Chronotherapy Randomized Controlled Trial

Major Depressive Disorder Clinical 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.

Status Terminated

Clinical 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. 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

Clinical Trial 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. ;

Related Conditions & MeSH terms

• Bipolar Depression
• Bipolar Disorder
• Depression
• Depressive Disorder
• Depressive Disorder, Major
• Major Depressive Disorder
• Sleep Deprivation
• Suicidal Ideation

• NCT number: NCT02176824
• Study type: Interventional
• Source: Medical University of South Carolina
• Status: Terminated
• Phase: N/A
• Start date: June 1, 2014
• Completion date: April 7, 2016