Treatment Resistant Depression and Obstructive Sleep Apne... | NCT00441636

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

NCT00441636

Sponsor

Queen's University

Status

Unknown status

Last Update Posted

Apr 30, 2018Actual

Enrollment

120Estimated

Phase

Not Applicable

Conditions

Depression
Sleep Apnea, Obstructive

Interventions

continuous positive airway pressure (CPAP)

Countries

Canada

Protocol Section

Identification Module Status Module Sponsor/Collaborators Module Oversight Module Description Module Conditions Module Design Module Arms/Interventions Module Outcomes Module Eligibility Module Contacts/Locations Module References Module IPD Sharing Statement Module

Results Section

Participant Flow Module Baseline Characteristics Module Outcome Measures Module Adverse Events Module More Info Module

Annotation Section

Annotation Module

Document Section

Large Document Module

Derived Section

Miscellaneous Info Module Condition Browse Module Intervention Browse Module

Protocol Section

Identification Module

NCT ID

Results Section

No data available

No data is available for this block.

Annotation Section

No data available

No data is available for this block.

Document Section

No data available

No data is available for this block.

Derived Section

Miscellaneous Info Module

Version Holder

Status Module

Record Verification Date

Apr 2018

Overall Recruitment Status or Expanded Access Status

Unknown status

Last Known Status

Recruiting

Delayed Posting

Not provided

Why Stopped

Not provided

Expanded Access Info

Start Date

Mar 2007

Primary Completion Date

Dec 2019Estimated

Completion Date

Dec 2019Estimated

First Submitted Date

Feb 27, 2007

First Submission Date that Met QC Criteria

Feb 28, 2007

First Posted Date

Mar 1, 2007Estimated

Results Waived

Not provided

Results First Submitted Date

Not provided

Results First Submitted that Met QC Criteria

Not provided

Results First Posted Date

Not provided

Certification/Extension (aka Delayed Results) First Submitted Date

Not provided

Certification/Extension First Submitted that Passed QC Review

Not provided

Certification/Extension First Posted Date

Not provided

Last Update Submitted Date

Apr 27, 2018

Last Update Posted Date

Apr 30, 2018Actual

Oversight Module

Has Data Monitoring Committee (DMC)

Yes

Is FDA Regulated Drug

Not provided

Is FDA Regulated Device

Not provided

Is Unapproved Device

Not provided

Pediatric Postmarket Surveillance of a Device Product

Not provided

Product Exported from US

Not provided

FDAAA801 Violation

Not provided

Description Module

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:

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?

Design Module

Study Type

Interventional

Number of References to an Expanded Access Study

Not provided

Expanded Access Types

Not provided

Patient Registry

Not provided

Target Follow-Up Duration

Not provided

Phases

Not Applicable

Interventional Study Design

Allocation

Biospecimen

No data available

No data is available for this block.

Enrollment

120Estimated

Arms/Interventions Module

Arm Groups

Label	Type	Description	Intervention Names
CPAP treatment	Experimental	Continuous Positive Airway Pressure (CPAP)for 4 weeks	Device: continuous positive airway pressure (CPAP)
No CPAP	No Intervention	routine psychiatric care for 4 weeks followed by CPAP titration and initiation after followup measures.
Control group	No Intervention	No obstructive sleep apnea detected.

Interventions

Name	Type	Description	Arm Group Labels	Other Names
continuous positive airway pressure (CPAP)	Device	CPAP (Respironics: RemStar plus M-series) machines for treatment of obstructive sleep apnea training for participant required by registered sleep technologist

Measure	Description	Time Frame
Montgomery Asberg Depression Rating Scale (MADRS)		baseline and 6 weeks

Measure	Description	Time Frame
Symbol digit modalities		baseline and 6 weeks
Stroop Test		baseline and 6 weeks
Trail-Making test

Eligibility Module

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.

Accepts Healthy Volunteers

Yes

Sex

All

Sex/Gender Based

Not provided

Sex/Gender Description

Not provided

Minimum Age

18 Years

Maximum Age

65 Years

Standard Ages

AdultOlder Adult

Study Population

Not provided

Sampling Method

Not provided

Contacts/Locations Module

Central Contacts

Name	Role	Phone	Extension	Email
Ruzica Jokic, MD	Contact			jokicr@pccchealth.org
Gisele Berube	Contact			berubeg@providencecare.ca

Overall Officials

Name	Affiliation	Role
Ruzica Jokic, MD	Queen's University	Principal Investigator

Locations

Facility	Status	City	State	ZIP	Country	Contacts
Providence Continuing Care Centre, Mental Health Services	Recruiting	Kingston	Ontario	K7L4X3	Canada

ID	Term
D003863	Depression
D020181	Sleep Apnea, Obstructive

ID	Term
D001526	Behavioral Symptoms
D001519	Behavior
D012891	Sleep Apnea Syndromes
D001049	Apnea

Intervention Browse Module

MeSH Terms

ID	Term
D045422	Continuous Positive Airway Pressure

Ancestor Terms

ID	Term
D011175	Positive-Pressure Respiration
D012121	Respiration, Artificial
D058109	Airway Management
D013812	Therapeutics

Browse Leaves

Not provided

Browse Branches

Not provided