NCT02176824

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

Trial Health

57
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Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
13

participants targeted

Target at below P25 for not_applicable major-depressive-disorder

Timeline
Completed

Started Jun 2014

Geographic Reach
1 country

1 active site

Status
terminated

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

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Study Timeline

Key milestones and dates

Study Start

First participant enrolled

June 1, 2014

Completed
23 days until next milestone

First Submitted

Initial submission to the registry

June 24, 2014

Completed
3 days until next milestone

First Posted

Study publicly available on registry

June 27, 2014

Completed
1.8 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

April 7, 2016

Completed
Same day until next milestone

Study Completion

Last participant's last visit for all outcomes

April 7, 2016

Completed
Last Updated

May 30, 2019

Status Verified

May 1, 2019

Enrollment Period

1.9 years

First QC Date

June 24, 2014

Last Update Submit

May 29, 2019

Conditions

Major Depressive DisorderBipolar DepressionSuicidal Ideation

Outcome Measures

Primary Outcomes (2)

  • Hamilton Depression Rating Scale

    Change in scores from Pre and Post Hamilton Depression scores

    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

    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.

Study Arms (3)

Triple Chronotherapy

EXPERIMENTAL

Total Sleep Deprivation, Sleep phase advance, and Bright Light Therapy. Carex Health Brands Day-Light Classic 10,000 Lux

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.

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.

Other: Treatment as usual

Interventions

Total Sleep deprivation, Sleep Phase Advance, and Bright Light TherapyBEHAVIORAL

Sleep deprivation, Sleep phase advance, and Bright light therapy

Triple Chronotherapy
Partial Sleep deprivation, Sleep Phase Delay, and Low amber light.BEHAVIORAL
Also known as: Carex Health Brands Day-Light Classic 10,000 LUX with custom amber filter from lowbluelights.com
Sham Triple Chronotherapy
Treatment as usualOTHER
Treatment As Usual

Eligibility Criteria

Age18 Years - 90 Years
Sexall
Healthy VolunteersNo
Age GroupsAdult (18-64), Older Adult (65+)

You may qualify if:

  • 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

You may not qualify if:

  • 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)

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

Medical University of South Carolina

Charleston, South Carolina, 29401, United States

Location

MeSH Terms

Conditions

Depressive Disorder, MajorBipolar DisorderSuicidal Ideation

Interventions

Ultraviolet TherapyTherapeutics

Condition Hierarchy (Ancestors)

Depressive DisorderMood DisordersMental DisordersBipolar and Related DisordersSuicideSelf-Injurious BehaviorBehavioral SymptomsBehavior

Intervention Hierarchy (Ancestors)

Phototherapy

Study Officials

  • Gregory Sahlem, MD

    Medical University of South Carolina

    PRINCIPAL INVESTIGATOR

Study Design

Study Type
interventional
Phase
not applicable
Allocation
RANDOMIZED
Masking
DOUBLE
Who Masked
PARTICIPANT, OUTCOMES ASSESSOR
Purpose
TREATMENT
Intervention Model
PARALLEL
Sponsor Type
OTHER
Responsible Party
SPONSOR

Study Record Dates

First Submitted

June 24, 2014

First Posted

June 27, 2014

Study Start

June 1, 2014

Primary Completion

April 7, 2016

Study Completion

April 7, 2016

Last Updated

May 30, 2019

Record last verified: 2019-05

Locations

US(1)