Back to results

Modulation of Regional Brain Activation in Schizophrenic Patients by Pharmacological Therapy

Primary Purpose

Schizophrenia

Status

Terminated

Phase

Phase 4

Locations

Study Type

Interventional

Intervention

Amisulpride

Olanzapine

Haloperidol

About this trial

This is an interventional treatment trial for Schizophrenia focused on measuring schizophrenia fMRI drug therapy amisulpride

Eligibility Criteria

18 Years - 65 Years (Adult, Older Adult)All SexesDoes not accept 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

Sites / Locations

Arms of the Study

Arm 1

Arm 2

Arm 3

Arm Type

Experimental

Active Comparator

Arm Label

Arm Description

Haloperidol

Outcomes

Primary Outcome Measures

Activation/deactivation in fMRI

Secondary Outcome Measures

Full Information

NCT ID

NCT00419653

First Posted

January 8, 2007

Last Updated

September 15, 2008

Sponsor

University of Jena

Collaborators

Sanofi

1. Study Identification

Unique Protocol Identification Number

NCT00419653

Brief Title

Modulation of Regional Brain Activation in Schizophrenic Patients by Pharmacological Therapy

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 Type

Interventional

2. Study Status

Record Verification Date

September 2008

Overall Recruitment Status

Terminated

Why Stopped

Recruitment issues

Study Start Date

January 2003 (undefined)

Primary Completion Date

September 2007 (Actual)

Study Completion Date

September 2007 (Actual)

3. Sponsor/Collaborators

Name of the Sponsor

University of Jena

Collaborators

Sanofi

4. Oversight

Data Monitoring Committee

5. Study Description

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).

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

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study

Schizophrenia

Keywords

schizophrenia fMRI drug therapy amisulpride

7. Study Design

Primary Purpose

Treatment

Study Phase

Phase 4

Interventional Study Model

Parallel Assignment

Masking

ParticipantCare ProviderInvestigatorOutcomes Assessor

Allocation

Randomized

Enrollment

19 (Actual)

8. Arms, Groups, and Interventions

Arm Title

Arm Type

Experimental

Arm Title

Arm Type

Active Comparator

Arm Title

Arm Type

Active Comparator

Arm Description

Haloperidol

Intervention Type

Drug

Intervention Name(s)

Amisulpride

Intervention Type

Drug

Intervention Name(s)

Olanzapine

Intervention Type

Drug

Intervention Name(s)

Haloperidol

Primary Outcome Measure Information:

Title

Activation/deactivation in fMRI

Time Frame

6 weeks

10. Eligibility

Sex

All

Minimum Age & Unit of Time

18 Years

Maximum Age & Unit of Time

65 Years

Accepts Healthy Volunteers

Eligibility 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

Overall Study Officials:

First Name & Middle Initial & Last Name & Degree

Ralf Schlösser, M.D.

Organizational Affiliation

FSU Jena

Official's Role

Principal Investigator

12. IPD Sharing Statement

Learn more about this trial

Modulation of Regional Brain Activation in Schizophrenic Patients by Pharmacological Therapy

We'll reach out to this number within 24 hrs