Wake Therapy in the Treatment of Depression

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Primary Purpose

Status

Completed

Phase

Not Applicable

Locations

United States

Study Type

Interventional

Intervention

Wake Therapy

light box

Lithium

About this trial

This is an interventional treatment trial for Major Depressive Disorder focused on measuring Depression

Eligibility Criteria

18 Years - 75 Years (Adult, Older Adult)All SexesDoes not accept healthy volunteers

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

Sites / Locations

Depression Evaluation Service - New York State Psychiatric Institute
New York State Psychiatric Institute

Arms of the Study

Arm 1

Arm Type

Experimental

Arm Label

Wake Therapy + light box +/- lithium

Arm Description

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

Outcomes

Primary Outcome Measures

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.

Secondary Outcome Measures

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

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.

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

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.

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.

Full Information

NCT ID

NCT01431573

First Posted

August 12, 2011

Last Updated

February 24, 2021

Sponsor

New York State Psychiatric Institute

1. Study Identification

Unique Protocol Identification Number

NCT01431573

Brief Title

Wake Therapy in the Treatment of Depression

Official Title

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

Study Type

Interventional

2. Study Status

Record Verification Date

February 2021

Overall Recruitment Status

Completed

Study Start Date

July 2011 (Actual)

Primary Completion Date

August 2016 (Actual)

Study Completion Date

August 2016 (Actual)

3. Sponsor/Collaborators

Responsible Party, by Official Title

Principal Investigator

Name of the Sponsor

New York State Psychiatric Institute

4. Oversight

Data Monitoring Committee

No

5. Study Description

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.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study

Major Depressive Disorder, Bipolar Disorder

Keywords

Depression

7. Study Design

Primary Purpose

Treatment

Study Phase

Not Applicable

Interventional Study Model

Single Group Assignment

Masking

None (Open Label)

Masking Description

This is an "open label" study so all participants know what the treatment is.

Allocation

N/A

Enrollment

8 (Actual)

8. Arms, Groups, and Interventions

Arm Title

Wake Therapy + light box +/- lithium

Arm Type

Experimental

Arm Description

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

Intervention Type

Behavioral

Intervention Name(s)

Wake Therapy

Intervention Description

Maintaining wakefulness on alternating nights over 7 days, with continued sleep deprivation the next day.

Intervention Type

Device

Intervention Name(s)

light box

Other Intervention Name(s)

Day Light

Intervention Description

use of a lightbox titrated between 15-60 minutes (typically 30 minutes), timed according to chronotype score on the Morningness-Eveningness Questionnaire

Intervention Type

Drug

Intervention Name(s)

Lithium

Other Intervention Name(s)

Lithobid, lithium carbonate

Intervention Description

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)

Primary Outcome Measure Information:

Title

Structured Interview for the Hamilton Depression Scale With Atypical Depression Supplement(SIGH-ADS)

Description

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.

Time Frame

up to 6 weeks

Secondary Outcome Measure Information:

Title

Morningness-Eveningness Questionnaire (MEQ),

Description

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

Time Frame

up to 6 weeks

Title

Symptom Check List (SCL-90)

Description

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.

Time Frame

up to 6 weeks

Title

Quick Inventory of Depressive Symptoms, Self Rated (QIDS-SR 16)

Description

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

Time Frame

up to 6 weeks

Title

Hypomania Interview Guide, Current Assessment Version (HIGH-C)

Description

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.

Time Frame

up to 6 weeks

Title

Clinical Global Improvement (CGI)

Description

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.

Time Frame

up to 6 weeks

10. Eligibility

Sex

All

Minimum Age & Unit of Time

18 Years

Maximum Age & Unit of Time

75 Years

Accepts Healthy Volunteers

No

Eligibility Criteria

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

Overall Study Officials:

First Name & Middle Initial & Last Name & Degree

Jonathan W. Stewart, M.D.

Organizational Affiliation

New York State Psychiatric Institute

Official's Role

Principal Investigator

Facility Information:

Facility Name

Depression Evaluation Service - New York State Psychiatric Institute

City

New York

State/Province

New York

ZIP/Postal Code

10032

Country

United States

Facility Name

New York State Psychiatric Institute

City

New York

State/Province

New York

ZIP/Postal Code

10032

Country

United States

12. IPD Sharing Statement

Links:

URL

http://www.depression-nyc.org

Description

Depression Evaluation Service

URL

http://columbiapsychiatry.org

Description

Columbia University Psychiatry

URL

http://nyspi.org

Description

New York State Psychiatric Institute

Major Depressive Disorder, Bipolar Disorder

About this trial

Eligibility Criteria

Sites / Locations

Arms of the Study

Arm 1

Outcomes

Primary Outcome Measures

Secondary Outcome Measures

Full Information

1. Study Identification

2. Study Status

3. Sponsor/Collaborators

4. Oversight

5. Study Description

6. Conditions and Keywords

7. Study Design

8. Arms, Groups, and Interventions

10. Eligibility

12. IPD Sharing Statement

Learn more about this trial