NCT00612079CompletedNot Applicable
The Effect of Sertindole on Sensory Gating and Cognition in Healthy Volunteers
Conditions
Interventions
Drugs
Trial Snapshot
- Phase
- Not Applicable
- Status
- Completed
- Sponsor
- University of Zurich
- Enrollment
- 30
- Locations
- 1
- Primary Endpoint
- Sensory (EEG: P50 suppression) and sensorimotor gating (EMG: PPI)
Study Overview
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.
Study Design
- Study Type
- Interventional
- Allocation
- Randomized
- Intervention Model
- Crossover
- Primary Purpose
- Basic Science
- Masking
- Double (Participant, Investigator)
Eligibility Criteria
- Ages
- 18 Years to 40 Years (Adult)
- Sex
- Male
- Accepts 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
Arms & Interventions
2
Experimental
Healthy volunteers with high sensory gating levels.
Intervention: Sertindole (Drug)
2
Experimental
Healthy volunteers with high sensory gating levels.
Intervention: Placebo (Drug)
1
Experimental
Healthy volunteers with low sensory gating levels.
Intervention: Sertindole (Drug)
1
Experimental
Healthy volunteers with low sensory gating levels.
Intervention: Placebo (Drug)
Outcomes
Primary Outcomes
Sensory (EEG: P50 suppression) and sensorimotor gating (EMG: PPI)
Time Frame: after placebo and and after medical treatment
Secondary Outcomes
- Cognitive performances(after placebo and and after medical treatment)
Investigators
Study Sites (1)
Loading locations...
Similar Trials
Completed
Not Applicable
Effects of Sensory Flicker and Electrical Flicker StimulationBrain DiseasesNCT04188834Emory University23
Completed
Not Applicable
Treatment With Spinal Cord Stimulation: Effect on Sensory ParametersChronic PainNCT01261468Danish Pain Research Center15
Completed
Phase 4
Memantine Effects on Sensorimotor Gating and Neurocognition in SchizophreniaSchizo Affective DisorderHealthySchizophreniaSchizoaffective DisorderNCT03860597University of California, San Diego42
Completed
Not Applicable
Cortico-cortical Connectivity During Midazolam Sedation in Humans; a TMS/EEG StudyHealthyNCT00734006University of Wisconsin, Madison20
Not yet recruiting
Not Applicable
The effect of implementing sensory stimulations program on clinical outcomes of brain injury patients admitted in Intensive Care UnitIRCT20120414009469N4Ahvaz University of Medical Sciences66