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
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).
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
Eligibility
Minimum age: 18 Years.
Maximum age: 65 Years.
Gender(s): Both.
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
Locations and Contacts
Additional Information
Starting date: January 2003
Last updated: September 15, 2008
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