Study Results
The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.
Basic Information
Get a concise snapshot of the trial, including recruitment status, study phase, enrollment targets, and key timeline milestones.
TERMINATED
NA
13 participants
INTERVENTIONAL
2014-06-01
2016-04-07
Brief Summary
Review the sponsor-provided synopsis that highlights what the study is about and why it is being conducted.
Related Clinical Trials
Explore similar clinical trials based on study characteristics and research focus.
Are Bright Lights and Regulated Sleep Effective Treatment for Depression?
NCT03010488
Wake Therapy in the Treatment of Depression
NCT01431573
Out-patient Wake Therapy, Light Therapy and Sleep Phase Advance for Depression
NCT02750631
Combined Dialectical Behavior Therapy and Digital Cognitive Behavioral Therapy for Insomnia for Adolescents at High Risk for Suicide
NCT05842863
Light Therapy for Chronic Insomnia in General Practice
NCT04612192
Detailed Description
Dive into the extended narrative that explains the scientific background, objectives, and procedures in greater depth.
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.
Conditions
See the medical conditions and disease areas that this research is targeting or investigating.
Study Design
Understand how the trial is structured, including allocation methods, masking strategies, primary purpose, and other design elements.
RANDOMIZED
PARALLEL
TREATMENT
DOUBLE
Study Groups
Review each arm or cohort in the study, along with the interventions and objectives associated with them.
Triple Chronotherapy
Total Sleep Deprivation, Sleep phase advance, and Bright Light Therapy. Carex Health Brands Day-Light Classic 10,000 Lux
Total Sleep deprivation, Sleep Phase Advance, and Bright Light Therapy
Sleep deprivation, Sleep phase advance, and Bright light therapy
Sham Triple Chronotherapy
Total sleep deprivation, Three day fixed wake schedule, and sham light therapy.
Partial Sleep deprivation, Sleep Phase Delay, and Low amber light.
Treatment As Usual
Normal inpatient care including pharmacotherapy, psychotherapy, milieu therapy, and social work interventions.
Treatment as usual
Interventions
Learn about the drugs, procedures, or behavioral strategies being tested and how they are applied within this trial.
Total Sleep deprivation, Sleep Phase Advance, and Bright Light Therapy
Sleep deprivation, Sleep phase advance, and Bright light therapy
Partial Sleep deprivation, Sleep Phase Delay, and Low amber light.
Treatment as usual
Other Intervention Names
Discover alternative or legacy names that may be used to describe the listed interventions across different sources.
Eligibility Criteria
Check the participation requirements, including inclusion and exclusion rules, age limits, and whether healthy volunteers are accepted.
Inclusion Criteria
* 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
* 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)
18 Years
90 Years
ALL
No
Sponsors
Meet the organizations funding or collaborating on the study and learn about their roles.
Medical University of South Carolina
OTHER
Responsible Party
Identify the individual or organization who holds primary responsibility for the study information submitted to regulators.
Principal Investigators
Learn about the lead researchers overseeing the trial and their institutional affiliations.
Gregory Sahlem, MD
Role: PRINCIPAL_INVESTIGATOR
Medical University of South Carolina
Locations
Explore where the study is taking place and check the recruitment status at each participating site.
Medical University of South Carolina
Charleston, South Carolina, United States
Countries
Review the countries where the study has at least one active or historical site.
Other Identifiers
Review additional registry numbers or institutional identifiers associated with this trial.
Chronotherapy RCT
Identifier Type: -
Identifier Source: org_study_id
More Related Trials
Additional clinical trials that may be relevant based on similarity analysis.