Modulation of Regional Brain Activation in Schizophrenic Patients by Pharmacological Therapy

Study Overview
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Brief Summary
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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
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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

Official Title
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Modulation of Regional Brain Activation in Schizophrenic Patients by Pharmacological Therapy With Amisulpride, Olanzapine or Haloperidol. A Study With Functional Magnetic Resonance Imaging (fMRI) and Diffusion Tensor Imaging (DTI)

Conditions
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Schizophrenia

Intervention / Treatment
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* Drug: Amisulpride
* Drug: Olanzapine
* Drug: Haloperidol


Participation Criteria
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Eligibility Criteria
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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

Ages Eligible for Study
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Minimum Age: 18 Years
Maximum Age: 65 Years

Sexes Eligible for Study
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All

Accepts Healthy Volunteers
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No

Study Plan
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How is the study designed?
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Design Details

Primary Purpose: Treatment
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Quadruple


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Experimental: 1<br> | Drug: Amisulpride<br> <br> |
| Active Comparator: 2<br> | Drug: Olanzapine<br> <br> |
| Active Comparator: 3<br>Haloperidol | Drug: Haloperidol<br> <br> |

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Activation/deactivation in fMRI |  | 6 weeks | 

 Terms related to the study
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Keywords Provided by Centre Hospitalier Valida
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schizophrenia fMRI drug therapy amisulpride