The Effect of Sertindole on Sensory Gating and Cognition in Healthy Volunteers
3 other identifiers
interventional
30
1 country
1
Brief 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.
Trial Health
Trial Health Score
Automated assessment based on enrollment pace, timeline, and geographic reach
participants targeted
Target at P25-P50 for not_applicable healthy
Started Sep 2007
Typical duration for not_applicable healthy
1 active site
Health score is calculated from publicly available data and should be used for screening purposes only.
Trial Relationships
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Study Timeline
Key milestones and dates
Study Start
First participant enrolled
September 1, 2007
CompletedFirst Submitted
Initial submission to the registry
January 23, 2008
CompletedFirst Posted
Study publicly available on registry
February 11, 2008
CompletedPrimary Completion
Last participant's last visit for primary outcome
October 1, 2008
CompletedStudy Completion
Last participant's last visit for all outcomes
November 1, 2008
CompletedSeptember 17, 2012
September 1, 2012
1.1 years
January 23, 2008
September 14, 2012
Conditions
Keywords
Outcome Measures
Primary Outcomes (1)
Sensory (EEG: P50 suppression) and sensorimotor gating (EMG: PPI)
after placebo and and after medical treatment
Secondary Outcomes (1)
Cognitive performances
after placebo and and after medical treatment
Study Arms (2)
2
EXPERIMENTALHealthy volunteers with high sensory gating levels.
1
EXPERIMENTALHealthy volunteers with low sensory gating levels.
Interventions
Eligibility Criteria
You may qualify if:
- Age: 18-40
- Gender: male
You may not qualify if:
- 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
Contact the study team to confirm eligibility.
Sponsors & Collaborators
- University of Zurichlead
- Psychiatric University Hospital, Zurichcollaborator
- H. Lundbeck A/Scollaborator
Study Sites (1)
University of Psychiatry Hospital
Zurich, Canton of Zurich, CH-8032, Switzerland
Related Publications (1)
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.
PMID: 21890590RESULT
MeSH Terms
Interventions
Study Officials
- PRINCIPAL INVESTIGATOR
Franz X. Vollenweider, Prof. Dr. med.
University Hospital of Psychiatry, Department Neuropsychopharmacology and Brain Imaging
Study Design
- Study Type
- interventional
- Phase
- not applicable
- Allocation
- RANDOMIZED
- Masking
- DOUBLE
- Who Masked
- PARTICIPANT, INVESTIGATOR
- Purpose
- BASIC SCIENCE
- Intervention Model
- CROSSOVER
- Sponsor Type
- OTHER
- Responsible Party
- SPONSOR
Study Record Dates
First Submitted
January 23, 2008
First Posted
February 11, 2008
Study Start
September 1, 2007
Primary Completion
October 1, 2008
Study Completion
November 1, 2008
Last Updated
September 17, 2012
Record last verified: 2012-09