAM-D21
timeFrame: baseline and 6 weeks
Other outcomes:
Locations:
city: Kingston
country: Canada
facility: Providence Continuing Care Centre, Mental Health Services
state: Ontario
Study officials:
affiliation: Queen's University
name: Ruzica Jokic, MD
role: PRINCIPAL_INVESTIGATOR
References: