- ICH GCP
- US Clinical Trials Registry
- Clinical Trial NCT01431573
Wake Therapy in the Treatment of Depression
Combined Wake Therapy, Light Therapy, and Lithium for Bipolar and Refractory Depression
Study Overview
Status
Conditions
Intervention / Treatment
Detailed Description
Study Type
Enrollment (Actual)
Phase
- Not Applicable
Contacts and Locations
Study Locations
-
-
New York
-
New York, New York, United States, 10032
- New York State Psychiatric Institute
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New York, New York, United States, 10032
- Depression Evaluation Service - New York State Psychiatric Institute
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Participation Criteria
Eligibility Criteria
Ages Eligible for Study
Accepts Healthy Volunteers
Genders Eligible for Study
Description
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 Plan
How is the study designed?
Design Details
- Primary Purpose: TREATMENT
- Allocation: NA
- Interventional Model: SINGLE_GROUP
- Masking: NONE
Arms and Interventions
Participant Group / Arm |
Intervention / Treatment |
---|---|
EXPERIMENTAL: Wake Therapy + light box +/- lithium
|
Maintaining wakefulness on alternating nights over 7 days, with continued sleep deprivation the next day.
use of a lightbox titrated between 15-60 minutes (typically 30 minutes), timed according to chronotype score on the Morningness-Eveningness Questionnaire
Other Names:
For patients not already taking lithium, dose will start at 600 mg daily (all in the evening) and be adjusted in 300 mg/d increments according to weekly blood levels (i.e., lithium dose may be changed once a week if most recent blood level is too low; if too high, it will be decreased or temporarily discontinued as clinically indicated; 150 mg increments will be utilized if multiples of 300 mg result in intolerance or blood levels outside the target range (0.6 - 1.0 mEq/L)
Other Names:
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What is the study measuring?
Primary Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
---|---|---|
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.
|
up to 6 weeks
|
Secondary Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
---|---|---|
Morningness-Eveningness Questionnaire (MEQ),
Time Frame: 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 |
up to 6 weeks
|
Symptom Check List (SCL-90)
Time Frame: 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. |
up to 6 weeks
|
Quick Inventory of Depressive Symptoms, Self Rated (QIDS-SR 16)
Time Frame: 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 |
up to 6 weeks
|
Hypomania Interview Guide, Current Assessment Version (HIGH-C)
Time Frame: 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. |
up to 6 weeks
|
Clinical Global Improvement (CGI)
Time Frame: 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. |
up to 6 weeks
|
Collaborators and Investigators
Publications and helpful links
Study record dates
Study Major Dates
Study Start (ACTUAL)
Primary Completion (ACTUAL)
Study Completion (ACTUAL)
Study Registration Dates
First Submitted
First Submitted That Met QC Criteria
First Posted (ESTIMATE)
Study Record Updates
Last Update Posted (ACTUAL)
Last Update Submitted That Met QC Criteria
Last Verified
More Information
Terms related to this study
Keywords
Additional Relevant MeSH Terms
- Behavioral Symptoms
- Mental Disorders
- Pathologic Processes
- Mood Disorders
- Bipolar and Related Disorders
- Depression
- Depressive Disorder
- Disease
- Bipolar Disorder
- Depressive Disorder, Major
- Physiological Effects of Drugs
- Molecular Mechanisms of Pharmacological Action
- Central Nervous System Depressants
- Enzyme Inhibitors
- Tranquilizing Agents
- Psychotropic Drugs
- Antidepressive Agents
- Antimanic Agents
- Lithium Carbonate
Other Study ID Numbers
- 5491/7316R
- IRB 5491 (OTHER_GRANT: there is no grantor or funder)
This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.
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