Beta-CIT-SPECT and Neurophysiology in Depression | NCT00145132

Studies
Beta-CIT-SPECT and Neurophysiology in Depression

NCT00145132

Sponsor

Ludwig-Maximilians - University of Munich

Status

Completed

Last Update Posted

Jun 2, 2010Estimated

Enrollment

30Actual

Phase

Phase 4

Conditions

Depression

Interventions

β-CIT-SPECT, Neurophysiology

Countries

Germany

Protocol Section

Identification Module Status Module Sponsor/Collaborators Module Oversight Module Description Module Conditions Module Design Module Arms/Interventions Module Outcomes Module Eligibility Module Contacts/Locations Module References Module IPD Sharing Statement Module

Results Section

Participant Flow Module Baseline Characteristics Module Outcome Measures Module Adverse Events Module More Info Module

Annotation Section

Annotation Module

Document Section

Large Document Module

Derived Section

Miscellaneous Info Module Condition Browse Module Intervention Browse Module

Protocol Section

Identification Module

NCT ID

Results Section

No data available

No data is available for this block.

Annotation Section

No data available

No data is available for this block.

Document Section

No data available

No data is available for this block.

Derived Section

Miscellaneous Info Module

Version Holder

ID	Type	Description	Link
EK287/98

Status Module

Record Verification Date

May 2010

Overall Recruitment Status or Expanded Access Status

Completed

Last Known Status

Not provided

Delayed Posting

Not provided

Why Stopped

Not provided

Expanded Access Info

Start Date

Jun 2005

Primary Completion Date

Dec 2009Actual

Completion Date

Dec 2009Actual

First Submitted Date

Sep 1, 2005

First Submission Date that Met QC Criteria

Sep 1, 2005

First Posted Date

Sep 5, 2005Estimated

Results Waived

Not provided

Results First Submitted Date

Not provided

Results First Submitted that Met QC Criteria

Not provided

Results First Posted Date

Not provided

Certification/Extension (aka Delayed Results) First Submitted Date

Not provided

Certification/Extension First Submitted that Passed QC Review

Not provided

Certification/Extension First Posted Date

Not provided

Last Update Submitted Date

Jun 1, 2010

Last Update Posted Date

Jun 2, 2010Estimated

Name	Class
H. Lundbeck A/S	INDUSTRY

Description Module

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.

Detailed Description

Not provided

Design Module

Study Type

Interventional

Number of References to an Expanded Access Study

Not provided

Expanded Access Types

Not provided

Patient Registry

Not provided

Target Follow-Up Duration

Not provided

Phases

Phase 4

Interventional Study Design

Allocation

Biospecimen

No data available

No data is available for this block.

Enrollment

30Actual

Arms/Interventions Module

Arm Groups

Not provided

Interventions

Name	Type	Description	Arm Group Labels	Other Names
β-CIT-SPECT, Neurophysiology	Procedure	β-CIT-SPECT scans and EEG recordings, two assessments each

Outcomes Module

Primary Outcomes

Measure	Description	Time Frame
changes in β-CIT/neurophysiological measurements from baseline to week 4		two assessments, at baseline and week 4

Secondary Outcomes

Not provided

Other Outcomes

Not provided

Eligibility Module

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

Accepts Healthy Volunteers

Sex

All

Sex/Gender Based

Not provided

Sex/Gender Description

Not provided

Minimum Age

18 Years

Maximum Age

Not provided

Standard Ages

AdultOlder Adult

Study Population

Not provided

Sampling Method

Not provided

Contacts/Locations Module

Central Contacts

Not provided

Overall Officials

Name	Affiliation	Role
Oliver Pogarell, MD	Dept. of Psychiatry, University of Munich	Principal Investigator

Locations

Facility	Status	City	State	ZIP	Country	Contacts
Depts. of Psychiatry and Nuclear Medicine, Ludwig-Maximilians-University of Munich		Munich		D-80336	Germany

Condition Browse Module

MeSH Terms

ID	Term
D003863	Depression

Ancestor Terms

ID	Term
D001526	Behavioral Symptoms
D001519	Behavior

Browse Leaves

Not provided

Browse Branches

Not provided