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Modulation of Regional Brain Activation in Schizophrenic Patients by Pharmacological Therapy

Information source: University of Jena
ClinicalTrials.gov processed this data on August 23, 2015
Link to the current ClinicalTrials.gov record.

Condition(s) targeted: Schizophrenia

Intervention: Amisulpride (Drug); Olanzapine (Drug); Haloperidol (Drug)

Phase: Phase 4

Status: Terminated

Sponsored by: University of Jena

Official(s) and/or principal investigator(s):
Ralf Schlösser, M.D., Principal Investigator, Affiliation: FSU Jena


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).

Clinical Details

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 design: Allocation: Randomized, Endpoint Classification: Efficacy Study, Intervention Model: Parallel Assignment, Masking: Double Blind (Subject, Caregiver, Investigator, Outcomes Assessor), Primary Purpose: Treatment

Primary outcome: Activation/deactivation in fMRI

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


Minimum age: 18 Years. Maximum age: 65 Years. Gender(s): Both.


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


- 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

Locations and Contacts

Additional Information

Starting date: January 2003
Last updated: September 15, 2008

Page last updated: August 23, 2015

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