NCT00441636

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).

Trial Health

43
At Risk

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Trial has exceeded expected completion date
Enrollment
120

participants targeted

Target at P50-P75 for not_applicable depression

Timeline
Completed

Started Mar 2007

Longer than P75 for not_applicable depression

Geographic Reach
1 country

1 active site

Status
unknown

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

First Submitted

Initial submission to the registry

February 27, 2007

Completed
2 days until next milestone

First Posted

Study publicly available on registry

March 1, 2007

Completed
Same day until next milestone

Study Start

First participant enrolled

March 1, 2007

Completed
12.8 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

December 1, 2019

Completed
Same day until next milestone

Study Completion

Last participant's last visit for all outcomes

December 1, 2019

Completed
Last Updated

April 30, 2018

Status Verified

April 1, 2018

Enrollment Period

12.8 years

First QC Date

February 27, 2007

Last Update Submit

April 27, 2018

Conditions

DepressionSleep Apnea, Obstructive

Keywords

depressionCPAPobstructive sleep apnea

Outcome Measures

Primary Outcomes (1)

  • Montgomery Asberg Depression Rating Scale (MADRS)

    baseline and 6 weeks

Secondary Outcomes (9)

  • Symbol digit modalities

    baseline and 6 weeks

  • Stroop Test

    baseline and 6 weeks

  • Trail-Making test

    baseline and 6 weeks

  • Pittsburgh Sleep Quality Index (PSQI)

    baseline and 6 weeks

  • Epworth Sleepiness Score (ESS)

    baseline and 6 weeks

  • +4 more secondary outcomes

Study Arms (3)

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

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

Also known as: CPAP - Respironics: RemStar plus M-series
CPAP treatment

Eligibility Criteria

Age18 Years - 65 Years
Sexall
Healthy VolunteersYes
Age GroupsAdult (18-64), Older Adult (65+)

You may qualify if:

  • 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.

You may not qualify if:

  • 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.

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

Providence Continuing Care Centre, Mental Health Services

Kingston, Ontario, K7L4X3, Canada

RECRUITING

MeSH Terms

Conditions

DepressionSleep Apnea, Obstructive

Interventions

Continuous Positive Airway Pressure

Condition Hierarchy (Ancestors)

Behavioral SymptomsBehaviorSleep Apnea SyndromesApneaRespiration DisordersRespiratory Tract DiseasesSleep Disorders, IntrinsicDyssomniasSleep Wake DisordersNervous System Diseases

Intervention Hierarchy (Ancestors)

Positive-Pressure RespirationRespiration, ArtificialAirway ManagementTherapeuticsRespiratory Therapy

Study Officials

  • Ruzica Jokic, MD

    Queen's University

    PRINCIPAL INVESTIGATOR

Central Study Contacts

Ruzica Jokic, MD

CONTACT

jokicr@pccchealth.org

Gisele Berube

CONTACT

berubeg@providencecare.ca

Study Design

Study Type
interventional
Phase
not applicable
Allocation
RANDOMIZED
Masking
SINGLE
Who Masked
OUTCOMES ASSESSOR
Purpose
TREATMENT
Intervention Model
PARALLEL
Sponsor Type
OTHER
Responsible Party
PRINCIPAL INVESTIGATOR
PI Title
Principal Investigator

Study Record Dates

First Submitted

February 27, 2007

First Posted

March 1, 2007

Study Start

March 1, 2007

Primary Completion

December 1, 2019

Study Completion

December 1, 2019

Last Updated

April 30, 2018

Record last verified: 2018-04

Locations

CA(1)