Wake Therapy in the Treatment of Depression
| Status: | Recruiting |
|---|---|
| Conditions: | Depression, Major Depression Disorder (MDD), Psychiatric, Bipolar Disorder |
| Therapuetic Areas: | Psychiatry / Psychology, Pulmonary / Respiratory Diseases |
| Healthy: | No |
| Age Range: | 18 - 75 |
| Updated: | 8/18/2018 |
| Start Date: | July 2011 |
| End Date: | August 2020 |
| Contact: | Peter C. Arden, BA |
| Email: | ardenpe@nyspi.columbia.edu |
| Phone: | 646-774-8004 |
Combined Wake Therapy, Light Therapy, and Lithium for Bipolar and Refractory Depression
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.
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.
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.
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.
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
We found this trial at
2
sites
1051 Riverside Dr
New York, New York 10032
New York, New York 10032
646-774-5000
Principal Investigator: Jonathan W. Stewart, M.D.
Phone: 646-774-8000
New York State Psychiatric Institute The New York State Psychiatric Institute (NYSPI), established in 1895,...
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New York, New York 10032
Principal Investigator: Jonathan W. Stewart, M.D.
Phone: 646-774-8070
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