The Effect of Sertindole on Sensory Gating and Cognition in Healthy Volunteers

Healthy Clinical Trial

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT00612079
• Other study ID #: 97_PPI-P50
• Secondary ID: E-07/20072007DR1
• Status: Completed
• Phase: N/A
• First received: January 23, 2008
• Last updated: September 14, 2012
• Start date: September 2007
• Est. completion date: November 2008

Study information

• Verified date: September 2012
• Source: University of Zurich
• Contact: n/a
• Is FDA regulated: No
• Health authority: Switzerland: Swissmedic andSwitzerland: Ethikkommission
• Study type: Interventional

Clinical Trial 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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 30
• Est. completion date: November 2008
• Est. primary completion date: October 2008
• Accepts healthy volunteers: Accepts Healthy Volunteers
• Gender: Male
• Age group: 18 Years to 40 Years

Eligibility

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

Study Design

Allocation: Randomized, Endpoint Classification: Efficacy Study, Intervention Model: Crossover Assignment, Masking: Double Blind (Subject, Investigator), Primary Purpose: Basic Science

Related Conditions & MeSH terms

• Healthy

Intervention

Drug:
• Sertindole
oral 3 x 4mg
• Placebo
3 x 4mg Placebo

Locations

Country	Name	City	State
Switzerland	University of Psychiatry Hospital	Zurich	ZH

Sponsors (3)

Lead Sponsor	Collaborator
University of Zurich	H. Lundbeck A/S, Psychiatric University Hospital, Zurich

Country where clinical trial is conducted

Switzerland, 

References & 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: 10.1177/026988111141 — View Citation

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Sensory (EEG: P50 suppression) and sensorimotor gating (EMG: PPI)		after placebo and and after medical treatment	No
Secondary	Cognitive performances		after placebo and and after medical treatment	No