Wake Therapy in the Treatment of Depression

NCT01431573 | Completed Results

• 2 other identifiers: 5491/7316RIRB 5491
• Study Type: interventional
• Target: 8
• Locations: 1 country
• Sites: 2

Brief Summary

This pilot study seeks to replicate previous findings that sleep deprivation results in marked improvement in depression symptoms, as well as to test whether concurrent treatment with Light Therapy and Lithium are successful in locking in and maintaining therapeutic effects in both bipolar and unipolar depressed subjects.

Conditions

Major Depressive Disorder; Bipolar Disorder

Keywords

Depression

Outcome Measures

Primary Outcomes (1)

• Structured Interview for the Hamilton Depression Scale With Atypical Depression Supplement(SIGH-ADS)

  This is a structured interview to obtain 17 Hamilton Depression Rating Scale ratings, with 8 additional items added to measure reverse vegetative features common in bipolar depression and depression with atypical features. There are total 25 items, score ranges from 0 to 90. Higher score means worse depression.

  up to 6 weeks

Secondary Outcomes (5)

• Morningness-Eveningness Questionnaire (MEQ),

  up to 6 weeks

• Symptom Check List (SCL-90)

  up to 6 weeks

• Quick Inventory of Depressive Symptoms, Self Rated (QIDS-SR 16)

  up to 6 weeks

• Hypomania Interview Guide, Current Assessment Version (HIGH-C)

  up to 6 weeks

• Clinical Global Improvement (CGI)

  up to 6 weeks

Study Arms (1)

Wake Therapy + light box +/- lithium

EXPERIMENTAL

* Bipolar patients must take lithium; others do not take lithium * all patients are hospitalized for a week during which they do not sleep on alternating nights * for six weeks, including the week in the hospital all patients sit in front of bright lights at specified times and for specified durations

Behavioral: Wake Therapy; Device: light box; Drug: Lithium

Interventions

Wake Therapy BEHAVIORAL

Maintaining wakefulness on alternating nights over 7 days, with continued sleep deprivation the next day.

Wake Therapy + light box +/- lithium

light box DEVICE

use of a lightbox titrated between 15-60 minutes (typically 30 minutes), timed according to chronotype score on the Morningness-Eveningness Questionnaire

Also known as: Day Light

Wake Therapy + light box +/- lithium

Lithium DRUG

For patients not already taking lithium, dose will start at 600 mg daily (all in the evening) and be adjusted in 300 mg/d increments according to weekly blood levels (i.e., lithium dose may be changed once a week if most recent blood level is too low; if too high, it will be decreased or temporarily discontinued as clinically indicated; 150 mg increments will be utilized if multiples of 300 mg result in intolerance or blood levels outside the target range (0.6 - 1.0 mEq/L)

Also known as: Lithobid, lithium carbonate

Wake Therapy + light box +/- lithium

Eligibility Criteria

• Age: 18 Years - 75 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• current major depressive episode (MDD, BP-I or BP-II)
• if not BP-I or BP-II, treatment refractory to ≥ 2 adequately used antidepressants having different mechanisms
• If BP-I or BP-II, treatment refractory to ≥ 1 standard treatment, such as lithium or valproate
• physically healthy
• age 18-75
• not taking current antidepressants(antidepressants deemed effective will not be discontinued

You may not qualify if:

• medically unstable condition
• past intolerance of lithium (bipolar only)
• history of (or current) psychosis or epilepsy
• current (past six months) drug or alcohol abuse/dependence
• pregnancy
• contraindication to lithium (bipolar only)
• significant retinal pathology (e.g., retinitis pigmentosa, macular degeneration)
• currently taking effective antidepressant
• cognitive dysfunction
• Parkinson's Disease
• Thyroid Stimulating Hormone \> 5 milli International Units/Liter
• left ventricular hypertrophy
• symptomatic mitral valve prolapse
• abnormal creatinine

Sponsors & Collaborators

• New York State Psychiatric Institute: lead

Study Sites (2)

Depression Evaluation Service - New York State Psychiatric Institute

New York, New York, 10032, United States

Location

New York State Psychiatric Institute

New York, New York, 10032, United States

Location

Related Links

• Depression Evaluation Service
• Columbia University Psychiatry
• New York State Psychiatric Institute

MeSH Terms

Conditions

Depressive Disorder, Major; Bipolar Disorder; Depression

Interventions

Lithium; Lithium Carbonate

Condition Hierarchy (Ancestors)

Depressive Disorder; Mood Disorders; Mental Disorders; Bipolar and Related Disorders; Behavioral Symptoms; Behavior

Intervention Hierarchy (Ancestors)

Metals, Alkali; Elements; Inorganic Chemicals; Metals, Light; Metals; Carbonates; Alkalies; Carbonic Acid; Carbon Compounds, Inorganic; Lithium Compounds

Results Point of Contact

• Title: David Hellerstein
• Organization: NYSPI

david.hellerstein@nyspi.columbia.edu

646-774-8069

Study Officials

• Jonathan W. Stewart, M.D.

  New York State Psychiatric Institute

  PRINCIPAL INVESTIGATOR

Publication Agreements

• PI is Sponsor Employee: Yes

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: NA
• Masking: NONE
• Masking Details: This is an "open label" study so all participants know what the treatment is.
• Purpose: TREATMENT
• Intervention Model: SINGLE GROUP
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Principal Investigator

Study Record Dates

• First Submitted: August 12, 2011
• First Posted: September 9, 2011
• Study Start: July 1, 2011
• Primary Completion: August 1, 2016
• Study Completion: August 1, 2016
• Last Updated: March 18, 2021
• Results First Posted: March 18, 2021

Record last verified: 2021-02

Locations

US (2)