We updated the design of this site on December 18, 2017. Learn more.
ClinicalTrials.gov Menu

Modulation of Regional Brain Activation in Schizophrenic Patients by Pharmacological Therapy

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details.
ClinicalTrials.gov Identifier: NCT00419653
Recruitment Status : Terminated (Recruitment issues)
First Posted : January 9, 2007
Last Update Posted : September 16, 2008
Information provided by:
University of Jena

Brief 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).

Condition or disease Intervention/treatment Phase
Schizophrenia Drug: Amisulpride Drug: Olanzapine Drug: Haloperidol Phase 4

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

Study Type : Interventional  (Clinical Trial)
Actual Enrollment : 19 participants
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Quadruple (Participant, Care Provider, Investigator, Outcomes Assessor)
Primary Purpose: Treatment
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 Start Date : January 2003
Primary Completion Date : September 2007
Study Completion Date : September 2007

Resource links provided by the National Library of Medicine

MedlinePlus related topics: Schizophrenia
U.S. FDA Resources

Arm Intervention/treatment
Experimental: 1 Drug: Amisulpride
Active Comparator: 2 Drug: Olanzapine
Active Comparator: 3
Drug: Haloperidol

Primary Outcome Measures :
  1. Activation/deactivation in fMRI [ Time Frame: 6 weeks ]

Information from the National Library of Medicine

Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the contacts provided below. For general information, Learn About Clinical Studies.

Ages Eligible for Study:   18 Years to 65 Years   (Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No

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

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT00419653

Sponsors and Collaborators
University of Jena
Principal Investigator: Ralf Schlösser, M.D. FSU Jena

Responsible Party: Dr. Ralf Schlösser, University of Jena
ClinicalTrials.gov Identifier: NCT00419653     History of Changes
Other Study ID Numbers: 001
First Posted: January 9, 2007    Key Record Dates
Last Update Posted: September 16, 2008
Last Verified: September 2008

Keywords provided by University of Jena:
schizophrenia fMRI drug therapy amisulpride

Additional relevant MeSH terms:
Schizophrenia Spectrum and Other Psychotic Disorders
Mental Disorders
Haloperidol decanoate
Autonomic Agents
Peripheral Nervous System Agents
Physiological Effects of Drugs
Gastrointestinal Agents
Antipsychotic Agents
Tranquilizing Agents
Central Nervous System Depressants
Psychotropic Drugs
Serotonin Uptake Inhibitors
Neurotransmitter Uptake Inhibitors
Membrane Transport Modulators
Molecular Mechanisms of Pharmacological Action
Neurotransmitter Agents
Serotonin Agents
Dopamine Antagonists
Dopamine Agents
Anti-Dyskinesia Agents
Antidepressive Agents, Second-Generation
Antidepressive Agents