Beta-CIT-SPECT and Neurophysiology in Depression

This study is currently recruiting participants.

Verified by Ludwig-Maximilians - University of Munich, May 2008

Sponsors and Collaborators:	Ludwig-Maximilians - University of Munich H. Lundbeck A/S
Information provided by:	Ludwig-Maximilians - University of Munich
ClinicalTrials.gov Identifier:	NCT00145132

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 IV

MedlinePlus related topics: Depression

Drug Information available for: Escitalopram Benzetimide Citalopram Citalopram hydrobromide Dexetimide Escitalopram oxalate Dopamine Dopamine hydrochloride Serotonin

U.S. FDA Resources

Study Type:	Interventional
Study Design:	Diagnostic, Non-Randomized, Open Label, Uncontrolled, Single Group Assignment, Pharmacodynamics Study
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

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 ] [ Designated as safety issue: No ]

Estimated Enrollment:	30
Study Start Date:	June 2005
Estimated Study Completion Date:	December 2009
Estimated Primary Completion Date:	December 2009 (Final data collection date for primary outcome measure)

Intervention Details:

β-CIT-SPECT scans and EEG recordings, two assessments each

Eligibility

Ages Eligible for Study:	18 Years and older
Genders Eligible for Study:	Both
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

Please refer to this study by its ClinicalTrials.gov identifier: NCT00145132

Contacts

Contact: Oliver Pogarell, MD

+49 89 5160 ext 5540

oliver.pogarell@med.uni-muenchen.de

Locations

Germany
Depts. of Psychiatry and Nuclear Medicine, Ludwig-Maximilians-University of Munich	Recruiting
Munich, Germany, D-80336
Contact: Oliver Pogarell, MD +49 89 5160 ext 5540 oliver.pogarell@med.uni-muenchen.de
Contact: Klaus Tatsch, MD +49 89 7095 ext 4650 klaus.tatsch@med.uni-muenchen.de
Principal Investigator: Oliver Pogarell, MD
Principal Investigator: Klaus Tatsch, MD

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:	University of Munich ( Oliver Pogarell, MD )
Study ID Numbers:	ESCIT-SPECT-Pogarell, EK287/98
Study First Received:	September 1, 2005
Last Updated:	May 6, 2008
ClinicalTrials.gov Identifier:	NCT00145132
Health Authority:	Germany: Federal Institute for Drugs and Medical Devices

Keywords provided by Ludwig-Maximilians - University of Munich:

depression
β-CIT-SPECT
SERT
DAT

neurophysiology
LDAEP
escitalopram
SSRI

Study placed in the following topic categories:

Dopamine
Depression
Mental Disorders
Mood Disorders
Dexetimide

Depressive Disorder
Citalopram
Serotonin
Behavioral Symptoms

Additional relevant MeSH terms:

Neurotransmitter Agents
Neurotransmitter Uptake Inhibitors
Serotonin Agents
Molecular Mechanisms of Pharmacological Action
Therapeutic Uses
Physiological Effects of Drugs

Psychotropic Drugs
Antidepressive Agents, Second-Generation
Serotonin Uptake Inhibitors
Central Nervous System Agents
Pharmacologic Actions
Antidepressive Agents

ClinicalTrials.gov processed this record on January 16, 2009