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Modulation of Regional Brain Activation in Schizophrenic Patients by Pharmacological Therapy

NCT ID: NCT00419653

Last Updated: 2008-09-16

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

TERMINATED

Clinical Phase

PHASE4

Total Enrollment

19 participants

Study Classification

INTERVENTIONAL

Study Start Date

2003-01-31

Study Completion Date

2007-09-30

Brief Summary

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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

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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

Conditions

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Schizophrenia

Keywords

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schizophrenia fMRI drug therapy amisulpride

Study Design

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Allocation Method

RANDOMIZED

Intervention Model

PARALLEL

Primary Study Purpose

TREATMENT

Blinding Strategy

QUADRUPLE

Participants Caregivers Investigators Outcome Assessors

Study Groups

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1

Group Type EXPERIMENTAL

Amisulpride

Intervention Type DRUG

2

Group Type ACTIVE_COMPARATOR

Olanzapine

Intervention Type DRUG

3

Haloperidol

Group Type ACTIVE_COMPARATOR

Haloperidol

Intervention Type DRUG

Interventions

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Amisulpride

Intervention Type DRUG

Olanzapine

Intervention Type DRUG

Haloperidol

Intervention Type DRUG

Eligibility Criteria

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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
Minimum Eligible Age

18 Years

Maximum Eligible Age

65 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

No

Sponsors

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Sanofi

INDUSTRY

Sponsor Role collaborator

University of Jena

OTHER

Sponsor Role lead

Responsible Party

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University of Jena

Principal Investigators

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Ralf Schlösser, M.D.

Role: PRINCIPAL_INVESTIGATOR

FSU Jena

Countries

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Germany

References

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Ibragimov K, Keane GP, Carreno Glaria C, Cheng J, Llosa AE. Haloperidol (oral) versus olanzapine (oral) for people with schizophrenia and schizophrenia-spectrum disorders. Cochrane Database Syst Rev. 2024 Jul 3;7(7):CD013425. doi: 10.1002/14651858.CD013425.pub2.

Reference Type DERIVED
PMID: 38958149 (View on PubMed)

Other Identifiers

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001

Identifier Type: -

Identifier Source: org_study_id