Unipolar DepressionPhase 4NCT00178074
The Effects of Sleep Deprivation on Antidepressant Response
A Phase 4 study testing total sleep deprivation and PET imaging in people with Unipolar Depression, run by University of Pittsburgh at 1 site in United States.
Trial summary
This study will use positron emission tomography (PET) to examine the effect of sleep deprivation on brain function. Read more about this study
- Who is it for?
- Ages 55 years and olderHealthy volunteers can take part
- Conditions the study is for
- Unipolar Depression
- What is being tested?
- total sleep deprivation and PET imaging
- Type of treatment
- Surgery or procedure, Lifestyle or therapy programme
- How many people
- 80 participants
- Where
- 1 siteUnited States
- Study dates
- Feb 1999to Apr 2003
- Phase
- Phase 4
- 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 55 years and older
- All sexes
- Healthy volunteers accepted
- Adult, Older adult
Who may be able to join
- Patients:
- DSM-IV criteria for current major depressive disorder
- Score of 15 or higher on the HRSD (17 item)
- Score of 17 or higher on the Folstein Mini-Mental Status Exam
- Control Subjects:
- -No history of psychiatric disorder or neurological illness
Who cannot join
- Patients:
- lifetime diagnosis of any psychotic disorder
- bipolar disorder
- alcohol or drug abuse within the last 6 months
- No contraindication to SSRI therapy
- History of seizure disorder
- Both Patient and Control Subjects:
- -Current diagnosis of diabetes or significantly altered plasma glucose levels
Trial locations and contacts
1 site in 1 country.
United States1 site
University of Pittsburgh Medical Center
Pittsburgh, Pennsylvania, 15213
About this study
Official title: The Effects of Sleep Deprivation on Antidepressant Response in Geriatric Depression: Neurometabolic Substrates Studied With PET
This study will use positron emission tomography (PET) to examine the effect of sleep deprivation on brain function.
Read the detailed description
This study seeks to better understand the effect of sleep deprivation (TSD) on brain function using Positron Emission Tomography (PET). PET is an established research procedure that produces images of the brain. The purpose of these images is to show changes in brain activity associated with sleep deprivation. The neurochemical mechanisms underlying the TSD acceleration of antidepressant efficacy have not been identified. An understanding of these neurochemical processes may lead to the development of pharmacologic strategies that would accelerate antidepressant response or more directly to the development of antidepressant treatments that are more efficacious.
This study will be conducted in collaboration with Dr. Charles Reynolds' ongoing protocol "Geriatric Depression: Neurobiology of Treatment" (IRB #970356). The impetus for the clinical studies is the finding that the clinical response to antidepressant treatment in geriatric depressed patients is delayed, with the median time to remission reported as up to 12 weeks. Thus, the development of a strategy to accelerate treatment response would represent a substantial contribution to the treatment of geriatric depression. One approach that has been reported to accelerate antidepressant response in mid-life depression is one night of total sleep deprivation (TSD) prior to initiating antidepressant treatment. TSD has also been shown to improve mood in depressed patients, the response to TSD may distinguish subsequent treatment responders from non-responders and depressive relapse may occur after naps or a night of recovery sleep. The neurochemical mechanisms underlying the TSD acceleration of antidepressant efficacy have not been identified. An understanding of these neurochemical processes may lead to the development of pharmacologic strategies that would accelerate antidepressant response or more directly to the development of antidepressant treatments that are more efficacious.
Advancements in brain imaging technology and radiotracer chemistry have made it possible to measure metabolic activity and specific neurochemical mechanisms using Positron Emission Tomography (PET). The proposed studies represent the initial step in characterizing the neurochemical alterations produced by TSD and the impact of TSD on antidepressant response by TSD in geriatric depressed patients using PET and a radiotracer for brain glucose metabolism, [18F]-2deoxy-2-fluoro-D-glucose ([18F]-2DG). Having established the regional metabolic alterations associated with sleep deprivation and recovery sleep in patients who are subsequent treatment responders and compared the metabolic changes with treatment non-responders, future studies will be undertaken using neuroreceptor radiotracers to define the specific neurochemical pathways subserving the regional pattern of metabolic alterations. The glucose metabolic response to sleep deprivation in mid-life depression has been investigated at the UPMC PET Facility and at other institutions (e.g. Dube et al., in preparation, Wu et al., 1991, 1992). The studies performed in the geriatric depressed patients will be compared with the PET studies conducted in mid-life depressed patients to assess the contribution of the aging process to the neurometabolic response to sleep.
