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

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ClinicalTrials.gov Identifier: NCT02750631
Recruitment Status : Completed
First Posted : April 25, 2016
Last Update Posted : August 29, 2017
Sponsor:
Information provided by (Responsible Party):
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.

Condition or disease Intervention/treatment Phase
Unipolar Depression Other: Triple Therapy Not Applicable

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.

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Study Type : Interventional  (Clinical Trial)
Actual Enrollment : 30 participants
Intervention Model: Single Group Assignment
Intervention 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.
Primary Purpose: Treatment
Official Title: Out-patient Wake Therapy, Light Therapy and Sleep Phase Advance for Depression
Study Start Date : April 2014
Actual Primary Completion Date : July 2017
Actual Study Completion Date : July 2017

Resource links provided by the National Library of Medicine


Arm Intervention/treatment
Experimental: Triple Therapy
Combined Wake Therapy (one night of missed sleep), early morning bright light and sleep phase advance
Other: Triple Therapy
The intervention consists of three interventions: missing a night of sleep, early morning bright lights and sleep phase advance
Other Name: Chronotherapeutics




Primary Outcome Measures :
  1. 17-item Hamilton Rating Scale for Depression [ Time Frame: 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



Information from the National Library of Medicine

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Ages Eligible for Study:   18 Years to 65 Years   (Adult, Older Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
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

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT02750631


Locations
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United States, New York
New York State Psychiatric Institute
New York, New York, United States, 10032
Sponsors and Collaborators
New York State Psychiatric Institute
Investigators
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Principal Investigator: Jonathan W Stewart, M.D. New York State Psychiatric Institute

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Responsible Party: New York State Psychiatric Institute
ClinicalTrials.gov Identifier: NCT02750631     History of Changes
Other Study ID Numbers: 6938
First Posted: April 25, 2016    Key Record Dates
Last Update Posted: August 29, 2017
Last Verified: August 2017
Individual Participant Data (IPD) Sharing Statement:
Plan to Share IPD: Undecided
Plan Description: No such plan at present

Keywords provided by New York State Psychiatric Institute:
depression
melatonin
light therapy
Wake Therapy
chronobiology

Additional relevant MeSH terms:
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Depression
Depressive Disorder
Behavioral Symptoms
Mood Disorders
Mental Disorders