Wake Therapy in the Treatment of Depression

Major Depressive Disorder Clinical Trial

Official title:

Combined Wake Therapy, Light Therapy, and Lithium for Bipolar and Refractory Depression

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT01431573
• Other study ID #: 5491/7316R
• Secondary ID: IRB 5491
• Status: Completed
• Phase: N/A
• Start date: July 2011
• Est. completion date: August 2016

Study information

• Verified date: February 2021
• Source: New York State Psychiatric Institute
• Contact: n/a
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial 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.

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 information / eligibility

• Status: Completed
• Enrollment: 8
• Est. completion date: August 2016
• Est. primary completion date: August 2016
• Accepts healthy volunteers: No
• Gender: All
• Age group: 18 Years to 75 Years

Eligibility

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

Related Conditions & MeSH terms

• Bipolar Disorder
• Depression
• Depressive Disorder
• Depressive Disorder, Major
• Disease
• Major Depressive Disorder

Intervention

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

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)

Locations

Country	Name	City	State
United States	Depression Evaluation Service - New York State Psychiatric Institute	New York	New York
United States	New York State Psychiatric Institute	New York	New York

Sponsors (1)

Lead Sponsor	Collaborator
New York State Psychiatric Institute

Country where clinical trial is conducted

United States, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Structured Interview for the Hamilton Depression Scale With Atypical Depression Supplement(SIGH-ADS)	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	Morningness-Eveningness Questionnaire (MEQ),	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
Secondary	Symptom Check List (SCL-90)	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
Secondary	Quick Inventory of Depressive Symptoms, Self Rated (QIDS-SR 16)	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
Secondary	Hypomania Interview Guide, Current Assessment Version (HIGH-C)	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
Secondary	Clinical Global Improvement (CGI)	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

External Links

•   Columbia University Psychiatry
•   Depression Evaluation Service
•   New York State Psychiatric Institute