Dopaminergic Neurotransmission in Schizophrenia, Patients... | NCT00166322

Studies
Dopaminergic Neurotransmission in Schizophrenia, Patients at Risk and Healthy Subjects

NCT00166322

Sponsor

Ludwig-Maximilians - University of Munich

Status

Completed

Last Update Posted

May 7, 2008Estimated

Enrollment

35Actual

Phase

Not Applicable

Conditions

Schizophrenia

Interventions

IBZM-SPECT (bolus and constant infusion paradigm)

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
EK076/03

Status Module

Record Verification Date

May 2008

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

Jan 2004

Primary Completion Date

Dec 2007Actual

Completion Date

Dec 2007Actual

First Submitted Date

Sep 9, 2005

First Submission Date that Met QC Criteria

Sep 9, 2005

First Posted Date

Sep 14, 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

May 6, 2008

Last Update Posted Date

May 7, 2008Estimated

Description Module

Brief Summary

This study is an investigation of the dopaminergic neurotransmission in patients with schizophrenia, patients at risk for the development of schizophrenia, and healthy controls using an iodobenzamide-single photon emission computed tomography (IBZM-SPECT) imaging technique under amphetamine challenge.

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

Not Applicable

Interventional Study Design

Allocation

Biospecimen

No data available

No data is available for this block.

Enrollment

35Actual

Arms/Interventions Module

Arm Groups

Not provided

Interventions

Name	Type	Description	Arm Group Labels	Other Names
IBZM-SPECT (bolus and constant infusion paradigm)	Procedure	single IBZM-SPECT assessment at study inclusion

Measure	Description	Time Frame
dopamine receptor availability		cross-sectional

Eligibility Module

Eligibility Criteria

Inclusion Criteria:

Clinical diagnosis of schizophrenia (currently unmedicated)
Subjects at risk for the development of schizophrenia (prodromal symptoms)
Healthy subjects
Written informed consent

Exclusion Criteria:

Neurological or severe somatic disorders
Women during pregnancy or lactation
Occupational exposition to radiation > 15mSv
Medication known to interfere with IBZM
Contraindications for the use of amphetamine challenge

Accepts Healthy Volunteers

Yes

Sex

All

Sex/Gender Based

Not provided

Sex/Gender Description

Not provided

Minimum Age

18 Years

Maximum Age

70 Years

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
Klaus Tatsch, MD	Dept. of Nuclear Medicine, University of Munich	Principal Investigator

Locations

Facility	Status	City	State	ZIP	Country	Contacts
Dept. of Psychiatry		Munich		D-80336	Germany
Dept. of Nuclear Medicine

Condition Browse Module

MeSH Terms

ID	Term
D012559	Schizophrenia

Ancestor Terms

ID	Term
D019967	Schizophrenia Spectrum and Other Psychotic Disorders
D001523	Mental Disorders

Browse Leaves

Not provided

Browse Branches

Not provided