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Beta-CIT-SPECT and Neurophysiology in Depression

This study has been completed.
Sponsor:
ClinicalTrials.gov Identifier:
NCT00145132
First Posted: September 5, 2005
Last Update Posted: June 2, 2010
The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details.
Collaborator:
H. Lundbeck A/S
Information provided by:
Ludwig-Maximilians - University of Munich
  Purpose
Aim of this project is to investigate the effects of escitalopram on monoamine transporter (SERT, DAT) availabilities as assessed by b-CIT and SPECT, and on neurophysiological parameters such as the loudness dependence of auditory evoked potentials (LDAEP) in patients with depression.

Condition Intervention Phase
Depression Procedure: β-CIT-SPECT, Neurophysiology Phase 4

Study Type: Interventional
Study Design: Allocation: Non-Randomized
Intervention Model: Single Group Assignment
Masking: None (Open Label)
Primary Purpose: Diagnostic
Official Title: Serotonin and Dopamine Transporter (SERT, DAT) Availabilities as Assessed by b-CIT and SPECT, and Neurophysiological Measures of Central Serotonergic Activity in Patients With Depression Under Treatment With Escitalopram

Resource links provided by NLM:


Further study details as provided by Ludwig-Maximilians - University of Munich:

Primary Outcome Measures:
  • changes in β-CIT/neurophysiological measurements from baseline to week 4 [ Time Frame: two assessments, at baseline and week 4 ]

Enrollment: 30
Study Start Date: June 2005
Study Completion Date: December 2009
Primary Completion Date: December 2009 (Final data collection date for primary outcome measure)
Intervention Details:
    Procedure: β-CIT-SPECT, Neurophysiology
    β-CIT-SPECT scans and EEG recordings, two assessments each
  Eligibility

Information from the National Library of Medicine

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Ages Eligible for Study:   18 Years and older   (Adult, Senior)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
Criteria

Inclusion Criteria:

  • Psychiatric in or outpatients with acute depressive episode
  • Indication for pharmacological treatment

Exclusion Criteria:

  • Acute suicidality
  • Neurological or severe somatic disorders
  • Occupational exposition to radiation >15 mSv per year
  • Women during pregnancy or lactation
  Contacts and Locations
Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT00145132


Locations
Germany
Depts. of Psychiatry and Nuclear Medicine, Ludwig-Maximilians-University of Munich
Munich, Germany, D-80336
Sponsors and Collaborators
Ludwig-Maximilians - University of Munich
H. Lundbeck A/S
Investigators
Principal Investigator: Oliver Pogarell, MD Dept. of Psychiatry, University of Munich
  More Information

Responsible Party: Oliver Pogarell, MD, University of Munich
ClinicalTrials.gov Identifier: NCT00145132     History of Changes
Other Study ID Numbers: ESCIT-SPECT-Pogarell
EK287/98
First Submitted: September 1, 2005
First Posted: September 5, 2005
Last Update Posted: June 2, 2010
Last Verified: May 2010

Keywords provided by Ludwig-Maximilians - University of Munich:
depression
β-CIT-SPECT
SERT
DAT
neurophysiology
LDAEP
escitalopram
SSRI

Additional relevant MeSH terms:
Depression
Depressive Disorder
Behavioral Symptoms
Mood Disorders
Mental Disorders
Citalopram
Serotonin Uptake Inhibitors
Neurotransmitter Uptake Inhibitors
Membrane Transport Modulators
Molecular Mechanisms of Pharmacological Action
Neurotransmitter Agents
Serotonin Agents
Physiological Effects of Drugs
Antidepressive Agents, Second-Generation
Antidepressive Agents
Psychotropic Drugs