NCT00161057

Brief Summary

In this study we, the investigators at UMC Utrecht, intend to investigate changes in brain activation patterns using functional magnetic resonance imaging (MRI), in patients suffering from schizophrenia who are medication naive or off medication, before using medication and after 8 weeks of medication. Patients will perform a working memory task, a language task and a motor task while lying in the scanner. We hypothesize that the efficiency of the working memory system is reduced and that the lateralization of language is diminished in these patients, and that these functions will normalize after treatment.

Trial Health

87
On Track

Trial Health Score

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

Enrollment
78

participants targeted

Target at P50-P75 for all trials

Timeline
Completed

Started Dec 2001

Longer than P75 for all trials

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

December 1, 2001

Completed
3.8 years until next milestone

First Submitted

Initial submission to the registry

September 8, 2005

Completed
4 days until next milestone

First Posted

Study publicly available on registry

September 12, 2005

Completed
3 years until next milestone

Study Completion

Last participant's last visit for all outcomes

September 1, 2008

Completed
Last Updated

April 23, 2009

Status Verified

April 1, 2009

First QC Date

September 8, 2005

Last Update Submit

April 22, 2009

Conditions

SchizophreniaSchizophreniform Disorders

Keywords

SchizophreniaMedication-naiveFunctional MRIWorking memoryLanguage lateralizationschizoaffective disorderpsychotic disorder Not Otherwise Specified

Eligibility Criteria

Age16 Years - 50 Years
Sexall
Healthy VolunteersYes
Age GroupsChild (0-17), Adult (18-64)
Sampling MethodProbability Sample
Study Population

first episode schizophrenia patients, medication naive (or medication-free) and matched healthy controls.

You may qualify if:

  • Diagnoses of schizophrenia, schizophreniform disorder, schizoaffective disorder or psychotic disorder NOS, confirmed on the basis of Comprehensive Assessment of Symptoms and History (CASH) or a Structured Clinical Interview for DSM-IV Disorders (SCID) interview
  • Ages between 16 and 50 years
  • CGI of at least 4
  • Patients are neuroleptic-naive or medication-free for at least 2 weeks
  • No psychiatric disorders (according to Diagnostic and Statistical Manual of Mental Disorders, 4th Edition \[DSM-IV\], Axis I)
  • No psychiatric disorders in first degree relatives.
  • Ages: between 18 and 50 years old

You may not qualify if:

  • Ferrous objects in or around the body
  • Neurological or medical illness, including closed head injury.
  • Mental retardation.
  • Diagnosis of substance dependence within the previous 3 months.
  • Pregnancy

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

Dept. of Psychiatry, UMC Utrecht

Utrecht, Utrecht, 3584 CX, Netherlands

Location

MeSH Terms

Conditions

SchizophreniaPsychotic Disorders

Condition Hierarchy (Ancestors)

Schizophrenia Spectrum and Other Psychotic DisordersMental Disorders

Study Officials

  • Nicoletta V Veelen

    UMC Utrecht

    PRINCIPAL INVESTIGATOR

  • Rene Kahn, M.D. Ph.D.

    UMC Utrecht

    STUDY CHAIR

Study Design

Study Type
observational
Observational Model
COHORT
Time Perspective
PROSPECTIVE
Sponsor Type
OTHER

Study Record Dates

First Submitted

September 8, 2005

First Posted

September 12, 2005

Study Start

December 1, 2001

Study Completion

September 1, 2008

Last Updated

April 23, 2009

Record last verified: 2009-04

Locations

NL(1)