Overview

Wake Therapy in the Treatment of Depression

Status:
Completed
Trial end date:
2016-08-01
Target enrollment:
0
Participant gender:
All
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.
Phase:
N/A
Accepts Healthy Volunteers?
No
Details
Lead Sponsor:
New York State Psychiatric Institute
Treatments:
Armodafinil
Lithium Carbonate
Modafinil
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 18-75

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. 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