Modulation of Regional Brain Activation in Schizophrenic Patients by Pharmacological Therapy - Full Text View

Sponsors and Collaborators:	University of Jena Sanofi-Aventis
Information provided by:	University of Jena
ClinicalTrials.gov Identifier:	NCT00419653

Purpose

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	Intervention	Phase
Schizophrenia	Drug: Amisulpride Drug: Olanzapine Drug: Haloperidol	Phase IV

MedlinePlus related topics: MRI Scans Schizophrenia

Drug Information available for: Olanzapine Haloperidol Haloperidol decanoate Amisulpride Sultopride

U.S. FDA Resources

Study Type:	Interventional
Study Design:	Treatment, Randomized, Double Blind (Subject, Caregiver, Investigator, Outcomes Assessor), Active Control, Parallel Assignment, Efficacy Study
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)

Further study details as provided by University of Jena:

Primary Outcome Measures:

Activation/deactivation in fMRI [ Time Frame: 6 weeks ] [ Designated as safety issue: No ]

Enrollment:	19
Study Start Date:	January 2003
Study Completion Date:	September 2007
Primary Completion Date:	September 2007 (Final data collection date for primary outcome measure)

Arms	Assigned Interventions
1: Experimental	Drug: Amisulpride
2: Active Comparator	Drug: Olanzapine
3: Active Comparator Haloperidol	Drug: Haloperidol

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

Ages Eligible for Study:	18 Years to 65 Years
Genders Eligible for Study:	Both
Accepts Healthy Volunteers:	No

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

Contacts and Locations

Please refer to this study by its ClinicalTrials.gov identifier: NCT00419653

Sponsors and Collaborators

University of Jena

Sanofi-Aventis

Investigators

Principal Investigator:

Ralf Schlösser, M.D.

FSU Jena

More Information

Responsible Party:	University of Jena ( Dr. Ralf Schlösser )
Study ID Numbers:	001
Study First Received:	January 8, 2007
Last Updated:	September 15, 2008
ClinicalTrials.gov Identifier:	NCT00419653
Health Authority:	Germany: Ethics Commission

Keywords provided by University of Jena:

schizophrenia fMRI drug therapy amisulpride

Study placed in the following topic categories:

Haloperidol
Schizophrenia
Haloperidol decanoate
Dopamine
Mental Disorders

Sultopride
Olanzapine
Psychotic Disorders
Serotonin
Schizophrenia and Disorders with Psychotic Features

Additional relevant MeSH terms:

Neurotransmitter Uptake Inhibitors
Neurotransmitter Agents
Tranquilizing Agents
Molecular Mechanisms of Pharmacological Action
Anti-Dyskinesia Agents
Physiological Effects of Drugs
Gastrointestinal Agents
Psychotropic Drugs
Antiemetics
Central Nervous System Depressants

Dopamine Antagonists
Antipsychotic Agents
Serotonin Uptake Inhibitors
Pharmacologic Actions
Serotonin Agents
Autonomic Agents
Therapeutic Uses
Dopamine Agents
Peripheral Nervous System Agents
Central Nervous System Agents

ClinicalTrials.gov processed this record on January 14, 2009