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Non-Psychotic Unipolar DepressionNCT02088580

Feasibility and Tolerability of Adjunct Chronotherapy in Depressed Inpatients

A study testing Triple Chronotherapy in people with Non-Psychotic Unipolar Depression and Bipolar Depression, run by Medical University of South Carolina at 1 site in United States.

Completed

Finished. The study has ended and is not enrolling. Results may be posted on the official record.

Official record
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Trial 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… Read more about this study

Who is it for?
Ages 18 years and older
What is being tested?
Triple Chronotherapy
Type of treatment
Surgery or procedure
Could I receive a placebo?
No, everyone receives an active treatment
How many people
13 participants
Where
1 siteUnited States
Study dates
Oct 2013to Apr 2014
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 years and older
  • 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 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.
Show all 10Show fewer
  • 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.

Trial locations and contacts

1 site in 1 country.

United States1 site
  • Medical University of South Carolina

    Charleston, South Carolina, 29425

Other trials in United States

About this study

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.

Read the detailed description

Acute depression, and suicidality continue to be significant causes of morbidity and mortality, and frequently result in acute inpatient hospitalization. Currently available treatments for depression have limitations for acute care including, either a slow onset of action such as is the case of pharmacotherapy, or high cost and limited availability such as is the case for ECT. This is exacerbated by ever shortening hospitalization times. Subsequently many of the individuals who are admitted for depression are discharged weeks before it can be expected for them to have symptomatic relief. Further more, in many cases treatment results in the trial of multiple medications before an effective treatment regimen is found (if such a treatment is found at all) (Rush, Trivedi et al. 2006). There is subsequently a great need for effective anti-depressant therapies with rapid onset of action, widespread availability, and cost effectiveness.

There is a consistent and expanding body of literature showing that chronotherapy is an effective, and rapid treatment of acute depression(Wu, Kelsoe et al. 2009, Martiny, Refsgaard et al. 2012, Echizenya, Suda et al. 2013). Published studies report response and remission rates in the range of 41-61%, 24-59% respectively acutely. Chronotherapy is a brief protocol that involves the combination of wake therapy (total sleep deprivation), sleep phase advance (a shift to an earlier sleep schedule with gradual normalization), and bright light therapy. The currently published reports have demonstrated efficacy in both unipolar and bipolar depression, and there has been reported stability of results for as long as 9 weeks (which was the longest designed study). Studies have been completed in real world clinical populations, which have included co-morbid populations, with the only groups showing a worsening of effect being those with psychotic depression (Benedetti, Zanardi et al. 1999), and those with panic disorder(Roy-Byrne, Uhde et al. 1986). The treatment itself has been well tolerated with a high percentage of individuals completing the procedure.

The current body of literature is encouraging, and the technique is being utilized clinically in some facilities (including our own institution), however there are still relatively few clinical trials published, and still unanswered questions that limit widespread clinical utility. One such issue is related to the high percentage of published trials performed outside of the US (although some have been done in the US). Because a high percentage of the studies have been done in other countries it is not clear if this procedure will translate well into the treatment paradigm in the US. Currently in the US, inpatient admission is restricted to individuals with severe, often highly treatment resistant disease that includes acute suicidality. To this writers knowledge there have not been any studies that specifically address suicidality. It is also not clear if patients in the US will tolerate the procedure. Tolerability has been addressed in many of the published papers, and in general the procedure is tolerated well with few if any side effects, however, again it is unclear how the procedure would be tolerated in clinical patients in the US.

Being tested
Triple Chronotherapy
Medical subject headings
Bipolar Disorder

What participants receive

What participants receive. In a randomised study each person is assigned to one group by chance.

  • Triple ChronotherapyProcedure or surgery

    Also called Sleep deprivation, Sleep phase advance, and Bright light therapy.

Study groups in NCT02088580
Study groupRoleWhat they receive
Triple ChronotherapyExperimentalTotal sleep deprivation, Sleep phase advance, and Bright light therapy.
Receives: Procedure: Triple Chronotherapy

What is being measured

The primary outcome is the main question the study is designed to answer.

  1. Hamilton Depression Rating Scale

    Change Score of Pre and Post Hamilton depression depression scores

    Measured: Day prior to total sleep deprivation, and then again over the next 4 consecutive days.

  2. Columbia Suicide Severity Rating Scale

    Change score in Columbia Suicide Severity Rating Scale

    Measured: Daily throughout the treatment (Days 0-4)

Timeline

From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.

  1. First posted17 Mar 2014 (estimated)
  2. Study startOct 2013
  3. Primary completionMar 2014
  4. Study completionApr 2014

Resources

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
Not applicable
Intervention model
Single group
Masking
None (open label)
Enrolment
13 participants (actual)
IDs, dates and publications
ClinicalTrials.gov ID
NCT02088580
Sponsor's protocol ID
Chronotherapy Pilot
Status last verified
Sep 2013
First submitted
18 Feb 2014
Last updated
2 Oct 2015
Results posted
No
Data monitoring committee
No

Questions about this trial

What is this clinical trial studying?

A study testing Triple Chronotherapy in people with Non-Psychotic Unipolar Depression 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 10 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: finished, as of the sponsor's last update on 2 Oct 2015. 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. 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 is completed, but results are not available in the source record. That does not mean the treatment did or did not work.

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.). 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 2 Oct 2015.

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