Beta-CIT-SPECT and Neurophysiology in Depression

Depression Clinical Trial

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

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT00145132
• Other study ID #: ESCIT-SPECT-Pogarell
• Secondary ID: EK287/98
• Status: Completed
• Phase: Phase 4
• First received: September 1, 2005
• Last updated: June 1, 2010
• Start date: June 2005
• Est. completion date: December 2009

Study information

• Verified date: May 2010
• Source: Ludwig-Maximilians - University of Munich
• Contact: n/a
• Is FDA regulated: No
• Health authority: Germany: Federal Institute for Drugs and Medical Devices
• Study type: Interventional

Clinical Trial 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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 30
• Est. completion date: December 2009
• Est. primary completion date: December 2009
• Accepts healthy volunteers: No
• Gender: Both
• Age group: 18 Years and older

Eligibility

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

Study Design

Allocation: Non-Randomized, Endpoint Classification: Pharmacodynamics Study, Intervention Model: Single Group Assignment, Masking: Open Label, Primary Purpose: Diagnostic

Related Conditions & MeSH terms

• Depression
• Depressive Disorder

Intervention

Procedure:
• ß-CIT-SPECT, Neurophysiology
ß-CIT-SPECT scans and EEG recordings, two assessments each

Locations

Country	Name	City	State
Germany	Depts. of Psychiatry and Nuclear Medicine, Ludwig-Maximilians-University of Munich	Munich

Sponsors (2)

Lead Sponsor	Collaborator
Ludwig-Maximilians - University of Munich	H. Lundbeck A/S

Country where clinical trial is conducted

Germany, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	changes in ß-CIT/neurophysiological measurements from baseline to week 4		two assessments, at baseline and week 4	No