Modulation of Regional Brain Activation in Schizophrenic Patients by Pharmacological Therapy

• Status: Terminated
• Trial end date: 2007-09-01
• Target enrollment: 0
• Participant gender: All

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).

• Phase: Phase 4
• Accepts Healthy Volunteers?: No

Details

• Lead Sponsor: University of Jena
• Collaborator: Sanofi
• Treatments: Amisulpride; Haloperidol; Haloperidol decanoate; Olanzapine; Sulpiride; Sultopride

Criteria

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