Modulation of Regional Brain Activation in Schizophrenic Patients by Pharmacological Therapy

Phase 4TerminatedNCT00419653

University of Jena19 enrolled

Overview

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).

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 Type

INTERVENTIONAL

Allocation

RANDOMIZED

Purpose

TREATMENT

Masking

QUADRUPLE

Enrollment

Conditions

Schizophrenia

Interventions

AmisulprideDRUG

OlanzapineDRUG

HaloperidolDRUG

Eligibility

Sex: ALLMin age: 18 YearsMax age: 65 Years

Medical Language ↔ Plain English

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

Outcomes

Primary Outcomes

Activation/deactivation in fMRI

Time frame: 6 weeks

Data from ClinicalTrials.gov

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