Major Depressive DisorderNCT01431573
Wake Therapy in the Treatment of Depression
A study testing Wake Therapy, light box and Lithium in people with Major Depressive Disorder and Bipolar Disorder, run by New York State Psychiatric Institute at 2 sites in United States.
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… Read more about this study
- Who is it for?
- Ages 18 to 75 years
- Conditions the study is for
- Major Depressive Disorder, Bipolar Disorder
- What is being tested?
- Wake Therapy, light box and Lithium
- Type of treatment
- Medical device, Lifestyle or therapy programme
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 8 participants
- Where
- 2 sitesUnited States
- Study dates
- Jul 2011to Aug 2016
- Phase
- Interventional
- Are there results?
- Yes, posted in the registrySummary in the doctors' view
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 to 75 years
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- 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
Who cannot join
- 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)
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- 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
Trial locations and contacts
2 sites in 1 country.
United States2 sites
Depression Evaluation Service - New York State Psychiatric Institute
New York, New York, 10032
New York State Psychiatric Institute
New York, New York, 10032
About this study
Official title: Combined Wake Therapy, Light Therapy, and Lithium for Bipolar and Refractory Depression
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.
Read the 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.
- Conditions
- Major Depressive Disorder, Bipolar Disorder
- Being tested
- Wake Therapy, light box, Lithium
- Keywords
- Depression
- Medical subject headings
- Depressive Disorder, Major, Bipolar Disorder, Depression
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Wake TherapyBehavioural
Maintaining wakefulness on alternating nights over 7 days, with continued sleep deprivation the next day.
light boxDevice
Also called Day Light
use of a lightbox titrated between 15-60 minutes (typically 30 minutes), timed according to chronotype score on the Morningness-Eveningness Questionnaire
LithiumDrug
Also called Lithobid, lithium carbonate
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)
| Study group | Role | What they receive |
|---|---|---|
| Wake Therapy + light box +/- lithium | Experimental | * 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 Receives: Behavioral: Wake Therapy; Device: light box; Drug: Lithium |
What is being measured
The primary outcome is the main question the study is designed to answer.
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.
Measured: up to 6 weeks
Secondary outcomes (5)
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
Measured: up to 6 weeks
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.
Measured: up to 6 weeks
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
Measured: up to 6 weeks
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.
Measured: up to 6 weeks
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.
Measured: up to 6 weeks
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted9 Sep 2011 (estimated)
- Study startJul 2011
- Primary completionAug 2016
- Study completionAug 2016
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Posted resultsParticipant flow, outcome measures and adverse events reported by the sponsor.
- Other trials for Major Depressive DisorderStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Treatment
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Enrolment
- 8 participants (actual)
Sponsor and investigators
- Lead sponsor
- New York State Psychiatric Institute
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, David J. Hellerstein, New York State Psychiatric Institute
- Investigators
- Jonathan W. Stewart, M.D., Principal investigator, New York State Psychiatric Institute
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT01431573
- Sponsor's protocol ID
- 5491/7316R
- Other IDs
- IRB 5491
- Status last verified
- Feb 2021
- First submitted
- 12 Aug 2011
- Last updated
- 18 Mar 2021
- Results posted
- Yes, on ClinicalTrials.gov
- Data monitoring committee
- No
Study at a glance
From the registry record, last updated by the sponsor on 18 Mar 2021. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Combined Wake Therapy, Light Therapy, and Lithium for Bipolar and Refractory Depression
- ClinicalTrials.gov ID
- NCT01431573
- Acronym / sponsor ID
- 5491/7316R
- Conditions
- Major Depressive Disorder, Bipolar Disorder
- Keywords
- Depression
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 8 participants (actual)
- Lead sponsor
- New York State Psychiatric InstituteUniversity, hospital or other
- Study start
- Jul 2011 (actual)
- Primary completion
- Aug 2016 (actual)
- Study completion
- Aug 2016 (actual)
- First posted
- 9 Sep 2011 (estimated)
- Results
- Posted 18 Mar 2021
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
Study design
- Primary purpose
- Treatment
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| Wake Therapy + light box +/- lithium | Experimental | Behavioral: Wake Therapy, Device: light box, Drug: 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 |
Who may qualify
- Ages
- 18 to 75 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (6 listed)
- 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
Key exclusion criteria (14 listed)
- 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
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Wake TherapyMaintaining wakefulness on alternating nights over 7 days, with continued sleep deprivation the next day. | Behavioural | Wake Therapy + light box +/- lithium |
| light boxAlso: Day Lightuse of a lightbox titrated between 15-60 minutes (typically 30 minutes), timed according to chronotype score on the Morningness-Eveningness Questionnaire | Device | Wake Therapy + light box +/- lithium |
| LithiumAlso: Lithobid, lithium carbonateFor 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) | Drug | Wake Therapy + light box +/- lithium |
Primary outcome
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.
5 secondary outcomes
Morningness-Eveningness Questionnaire (MEQ),
Time frame: up to 6 weeks
Symptom Check List (SCL-90)
Time frame: up to 6 weeks
Quick Inventory of Depressive Symptoms, Self Rated (QIDS-SR 16)
Time frame: up to 6 weeks
Hypomania Interview Guide, Current Assessment Version (HIGH-C)
Time frame: up to 6 weeks
Clinical Global Improvement (CGI)
Time frame: up to 6 weeks
Results and safety
Loading the posted results from ClinicalTrials.gov…
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 18 Mar 2021.
- Posted resultsParticipant flow, baseline, all outcome measures and adverse events.
- Depression Evaluation ServiceLink provided by the sponsor.
- Columbia University PsychiatryLink provided by the sponsor.
- New York State Psychiatric InstituteLink provided by the sponsor.
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Jonathan W. Stewart, M.D. principal investigator
New York State Psychiatric Institute
2 sites in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Wake Therapy, light box and Lithium in people with Major Depressive Disorder and Bipolar Disorder, run by New York State Psychiatric Institute at 2 sites in United States.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 6 inclusion and 14 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: finished, as of the sponsor's last update on 18 Mar 2021. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 2 sites in United States. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
Yes. Results are posted in the registry (first posted 18 Mar 2021). A summary is in the For doctors view, and the full results are on ClinicalTrials.gov.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Structured Interview for the Hamilton Depression Scale With Atypical Depression Supplement(SIGH-ADS) (time frame: up to 6 weeks). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 18 Mar 2021.