The Effect of Sertindole on Sensory Gating and Cognition in Schizophrenic Patients

Status

Terminated

Phases

Study type

Interventional

Source

ClinicalTrials.gov

Registry ID

NCT00629252

Enrollment

Registered

2008-03-05

Start date

2008-02-29

Completion date

2012-08-31

Last updated

2012-09-17

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

Schizophrenia

Keywords

Schizophrenia, PPI, P50, CANTAB, sensory gating, Schizophrenic patients according to DSM-IV

Brief summary

This study aims to investigate whether the atypical antipsychotic and mixed 5-HT2/D2 antagonist sertindole modulates or improves both subcortical and cortical information processing in schizophrenic patients who had not or insufficiently responded to previous antipsychotic medication. This goal shall be accomplished by investigating the effect of sertindole of both prepulse inhibition of the acoustic startle (PPI) and P50 suppression of auditory evoked potentials in schizophrenic patients. These effects shall be compared to the effect of risperidone and shall also be compared to untreated healthy controls.

Interventions

DRUGSertindole

oral 12-20 mg/day

DRUGRisperidone

oral 2-6mg / day

Study design

Allocation

NON_RANDOMIZED

Intervention model

PARALLEL

Primary purpose

BASIC_SCIENCE

Masking

SINGLE (Investigator)

Eligibility

Sex/Gender

ALL

Age

18 Years to 40 Years

Healthy volunteers

Yes

Inclusion criteria

* Schizophrenia according to DSM IV * Selected and treated in respect of the SPC (20 mg Serdolect max. and population at risk will be excluded)

Exclusion criteria

* DSM IV Axis I disorders other than schizophrenia: Substance-dependence (excepting nicotine-dependence and substance-abuse), recent (2 months) DSM IV diagnosis according to DIA-X of a major affective, anxiety disorder, eating-disorder. * DSM IV Axis II disorders: Lifetime DSM IV diagnosis of personality disorder. * 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)	Before and six weeks after antipsychotic treatment

Secondary

Measure	Time frame
Cognitive performances	Before and six weeks after antipsychotic treatment
Psychopathology (PANSS rating)	Before and six weeks after antipsychotic treatment

Countries

Switzerland

Outcome results

None listed

Source: ClinicalTrials.gov · Data processed: Feb 4, 2026