Combined Wake Therapy, Light Therapy, and Lithium for Bipolar and Refractory Depression
Overview
- Phase
- Not Applicable
- Intervention
- Wake Therapy
- Conditions
- Major Depressive Disorder
- Sponsor
- New York State Psychiatric Institute
- Enrollment
- 8
- Locations
- 2
- Primary Endpoint
- Structured Interview for the Hamilton Depression Scale With Atypical Depression Supplement(SIGH-ADS)
- Status
- Completed
- Last Updated
- 5 years ago
Overview
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.
Investigators
David J. Hellerstein
Principal Investigator
New York State Psychiatric Institute
Eligibility Criteria
Inclusion Criteria
- •current major depressive episode (MDD, BP-I or BP-II)
- •if not BP-I or BP-II, treatment refractory to ≥ 2 adequately used antidepressants having different mechanisms
- •If BP-I or BP-II, treatment refractory to ≥ 1 standard treatment, such as lithium or valproate
- •physically healthy
- •not taking current antidepressants(antidepressants deemed effective will not be discontinued
Exclusion Criteria
- •medically unstable condition
- •past intolerance of lithium (bipolar only)
- •history of (or current) psychosis or epilepsy
- •current (past six months) drug or alcohol abuse/dependence
- •contraindication to lithium (bipolar only)
- •significant retinal pathology (e.g., retinitis pigmentosa, macular degeneration)
- •currently taking effective antidepressant
- •cognitive dysfunction
- •Parkinson's Disease
- •Thyroid Stimulating Hormone \> 5 milli International Units/Liter
Arms & Interventions
Wake Therapy + light box +/- lithium
* Bipolar patients must take lithium; others do not take lithium * all patients are hospitalized for a week during which they do not sleep on alternating nights * for six weeks, including the week in the hospital all patients sit in front of bright lights at specified times and for specified durations
Intervention: Wake Therapy
Wake Therapy + light box +/- lithium
* Bipolar patients must take lithium; others do not take lithium * all patients are hospitalized for a week during which they do not sleep on alternating nights * for six weeks, including the week in the hospital all patients sit in front of bright lights at specified times and for specified durations
Intervention: light box
Wake Therapy + light box +/- lithium
* Bipolar patients must take lithium; others do not take lithium * all patients are hospitalized for a week during which they do not sleep on alternating nights * for six weeks, including the week in the hospital all patients sit in front of bright lights at specified times and for specified durations
Intervention: Lithium
Outcomes
Primary Outcomes
Structured Interview for the Hamilton Depression Scale With Atypical Depression Supplement(SIGH-ADS)
Time Frame: up to 6 weeks
This is a structured interview to obtain 17 Hamilton Depression Rating Scale ratings, with 8 additional items added to measure reverse vegetative features common in bipolar depression and depression with atypical features. There are total 25 items, score ranges from 0 to 90. Higher score means worse depression.
Secondary Outcomes
- Morningness-Eveningness Questionnaire (MEQ),(up to 6 weeks)
- Symptom Check List (SCL-90)(up to 6 weeks)
- Quick Inventory of Depressive Symptoms, Self Rated (QIDS-SR 16)(up to 6 weeks)
- Hypomania Interview Guide, Current Assessment Version (HIGH-C)(up to 6 weeks)
- Clinical Global Improvement (CGI)(up to 6 weeks)