Beta-CIT-SPECT and Neurophysiology in Depression

• Sponsor: Ludwig-Maximilians - University of Munich (Other)
• Overall Status: Completed
• CT.gov ID: NCT00145132
• Collaborator: H. Lundbeck A/S (Industry)
• Enrollment: 30
• Location: 1
• Duration (Months): 54
• Patients Per Site Per Month: 0.6

Study Details

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.

Condition or Disease	Intervention/Treatment	Phase
Depression	Procedure: β-CIT-SPECT, Neurophysiology	Phase 4

Study Design

• Study Type: Interventional
• Actual Enrollment: 30 participants
• Allocation: Non-Randomized
• Intervention Model: Single Group Assignment
• Masking: None (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
• Study Start Date: Jun 1, 2005
• Actual Primary Completion Date: Dec 1, 2009
• Actual Study Completion Date: Dec 1, 2009

Outcome Measures

Primary Outcome Measures

1. changes in β-CIT/neurophysiological measurements from baseline to week 4 [two assessments, at baseline and week 4]

Eligibility Criteria

Criteria

• Ages Eligible for Study: 18 Years and Older
• Sexes Eligible for Study: All
• Accepts Healthy Volunteers: No

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

Locations

	Site	City	State	Country	Postal Code
1	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

Study Documents (Full-Text)

None provided.

More Information

Publications

None provided.

• ClinicalTrials.gov Identifier: NCT00145132
• Other Study ID Numbers: ESCIT-SPECT-Pogarell; EK287/98
• First Posted: Sep 5, 2005
• Last Update Posted: Jun 2, 2010
• Last Verified: May 1, 2010

• Keywords provided by , ,: depression; β-CIT-SPECT; SERT; DAT; neurophysiology; LDAEP; escitalopram; SSRI
• Additional relevant MeSH terms: Depression; Depressive Disorder

Study Results

No Results Posted as of Jun 2, 2010