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Main
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Note: This record shows only 22 elements of the WHO Trial Registration Data Set. To view changes that have been made to the source record, or for additional information about this trial, click on the URL below to go to the source record in the primary register. |
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Register:
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ClinicalTrials.gov |
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Last refreshed on:
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19 February 2015 |
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Main ID: |
NCT00612079 |
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Date of registration:
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23/01/2008 |
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Prospective Registration:
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No |
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Primary sponsor: |
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Public title:
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The Effect of Sertindole on Sensory Gating and Cognition in Healthy Volunteers
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Scientific title:
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Date of first enrolment:
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September 2007 |
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Target sample size:
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30 |
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Recruitment status: |
Completed |
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URL:
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http://clinicaltrials.gov/show/NCT00612079 |
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Study type:
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Interventional |
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Study design:
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Allocation: Randomized, Endpoint Classification: Efficacy Study, Intervention Model: Crossover Assignment, Masking: Double Blind (Subject, Investigator), Primary Purpose: Basic Science
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Phase:
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N/A
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Countries of recruitment
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Switzerland
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Contacts
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Name:
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Franz X. Vollenweider, Prof. Dr. med. |
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Address:
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Telephone:
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Email:
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Affiliation:
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University Hospital of Psychiatry, Department Neuropsychopharmacology and Brain Imaging |
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Key inclusion & exclusion criteria
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Inclusion Criteria:
- Age: 18-40
- Gender: male
Exclusion Criteria:
- 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
Age minimum:
18 Years
Age maximum:
40 Years
Gender:
Male
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Health Condition(s) or Problem(s) studied
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Healthy
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Intervention(s)
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Drug: Placebo
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Drug: Sertindole
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Primary Outcome(s)
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Sensory (EEG: P50 suppression) and sensorimotor gating (EMG: PPI)
[Time Frame: after placebo and and after medical treatment]
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Secondary Outcome(s)
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Cognitive performances
[Time Frame: after placebo and and after medical treatment]
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Secondary ID(s)
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2007DR1251
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97_PPI-P50
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E-07/2007
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Source(s) of Monetary Support
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Please refer to primary and secondary sponsors
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Results
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Results available:
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Date Posted:
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Date Completed:
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URL:
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