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

NCT02750631 | Completed

• 1 other identifier: 6938
• Study Type: interventional
• Target: 30
• Locations: 1 country
• Sites: 1

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.

Conditions

Unipolar Depression

Keywords

depression; melatonin; light therapy; Wake Therapy; chronobiology

Outcome Measures

Primary Outcomes (1)

• 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

Study Arms (1)

Triple Therapy

EXPERIMENTAL

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

Other: Triple Therapy

Interventions

Triple Therapy OTHER

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

Also known as: Chronotherapeutics

Triple Therapy

Eligibility Criteria

• Age: 18 Years - 65 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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

You may not qualify if:

• medically unstable condition
• bipolar disorder
• current (past six months) substance use disorder
• significant suicide risk
• need for hospitalization
• history of psychosis

Sponsors & Collaborators

• New York State Psychiatric Institute: lead

Study Sites (1)

New York State Psychiatric Institute

New York, New York, 10032, United States

Location

MeSH Terms

Conditions

Depressive Disorder; Depression

Condition Hierarchy (Ancestors)

Mood Disorders; Mental Disorders; Behavioral Symptoms; Behavior

Study Officials

• Jonathan W Stewart, M.D.

  New York State Psychiatric Institute

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: NA
• Masking: NONE
• Masking Details: All patients and staff know what the treatment is.
• Purpose: TREATMENT
• Intervention Model: SINGLE GROUP
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Model Details: 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).

Study Record Dates

• First Submitted: April 20, 2016
• First Posted: April 25, 2016
• Study Start: April 1, 2014
• Primary Completion: July 1, 2017
• Study Completion: July 1, 2017
• Last Updated: August 29, 2017

Record last verified: 2017-08

Locations

US (1)