Healthy
Conditions
Keywords
Sertindole, sensory gating, PPI, P50 suppression, CANTAB, Effect of Sertindole on sensory gating (P50 suppression), on sensorimotor gating (PPI), and cognition (CANTAB)
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.
Interventions
DRUGSertindole
oral 3 x 4mg
DRUGPlacebo
3 x 4mg Placebo
Sponsors
Psychiatric University Hospital, Zurich
H. Lundbeck A/S
University of Zurich
Study design
Allocation
RANDOMIZED
Intervention model
CROSSOVER
Primary purpose
BASIC_SCIENCE
Masking
DOUBLE (Subject, Investigator)
Eligibility
Sex/Gender
MALE
Age
18 Years to 40 Years
Healthy volunteers
Yes
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
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| Sensory (EEG: P50 suppression) and sensorimotor gating (EMG: PPI) | after placebo and and after medical treatment |
Secondary
| Measure | Time frame |
|---|---|
| Cognitive performances | after placebo and and after medical treatment |
Countries
Switzerland
Outcome results
None listed