The Effects of Sleep Deprivation on Antidepressant Response

This study has been completed.
Sponsor:
Information provided by:
University of Pittsburgh
ClinicalTrials.gov Identifier:
NCT00178074
First received: September 13, 2005
Last updated: July 31, 2013
Last verified: July 2013
  Purpose

This study will use positron emission tomography (PET) to examine the effect of sleep deprivation on brain function.


Condition Intervention Phase
Unipolar Depression
Behavioral: total sleep deprivation
Procedure: PET imaging
Phase 4

Study Type: Interventional
Study Design: Allocation: Non-Randomized
Endpoint Classification: Safety/Efficacy Study
Intervention Model: Factorial Assignment
Masking: Open Label
Primary Purpose: Diagnostic
Official Title: The Effects of Sleep Deprivation on Antidepressant Response in Geriatric Depression: Neurometabolic Substrates Studied With PET

Resource links provided by NLM:


Further study details as provided by University of Pittsburgh:

Primary Outcome Measures:
  • 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 Outcome Measures:
  • Beck Depression Inventory
  • Profile of Mood States
  • Serum anticholinergicity and paroxetine blood levels
  • SCID
  • Hamilton Depression Rating Scale
  • Folstein Mini-Mental State Exam

Estimated Enrollment: 80
Study Start Date: February 1999
Estimated Study Completion Date: April 2003
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

  Eligibility

Ages Eligible for Study:   55 Years and older
Genders Eligible for Study:   Both
Accepts Healthy Volunteers:   Yes
Criteria

Inclusion Criteria:

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

Exclusion Criteria:

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

  Contacts and Locations
Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the Contacts provided below. For general information, see Learn About Clinical Studies.

Please refer to this study by its ClinicalTrials.gov identifier: NCT00178074

Locations
United States, Pennsylvania
University of Pittsburgh Medical Center
Pittsburgh, Pennsylvania, United States, 15213
Sponsors and Collaborators
University of Pittsburgh
Investigators
Principal Investigator: Charles F Reynolds III, M.D. University of Pittsburgh
  More Information

Additional Information:
No publications provided

ClinicalTrials.gov Identifier: NCT00178074     History of Changes
Other Study ID Numbers: R01 MH037869-03, 980753, DATR A4-GPS
Study First Received: September 13, 2005
Last Updated: July 31, 2013
Health Authority: United States: Federal Government

Keywords provided by University of Pittsburgh:
depression
imaging
PET
elderly
late life
sleep deprivation

Additional relevant MeSH terms:
Depression
Depressive Disorder
Sleep Deprivation
Behavioral Symptoms
Mood Disorders
Mental Disorders
Dyssomnias
Sleep Disorders
Nervous System Diseases
Neurologic Manifestations
Signs and Symptoms
Antidepressive Agents
Psychotropic Drugs
Central Nervous System Agents
Therapeutic Uses
Pharmacologic Actions

ClinicalTrials.gov processed this record on October 19, 2014