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

Unipolar Depression Clinical Trial

— WakeTherapy  

Official title:

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

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT02750631
• Other study ID #: 6938
• Status: Completed
• Phase: N/A
• First received: April 20, 2016
• Last updated: August 28, 2017
• Start date: April 2014
• Est. completion date: July 2017

Study information

• Verified date: August 2017
• Source: New York State Psychiatric Institute
• Contact: n/a
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial 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.

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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 30
• Est. completion date: July 2017
• Est. primary completion date: July 2017
• Accepts healthy volunteers: No
• Gender: All
• Age group: 18 Years to 65 Years

Eligibility

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

Related Conditions & MeSH terms

• Depression
• Depressive Disorder
• Unipolar Depression

Intervention

Other:
• Triple Therapy
The intervention consists of three interventions: missing a night of sleep, early morning bright lights and sleep phase advance

Locations

Country	Name	City	State
United States	New York State Psychiatric Institute	New York	New York

Sponsors (1)

Lead Sponsor	Collaborator
New York State Psychiatric Institute

Country where clinical trial is conducted

United States, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	17-item Hamilton Rating Scale for Depression	The Hamilton Rating Scale for Depression is a standard clinician scored rating of depressed mood and the symptoms commonly associated with clinical depression	1 week