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

The recruitment status of this study is unknown because the information has not been verified recently.
Verified April 2012 by Queen's University.
Recruitment status was  Recruiting
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

February 27, 2007
April 27, 2012
March 2007
December 2012   (final data collection date for primary outcome measure)
Montgomery Asberg Depression Rating Scale (MADRS) [ Time Frame: baseline and 6 weeks ] [ Designated as safety issue: No ]
  • Montgomery Asberg Depression Rating Scale (MADRS)
  • HAM-D
  • Profile of Mood States (POMS)
  • Beck Anxiety Inventory (BAI)
  • SF-36 questionnaire
Complete list of historical versions of study NCT00441636 on ClinicalTrials.gov Archive Site
  • 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
  • Symbol digit modalities
  • STROOP test
  • Trail-Making test
  • Pittsburgh Sleep Quality Index (PSQI)
  • Epworth Sleepiness Score (ESS)
Not Provided
Not Provided
 
Treatment Resistant Depression and Obstructive Sleep Apnea, Effect of Continuous Positive Airway Pressure (CPAP)
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).

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?
Interventional
Not Provided
Allocation: Randomized
Endpoint Classification: Efficacy Study
Intervention Model: Parallel Assignment
Masking: Single Blind (Outcomes Assessor)
Primary Purpose: Treatment
  • Depression
  • Sleep Apnea, Obstructive
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
  • Experimental: CPAP treatment
    Continuous Positive Airway Pressure (CPAP)for 4 weeks
    Intervention: Device: continuous positive airway pressure (CPAP)
  • 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.
Not Provided

*   Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline.
 
Recruiting
120
December 2012
December 2012   (final data collection date for primary outcome measure)

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.
Both
18 Years to 65 Years
Yes
Contact: Ruzica Jokic, MD jokicr@pccchealth.org
Canada
 
NCT00441636
PSIY-247-06
Yes
Queen's University
Queen's University
Not Provided
Principal Investigator: Ruzica Jokic, MD Queen's University
Queen's University
April 2012

ICMJE     Data element required by the International Committee of Medical Journal Editors and the World Health Organization ICTRP