Wake Therapy in the Treatment of Depression
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|ClinicalTrials.gov Identifier: NCT01431573|
Recruitment Status : Completed
First Posted : September 9, 2011
Results First Posted : March 18, 2021
Last Update Posted : March 18, 2021
|Condition or disease||Intervention/treatment||Phase|
|Major Depressive Disorder Bipolar Disorder||Behavioral: Wake Therapy Device: light box Drug: Lithium||Not Applicable|
|Study Type :||Interventional (Clinical Trial)|
|Actual Enrollment :||8 participants|
|Intervention Model:||Single Group Assignment|
|Masking:||None (Open Label)|
|Masking Description:||This is an "open label" study so all participants know what the treatment is.|
|Official Title:||Combined Wake Therapy, Light Therapy, and Lithium for Bipolar and Refractory Depression|
|Actual Study Start Date :||July 2011|
|Actual Primary Completion Date :||August 2016|
|Actual Study Completion Date :||August 2016|
Experimental: Wake Therapy + light box +/- lithium
Behavioral: Wake Therapy
Maintaining wakefulness on alternating nights over 7 days, with continued sleep deprivation the next day.
Device: light box
use of a lightbox titrated between 15-60 minutes (typically 30 minutes), timed according to chronotype score on the Morningness-Eveningness Questionnaire
Other Name: Day Light
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 Name: Lithobid, lithium carbonate
- 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.
- 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
- 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.
- 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
- 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.
- 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.
To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.
Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT01431573
|United States, New York|
|Depression Evaluation Service - New York State Psychiatric Institute|
|New York, New York, United States, 10032|
|New York State Psychiatric Institute|
|New York, New York, United States, 10032|
|Principal Investigator:||Jonathan W. Stewart, M.D.||New York State Psychiatric Institute|