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OpenTrials
Completed

NCT Number: NCT00612079

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

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.

Completed

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Key information

Conditions

Healthy

Age range

18 year–40 year

Sex eligibility

Male

Study type

Interventional

Phase

Not applicable

Primary location

University of Psychiatry Hospital

Zurich, Canton of Zurich, CH-8032, Switzerland

Who can participate

Healthy volunteers accepted: Yes

Only the study team can determine whether someone qualifies for participation.

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

Treatment and study plan

Sertindole

Drug

oral 3 x 4mg

Placebo

Drug

3 x 4mg Placebo

Primary outcomes

  1. Sensory (EEG: P50 suppression) and sensorimotor gating (EMG: PPI)

    Time frame: after placebo and and after medical treatment

Secondary outcomes

  1. Cognitive performances

    Time frame: after placebo and and after medical treatment

Sponsors and collaborators

Lead sponsor

University of Zurich

Other

Collaborators

  • H. Lundbeck A/S
  • Psychiatric University Hospital, Zurich

Registry information

Important dates

Study start
2007
Primary completion
2008
Study completion
2008
First posted
Feb 11, 2008
Registry last updated
Sep 17, 2012

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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