Sertindole in Asian Patients With Schizophrenia

Lundbeck

Status and phase

Completed

Phase 3

Conditions

Schizophrenia

Treatments

Drug: Olanzapine

Drug: Sertindole

Study type

Interventional

Funder types

Industry

Identifiers

NCT00864045

11286

Details and patient eligibility

About

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

Full 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.

Enrollment

394 patients

Sex

All

Ages

18 to 65 years old

Volunteers

No Healthy Volunteers

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.