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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
Sponsor:
Information provided by (Responsible Party):
David J. Hellerstein, 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.

Condition or disease Intervention/treatment Phase
Major Depressive Disorder Bipolar Disorder Behavioral: Wake Therapy Device: light box Drug: Lithium Not Applicable

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.

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Study Type : Interventional  (Clinical Trial)
Actual Enrollment : 8 participants
Allocation: N/A
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.
Primary Purpose: Treatment
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

Resource links provided by the National Library of Medicine


Arm Intervention/treatment
Experimental: 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
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

Drug: Lithium
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




Primary Outcome Measures :
  1. 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 Outcome Measures :
  1. 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


  2. 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.


  3. 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


  4. 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.


  5. 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.




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Ages Eligible for Study:   18 Years to 75 Years   (Adult, Older Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
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

Information from the National Library of Medicine

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


Locations
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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
Sponsors and Collaborators
New York State Psychiatric Institute
Investigators
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Principal Investigator: Jonathan W. Stewart, M.D. New York State Psychiatric Institute
  Study Documents (Full-Text)

Documents provided by David J. Hellerstein, New York State Psychiatric Institute:
Informed Consent Form  [PDF] October 31, 2016

Additional Information:
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Responsible Party: David J. Hellerstein, Principal Investigator, New York State Psychiatric Institute
ClinicalTrials.gov Identifier: NCT01431573    
Other Study ID Numbers: 5491/7316R
IRB 5491 ( Other Grant/Funding Number: there is no grantor or funder )
First Posted: September 9, 2011    Key Record Dates
Results First Posted: March 18, 2021
Last Update Posted: March 18, 2021
Last Verified: February 2021
Keywords provided by David J. Hellerstein, New York State Psychiatric Institute:
Depression
Additional relevant MeSH terms:
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Disease
Depression
Depressive Disorder
Depressive Disorder, Major
Bipolar Disorder
Pathologic Processes
Behavioral Symptoms
Mood Disorders
Mental Disorders
Bipolar and Related Disorders
Lithium Carbonate
Antidepressive Agents
Psychotropic Drugs
Enzyme Inhibitors
Molecular Mechanisms of Pharmacological Action
Antimanic Agents
Tranquilizing Agents
Central Nervous System Depressants
Physiological Effects of Drugs