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Wake Therapy in the Treatment of Depression

Information source: New York State Psychiatric Institute
ClinicalTrials.gov processed this data on August 23, 2015
Link to the current ClinicalTrials.gov record.

Condition(s) targeted: Major Depressive Disorder; Bipolar Disorder

Intervention: Wake Therapy (Behavioral); lightbox (Device); Lithium Carbonate (Drug); Armodafinil (Drug)

Phase: N/A

Status: Recruiting

Sponsored by: New York State Psychiatric Institute

Official(s) and/or principal investigator(s):
Jonathan Stewart, M.D., Principal Investigator, Affiliation: New York State Psychiatric Institute

Overall contact:
Vito Agosti, MSW, Phone: 212-543-5605, Email: agostiv@nypsi.columbia.edu

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.

Clinical Details

Official title: Combined Wake Therapy, Light Therapy, and Lithium for Bipolar and Refractory Depression

Study design: Endpoint Classification: Efficacy Study, Intervention Model: Single Group Assignment, Masking: Open Label, Primary Purpose: Treatment

Primary outcome: Structured Interview for the Hamilton Depression Scale with Atypical Depression Supplement(SIGH-ADS)

Secondary outcome:

Morningness-Eveningness Questionnaire (MEQ),

Symptom Check List (SCL-90)

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

Hypomania Interview Guide, Current assessment version(HIGH-C)

Clinical Global Improvement (CGI)

Detailed 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.

Eligibility

Minimum age: 18 Years. Maximum age: 60 Years. Gender(s): Both.

Criteria:

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 antidepressants having different mechanisms 3. If BP-I or BP-II, treatment refractory to ≥ 1 standard treatment, such as lithium or valproate 4. physically healthy 5. age 18-60 6. not taking current antidepressants(antidepressants deemed effective will not be discontinued 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. baseline HAMD > 40 10. cognitive dysfunction 11. Parkinson's Disease 12. TSH > 5 mIU/L 13. left ventricular hypertrophy 14. symptomatic mitral valve prolapse 15. abnormal creatinine

Locations and Contacts

Vito Agosti, MSW, Phone: 212-543-5605, Email: agostiv@nypsi.columbia.edu

Depression Evaluation Service - New York State Psychiatric Institute, New York, New York 10032, United States; Recruiting
Jonathan W. Stewart, M.D., Phone: 212-543-5745, Email: jws6@columbia.edu
Patrick J. McGrath, M.D., Phone: (212) 543 5764, Email: mcgrath@pi.cpmc.columbia.edu
Jonathan W. Stewart, M.D., Principal Investigator
Patrick J. McGrath, M.D., Sub-Investigator
Michael Terman, Ph.D., Sub-Investigator

New York State Psychiatric Institute, New York, New York 10032, United States; Recruiting
Vito Agosti, MSW, Phone: 212-543-5605, Email: agostiv@nyspi.columbia.edu
Brittany Anderson, BA, Phone: 212-543-5734, Email: banders@nyspi.columbia.edu

Additional Information

Depression Evaluation Service

Columbia University Psychiatry

New York State Psychiatric Institute

Starting date: July 2011
Last updated: April 26, 2012

Page last updated: August 23, 2015

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