Efficacy Study Exploring the Effects on Cognition of Sertindole Versus Comparator in Patients With Schizophrenia

Lundbeck

Status and phase

Completed

Phase 3

Conditions

Schizophrenia

Cognition

Treatments

Drug: Quetiapine

Drug: Sertindole

Study type

Interventional

Funder types

Industry

Identifiers

NCT00654706

11723A

Details and patient eligibility

About

The objective of this study is to explore the neurocognitive efficacy of Sertindole versus comparator in patients with schizophrenia using the MCCB.

Full description

Sertindole is an atypical antipsychotic approved in the European Union (EU) for use in patients with schizophrenia who are intolerant to at least one other antipsychotic agent. During clinical development sertindole was found to be as effective in the treatment of schizophrenia as the first-generation antipsychotic haloperidol and as the second-generation antipsychotic risperidone.

Sertindole is generally well tolerated and has a benign side-effect profile, including an absence of sedation, no effect on plasma prolactin levels, moderate weight gain, no anticholinergic-mediated cognitive impairment and a low rate of extrapyramidal symptoms (EPS). Sertindole has been shown to prolong the QT interval and is contraindicated in patients with prolonged QT interval and in patients receiving drugs known to significantly prolong the QT interval.

The study is designed to provide data on the neurocognitive properties of sertindole versus quetiapine in patients with schizophrenia. Efficacy for cognitive impairment is assessed in patients who are in a stable phase of their illness, with a predefined maximum level of symptoms that will allow them to be included in the study. Prior antipsychotic medication will be withdrawn (down-tapered) and patients will be randomly assigned to one of the study drugs.

Cognitive deficiencies are an important feature of schizophrenia and correlate strongly with functional impairment. Improving functional outcomes in schizophrenia has a high priority and has resulted in the initiation of a program called Measurement and Treatment Research to Improve Cognition in Schizophrenia (MATRICS) leading to the development of a neuropsychological test battery, the MCCB which is used in this study.

Enrollment

264 patients

Sex

All

Ages

18 to 55 years old

Volunteers

No Healthy Volunteers

Inclusion criteria

Primary diagnosis of schizophrenia
Man or woman, aged between 18 and 55 years

Exclusion criteria

Current Axis I primary psychiatric diagnosis other than schizophrenia
Not previously received antipsychotic drugs for schizophrenia
Acute exacerbation requiring hospitalisation within the last 3 months
Clinically significant extrapyramidal symptoms
Clinically significant cardiovascular disease, congestive heart failure, cardiac hypertrophy, arrhythmia or bradycardia
Congenital long QT syndrome or a family history of this disease, or known acquired QT interval prolongation
Significant ECG abnormalities
Hypokalaemia or hypomagnesaemia
In concurrent treatment with drugs inhibiting the P450 enzymes system CYP3A