NCT00145132

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.

Trial Health

87
On Track

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
30

participants targeted

Target at P25-P50 for phase_4 depression

Timeline
Completed

Started Jun 2005

Typical duration for phase_4 depression

Geographic Reach
1 country

1 active site

Status
completed

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

Study Start

First participant enrolled

June 1, 2005

Completed
3 months until next milestone

First Submitted

Initial submission to the registry

September 1, 2005

Completed
4 days until next milestone

First Posted

Study publicly available on registry

September 5, 2005

Completed
4.2 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

December 1, 2009

Completed
Same day until next milestone

Study Completion

Last participant's last visit for all outcomes

December 1, 2009

Completed
Last Updated

June 2, 2010

Status Verified

May 1, 2010

Enrollment Period

4.5 years

First QC Date

September 1, 2005

Last Update Submit

June 1, 2010

Conditions

Depression

Keywords

depressionβ-CIT-SPECTSERTDATneurophysiologyLDAEPescitalopramSSRI

Outcome Measures

Primary Outcomes (1)

  • changes in β-CIT/neurophysiological measurements from baseline to week 4

    two assessments, at baseline and week 4

Interventions

β-CIT-SPECT, NeurophysiologyPROCEDURE

β-CIT-SPECT scans and EEG recordings, two assessments each

Eligibility Criteria

Age18 Years+
Sexall
Healthy VolunteersNo
Age GroupsAdult (18-64), Older Adult (65+)

You may qualify if:

  • Psychiatric in or outpatients with acute depressive episode
  • Indication for pharmacological treatment

You may not qualify if:

  • Acute suicidality
  • Neurological or severe somatic disorders
  • Occupational exposition to radiation \>15 mSv per year
  • Women during pregnancy or lactation

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

Depts. of Psychiatry and Nuclear Medicine, Ludwig-Maximilians-University of Munich

Munich, D-80336, Germany

Location

MeSH Terms

Conditions

Depression

Condition Hierarchy (Ancestors)

Behavioral SymptomsBehavior

Study Officials

  • Oliver Pogarell, MD

    Dept. of Psychiatry, University of Munich

    PRINCIPAL INVESTIGATOR

Study Design

Study Type
interventional
Phase
phase 4
Allocation
NON RANDOMIZED
Masking
NONE
Purpose
DIAGNOSTIC
Intervention Model
SINGLE GROUP
Sponsor Type
OTHER

Study Record Dates

First Submitted

September 1, 2005

First Posted

September 5, 2005

Study Start

June 1, 2005

Primary Completion

December 1, 2009

Study Completion

December 1, 2009

Last Updated

June 2, 2010

Record last verified: 2010-05

Locations

DE(1)