Sertindole in Asian Patients With Schizophrenia

Phase 3

Completed

• Conditions: Schizophrenia
• Interventions: Drug: Olanzapine; Drug: Sertindole

• Registration Number: NCT00864045
• Lead Sponsor: H. Lundbeck A/S

Brief Summary

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

Detailed Description

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.

Study Timeline

• Study Start: 2007-03
• Primary Completion: 2008-03
• Study Completion: 2008-05
• Study First Submitted: 2009-03-17
• Study First Submitted QC: 2009-03-17
• Study First Posted: 2009-03-18
• Status Verified: 2013-09
• Last Update Submitted: 2013-09-19
• Last Update Posted: 2013-09-20

Recruitment & Eligibility

• Status: COMPLETED
• Sex: All
• Target Recruitment: 394

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.

Study & Design

• Study Type: INTERVENTIONAL
• Study Design: PARALLEL

Arm && Interventions

Group	Intervention	Description
Olanzapine	Olanzapine	-
Sertindole	Sertindole	-

Primary Outcome Measures

Name	Time	Method
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

Name	Time	Method
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

Trial Locations

Locations (1)

CN001; 🇨🇳 Beijing, China