NCT00178074

Brief Summary

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

Trial Health

87
On Track

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
80

participants targeted

Target at P25-P50 for phase_4

Timeline
Completed

Started Feb 1999

Longer than P75 for phase_4

Geographic Reach
1 country

1 active site

Status
completed

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

February 1, 1999

Completed
4.2 years until next milestone

Study Completion

Last participant's last visit for all outcomes

April 1, 2003

Completed
2.5 years until next milestone

First Submitted

Initial submission to the registry

September 13, 2005

Completed
2 days until next milestone

First Posted

Study publicly available on registry

September 15, 2005

Completed
Last Updated

August 2, 2013

Status Verified

July 1, 2013

First QC Date

September 13, 2005

Last Update Submit

July 31, 2013

Conditions

Unipolar Depression

Keywords

depressionimagingPETelderlylate lifesleep deprivation

Outcome Measures

Primary Outcomes (4)

  • 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

  • +1 more secondary outcomes

Interventions

total sleep deprivationBEHAVIORAL
PET imagingPROCEDURE

Eligibility Criteria

Age55 Years+
Sexall
Healthy VolunteersYes
Age GroupsAdult (18-64), Older Adult (65+)

You may qualify if:

  • 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

You may not qualify if:

  • 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

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

University of Pittsburgh Medical Center

Pittsburgh, Pennsylvania, 15213, United States

Location

MeSH Terms

Conditions

Depressive DisorderDepressionSleep Deprivation

Interventions

Magnetic Resonance Spectroscopy

Condition Hierarchy (Ancestors)

Mood DisordersMental DisordersBehavioral SymptomsBehaviorDyssomniasSleep Wake DisordersNervous System DiseasesNeurologic ManifestationsSigns and SymptomsPathological Conditions, Signs and Symptoms

Intervention Hierarchy (Ancestors)

Spectrum AnalysisChemistry Techniques, AnalyticalInvestigative Techniques

Study Officials

  • Charles F Reynolds III, M.D.

    University of Pittsburgh

    PRINCIPAL INVESTIGATOR

Study Design

Study Type
interventional
Phase
phase 4
Allocation
NON RANDOMIZED
Masking
NONE
Purpose
DIAGNOSTIC
Intervention Model
FACTORIAL
Sponsor Type
OTHER

Study Record Dates

First Submitted

September 13, 2005

First Posted

September 15, 2005

Study Start

February 1, 1999

Study Completion

April 1, 2003

Last Updated

August 2, 2013

Record last verified: 2013-07

Locations

US(1)