Chronotherapy Randomized Controlled Trial
Primary Purpose
Major Depressive Disorder, Bipolar Depression, Suicidal Ideation
Status
Terminated
Phase
Not Applicable
Locations
United States
Study Type
Interventional
Intervention
Total Sleep deprivation, Sleep Phase Advance, and Bright Light Therapy
Partial Sleep deprivation, Sleep Phase Delay, and Low amber light.
Treatment as usual
Sponsored by
About this trial
This is an interventional treatment trial for Major Depressive Disorder
Eligibility Criteria
Inclusion Criteria:
- A current episode of non-psychotic major depression
- Currently hospitalized
- Age greater than 18
- If bipolar illness, must not be a mixed state, and must be on a therapeutic dose of a mood stabilizer
Exclusion Criteria:
- Urine drug screen positive for cocaine, or current alcohol/dependence that requires detox
- current psychosis
- Panic Disorder
- Severe Borderline Personality Disorder
- A history of seizures, uncontrolled severe headaches, stroke, or other neurologic illness that produces either gait abnormalities or lowered seizure threshold
- Medical illness that would make wake therapy intolerable
- Cataracts, glaucoma, or other intrinsic eye condition
- Currently taking light sensitizing medications
- Current pregnancy
- Mental retardation or dementia
- Untreated sleep disorder such as Obstructive Sleep Apnea(OSA), narcolepsy, or periodic limb movement disorder(PLMD) that results in excessive sleepiness
- Currently receiving electroconvulsive therapy (ECT)
Sites / Locations
- Medical University of South Carolina
Arms of the Study
Arm 1
Arm 2
Arm 3
Arm Type
Experimental
Sham Comparator
Active Comparator
Arm Label
Triple Chronotherapy
Sham Triple Chronotherapy
Treatment As Usual
Arm Description
Total Sleep Deprivation, Sleep phase advance, and Bright Light Therapy. Carex Health Brands Day-Light Classic 10,000 Lux
Total sleep deprivation, Three day fixed wake schedule, and sham light therapy.
Normal inpatient care including pharmacotherapy, psychotherapy, milieu therapy, and social work interventions.
Outcomes
Primary Outcome Measures
Hamilton Depression Rating Scale
Change in scores from Pre and Post Hamilton Depression scores
Columbia Suicide Severity Rating Scale
Change in score of Columbia Suicide Severity Rating Scale
Secondary Outcome Measures
Full Information
NCT ID
NCT02176824
First Posted
June 24, 2014
Last Updated
May 29, 2019
Sponsor
Medical University of South Carolina
1. Study Identification
Unique Protocol Identification Number
NCT02176824
Brief Title
Chronotherapy Randomized Controlled Trial
Official Title
Adjunct Total Sleep Deprivation, Sleep Phase Advance, and White Light Therapy Vs. Partial Sleep Deprivation, Sleep Phase Delay, and Amber Light Therapy as Adjunctive Treatments in Acutely Suicidal and Depressed Inpatients.
Study Type
Interventional
2. Study Status
Record Verification Date
May 2019
Overall Recruitment Status
Terminated
Why Stopped
PI
Study Start Date
June 1, 2014 (undefined)
Primary Completion Date
April 7, 2016 (Actual)
Study Completion Date
April 7, 2016 (Actual)
3. Sponsor/Collaborators
Responsible Party, by Official Title
Sponsor
Name of the Sponsor
Medical University of South Carolina
4. Oversight
Data Monitoring Committee
No
5. Study Description
Brief Summary
Chronotherapy is a term that describes therapeutic alterations of sleep wake cycles. Different variations of sleep deprivation, set sleep wake schedules, and types of light therapy have demonstrated efficacy in rapidly treating depression, and suicidal thinking. This study seeks to explore the effect of two different chronotherapuetic protocols on acutely depressed and suicidal inpatients admitted to the Medical University of South Carolina
Detailed Description
There is a consistently reported, rapid antidepressant response to a single night of total sleep deprivation in both unipolar, and bipolar depression. The clinical utility of this technique has been limited however, because responders have typically relapsed rapidly following recovery sleep. The addition of pharmacotherapy, sleep phase advance (a shift to an earlier sleep schedule with normalization over three days), and bright light therapy to sleep deprivation have each demonstrated efficacy in preventing relapse into depression. Combined total sleep deprivation, sleep phase advance, and bright light therapy, dubbed Triple Chronotherapy along with concomitant pharmacotherapy has demonstrated a rapid improvement in depressive symptoms that has remained durable for as long as 9 weeks post intervention. If the early, encouraging results of Triple Chronotherapy hold up to further study, the technique represents a near ideal inpatient treatment, as it is inexpensive, relatively easy to carry out, and has minimal side effects.
