Sertindole in Asian Patients With Schizophrenia

Study Overview
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Brief Summary
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The purpose of this study is to assess the efficacy and safety of sertindole in patients with schizophrenia in Asia.

Detailed Description
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This study is the first randomised clinical trial performed in Asia with sertindole, aiming at comparing sertindole efficacy and safety to that of another atypical antipsychotic. Sertindole is a limbic-selective antipsychotic agent with a unique neuropharmacological profile. Sertindole has shown significant improvements relative to placebo against both positive and negative symptoms of schizophrenia (measured by PANSS total, PANSS negative and positive subscale scores). It is well tolerated and shows placebo-level incidence of extrapyramidal symptoms (EPS). Sertindole is associated with a dose-dependent increase in the QT interval, but this does not translate into an excess mortality with sertindole relative to that of other recently developed antipsychotics in their respective clinical development programmes.

Official Title
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A Randomised, Double-blind, Parallel-group, Flexible-dose Trial Evaluating the Efficacy and Safety of 12 Weeks of Treatment With Sertindole or Olanzapine in Patients With Schizophrenia in Asia

Conditions
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Schizophrenia

Intervention / Treatment
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* Drug: Sertindole
* Drug: Olanzapine


Participation Criteria
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Eligibility Criteria
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Inclusion Criteria: Male and female patients, aged 18-65 years (extremes included), suffering from schizophrenia Positive and Negative Syndrome Scales (PANSS) total score between 60 and 120 (extremes included) at screening and baseline Based on the patient's clinical status, an antipsychotic treatment is indicated Otherwise healthy Female patients of non-childbearing potential, or non-pregnant, not breast-feeding women of childbearing potential, using adequate birth control methods Exclusion Criteria: Current Axis I primary psychiatric diagnosis other than schizophrenia Has never before received antipsychotic drugs Has received a depot antipsychotic medication within less than one dose interval prior to Screening History of clinically significant cardiovascular disease, congestive heart failure, cardiac hypertrophy, arrhythmia or bradycardia (<50 beats per minute) Congenital long QT syndrome or a family history of this disease, or in patients with known acquired QT interval prolongation (QTc above 450 msec in males and 470 msec in females at Screening) Significant risk of suicide and/or violent behaviour Known history of narrow angle glaucoma Substance or alcohol abuse, current alcohol dependence Use of disallowed concomitant medication Other protocol-defined inclusion and exclusion criteria may apply.

Ages Eligible for Study
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Minimum Age: 18 Years
Maximum Age: 65 Years

Sexes Eligible for Study
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All

Accepts Healthy Volunteers
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No

Study Plan
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How is the study designed?
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Design Details

Primary Purpose: Treatment
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Double


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Experimental: Sertindole<br> | Drug: Sertindole<br>* Sertindole flexible doses per os, 12, 16 or 20mg/day according to response and tolerability, initially up-titrated from 4mg/day to target dose 16mg/day within the first 16 days<br>|
| Active Comparator: Olanzapine<br> | Drug: Olanzapine<br>* Olanzapine flexible doses per os, 10, 15 or 20mg/day according to response and tolerability, initially up-titrated from 10mg/day to target dose 15mg/day within the first 16 days<br>|

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| To evaluate the efficacy of 12 weeks treatment with flexible doses of sertindole in comparison to flexible doses of olanzapine in patients with schizophrenia. |  | 12 weeks | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| To evaluate the safety and tolerability of 12 weeks treatment with flexible doses of sertindole in comparison to flexible doses of olanzapine in patients with schizophrenia. |  | 12 weeks |