Out-patient Wake Therapy, Light Therapy and Sleep Phase Advance for Depression

Not Applicable

Completed

• Conditions: Unipolar Depression

• Registration Number: NCT02750631
• Lead Sponsor: New York State Psychiatric Institute

Brief Summary

Depressed patients miss a night of sleep (Wake Night), then sleep at predetermined times ending at their desired sleep time. Beginning the morning following their Wake Night, patients sit in front of a bright light, continuing morning bright light and specified sleep time for six weeks with weekly visits measuring depressive symptoms.

Detailed Description

Nonpsychotic, nonbipolar, physically healthy depressed patients keep sleep, mood and energy logs for a week, complete the Morningness-Eveningness Questionnaire (measuring "morningness" and "eveningness") and determine the time patients want to sleep. Patients then miss a night of sleep and subsequently are allowed later and later sleep times until patients are sleeping at their desired time. Beginning the morning following their Wake Night, patients sit in front of bright lights at their intended wake-up time for the next six weeks and once their allowed sleep time is their intended sleep time, patients also continue to only be allowed to sleep between those times (e.g., 11 p.m. to 7 a.m.). Daily sleep, energy and mood logs and activity monitoring are maintained throughout with weekly clinician ratings. In additional, daily telephone check ins occur during the first week following the Wake Night both to be sure the patient is following the protocol and to obtain symptom ratings. Saliva to be measured for melatonin is collected prior to and following sleep adjustment.

Study Timeline

• Study Start: 2014-04
• Study First Submitted: 2016-04-20
• Study First Submitted QC: 2016-04-22
• Study First Posted: 2016-04-25
• Primary Completion: 2017-07
• Study Completion: 2017-07
• Status Verified: 2017-08
• Last Update Submitted: 2017-08-28
• Last Update Posted: 2017-08-29

Recruitment & Eligibility

• Status: COMPLETED
• Sex: All
• Target Recruitment: 30

Inclusion Criteria

• major depressive disorder or persistent depressive disorder or unspecified depressive disorder
• physically healthy
• patients over age 60 need primary care physician's approval, electrocardiogram and Mini Mental Status Examination

Exclusion Criteria

• medically unstable condition
• bipolar disorder
• current (past six months) substance use disorder
• significant suicide risk
• need for hospitalization
• history of psychosis

Study & Design

• Study Type: INTERVENTIONAL
• Study Design: SINGLE_GROUP

Primary Outcome Measures

Name	Time	Method
17-item Hamilton Rating Scale for Depression	1 week	The Hamilton Rating Scale for Depression is a standard clinician scored rating of depressed mood and the symptoms commonly associated with clinical depression

Trial Locations

Locations (1)

New York State Psychiatric Institute; 🇺🇸 New York, New York, United States