Wake Therapy in the Treatment of Depression

Last updated: February 24, 2021
Sponsor: New York State Psychiatric Institute
Overall Status: Completed

Phase

N/A

Condition

Depression (Major/severe)

Affective Disorders

Bipolar Disorder

Treatment

N/A

Clinical Study ID

NCT01431573
5491/7316R
IRB 5491
  • Ages 18-75
  • All Genders

Study 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.

Eligibility Criteria

Inclusion

Inclusion Criteria:

  1. current major depressive episode (MDD, BP-I or BP-II)
  2. if not BP-I or BP-II, treatment refractory to ≥ 2 adequately used antidepressantshaving different mechanisms
  3. If BP-I or BP-II, treatment refractory to ≥ 1 standard treatment, such as lithium orvalproate
  4. physically healthy
  5. age 18-75
  6. not taking current antidepressants(antidepressants deemed effective will not bediscontinued

Exclusion

Exclusion Criteria:

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

Study Design

Total Participants: 8
Study Start date:
July 01, 2011
Estimated Completion Date:
August 31, 2016

Study Description

Both refractory depression and bipolar depression are difficult to treat. A night of complete sleep deprivation has been shown to result in marked improvement in 60% of depressed patients, although maintenance of therapeutic effects have not been sustained with wake therapy alone. This pilot study will assess the effectiveness of wake therapy in treating both bipolar depression (5 participants)and major depression (5 participants), as well as the effectiveness of concomitant light therapy and lithium in maintaining the therapeutic effects. Participants will undergo direct observation in the hospital for one week during initial treatment with alternating nights of sleep deprivation, light therapy and lithium treatment, and then will be seen weekly as outpatients for 6 weeks.

Connect with a study center

  • Depression Evaluation Service - New York State Psychiatric Institute

    New York, New York 10032
    United States

    Site Not Available

  • New York State Psychiatric Institute

    New York, New York 10032
    United States

    Site Not Available

Map preview placeholder

Not the study for you?

Let us help you find the best match. Sign up as a volunteer and receive email notifications when clinical trials are posted in the medical category of interest to you.