Trial Outcomes & Findings for Wake Therapy in the Treatment of Depression (NCT NCT01431573)

NCT ID: NCT01431573

Last Updated: 2021-03-18

Results Overview

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.

• Recruitment status: COMPLETED
• Study phase: NA
• Target enrollment: 8 participants
• Primary outcome timeframe: up to 6 weeks
• Results posted on: 2021-03-18

Participant Flow

Participant milestones

Measure	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 Wake Therapy: Maintaining wakefulness on alternating nights over 7 days, with continued sleep deprivation the next day. light box: use of a lightbox titrated between 15-60 minutes (typically 30 minutes), timed according to chronotype score on the Morningness-Eveningness Questionnaire 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)
Overall Study STARTED	8
Overall Study COMPLETED	8
Overall Study NOT COMPLETED	0

Reasons for withdrawal

Withdrawal data not reported

Baseline Characteristics

Wake Therapy in the Treatment of Depression

Baseline characteristics by cohort

Measure	Wake Therapy + Light Box +/- Lithium n=8 Participants * 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 Wake Therapy: Maintaining wakefulness on alternating nights over 7 days, with continued sleep deprivation the next day. light box: use of a lightbox titrated between 15-60 minutes (typically 30 minutes), timed according to chronotype score on the Morningness-Eveningness Questionnaire 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)
Age, Categorical <=18 years	0 Participants n=5 Participants
Age, Categorical Between 18 and 65 years	7 Participants n=5 Participants
Age, Categorical >=65 years	1 Participants n=5 Participants
Age, Continuous	42.9 years STANDARD_DEVIATION 14.6 • n=5 Participants
Sex: Female, Male Female	6 Participants n=5 Participants
Sex: Female, Male Male	2 Participants n=5 Participants
Ethnicity (NIH/OMB) Hispanic or Latino	0 Participants n=5 Participants
Ethnicity (NIH/OMB) Not Hispanic or Latino	8 Participants n=5 Participants
Ethnicity (NIH/OMB) Unknown or Not Reported	0 Participants n=5 Participants
Race (NIH/OMB) American Indian or Alaska Native	0 Participants n=5 Participants
Race (NIH/OMB) Asian	1 Participants n=5 Participants
Race (NIH/OMB) Native Hawaiian or Other Pacific Islander	0 Participants n=5 Participants
Race (NIH/OMB) Black or African American	0 Participants n=5 Participants
Race (NIH/OMB) White	7 Participants n=5 Participants
Race (NIH/OMB) More than one race	0 Participants n=5 Participants
Race (NIH/OMB) Unknown or Not Reported	0 Participants n=5 Participants
Region of Enrollment United States	8 participants n=5 Participants

PRIMARY outcome

Timeframe: 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.

Outcome measures

Measure

Wake Therapy + Light Box +/- Lithium n=8 Participants * 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 Wake Therapy: Maintaining wakefulness on alternating nights over 7 days, with continued sleep deprivation the next day. light box: use of a lightbox titrated between 15-60 minutes (typically 30 minutes), timed according to chronotype score on the Morningness-Eveningness Questionnaire 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)

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

16.6 score on a scale Standard Deviation 5.5

SECONDARY outcome

Timeframe: up to 6 weeks

Population: One patient did not complete the Week 6 assessments, mean and standard deviation are based on the 7 subjects who completed the week 6 assessments.

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

Outcome measures

Measure

Wake Therapy + Light Box +/- Lithium n=7 Participants * 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 Wake Therapy: Maintaining wakefulness on alternating nights over 7 days, with continued sleep deprivation the next day. light box: use of a lightbox titrated between 15-60 minutes (typically 30 minutes), timed according to chronotype score on the Morningness-Eveningness Questionnaire 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)

Morningness-Eveningness Questionnaire (MEQ),

45.3 score on a scale Standard Deviation 11.3

SECONDARY outcome

Timeframe: 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.

Outcome measures

Measure

Wake Therapy + Light Box +/- Lithium n=8 Participants * 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 Wake Therapy: Maintaining wakefulness on alternating nights over 7 days, with continued sleep deprivation the next day. light box: use of a lightbox titrated between 15-60 minutes (typically 30 minutes), timed according to chronotype score on the Morningness-Eveningness Questionnaire 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)

Symptom Check List (SCL-90)

1.03 score on a scale Standard Deviation 0.44

SECONDARY outcome

Timeframe: 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

Outcome measures

Measure

Wake Therapy + Light Box +/- Lithium n=8 Participants * 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 Wake Therapy: Maintaining wakefulness on alternating nights over 7 days, with continued sleep deprivation the next day. light box: use of a lightbox titrated between 15-60 minutes (typically 30 minutes), timed according to chronotype score on the Morningness-Eveningness Questionnaire 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)

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

11.5 score on a scale Standard Deviation 4.8

SECONDARY outcome

Timeframe: 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.

Outcome measures

Measure

Wake Therapy + Light Box +/- Lithium n=8 Participants * 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 Wake Therapy: Maintaining wakefulness on alternating nights over 7 days, with continued sleep deprivation the next day. light box: use of a lightbox titrated between 15-60 minutes (typically 30 minutes), timed according to chronotype score on the Morningness-Eveningness Questionnaire 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)

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

2.0 score on a scale Standard Deviation 1.3

SECONDARY outcome

Timeframe: 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.

Outcome measures

Measure

Wake Therapy + Light Box +/- Lithium n=8 Participants * 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 Wake Therapy: Maintaining wakefulness on alternating nights over 7 days, with continued sleep deprivation the next day. light box: use of a lightbox titrated between 15-60 minutes (typically 30 minutes), timed according to chronotype score on the Morningness-Eveningness Questionnaire 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)

Clinical Global Improvement (CGI)

3.25 score on a scale Standard Deviation 1.04

Adverse Events

Wake Therapy + Light Box +/- Lithium

Serious events: 0 serious events

Other events: 0 other events

Deaths: 0 deaths

Serious adverse events

Adverse event data not reported

Other adverse events

Adverse event data not reported

Additional Information

David Hellerstein

NYSPI

Phone: 646-774-8069

Email: david.hellerstein@nyspi.columbia.edu

Results disclosure agreements

• Principal investigator is a sponsor employee
• Publication restrictions are in place