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Completed

NCT Number: NCT02750631

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

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.

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Key information

Age range

18 year–65 year

Sex eligibility

All sexes

Study type

Interventional

Phase

Not applicable

Primary location

New York State Psychiatric Institute

New York, 10032, United States

About this study

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.

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

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

Treatment and study plan

Triple Therapy

Other

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

Other names: Chronotherapeutics

Primary outcomes

  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

Sponsors and collaborators

Lead sponsor

New York State Psychiatric Institute

Other

Registry information

Acronym: WakeTherapy

Important dates

Study start
2014
Primary completion
2017
Study completion
2017
First posted
Apr 25, 2016
Registry last updated
Aug 29, 2017

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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