Beta-CIT-SPECT and Neurophysiology in Depression
Primary Purpose
Depression
Status
Completed
Phase
Phase 4
Locations
Germany
Study Type
Interventional
Intervention
β-CIT-SPECT, Neurophysiology
Sponsored by
About this trial
This is an interventional diagnostic trial for Depression focused on measuring depression, β-CIT-SPECT, SERT, DAT, neurophysiology, LDAEP, escitalopram, SSRI
Eligibility 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
Sites / Locations
- Depts. of Psychiatry and Nuclear Medicine, Ludwig-Maximilians-University of Munich
Outcomes
Primary Outcome Measures
changes in β-CIT/neurophysiological measurements from baseline to week 4
Secondary Outcome Measures
Full Information
NCT ID
NCT00145132
First Posted
September 1, 2005
Last Updated
June 1, 2010
Sponsor
Ludwig-Maximilians - University of Munich
Collaborators
H. Lundbeck A/S
1. Study Identification
Unique Protocol Identification Number
NCT00145132
Brief Title
Beta-CIT-SPECT and Neurophysiology in Depression
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 Type
Interventional
2. Study Status
Record Verification Date
May 2010
Overall Recruitment Status
Completed
Study Start Date
June 2005 (undefined)
Primary Completion Date
December 2009 (Actual)
Study Completion Date
December 2009 (Actual)
3. Sponsor/Collaborators
Name of the Sponsor
Ludwig-Maximilians - University of Munich
Collaborators
H. Lundbeck A/S
4. Oversight
5. 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.
6. Conditions and Keywords
Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Depression
Keywords
depression, β-CIT-SPECT, SERT, DAT, neurophysiology, LDAEP, escitalopram, SSRI
7. Study Design
Primary Purpose
Diagnostic
Study Phase
Phase 4
Interventional Study Model
Single Group Assignment
Masking
None (Open Label)
Allocation
Non-Randomized
Enrollment
30 (Actual)
8. Arms, Groups, and Interventions
Intervention Type
Procedure
Intervention Name(s)
β-CIT-SPECT, Neurophysiology
Intervention Description
β-CIT-SPECT scans and EEG recordings, two assessments each
Primary Outcome Measure Information:
Title
changes in β-CIT/neurophysiological measurements from baseline to week 4
Time Frame
two assessments, at baseline and week 4
10. Eligibility
Sex
All
Minimum Age & Unit of Time
18 Years
Accepts Healthy Volunteers
No
Eligibility 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
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Oliver Pogarell, MD
Organizational Affiliation
Dept. of Psychiatry, University of Munich
Official's Role
Principal Investigator
Facility Information:
Facility Name
Depts. of Psychiatry and Nuclear Medicine, Ludwig-Maximilians-University of Munich
City
Munich
ZIP/Postal Code
D-80336
Country
Germany
12. IPD Sharing Statement
Learn more about this trial
Beta-CIT-SPECT and Neurophysiology in Depression
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