Clinical trial NCT01431573: Wake Therapy in the Treatment of Depression
Official title: Combined Wake Therapy, Light Therapy, and Lithium for Bipolar and Refractory Depression
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: NA
Conditions: Major Depressive Disorder
Bipolar Disorder
Keywords: Depression
Lead sponsor: New York State Psychiatric Institute
Sponsor class: OTHER
First posted: 2011-09-09
Enrollment: 8
Sex: ALL
Minimum age (years): 18
Maximum age (years): 75
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: NA
Intervention model: SINGLE_GROUP
Primary purpose: TREATMENT

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.

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 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

Primary outcomes:
measure: Structured Interview for the Hamilton Depression Scale With Atypical Depression Supplement(SIGH-ADS)
timeFrame: up to 6 weeks
Secondary outcomes:
measure: Morningness-Eveningness Questionnaire (MEQ),
timeFrame: up to 6 weeks
measure: Symptom Check List (SCL-90)
timeFrame: up to 6 weeks
measure: Quick Inventory of Depressive Symptoms, Self Rated (QIDS-SR 16)
timeFrame: up to 6 weeks
measure: Hypomania Interview Guide, Current Assessment Version (HIGH-C)
timeFrame: up to 6 weeks
measure: Clinical Global Improvement (CGI)
timeFrame: up to 6 weeks
Other outcomes:
Locations:
city: New York
country: United States
facility: Depression Evaluation Service - New York State Psychiatric Institute
state: New York
city: New York
country: United States
facility: New York State Psychiatric Institute
state: New York
Study officials:
affiliation: New York State Psychiatric Institute
name: Jonathan W. Stewart, M.D.
role: PRINCIPAL_INVESTIGATOR
References: