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

Depression Clinical Trial

Official title:

Treatment Resistant Depression and Obstructive Sleep Apnea: Effect of Treatment With CPAP on Mood, Anxiety and Quality of Life

Clinical Trial Details — Status: Recruiting

Administrative data

• NCT number: NCT00441636
• Other study ID #: PSIY-247-06
• Status: Recruiting
• Phase: N/A
• Start date: March 2007
• Est. completion date: December 2019

Study information

• Verified date: April 2018
• Source: Queen's University
• Contact: Ruzica Jokic, MD
• Email: jokicr[@]pccchealth.org
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial 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).

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?

Recruitment information / eligibility

• Status: Recruiting
• Enrollment: 120
• Est. completion date: December 2019
• Est. primary completion date: December 2019
• Accepts healthy volunteers: Accepts Healthy Volunteers
• Gender: All
• Age group: 18 Years to 65 Years

Eligibility

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.

Related Conditions & MeSH terms

• Apnea
• Depression
• Depressive Disorder
• Depressive Disorder, Treatment-Resistant
• Sleep Apnea Syndromes
• Sleep Apnea, Obstructive

Intervention

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

Locations

Country	Name	City	State
Canada	Providence Continuing Care Centre, Mental Health Services	Kingston	Ontario

Sponsors (1)

Lead Sponsor	Collaborator
Queen's University

Country where clinical trial is conducted

Canada, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Montgomery Asberg Depression Rating Scale (MADRS)		baseline and 6 weeks
Secondary	Symbol digit modalities		baseline and 6 weeks
Secondary	Stroop Test		baseline and 6 weeks
Secondary	Trail-Making test		baseline and 6 weeks
Secondary	Pittsburgh Sleep Quality Index (PSQI)		baseline and 6 weeks
Secondary	Epworth Sleepiness Score (ESS)		baseline and 6 weeks
Secondary	Beck Anxiety Inventory (BAI)		baseline and 6 weeks
Secondary	SF-36 questionnaire		baseline and 6 weeks
Secondary	Profile of mood state (POMS)		baseline and 6 weeks
Secondary	HAM-D21	Hamilton depression inventory	baseline and 6 weeks