SchizophreniaNCT00629252
The Effect of Sertindole on Sensory Gating and Cognition in Schizophrenic Patients
A study testing Sertindole and Risperidone in people with Schizophrenia, run by University of Zurich at 1 site in Switzerland.
Trial summary
This study aims to investigate whether the atypical antipsychotic and mixed 5-HT2/D2 antagonist sertindole modulates or improves both subcortical and cortical information processing in schizophrenic patients who had not or insufficiently responded to previous antipsychotic medication. Read more about this study
- Who is it for?
- Ages 18 to 40 yearsHealthy volunteers can take part
- Conditions the study is for
- Schizophrenia
- What is being tested?
- Sertindole and Risperidone
- Type of treatment
- Pill or oral medicine
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 14 participants
- Where
- 1 siteSwitzerland
- Study dates
- Feb 2008to Aug 2012
- Phase
- Interventional
- 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 40 years
- All sexes
- Healthy volunteers accepted
- Adult
Who may be able to join
- Schizophrenia according to DSM IV
- Selected and treated in respect of the SPC (20 mg Serdolect max. and population at risk will be excluded)
Who cannot join
- DSM IV Axis I disorders other than schizophrenia: Substance-dependence (excepting nicotine-dependence and substance-abuse), recent (2 months) DSM IV diagnosis according to DIA-X of a major affective, anxiety disorder, eating-disorder.
- DSM IV Axis II disorders: Lifetime DSM IV diagnosis of personality disorder.
- ECG: QTc-interval >450 msec.
- Systolic blood pressure <100 mmHg
- Bradycardia (Hf < 50/Min) und Arrhythmias
- Hypokalemia or Hypomagnesemia
Trial locations and contacts
1 site in 1 country.
Switzerland1 site
University Hospital of Psychiatry, Department Neuropsychopharmacology and Brain Imaging
Zurich, Canton of Zurich, CH-8032
About this study
This study aims to investigate whether the atypical antipsychotic and mixed 5-HT2/D2 antagonist sertindole modulates or improves both subcortical and cortical information processing in schizophrenic patients who had not or insufficiently responded to previous antipsychotic medication. This goal shall be accomplished by investigating the effect of sertindole of both prepulse inhibition of the acoustic startle (PPI) and P50 suppression of auditory evoked potentials in schizophrenic patients. These effects shall be compared to the effect of risperidone and shall also be compared to untreated healthy controls.
- Conditions
- Schizophrenia
- Being tested
- Sertindole, Risperidone
- Keywords
- Schizophrenia, PPI, P50, CANTAB, sensory gating, Schizophrenic patients according to DSM-IV
- Medical subject headings
- Schizophrenia
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
SertindoleDrug
oral 12-20 mg/day
RisperidoneDrug
oral 2-6mg / day
| Study group | Role | What they receive |
|---|---|---|
| 1 | Experimental | Schizophrenic patients treated with sertindole Receives: Drug: Sertindole |
| 2 | Active comparator | Schizophrenic patients treated with risperidone Receives: Drug: Risperidone |
| 3 | No intervention | Healthy controls without any treatment. |
What is being measured
The primary outcome is the main question the study is designed to answer.
sensory (EEG: P50 suppression) and sensorimotor gating (EMG: PPI)
Measured: Before and six weeks after antipsychotic treatment
Secondary outcomes (2)
Cognitive performances
Measured: Before and six weeks after antipsychotic treatment
Psychopathology (PANSS rating)
Measured: Before and six weeks after antipsychotic treatment
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted5 Mar 2008 (estimated)
- Study startFeb 2008
- Primary completionAug 2012
- Study completionAug 2012
Why it stopped: Not enough subjects have been recruited in the expected period.
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for SchizophreniaStudies of the same condition, open and under way.
- More trials run by University of ZurichThe sponsor's other registered studies.
- 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 N/A
- Primary purpose
- Basic science
- Allocation
- Non-randomised
- Intervention model
- Parallel groups
- Masking
- Single blind
- Who is masked
- Investigator
- Enrolment
- 14 participants (actual)
Sponsor and investigators
- Lead sponsor
- University of Zurich
- Sponsor type
- University, hospital or other
- Collaborators
- University Hospital of Psychiatry, Department Neuropsychopharmacology and Brain Imaging, H. Lundbeck A/S
- Responsible party
- Sponsor
- Investigators
- Franz X. Vollenweider, Prof. Dr. med., Principal investigator, University Hospital of Psychiatry, Department Neuropsychopharmacology and Brain Imaging
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT00629252
- Sponsor's protocol ID
- 98_PPI-P50
- Other IDs
- E-11/2007, 2007DR1253
- Status last verified
- Sep 2012
- First submitted
- 21 Jan 2008
- Last updated
- 17 Sep 2012
- Results posted
- No
- Data monitoring committee
- No
Study at a glance
From the registry record, last updated by the sponsor on 17 Sep 2012. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- The Effect of Sertindole on Sensory Gating and Cognition in Schizophrenic Patients
- ClinicalTrials.gov ID
- NCT00629252
- Acronym / sponsor ID
- 98_PPI-P50
- Conditions
- Schizophrenia
- Keywords
- Schizophrenia, PPI, P50, CANTAB, sensory gating, Schizophrenic patients according to DSM-IV
- Study type
- Interventional
- Recruitment status
- TerminatedReason stopped: Not enough subjects have been recruited in the expected period.
- Enrolment
- 14 participants (actual)
- Lead sponsor
- University of ZurichUniversity, hospital or other
- Collaborators
- University Hospital of Psychiatry, Department Neuropsychopharmacology and Brain Imaging, H. Lundbeck A/S
- Study start
- Feb 2008
- Primary completion
- Aug 2012 (actual)
- Study completion
- Aug 2012 (actual)
- First posted
- 5 Mar 2008 (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.
This study aims to investigate whether the atypical antipsychotic and mixed 5-HT2/D2 antagonist sertindole modulates or improves both subcortical and cortical information processing in schizophrenic patients who had not or insufficiently responded to previous antipsychotic medication. This goal shall be accomplished by investigating the effect of sertindole of both prepulse inhibition of the acoustic startle (PPI) and P50 suppression of auditory evoked potentials in schizophrenic patients. These effects shall be compared to the effect of risperidone and shall also be compared to untreated healthy controls.
Study design
- Primary purpose
- Basic science
- Allocation
- Non-randomised
- Intervention model
- Parallel groups
- Masking
- Single blind (investigator)
- Number of arms
- 3
| Arm | Type | Receives |
|---|---|---|
| 1 | Experimental | Drug: SertindoleSchizophrenic patients treated with sertindole |
| 2 | Active comparator | Drug: RisperidoneSchizophrenic patients treated with risperidone |
| 3 | No intervention | –Healthy controls without any treatment. |
Who may qualify
- Ages
- 18 to 40 years
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Adult
Key inclusion criteria (2 listed)
- Schizophrenia according to DSM IV
- Selected and treated in respect of the SPC (20 mg Serdolect max. and population at risk will be excluded)
Key exclusion criteria (6 listed)
- DSM IV Axis I disorders other than schizophrenia: Substance-dependence (excepting nicotine-dependence and substance-abuse), recent (2 months) DSM IV diagnosis according to DIA-X of a major affective, anxiety disorder, eating-disorder.
- DSM IV Axis II disorders: Lifetime DSM IV diagnosis of personality disorder.
- ECG: QTc-interval >450 msec.
- Systolic blood pressure <100 mmHg
- Bradycardia (Hf < 50/Min) und Arrhythmias
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 |
|---|---|---|
| Sertindoleoral 12-20 mg/day | Drug | 1 |
| Risperidoneoral 2-6mg / day | Drug | 2 |
Primary outcome
sensory (EEG: P50 suppression) and sensorimotor gating (EMG: PPI)
Time frame: Before and six weeks after antipsychotic treatment
2 secondary outcomes
Cognitive performances
Time frame: Before and six weeks after antipsychotic treatment
Psychopathology (PANSS rating)
Time frame: Before and six weeks after antipsychotic treatment
Results and safety
The study was stopped early (reason given: Not enough subjects have been recruited in the expected period.). Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 17 Sep 2012.
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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.
Franz X. Vollenweider, Prof. Dr. med. principal investigator
University Hospital of Psychiatry, Department Neuropsychopharmacology and Brain Imaging
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Sertindole and Risperidone in people with Schizophrenia, run by University of Zurich at 1 site in Switzerland.
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 2 inclusion and 6 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 17 Sep 2012. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in Switzerland. Whether a site is taking part right now should be confirmed with that site. See every site.
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.
Are results available for this study?
The study was stopped early (reason given: Not enough subjects have been recruited in the expected period.). 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?
sensory (EEG: P50 suppression) and sensorimotor gating (EMG: PPI) (time frame: Before and six weeks after antipsychotic treatment). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
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 17 Sep 2012.