Modulation of Regional Brain Activation in Schizophrenic Patients by Pharmacological Therapy

University of Jena

Status and phase: Terminated; Phase 4

Conditions: Schizophrenia

Treatments: Drug: Amisulpride; Drug: Haloperidol; Drug: Olanzapine

Study type: Interventional

Funder types: Other; Industry

Identifiers

NCT00419653

001

Details and patient eligibility

About

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).

Full 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

Enrollment: 19 patients

Sex: All

Ages: 18 to 65 years old

Volunteers: No 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

Trial design

Primary purpose: Treatment

Allocation: Randomized

Interventional model: Parallel Assignment

Masking: Quadruple Blind

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19 participants in 3 patient groups

1

Experimental group

Treatment:

Drug: Amisulpride

2

Active Comparator group

Treatment:

Drug: Olanzapine

3

Active Comparator group

Description:

Haloperidol

Treatment:

Drug: Haloperidol