Modulation of Regional Brain Activation in Schizophrenic Patients by Pharmacological Therapy

Phase 4

Terminated

• Conditions: Schizophrenia
• Interventions: Drug: Amisulpride; Drug: Olanzapine; Drug: Haloperidol

• Registration Number: NCT00419653
• Lead Sponsor: University of Jena

Brief Summary

The study aims to investigate the modulation of regional brain activation in schizophrenic patients by psychopharmacological treatment with either haloperidol, amisulpride or olanzapine. The study will be performed with functional magnetic resonance imaging (fMRI) and diffusion tensor imaging (DTI).

Detailed Description

The current study aims to investigate the following issues:

* Changes in cognitive activation patterns under therapy with the typical neuroleptic haloperidol as compared to the atypical antipsychotics amisulpride and olanzapine

* Relationship of these changes in activity to psychopathological, neuropsychological and pharmacotherapeutic variables (e.g. drug plasma level) as well as to certain biological markers (HVA, prolactin)

* Relationship between diffusion anisotropy as an indicator for structural connectivity and cognitive activation patterns under antipsychotic treatment

Study Timeline

• Study Start: 2003-01
• Study First Submitted: 2007-01-08
• Study First Submitted QC: 2007-01-08
• Study First Posted: 2007-01-09
• Primary Completion: 2007-09
• Study Completion: 2007-09
• Status Verified: 2008-09
• Last Update Submitted: 2008-09-15
• Last Update Posted: 2008-09-16

Recruitment & Eligibility

• Status: TERMINATED
• Sex: All
• Target Recruitment: 19

Inclusion Criteria

• In- and outpatients of either sex
• Able to comply with the protocol
• Having given their written informed consent of their own free will
• Total BPRS (PANSS-derived, 1-7 points) minimum 36 points at baseline
• Schizophrenic or schizophreniform disorder according to DSM-IV criteria (295.10, .30, .40, .90)
• Definite right-handedness (according to the modified Edinburgh Handedness Inventory)
• Age 18 - 50 years

Exclusion Criteria

• Co-morbid psychiatric axis I disorder (DSM-IV) other than schizophrenia
• Axis II disorder according to DSM-IV
• Present or past history of substance and drug dependence (including alcohol dependence)
• Participation in a clinical trial within the previous three months
• Lack of insight
• Suicidal ideations or aggression against others
• Consumption of caffeine-containing beverages within 6 hours before assessments
• Clinically significant findings in ECG or EEG
• Known intolerance against neuroleptics

Study & Design

• Study Type: INTERVENTIONAL
• Study Design: PARALLEL

Arm && Interventions

Group	Intervention	Description
1	Amisulpride	-
2	Olanzapine	-
3	Haloperidol	Haloperidol

Primary Outcome Measures

Name	Time	Method
Activation/deactivation in fMRI	6 weeks