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

Study Overview
=================
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.

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

Conditions
-----------------
Unipolar Depression

Intervention / Treatment
-----------------
* Other: Triple Therapy


Participation Criteria
=================
Eligibility Criteria
-----------------
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

Ages Eligible for Study
-----------------
Minimum Age: 18 Years
Maximum Age: 65 Years

Sexes Eligible for Study
-----------------
All

Accepts Healthy Volunteers
-----------------
No

Study Plan
=================
How is the study designed?
-----------------

Design Details

Primary Purpose: Treatment
Intervention Model: Single Group Assignment
Interventional Model Description: All patients receive Chronotherapy, which consists of a night of no sleep (Wake Therapy) followed by bright lights at their desired sleep time and two nights of Sleep Phase Advance (i.e., sleeping 6 hours earlier than desired for 1 night and 3 hours earlier for the next night, then desired sleep time).
Masking: None (Open Label)


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Experimental: Triple Therapy<br>Combined Wake Therapy (one night of missed sleep), early morning bright light and sleep phase advance | Other: Triple Therapy<br>* The intervention consists of three interventions: missing a night of sleep, early morning bright lights and sleep phase advance<br>* Other names: Chronotherapeutics;|

What is the study measuring?
-----------------
Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| 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 | 

 Terms related to the study
=================
Keywords Provided by Centre Hospitalier Valida
-----------------
depression, melatonin, light therapy, Wake Therapy, chronobiology