Modulation of Regional Brain Activation in Schizophrenic Patients by Pharmacological Therapy

Schizophrenia Clinical Trial

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)

Clinical Trial Details — Status: Terminated

Administrative data

• NCT number: NCT00419653
• Other study ID #: 001
• Status: Terminated
• Phase: Phase 4
• First received: January 8, 2007
• Last updated: September 15, 2008
• Start date: January 2003
• Est. completion date: September 2007

Study information

• Verified date: September 2008
• Source: University of Jena
• Contact: n/a
• Is FDA regulated: No
• Health authority: Germany: Ethics Commission
• Study type: Interventional

Clinical Trial 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).

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

Recruitment information / eligibility

• Status: Terminated
• Enrollment: 19
• Est. completion date: September 2007
• Est. primary completion date: September 2007
• Accepts healthy volunteers: No
• Gender: Both
• Age group: 18 Years to 65 Years

Eligibility

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

Study Design

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

Related Conditions & MeSH terms

• Schizophrenia

Intervention

Drug:
• Amisulpride

• Olanzapine

• Haloperidol

Locations

Country	Name	City	State
n/a

Sponsors (2)

Lead Sponsor	Collaborator
University of Jena	Sanofi

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Activation/deactivation in fMRI		6 weeks	No