Modulation of Regional Brain Activation in Schizophrenic Patients by Pharmacological Therapy

Sponsor

University of Jena (Other)

Overall Status

Terminated

CT.gov ID

NCT00419653

Collaborator

Sanofi (Industry)

Enrollment

Arms

Duration (Months)

Study Details

Study Description

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).

Condition or Disease	Intervention/Treatment	Phase
Schizophrenia	Drug: Amisulpride Drug: Olanzapine Drug: Haloperidol	Phase 4

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 Design

Study Type:

Interventional

Actual Enrollment :

19 participants

Allocation:

Randomized

Intervention Model:

Parallel Assignment

Masking:

Quadruple (Participant, Care Provider, Investigator, Outcomes Assessor)

Primary Purpose:

Treatment

Official Title:

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)

Study Start Date :

Jan 1, 2003

Actual Primary Completion Date :

Sep 1, 2007

Actual Study Completion Date :

Sep 1, 2007

Arms and Interventions

Arm	Intervention/Treatment
Experimental: 1	Drug: Amisulpride
Active Comparator: 2	Drug: Olanzapine
Active Comparator: 3 Haloperidol	Drug: Haloperidol

Arm

Intervention/Treatment

Experimental: 1

Drug: Amisulpride

Active Comparator: 2

Drug: Olanzapine

Active Comparator: 3

Haloperidol

Drug: Haloperidol

Outcome Measures

Primary Outcome Measures

Activation/deactivation in fMRI [6 weeks]

Eligibility Criteria

Criteria

Ages Eligible for Study:

18 Years to 65 Years

Sexes Eligible for Study:

All

Accepts 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