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Beta-CIT-SPECT and Neurophysiology in Depression

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ClinicalTrials.gov Identifier: NCT00145132
Recruitment Status : Completed
First Posted : September 5, 2005
Last Update Posted : June 2, 2010
Sponsor:
Collaborator:
Information provided by:

Study Description
Brief Summary:
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 or disease Intervention/treatment Phase
Depression Procedure: β-CIT-SPECT, Neurophysiology Phase 4

Study Design

Study Type : Interventional  (Clinical Trial)
Actual Enrollment : 30 participants
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
Study Start Date : June 2005
Primary Completion Date : December 2009
Study Completion Date : December 2009

Resource links provided by the National Library of Medicine

U.S. FDA Resources

Arms and Interventions

Intervention Details:
    Procedure: β-CIT-SPECT, Neurophysiology
    β-CIT-SPECT scans and EEG recordings, two assessments each

Outcome Measures

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

Eligibility Criteria

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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

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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 Posted: September 5, 2005    Key Record Dates
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