Despite encouraging early results, only one published report has attempted to use triple chronotherapy in suicidal patients, and in that trial only bipolar depressed patients were included, and one single variation of chronotherapy was tested (Three nights of sleep deprivation every other night with three light therapy sessions, combined with lithium). The lack of data in acutely suicidal patients significantly limits the utility of this intervention in the United States, where few non-suicidal patients are admitted. Published trials to this point have also excluded those with comorbid illness, which also limits the clinical usefulness of this intervention to a minority of patients. Furthermore there are sparse randomized adequately controlled trials, and still limited durability data on the technique.
We recently explored the tolerability and feasibility of the technique on acutely depressed and suicidal inpatients admitted to our inpatient unit with encouraging results. We subsequently propose to further explore the utility of this technique by piloting its effect compared to an active sham condition to determine if further study is indicated. Should further study be warranted, we hope to use the collected pilot data to determine the necessary number of participants to detect an effect.
6. Conditions and Keywords
Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Major Depressive Disorder, Bipolar Depression, Suicidal Ideation
7. Study Design
Primary Purpose
Treatment
Study Phase
Not Applicable
Interventional Study Model
Parallel Assignment
Masking
ParticipantOutcomes Assessor
Allocation
Randomized
Enrollment
13 (Actual)
8. Arms, Groups, and Interventions
Arm Title
Triple Chronotherapy
Arm Type
Experimental
Arm Description
Total Sleep Deprivation, Sleep phase advance, and Bright Light Therapy. Carex Health Brands Day-Light Classic 10,000 Lux
Arm Title
Sham Triple Chronotherapy
Arm Type
Sham Comparator
Arm Description
Total sleep deprivation, Three day fixed wake schedule, and sham light therapy.
Arm Title
Treatment As Usual
Arm Type
Active Comparator
Arm Description
Normal inpatient care including pharmacotherapy, psychotherapy, milieu therapy, and social work interventions.
Intervention Type
Behavioral
Intervention Name(s)
Total Sleep deprivation, Sleep Phase Advance, and Bright Light Therapy
Intervention Description
Sleep deprivation, Sleep phase advance, and Bright light therapy
Intervention Type
Behavioral
Intervention Name(s)
Partial Sleep deprivation, Sleep Phase Delay, and Low amber light.
Other Intervention Name(s)
Carex Health Brands Day-Light Classic 10,000 LUX with custom amber filter from lowbluelights.com
Intervention Type
Other
Intervention Name(s)
Treatment as usual
Primary Outcome Measure Information:
Title
Hamilton Depression Rating Scale
Description
Change in scores from Pre and Post Hamilton Depression scores
Time Frame
Day prior to total sleep deprivation, and then again over the next 4 consecutive days. There will then be a continuation phase where data will be collected at one week, two weeks, 4 weeks, and 8 weeks.
Title
Columbia Suicide Severity Rating Scale
Description
Change in score of Columbia Suicide Severity Rating Scale
Time Frame
Day prior to total sleep deprivation, and then again over the next 4 consecutive days. There will then be a continuation phase where data will be collected at one week, two weeks, 4 weeks, and 8 weeks.
10. Eligibility
Sex
All
Minimum Age & Unit of Time
18 Years
Maximum Age & Unit of Time
90 Years
Accepts Healthy Volunteers
No
Eligibility Criteria
Inclusion Criteria:
A current episode of non-psychotic major depression
Currently hospitalized
Age greater than 18
If bipolar illness, must not be a mixed state, and must be on a therapeutic dose of a mood stabilizer
Exclusion Criteria:
Urine drug screen positive for cocaine, or current alcohol/dependence that requires detox
current psychosis
Panic Disorder
Severe Borderline Personality Disorder
A history of seizures, uncontrolled severe headaches, stroke, or other neurologic illness that produces either gait abnormalities or lowered seizure threshold
Medical illness that would make wake therapy intolerable
Cataracts, glaucoma, or other intrinsic eye condition
Currently taking light sensitizing medications
Current pregnancy
Mental retardation or dementia
Untreated sleep disorder such as Obstructive Sleep Apnea(OSA), narcolepsy, or periodic limb movement disorder(PLMD) that results in excessive sleepiness
Currently receiving electroconvulsive therapy (ECT)
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Gregory Sahlem, MD
Organizational Affiliation
Medical University of South Carolina
Official's Role
Principal Investigator
Facility Information:
Facility Name
Medical University of South Carolina
City
Charleston
State/Province
South Carolina
ZIP/Postal Code
29401
Country
United States
12. IPD Sharing Statement
Learn more about this trial
Chronotherapy Randomized Controlled Trial
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