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

University of Zurich (UZH)

Status: Completed

Conditions: Healthy

Treatments: Drug: Sertindole; Drug: Placebo

Study type: Interventional

Funder types: Other; Industry

Identifiers

NCT00612079

97_PPI-P50

E-07/2007

2007DR1251

Details and patient eligibility

About

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.

Enrollment: 30 patients

Sex: Male

Ages: 18 to 40 years old

Volunteers: Accepts Healthy Volunteers

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

Trial design

Primary purpose: Basic Science

Allocation: Randomized

Interventional model: Crossover Assignment

Masking: Double Blind

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30 participants in 2 patient groups

2

Experimental group

Description:

Healthy volunteers with high sensory gating levels.

Treatment:

Drug: Placebo

Drug: Sertindole

1

Experimental group

Description:

Healthy volunteers with low sensory gating levels.

Treatment:

Drug: Placebo

Drug: Sertindole