Major Depressive DisorderNCT02176824
Chronotherapy Randomized Controlled Trial
A study testing Total Sleep deprivation, Sleep Phase Advance, and Bright Light Therapy, Partial Sleep deprivation, Sleep Phase Delay, and Low amber light. and Treatment as usual in people with Major Depressive Disorder and Bipolar Depression, run by Medical University of South Carolina at 1 site in United States.
Trial 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. Read more about this study
- Who is it for?
- Ages 18 to 90 years
- Conditions the study is for
- Major Depressive Disorder, Bipolar Depression, Suicidal Ideation
- What is being tested?
- Total Sleep deprivation, Sleep Phase Advance, and Bright Light Therapy, Partial Sleep deprivation, Sleep Phase Delay, and Low amber light. and Treatment as usual
- Type of treatment
- Lifestyle or therapy programme
- Could I receive a placebo?
- Yes, some participants may receive a placebo
- How many people
- 13 participants
- Where
- 1 siteUnited States
- Study dates
- 1 Jun 2014to 7 Apr 2016
- Phase
- Interventional
- Are there results?
- None posted in the registry
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 90 years
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- 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
Who cannot join
- 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
Show all 12Show fewer
- 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)
Trial locations and contacts
1 site in 1 country.
United States1 site
Medical University of South Carolina
Charleston, South Carolina, 29401
About this study
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.
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
Read the 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.
- Being tested
- Total Sleep deprivation, Sleep Phase Advance, and Bright Light Therapy, Partial Sleep deprivation, Sleep Phase Delay, and Low amber light., Treatment as usual
- Medical subject headings
- Depressive Disorder, Major, Bipolar Disorder, Suicidal Ideation
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Total Sleep deprivation, Sleep Phase Advance, and Bright Light TherapyBehavioural
Sleep deprivation, Sleep phase advance, and Bright light therapy
Partial Sleep deprivation, Sleep Phase Delay, and Low amber light.Behavioural
Also called Carex Health Brands Day-Light Classic 10,000 LUX with custom amber filter from lowbluelights.com
Treatment as usualOther
| Study group | Role | What they receive |
|---|---|---|
| Triple Chronotherapy | Experimental | Total Sleep Deprivation, Sleep phase advance, and Bright Light Therapy. Carex Health Brands Day-Light Classic 10,000 Lux Receives: Behavioral: Total Sleep deprivation, Sleep Phase Advance, and Bright Light Therapy |
| Sham Triple Chronotherapy | Sham comparator | Total sleep deprivation, Three day fixed wake schedule, and sham light therapy. Receives: Behavioral: Partial Sleep deprivation, Sleep Phase Delay, and Low amber light. |
| Treatment As Usual | Active comparator | Normal inpatient care including pharmacotherapy, psychotherapy, milieu therapy, and social work interventions. Receives: Other: Treatment as usual |
What is being measured
The primary outcome is the main question the study is designed to answer.
Hamilton Depression Rating Scale
Change in scores from Pre and Post Hamilton Depression scores
Measured: 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.
Columbia Suicide Severity Rating Scale
Change in score of Columbia Suicide Severity Rating Scale
Measured: 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.
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted27 Jun 2014 (estimated)
- Study start1 Jun 2014
- Primary completion7 Apr 2016
- Study completion7 Apr 2016
Why it stopped: PI
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- 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
- Randomised
- Intervention model
- Parallel groups
- Masking
- Double blind
- Who is masked
- Participant, Outcomes assessor
- Enrolment
- 13 participants (actual)
Sponsor and investigators
- Lead sponsor
- Medical University of South Carolina
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor
- Investigators
- Gregory Sahlem, MD, Principal investigator, Medical University of South Carolina
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT02176824
- Sponsor's protocol ID
- Chronotherapy RCT
- Status last verified
- May 2019
- First submitted
- 24 Jun 2014
- Last updated
- 30 May 2019
- Results posted
- No
- Data monitoring committee
- No
Study at a glance
From the registry record, last updated by the sponsor on 30 May 2019. Recruitment status is as the sponsor reported it: confirm with the study team.
- 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.
- ClinicalTrials.gov ID
- NCT02176824
- Acronym / sponsor ID
- Chronotherapy RCT
- Study type
- Interventional
- Recruitment status
- TerminatedReason stopped: PI
- Enrolment
- 13 participants (actual)
- Lead sponsor
- Medical University of South CarolinaUniversity, hospital or other
- Study start
- 1 Jun 2014
- Primary completion
- 7 Apr 2016 (actual)
- Study completion
- 7 Apr 2016 (actual)
- First posted
- 27 Jun 2014 (estimated)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Double blind (participant, outcomes assessor)
- Number of arms
- 3
| Arm | Type | Receives |
|---|---|---|
| Triple Chronotherapy | Experimental | Behavioral: Total Sleep deprivation, Sleep Phase Advance, and Bright Light TherapyTotal Sleep Deprivation, Sleep phase advance, and Bright Light Therapy. Carex Health Brands Day-Light Classic 10,000 Lux |
| Sham Triple Chronotherapy | Sham comparator | Behavioral: Partial Sleep deprivation, Sleep Phase Delay, and Low amber light.Total sleep deprivation, Three day fixed wake schedule, and sham light therapy. |
| Treatment As Usual | Active comparator | Other: Treatment as usualNormal inpatient care including pharmacotherapy, psychotherapy, milieu therapy, and social work interventions. |
Who may qualify
- Ages
- 18 to 90 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (4 listed)
- 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
Key exclusion criteria (12 listed)
- 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
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 |
|---|---|---|
| Total Sleep deprivation, Sleep Phase Advance, and Bright Light TherapySleep deprivation, Sleep phase advance, and Bright light therapy | Behavioural | Triple Chronotherapy |
| Partial Sleep deprivation, Sleep Phase Delay, and Low amber light.Also: Carex Health Brands Day-Light Classic 10,000 LUX with custom amber filter from lowbluelights.com | Behavioural | Sham Triple Chronotherapy |
| Treatment as usual | Other | Treatment As Usual |
Primary outcome
Hamilton Depression 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.
Change in scores from Pre and Post Hamilton Depression scores
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.
Change in score of Columbia Suicide Severity Rating Scale
Results and safety
The study was stopped early (reason given: PI). Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 30 May 2019.
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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.
Gregory Sahlem, MD principal investigator
Medical University of South Carolina
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Total Sleep deprivation, Sleep Phase Advance, and Bright Light Therapy, Partial Sleep deprivation, Sleep Phase Delay, and Low amber light. and Treatment as usual in people with Major Depressive Disorder and Bipolar Depression, run by Medical University of South Carolina at 1 site 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 4 inclusion and 12 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: stopped early, as of the sponsor's last update on 30 May 2019. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site 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. Some participants in this study may receive a placebo. 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?
The study was stopped early (reason given: PI). Results are not available in the source record.
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?
Hamilton Depression 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.). The study lists 2 primary outcomes in all. 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 30 May 2019.