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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

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

18 Years - undefined (Adult, Older Adult)All SexesDoes not accept healthy volunteers

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

Eligibility Criteria

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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