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Beta-CIT-SPECT and Neurophysiology in Depression

This study has been completed.
Sponsor:
Collaborator:
H. Lundbeck A/S
Information provided by:
Ludwig-Maximilians - University of Munich
ClinicalTrials.gov Identifier:
NCT00145132
First received: September 1, 2005
Last updated: June 1, 2010
Last verified: May 2010
History of Changes
  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
Endpoint Classification: Pharmacodynamics Study
Intervention Model: Single Group Assignment
Masking: 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:

MedlinePlus related topics: Depression
U.S. FDA Resources

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 ]

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

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

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

No publications provided

Responsible Party: Oliver Pogarell, MD, University of Munich
ClinicalTrials.gov Identifier: NCT00145132     History of Changes
Other Study ID Numbers: ESCIT-SPECT-Pogarell, EK287/98
Study First Received: September 1, 2005
Last Updated: June 1, 2010
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

Additional relevant MeSH terms:
Depression
Depressive Disorder
Behavioral Symptoms
Mood Disorders
Mental Disorders
Citalopram
Antidepressive Agents, Second-Generation
Antidepressive Agents
Psychotropic Drugs
 Central Nervous System Agents
Therapeutic Uses
Pharmacologic Actions
Serotonin Uptake Inhibitors
Neurotransmitter Uptake Inhibitors
Neurotransmitter Agents
Molecular Mechanisms of Pharmacological Action
Serotonin Agents
Physiological Effects of Drugs

ClinicalTrials.gov processed this record on May 16, 2013