Feasibility and Tolerability of Adjunct Chronotherapy in Depressed Inpatients
1 other identifier
interventional
13
1 country
1
Brief Summary
This study will attempt to study the effect of adjunctive chronotherapy (wake therapy, sleep phase advance, and bright light therapy) on acutely depressed inpatients. The investigators will attempt to recruit individuals admitted to the acute inpatient unit and study the results of the treatment on depressive symptoms, and suicidality.
Trial Health
Trial Health Score
Automated assessment based on enrollment pace, timeline, and geographic reach
participants targeted
Target at below P25 for not_applicable
Started Oct 2013
Shorter than P25 for not_applicable
1 active site
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
October 1, 2013
CompletedFirst Submitted
Initial submission to the registry
February 18, 2014
CompletedPrimary Completion
Last participant's last visit for primary outcome
March 1, 2014
CompletedFirst Posted
Study publicly available on registry
March 17, 2014
CompletedStudy Completion
Last participant's last visit for all outcomes
April 1, 2014
CompletedOctober 2, 2015
September 1, 2013
5 months
February 18, 2014
October 1, 2015
Conditions
Outcome Measures
Primary Outcomes (2)
Hamilton Depression Rating Scale
Change Score of Pre and Post Hamilton depression depression scores
Day prior to total sleep deprivation, and then again over the next 4 consecutive days.
Columbia Suicide Severity Rating Scale
Change score in Columbia Suicide Severity Rating Scale
Daily throughout the treatment (Days 0-4)
Study Arms (1)
Triple Chronotherapy
EXPERIMENTALTotal sleep deprivation, Sleep phase advance, and Bright light therapy.
Interventions
Eligibility Criteria
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 abuse/dependence that requires detox.
- Current psychosis.
- Panic disorder.
- A history of seizures, uncontrolled severe headaches, stroke, or other neurologic illness that produces either gait abnormalities or a lowered seizure threshold.
- Medical illness that would make wake therapy intolerable, or significant cardiac disease.
- Cataracts, glaucoma, or other intrinsic eye condition.
- Currently taking light sensitizing medications.
- Current pregnancy which is routinely tested for prior to admission.
- Mental retardation, or dementia.
- Untreated sleep disorder such as Obstructive sleep apnea, narcolepsy, or PLMD.
Contact the study team to confirm eligibility.
Sponsors & Collaborators
Study Sites (1)
Medical University of South Carolina
Charleston, South Carolina, 29425, United States
MeSH Terms
Conditions
Interventions
Condition Hierarchy (Ancestors)
Intervention Hierarchy (Ancestors)
Study Officials
- PRINCIPAL INVESTIGATOR
Gregory Sahlem, MD
Medical University of South Carolina
Study Design
- Study Type
- interventional
- Phase
- not applicable
- Allocation
- NA
- Masking
- NONE
- Purpose
- TREATMENT
- Intervention Model
- SINGLE GROUP
- Sponsor Type
- OTHER
- Responsible Party
- SPONSOR
Study Record Dates
First Submitted
February 18, 2014
First Posted
March 17, 2014
Study Start
October 1, 2013
Primary Completion
March 1, 2014
Study Completion
April 1, 2014
Last Updated
October 2, 2015
Record last verified: 2013-09