For information on related studies, please follow these links:
http://clinicaltrials.gov/show/NCT00177294
http://clinicaltrials.gov/show/NCT00178035
- Conditions
- Unipolar Depression
- Being tested
- total sleep deprivation, PET imaging
- Keywords
- depression, imaging, PET, elderly, late life, sleep deprivation
- Medical subject headings
- Depressive Disorder, Depression, Sleep Deprivation
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
total sleep deprivationBehavioural
PET imagingProcedure or surgery
What is being measured
The primary outcome is the main question the study is designed to answer.
To gain an understanding of the neurochemical processes that may lead to development of pharmacologic strategies that would accelerate antidepressant response or more directly to the development of antidepressant treatments.
PET study
Regional glucose metabolic rates and regional [18F]-altanserin binding
MRI scan
Secondary outcomes (6)
Beck Depression Inventory
Profile of Mood States
Serum anticholinergicity and paroxetine blood levels
SCID
Hamilton Depression Rating Scale
Folstein Mini-Mental State Exam
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted15 Sep 2005 (estimated)
- Study startFeb 1999
- Study completionApr 2003
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Unipolar DepressionStudies of the same condition, open and under way.
- More trials run by University of PittsburghThe 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 4
- Primary purpose
- Diagnosis
- Allocation
- Non-randomised
- Intervention model
- Factorial
- Masking
- None (open label)
- Enrolment
- 80 participants
Sponsor and investigators
- Lead sponsor
- University of Pittsburgh
- Sponsor type
- University, hospital or other
- Investigators
- Charles F Reynolds III, M.D., Principal investigator, University of Pittsburgh
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT00178074
- Sponsor's protocol ID
- R01MH037869-03
- Other IDs
- 980753, DATR A4-GPS
- Status last verified
- Jul 2013
- First submitted
- 13 Sep 2005
- Last updated
- 2 Aug 2013
- Results posted
- No
Study at a glance
From the registry record, last updated by the sponsor on 2 Aug 2013. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- The Effects of Sleep Deprivation on Antidepressant Response in Geriatric Depression: Neurometabolic Substrates Studied With PET
- ClinicalTrials.gov ID
- NCT00178074
- Acronym / sponsor ID
- R01MH037869-03
- Conditions
- Unipolar Depression
- Keywords
- depression, imaging, PET, elderly, late life, sleep deprivation
- Phase
- Phase 4
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 80 participants
- Lead sponsor
- University of PittsburghUniversity, hospital or other
- Study start
- Feb 1999
- Study completion
- Apr 2003
- First posted
- 15 Sep 2005 (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 use positron emission tomography (PET) to examine the effect of sleep deprivation on brain function.
Detailed description
This study seeks to better understand the effect of sleep deprivation (TSD) on brain function using Positron Emission Tomography (PET). PET is an established research procedure that produces images of the brain. The purpose of these images is to show changes in brain activity associated with sleep deprivation. The neurochemical mechanisms underlying the TSD acceleration of antidepressant efficacy have not been identified. An understanding of these neurochemical processes may lead to the development of pharmacologic strategies that would accelerate antidepressant response or more directly to the development of antidepressant treatments that are more efficacious.
