SchizophreniaPhase 4NCT00419653
Modulation of Regional Brain Activation in Schizophrenic Patients by Pharmacological Therapy
A Phase 4 study testing Amisulpride, Olanzapine and Haloperidol in people with Schizophrenia, run by University of Jena.
Trial 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). Read more about this study
- Who is it for?
- Ages 18 to 65 years
- Conditions the study is for
- Schizophrenia
- What is being tested?
- Amisulpride, Olanzapine and Haloperidol
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 19 participants
- Where
- No sites listed yet
- Study dates
- Jan 2003to Sep 2007
- Phase
- Phase 4
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 to 65 years
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- 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
Who cannot join
- 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
Show all 9Show fewer
- Consumption of caffeine-containing beverages within 6 hours before assessments
- Clinically significant findings in ECG or EEG
- Known intolerance against neuroleptics
About this study
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)
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).
Read the 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
- Conditions
- Schizophrenia
- Being tested
- Amisulpride, Olanzapine, Haloperidol
- Keywords
- schizophrenia fMRI drug therapy amisulpride
- Medical subject headings
- Schizophrenia
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
AmisulprideDrug
OlanzapineDrug
HaloperidolDrug
| Study group | Role | What they receive |
|---|---|---|
| 1 | Experimental | Not described Receives: Drug: Amisulpride |
| 2 | Active comparator | Not described Receives: Drug: Olanzapine |
| 3 | Active comparator | Haloperidol Receives: Drug: Haloperidol |
What is being measured
The primary outcome is the main question the study is designed to answer.
Activation/deactivation in fMRI
Measured: 6 weeks
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted9 Jan 2007 (estimated)
- Study startJan 2003
- Primary completionSep 2007
- Study completionSep 2007
Why it stopped: Recruitment issues
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (1)Papers the sponsor has linked to this study.
- Other trials for SchizophreniaStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase 4
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Quadruple blind
- Who is masked
- Participant, Care provider, Investigator, Outcomes assessor
- Enrolment
- 19 participants (actual)
Sponsor and investigators
- Lead sponsor
- University of Jena
- Sponsor type
- University, hospital or other
- Collaborators
- Sanofi
- Investigators
- Ralf Schlösser, M.D., Principal investigator, FSU Jena
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT00419653
- Sponsor's protocol ID
- 001
- Status last verified
- Sep 2008
- First submitted
- 8 Jan 2007
- Last updated
- 16 Sep 2008
- Results posted
- No
- Data monitoring committee
- No
Publications
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.
PubMed 38958149
Study at a glance
From the registry record, last updated by the sponsor on 16 Sep 2008. Recruitment status is as the sponsor reported it: confirm with the study team.
- 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)
- ClinicalTrials.gov ID
- NCT00419653
- Acronym / sponsor ID
- 001
- Conditions
- Schizophrenia
- Keywords
- schizophrenia fMRI drug therapy amisulpride
- Phase
- Phase 4
- Study type
- Interventional
- Recruitment status
- TerminatedReason stopped: Recruitment issues
- Enrolment
- 19 participants (actual)
- Lead sponsor
- University of JenaUniversity, hospital or other
- Collaborators
- Sanofi
- Study start
- Jan 2003
- Primary completion
- Sep 2007 (actual)
- Study completion
- Sep 2007 (actual)
- First posted
- 9 Jan 2007 (estimated)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Quadruple blind (participant, care provider, investigator, outcomes assessor)
- Number of arms
- 3
| Arm | Type | Receives |
|---|---|---|
| 1 | Experimental | Drug: Amisulpride |
| 2 | Active comparator | Drug: Olanzapine |
| 3 | Active comparator | Drug: HaloperidolHaloperidol |
Who may qualify
- Ages
- 18 to 65 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (7 listed)
- 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)
Key exclusion criteria (9 listed)
- 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
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Amisulpride | Drug | 1 |
| Olanzapine | Drug | 2 |
| Haloperidol | Drug | 3 |
Primary outcome
Activation/deactivation in fMRI
Time frame: 6 weeks
Results and safety
The study was stopped early (reason given: Recruitment issues). Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 16 Sep 2008.
- Derived from this study: PubMed 38958149Ibragimov 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.
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Ralf Schlösser, M.D. principal investigator
FSU Jena
Questions about this trial
What is this clinical trial studying?
A Phase 4 study testing Amisulpride, Olanzapine and Haloperidol in people with Schizophrenia, run by University of Jena.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 7 inclusion and 9 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: stopped early, as of the sponsor's last update on 16 Sep 2008. Status can change between updates, so confirm with the study contact before making plans.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
What does this phase mean?
Phase 4 studies take place after a treatment is approved, to learn more about its long-term benefits and risks in everyday use.
Not every study follows the same path, and some studies (observational studies, device studies) have no phase.
Are results available for this study?
The study was stopped early (reason given: Recruitment issues). Results are not available in the source record.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Activation/deactivation in fMRI (time frame: 6 weeks). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
On the ClinicalTrials.gov record for NCT00419653, which also lists 1 linked publication.
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 16 Sep 2008.