Modulation of Regional Brain Activation in Schizophrenic Patients by Pharmacological Therapy

NCT00419653 | Terminated Phase 4

• 1 other identifier: 001
• Study Type: interventional
• Target: 19
• Locations: 0 countries
• Sites: N/A

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).

Conditions

Schizophrenia

Keywords

schizophrenia fMRI drug therapy amisulpride

Outcome Measures

Primary Outcomes (1)

• Activation/deactivation in fMRI

  6 weeks

Study Arms (3)

1

EXPERIMENTAL

Drug: Amisulpride

2

ACTIVE COMPARATOR

Drug: Olanzapine

3

ACTIVE COMPARATOR

Haloperidol

Drug: Haloperidol

Interventions

Amisulpride DRUG

1

Olanzapine DRUG

2

Haloperidol DRUG

3

Eligibility Criteria

• Age: 18 Years - 65 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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

You may not qualify if:

• 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

Sponsors & Collaborators

• University of Jena: lead
• Sanofi: collaborator

Related Publications (1)

• 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.

  PMID: 38958149 DERIVED

MeSH Terms

Conditions

Schizophrenia

Interventions

Amisulpride; Olanzapine; Haloperidol

Condition Hierarchy (Ancestors)

Schizophrenia Spectrum and Other Psychotic Disorders; Mental Disorders

Intervention Hierarchy (Ancestors)

Benzamides; Amides; Organic Chemicals; Benzoates; Acids, Carbocyclic; Carboxylic Acids; Benzene Derivatives; Hydrocarbons, Aromatic; Hydrocarbons, Cyclic; Hydrocarbons; Benzodiazepines; Benzazepines; Heterocyclic Compounds, 2-Ring; Heterocyclic Compounds, Fused-Ring; Heterocyclic Compounds; Butyrophenones; Ketones

Study Officials

• Ralf Schlösser, M.D.

  FSU Jena

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: interventional
• Phase: phase 4
• Allocation: RANDOMIZED
• Masking: QUADRUPLE
• Who Masked: PARTICIPANT, CARE PROVIDER, INVESTIGATOR, OUTCOMES ASSESSOR
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: OTHER

Study Record Dates

• First Submitted: January 8, 2007
• First Posted: January 9, 2007
• Study Start: January 1, 2003
• Primary Completion: September 1, 2007
• Study Completion: September 1, 2007
• Last Updated: September 16, 2008

Record last verified: 2008-09