Clinical trial NCT02750631: Out-patient Wake Therapy, Light Therapy and Sleep Phase Advance for Depression
Official title: Out-patient Wake Therapy, Light Therapy and Sleep Phase Advance for Depression
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: NA
Conditions: Unipolar Depression
Keywords: depression
melatonin
light therapy
Wake Therapy
chronobiology
Lead sponsor: New York State Psychiatric Institute
Sponsor class: OTHER
First posted: 2016-04-25
Enrollment: 30
Sex: ALL
Minimum age (years): 18
Maximum age (years): 65
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: NA
Intervention model: SINGLE_GROUP
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).
Primary purpose: TREATMENT

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.

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

Primary outcomes:
measure: 17-item Hamilton Rating Scale for Depression
timeFrame: 1 week
Secondary outcomes:
Other outcomes:
Locations:
city: New York
country: United States
facility: New York State Psychiatric Institute
state: New York
Study officials:
affiliation: New York State Psychiatric Institute
name: Jonathan W Stewart, M.D.
role: PRINCIPAL_INVESTIGATOR
References: