HealthyNCT00612079
The Effect of Sertindole on Sensory Gating and Cognition in Healthy Volunteers
A study testing Sertindole in people with Healthy, run by University of Zurich at 1 site in Switzerland.
Trial summary
This study aims to further validate and extend our previous findings insofar that the effect of the atypical antipsychotic and mixed 5-HT2/D2 antagonist sertindole on sensorimotor gating processes and its relationship to cognitive performance shall be explored. Read more about this study
- Who is it for?
- Ages 18 to 40 years, men onlyHealthy volunteers can take part
- Conditions the study is for
- Healthy
- What is being tested?
- Sertindole
- Type of treatment
- Pill or oral medicine
- Could I receive a placebo?
- Yes, some participants may receive a placebo
- How many people
- 30 participants
- Where
- 1 siteSwitzerland
- Study dates
- Sep 2007to Nov 2008
- 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
- Men only
- Healthy volunteers accepted
- Adult
Who may be able to join
- Age: 18-40
- Gender: male
Who cannot join
- Axis I Disorders: lifetime DSM IV diagnosis according to DIA-X of alcohol or illicit drug dependence. No life-time DSM IV diagnosis according to DIA-X of a major affective, psychotic, anxiety disorder, eating-disorder as defined above.
- Axis II Disorders: lifetime DSM IV diagnosis of personality disorder according to SCID-II.
- Family history: lifetime history of 1st degree relative (parents and siblings) of a major affective, psychotic, or anxiety disorder as defined above.
- 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 of Psychiatry Hospital
Zurich, Canton of Zurich, CH-8032
About this study
This study aims to further validate and extend our previous findings insofar that the effect of the atypical antipsychotic and mixed 5-HT2/D2 antagonist sertindole on sensorimotor gating processes and its relationship to cognitive performance shall be explored.
- Conditions
- Healthy
- Being tested
- Sertindole, Placebo
- Keywords
- Sertindole, sensory gating, PPI, P50 suppression, CANTAB, Effect of Sertindole on sensory gating (P50 suppression), on sensorimotor gating (PPI), and cognition (CANTAB)
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
SertindoleDrug
oral 3 x 4mg
PlaceboDrug
3 x 4mg Placebo
| Study group | Role | What they receive |
|---|---|---|
| 2 | Experimental | Healthy volunteers with high sensory gating levels. Receives: Drug: Sertindole; Drug: Placebo |
| 1 | Experimental | Healthy volunteers with low sensory gating levels. Receives: Drug: Sertindole; Drug: Placebo |
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: after placebo and and after medical treatment
Secondary outcomes (1)
Cognitive performances
Measured: after placebo and and after medical treatment
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted11 Feb 2008 (estimated)
- Study startSep 2007
- Primary completionOct 2008
- Study completionNov 2008
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 HealthyStudies 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
- Randomised
- Intervention model
- Crossover
- Masking
- Double blind
- Who is masked
- Participant, Investigator
- Enrolment
- 30 participants (actual)
Sponsor and investigators
- Lead sponsor
- University of Zurich
- Sponsor type
- University, hospital or other
- Collaborators
- Psychiatric University Hospital, Zurich, 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
- NCT00612079
- Sponsor's protocol ID
- 97_PPI-P50
- Other IDs
- E-07/2007, 2007DR1251
- Status last verified
- Sep 2012
- First submitted
- 23 Jan 2008
- Last updated
- 17 Sep 2012
- Results posted
- No
- Data monitoring committee
- No
Publications
Holstein DH, Csomor PA, Geyer MA, Huber T, Brugger N, Studerus E, Vollenweider FX. The effects of sertindole on sensory gating, sensorimotor gating, and cognition in healthy volunteers. J Psychopharmacol. 2011 Dec;25(12):1600-13. doi: 10.1177/0269881111415734. Epub 2011 Sep 2.
PubMed 21890590
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 Healthy Volunteers
- ClinicalTrials.gov ID
- NCT00612079
- Acronym / sponsor ID
- 97_PPI-P50
- Conditions
- Healthy
- Keywords
- Sertindole, sensory gating, PPI, P50 suppression, CANTAB, Effect of Sertindole on sensory gating (P50 suppression), on sensorimotor gating (PPI), and cognition (CANTAB)
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 30 participants (actual)
- Lead sponsor
- University of ZurichUniversity, hospital or other
- Collaborators
- Psychiatric University Hospital, Zurich, H. Lundbeck A/S
- Study start
- Sep 2007
- Primary completion
- Oct 2008 (actual)
- Study completion
- Nov 2008 (actual)
- First posted
- 11 Feb 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 further validate and extend our previous findings insofar that the effect of the atypical antipsychotic and mixed 5-HT2/D2 antagonist sertindole on sensorimotor gating processes and its relationship to cognitive performance shall be explored.
Study design
- Primary purpose
- Basic science
- Allocation
- Randomised
- Intervention model
- Crossover
- Masking
- Double blind (participant, investigator)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| 2 | Experimental | Drug: Sertindole, Drug: PlaceboHealthy volunteers with high sensory gating levels. |
| 1 | Experimental | Drug: Sertindole, Drug: PlaceboHealthy volunteers with low sensory gating levels. |
Who may qualify
- Ages
- 18 to 40 years
- Sex
- Male only
- Healthy volunteers
- Accepted
- Age groups
- Adult
Key inclusion criteria (2 listed)
- Age: 18-40
- Gender: male
Key exclusion criteria (7 listed)
- Axis I Disorders: lifetime DSM IV diagnosis according to DIA-X of alcohol or illicit drug dependence. No life-time DSM IV diagnosis according to DIA-X of a major affective, psychotic, anxiety disorder, eating-disorder as defined above.
- Axis II Disorders: lifetime DSM IV diagnosis of personality disorder according to SCID-II.
- Family history: lifetime history of 1st degree relative (parents and siblings) of a major affective, psychotic, or anxiety disorder as defined above.
- ECG: QTc-interval >450 msec.
- Systolic blood pressure <100 mmHg
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 3 x 4mg | Drug | 1, 2 |
| Placebo3 x 4mg Placebo | Drug | 1, 2 |
Primary outcome
Sensory (EEG: P50 suppression) and sensorimotor gating (EMG: PPI)
Time frame: after placebo and and after medical treatment
1 secondary outcome
Cognitive performances
Time frame: after placebo and and after medical treatment
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 17 Sep 2012.
- Results publication: PubMed 21890590Holstein DH, Csomor PA, Geyer MA, Huber T, Brugger N, Studerus E, Vollenweider FX. The effects of sertindole on sensory gating, sensorimotor gating, and cognition in healthy volunteers. J Psychopharmacol. 2011 Dec;25(12):1600-13. doi: 10.1177/0269881111415734. Epub 2011 Sep 2.
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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 in people with Healthy, 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 7 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: finished, 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 is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
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: after placebo and and after medical treatment). 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 NCT00612079, 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 17 Sep 2012.