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.
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
- Conditions the study is for
- Non-Psychotic Unipolar Depression, Bipolar Depression
- 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.
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- 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
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 group | Role | What they receive |
|---|---|---|
| Triple Chronotherapy | Experimental | Total 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.
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.
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.
- First posted17 Mar 2014 (estimated)
- Study startOct 2013
- Primary completionMar 2014
- Study completionApr 2014
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Non-Psychotic Unipolar DepressionStudies of the same condition, open and under way.
- More trials run by Medical University of South CarolinaThe sponsor's other registered studies.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
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)
Sponsor and investigators
- Lead sponsor
- Medical University of South Carolina
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor
- Investigators
- Gregory Sahlem, MD, Principal investigator, Medical University of South Carolina
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
Study at a glance
From the registry record, last updated by the sponsor on 2 Oct 2015. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Feasibility and Tolerability of Adjunct Chronotherapy in Depressed Inpatients
- ClinicalTrials.gov ID
- NCT02088580
- Acronym / sponsor ID
- Chronotherapy Pilot
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 13 participants (actual)
- Lead sponsor
- Medical University of South CarolinaUniversity, hospital or other
- Study start
- Oct 2013
- Primary completion
- Mar 2014 (actual)
- Study completion
- Apr 2014 (actual)
- First posted
- 17 Mar 2014 (estimated)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
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.
Study design
- Primary purpose
- Treatment
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| Triple Chronotherapy | Experimental | Procedure: Triple ChronotherapyTotal sleep deprivation, Sleep phase advance, and Bright light therapy. |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (4 listed)
- 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.
Key exclusion criteria (10 listed)
- 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.
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Triple ChronotherapyAlso: Sleep deprivation, Sleep phase advance, and Bright light therapy. | Procedure or surgery | Triple Chronotherapy |
Primary outcome
Hamilton Depression Rating Scale
Time frame: Day prior to total sleep deprivation, and then again over the next 4 consecutive days.
Change Score of Pre and Post Hamilton depression depression scores
Columbia Suicide Severity Rating Scale
Time frame: Daily throughout the treatment (Days 0-4)
Change score in Columbia Suicide Severity Rating Scale
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 2 Oct 2015.
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Gregory Sahlem, MD principal investigator
Medical University of South Carolina
1 site in 1 country: see every site and its status.
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.