Wake Therapy in the Treatment of Depression

Not Applicable

Completed

Conditions: Bipolar Disorder
Major Depressive Disorder

Interventions: Behavioral: Wake Therapy
Device: light box
Drug: Lithium

Registration Number: NCT01431573

Lead Sponsor: New York State Psychiatric Institute

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.

Recruitment & Eligibility

Status: COMPLETED

Sex: All

Target Recruitment: 8

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
age 18-75
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
pregnancy
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
left ventricular hypertrophy
symptomatic mitral valve prolapse
abnormal creatinine

Study & Design

Study Type: INTERVENTIONAL

Study Design: SINGLE_GROUP

Arm && Interventions

Group	Intervention	Description
Wake Therapy + light box +/- lithium	Wake Therapy	* 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
Wake Therapy + light box +/- lithium	light box	* 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
Wake Therapy + light box +/- lithium	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

Primary Outcome Measures

Name	Time	Method
Structured Interview for the Hamilton Depression Scale With Atypical Depression Supplement(SIGH-ADS)	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 Outcome Measures

Name	Time	Method
Morningness-Eveningness Questionnaire (MEQ),	up to 6 weeks	This is a standard self-report instrument for measuring the extent to which an individual is an "early bird" vs. a "night owl," asking a variety of questions concerning the time of day individuals prefer engagement in various activities. Scores correlate highly with biologic measures of circadian rhythm phase and will be used to custom program the timing of each patient's light therapy and habitual sleep Numerical scales: Multiple choice, 4-5 point scale. The sum gives a score ranging from 16 to 86; scores of 41 and below indicate "evening types", scores of 59 and above indicate "morning types", scores between 42-58 indicate "intermediate types"; 49.8% of the total population was classified as morning type compared to 5.6% having an evening-type preference
Symptom Check List (SCL-90)	up to 6 weeks	This a standard listing covering most major categories of psychiatric symptoms. It allows measurement not only of depressive symptoms over time, but also other common symptoms, such as those of panic attacks or other anxiety disorders. It consists of 90 items that yields nine scores along primary symptom dimensions and three scores among global distress indices. Each item scores 0-4, higher scores indicate greater distress. Mean of the respective item scores are used. Range from 0-4, higher value indicate greater distress.
Quick Inventory of Depressive Symptoms, Self Rated (QIDS-SR 16)	up to 6 weeks	The responses to this question set, adapted from John Rush's Inventory of Depressive Symptoms: Total QIDS scores range from 0 to 27, with scores of 5 or lower indicative of no depression, scores from 6 to 10 indicating mild depression, 11 to 15 indicating moderate depression, 16 to 20 reflecting severe depression, and total scores greater than 21 indicating very severe depression
Hypomania Interview Guide, Current Assessment Version (HIGH-C)	up to 6 weeks	The HIGH-C is structured like the SIGH-ADS, and provides assessments of manic and hypomanic symptoms , in order to help identify and quantify switches and mixed states. All items are scored from 0 to 4, range from 0-60. An item score of "0" indicates absence of the symptom; "1" and "2" indicate incremental levels of mild presentations short of hypomania (but typical of hyperthymia); "3" indicates moderate severity, persistent and uncharacteristic for the patient, and in most cases, observable by others(as is typical of hypomania); and "4" indicates a marked or severe symptom (typical of mania). The sum of points on all items constitutes the total HIGH-R score.
Clinical Global Improvement (CGI)	up to 6 weeks	This is a standard measure of the clinician's overall impression of how the patient is doing. It includes two measurements, one for the patient's severity of overall symptomatology, and the other for improvement since starting treatment. is rated on a seven-point scale: "Compared to the patient's condition at admission to the project \[prior to medication initiation\], this patient's condition is: 1=very much improved since the initiation of treatment; 2=much improved; 3=minimally improved; 4=no change from baseline (the initiation of treatment); 5=minimally worse; 6= much worse; 7=very much worse since the initiation of treatment.

Trial Locations

Locations (2): Depression Evaluation Service - New York State Psychiatric Institute
🇺🇸
New York, New York, United States
New York State Psychiatric Institute
🇺🇸
New York, New York, United States