Modulation of Regional Brain Activation in Schizophrenic Patients by Pharmacological Therapy

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)

Status

Terminated

Phases

Phase 4

Study type

Interventional

Source

ClinicalTrials.gov

Registry ID

NCT00419653

Enrollment

Registered

2007-01-09

Start date

2003-01-31

Completion date

2007-09-30

Last updated

2008-09-16

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

Schizophrenia

Keywords

schizophrenia fMRI drug therapy amisulpride

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

Interventions

DRUGAmisulpride

DRUGOlanzapine

DRUGHaloperidol

Study design

Allocation

RANDOMIZED

Intervention model

PARALLEL

Primary purpose

TREATMENT

Masking

QUADRUPLE (Subject, Caregiver, Investigator, Outcomes Assessor)

Eligibility

Sex/Gender

ALL

Age

18 Years to 65 Years

Healthy volunteers

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

Design outcomes

Primary

Measure	Time frame
Activation/deactivation in fMRI	6 weeks

Outcome results

None listed

Source: ClinicalTrials.gov · Data processed: Feb 4, 2026