Modulation of Regional Brain Activation in Schizophrenic Patients by Pharmacological Therapy

This study has been terminated.
(Recruitment issues)
Sponsor:
Collaborator:
Sanofi
Information provided by:
University of Jena
ClinicalTrials.gov Identifier:
NCT00419653
First received: January 8, 2007
Last updated: September 15, 2008
Last verified: September 2008
  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 4

Study Type: Interventional
Study Design: Allocation: Randomized
Endpoint Classification: Efficacy Study
Intervention Model: Parallel Assignment
Masking: Double Blind (Subject, Caregiver, 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)

Resource links provided by NLM:


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
Experimental: 1 Drug: Amisulpride
Active Comparator: 2 Drug: Olanzapine
Active Comparator: 3
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
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, see Learn About Clinical Studies.

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

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

No publications provided

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

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

Additional relevant MeSH terms:
Schizophrenia
Schizophrenia and Disorders with Psychotic Features
Mental Disorders
Haloperidol
Olanzapine
Haloperidol decanoate
Sultopride
Antiemetics
Autonomic Agents
Peripheral Nervous System Agents
Physiological Effects of Drugs
Pharmacologic Actions
Central Nervous System Agents
Therapeutic Uses
Gastrointestinal Agents
Antipsychotic Agents
Tranquilizing Agents
Central Nervous System Depressants
Psychotropic Drugs
Dopamine Antagonists
Dopamine Agents
Neurotransmitter Agents
Molecular Mechanisms of Pharmacological Action
Anti-Dyskinesia Agents
Serotonin Uptake Inhibitors
Neurotransmitter Uptake Inhibitors
Serotonin Agents

ClinicalTrials.gov processed this record on July 28, 2014