The Effect of Sertindole on Sensory Gating and Cognition in Healthy Volunteers
NCT ID: NCT00612079
Last Updated: 2012-09-17
Study Results
The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.
Basic Information
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COMPLETED
NA
30 participants
INTERVENTIONAL
2007-09-30
2008-11-30
Brief Summary
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Detailed Description
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Conditions
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Keywords
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Study Design
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RANDOMIZED
CROSSOVER
BASIC_SCIENCE
DOUBLE
Study Groups
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2
Healthy volunteers with high sensory gating levels.
Sertindole
oral 3 x 4mg
Placebo
3 x 4mg Placebo
1
Healthy volunteers with low sensory gating levels.
Sertindole
oral 3 x 4mg
Placebo
3 x 4mg Placebo
Interventions
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Sertindole
oral 3 x 4mg
Placebo
3 x 4mg Placebo
Eligibility Criteria
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Inclusion Criteria
* Gender: male
Exclusion Criteria
* 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
18 Years
40 Years
MALE
Yes
Sponsors
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Psychiatric University Hospital, Zurich
OTHER
H. Lundbeck A/S
INDUSTRY
University of Zurich
OTHER
Responsible Party
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Principal Investigators
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Franz X. Vollenweider, Prof. Dr. med.
Role: PRINCIPAL_INVESTIGATOR
University Hospital of Psychiatry, Department Neuropsychopharmacology and Brain Imaging
Locations
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University of Psychiatry Hospital
Zurich, Canton of Zurich, Switzerland
Countries
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References
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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.
Other Identifiers
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E-07/2007
Identifier Type: -
Identifier Source: secondary_id
2007DR1251
Identifier Type: -
Identifier Source: secondary_id
97_PPI-P50
Identifier Type: -
Identifier Source: org_study_id