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

Primary Purpose

Unipolar Depression

Status
Completed
Phase
Not Applicable
Locations
United States
Study Type
Interventional
Intervention
Triple Therapy
Sponsored by
New York State Psychiatric Institute
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional treatment trial for Unipolar Depression focused on measuring depression, melatonin, light therapy, Wake Therapy, chronobiology

Eligibility Criteria

18 Years - 65 Years (Adult, Older Adult)All SexesDoes not accept healthy volunteers

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

Sites / Locations

  • New York State Psychiatric Institute

Arms of the Study

Arm 1

Arm Type

Experimental

Arm Label

Triple Therapy

Arm Description

Combined Wake Therapy (one night of missed sleep), early morning bright light and sleep phase advance

Outcomes

Primary Outcome Measures

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

Secondary Outcome Measures

Full Information

First Posted
April 20, 2016
Last Updated
August 28, 2017
Sponsor
New York State Psychiatric Institute
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1. Study Identification

Unique Protocol Identification Number
NCT02750631
Brief Title
Out-patient Wake Therapy, Light Therapy and Sleep Phase Advance for Depression
Acronym
WakeTherapy
Official Title
Out-patient Wake Therapy, Light Therapy and Sleep Phase Advance for Depression
Study Type
Interventional

2. Study Status

Record Verification Date
August 2017
Overall Recruitment Status
Completed
Study Start Date
April 2014 (undefined)
Primary Completion Date
July 2017 (Actual)
Study Completion Date
July 2017 (Actual)

3. Sponsor/Collaborators

Responsible Party, by Official Title
Sponsor
Name of the Sponsor
New York State Psychiatric Institute

4. Oversight

Data Monitoring Committee
No

5. Study Description

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.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Unipolar Depression
Keywords
depression, melatonin, light therapy, Wake Therapy, chronobiology

7. Study Design

Primary Purpose
Treatment
Study Phase
Not Applicable
Interventional Study Model
Single Group Assignment
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)
Masking Description
All patients and staff know what the treatment is.
Allocation
N/A
Enrollment
30 (Actual)

8. Arms, Groups, and Interventions

Arm Title
Triple Therapy
Arm Type
Experimental
Arm Description
Combined Wake Therapy (one night of missed sleep), early morning bright light and sleep phase advance
Intervention Type
Other
Intervention Name(s)
Triple Therapy
Other Intervention Name(s)
Chronotherapeutics
Intervention Description
The intervention consists of three interventions: missing a night of sleep, early morning bright lights and sleep phase advance
Primary Outcome Measure Information:
Title
17-item Hamilton Rating Scale for Depression
Description
The Hamilton Rating Scale for Depression is a standard clinician scored rating of depressed mood and the symptoms commonly associated with clinical depression
Time Frame
1 week

10. Eligibility

Sex
All
Minimum Age & Unit of Time
18 Years
Maximum Age & Unit of Time
65 Years
Accepts Healthy Volunteers
No
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
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Jonathan W Stewart, M.D.
Organizational Affiliation
New York State Psychiatric Institute
Official's Role
Principal Investigator
Facility Information:
Facility Name
New York State Psychiatric Institute
City
New York
State/Province
New York
ZIP/Postal Code
10032
Country
United States

12. IPD Sharing Statement

Plan to Share IPD
Undecided
IPD Sharing Plan Description
No such plan at present

Learn more about this trial

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

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