This study will be conducted in collaboration with Dr. Charles Reynolds' ongoing protocol "Geriatric Depression: Neurobiology of Treatment" (IRB #970356). The impetus for the clinical studies is the finding that the clinical response to antidepressant treatment in geriatric depressed patients is delayed, with the median time to remission reported as up to 12 weeks. Thus, the development of a strategy to accelerate treatment response would represent a substantial contribution to the treatment of geriatric depression. One approach that has been reported to accelerate antidepressant response in mid-life depression is one night of total sleep deprivation (TSD) prior to initiating antidepressant treatment. TSD has also been shown to improve mood in depressed patients, the response to TSD may distinguish subsequent treatment responders from non-responders and depressive relapse may occur after naps or a night of recovery sleep. The neurochemical mechanisms underlying the TSD acceleration of antidepressant efficacy have not been identified. An understanding of these neurochemical processes may lead to the development of pharmacologic strategies that would accelerate antidepressant response or more directly to the development of antidepressant treatments that are more efficacious.
Advancements in brain imaging technology and radiotracer chemistry have made it possible to measure metabolic activity and specific neurochemical mechanisms using Positron Emission Tomography (PET). The proposed studies represent the initial step in characterizing the neurochemical alterations produced by TSD and the impact of TSD on antidepressant response by TSD in geriatric depressed patients using PET and a radiotracer for brain glucose metabolism, [18F]-2deoxy-2-fluoro-D-glucose ([18F]-2DG). Having established the regional metabolic alterations associated with sleep deprivation and recovery sleep in patients who are subsequent treatment responders and compared the metabolic changes with treatment non-responders, future studies will be undertaken using neuroreceptor radiotracers to define the specific neurochemical pathways subserving the regional pattern of metabolic alterations. The glucose metabolic response to sleep deprivation in mid-life depression has been investigated at the UPMC PET Facility and at other institutions (e.g. Dube et al., in preparation, Wu et al., 1991, 1992). The studies performed in the geriatric depressed patients will be compared with the PET studies conducted in mid-life depressed patients to assess the contribution of the aging process to the neurometabolic response to sleep.
For information on related studies, please follow these links:
http://clinicaltrials.gov/show/NCT00177294
http://clinicaltrials.gov/show/NCT00178035
Study design
- Primary purpose
- Diagnosis
- Allocation
- Non-randomised
- Intervention model
- Factorial
- Masking
- None (open label)
Who may qualify
- Ages
- 55 years and older
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (6 listed)
- DSM-IV criteria for current major depressive disorder
- Score of 15 or higher on the HRSD (17 item)
- Score of 17 or higher on the Folstein Mini-Mental Status Exam
- -No history of psychiatric disorder or neurological illness
Key exclusion criteria (8 listed)
- lifetime diagnosis of any psychotic disorder
- bipolar disorder
- alcohol or drug abuse within the last 6 months
- No contraindication to SSRI therapy
- History of seizure disorder
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 |
|---|---|---|
| total sleep deprivation | Behavioural | – |
| PET imaging | Procedure or surgery | – |
Primary outcome
To gain an understanding of the neurochemical processes that may lead to development of pharmacologic strategies that would accelerate antidepressant response or more directly to the development of antidepressant treatments.
PET study
Regional glucose metabolic rates and regional [18F]-altanserin binding
MRI scan
6 secondary outcomes
Beck Depression Inventory
Profile of Mood States
Serum anticholinergicity and paroxetine blood levels
SCID
Hamilton Depression Rating Scale
Folstein Mini-Mental State Exam
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 Aug 2013.
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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.
Charles F Reynolds III, M.D. principal investigator
University of Pittsburgh
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A Phase 4 study testing total sleep deprivation and PET imaging in people with Unipolar Depression, run by University of Pittsburgh 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 6 inclusion and 8 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 Aug 2013. 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.
What does this phase mean?
Phase 4 studies take place after a treatment is approved, to learn more about its long-term benefits and risks in everyday use.
Not every study follows the same path, and some studies (observational studies, device studies) have no phase.
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?
To gain an understanding of the neurochemical processes that may lead to development of pharmacologic strategies that would accelerate antidepressant response or more directly to the development of antidepressant treatments.. The study lists 4 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 Aug 2013.