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

Schizophrenia Clinical Trial

Official title:

A Randomised, Double-Blind, Parallel-Group, Flexible-Dose Study Exploring the Neurocognitive Effect of Sertindole Versus Comparator in Patients With Schizophrenia Using the MATRICS Consensus Cognitive Battery (MCCB)

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT00654706
• Other study ID #: 11723A
• Status: Completed
• Phase: Phase 3
• First received: April 3, 2008
• Last updated: May 14, 2014
• Start date: March 2008
• Est. completion date: March 2010

Study information

• Verified date: May 2014
• Source: H. Lundbeck A/S
• Contact: n/a
• Is FDA regulated: No
• Health authority: United States: Food and Drug AdministrationUnited States: Institutional Review Board
• Study type: Interventional

Clinical Trial Summary

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

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 Prior antipsychotic medication will be withdrawn (down-tapered) and patients will be randomly assigned to one of the study drugs.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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 264
• Est. completion date: March 2010
• Est. primary completion date: January 2010
• Accepts healthy volunteers: No
• Gender: Both
• Age group: 18 Years to 55 Years

Eligibility

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

Study Design

Allocation: Randomized, Endpoint Classification: Safety/Efficacy Study, Intervention Model: Parallel Assignment, Masking: Double Blind (Subject, Investigator), Primary Purpose: Treatment

Related Conditions & MeSH terms

• Cognition
• Schizophrenia

Intervention

Drug:
• Sertindole
Once daily oral dose. Day 1-20: 4-16 mg/day (titration period). Day 21-84: 12, 16 or 20 mg/day (flexible treatment period).
• Quetiapine
Twice daily oral dose. Day 1-20: 50-500 mg/day (titration period). Day 21-84: 400, 500 or 600 mg/day (flexible treatment period).

Locations

Country	Name	City	State
United States	US007	Atlanta	Georgia
United States	US016	Aurora	Colorado
United States	US023	Austin	Texas
United States	US012	Baltimore	Maryland
United States	US013	Brooklyn	New York
United States	US005	Charlotte	North Carolina
United States	US024	Chicago	Illinois
United States	US021	Clementon	New Jersey
United States	US020	Dallas	Texas
United States	US004	Desoto	Texas
United States	US018	Durham	North Carolina
United States	US017	Garden Grove	California
United States	US027	Glen Burnie	Maryland
United States	US028	Houston	Texas
United States	US002	Joliet	Illinois
United States	US019	Lebanon	New Hampshire
United States	US008	National City	California
United States	US015	Orange City	Florida
United States	US001	Pasadena	California
United States	US022	Philadelphia	Pennsylvania
United States	US006	Pico Rivera	California
United States	US011	San Diego	California
United States	US014	Stanford	California
United States	US025	Staten Island	New York
United States	US010	Tampa	Florida
United States	US026	Torrance	California

Sponsors (1)

Lead Sponsor	Collaborator
H. Lundbeck A/S

Country where clinical trial is conducted

United States, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Neurocognitive effect of treatment based on the overall composite score on the MCCB		12 weeks	No
Secondary	Domain specific scores on MCCB; PANSS total score, PANSS positive symptom subscale score, PANSS negative symptom subscale score, and PANSS general psychopathology subscale score; CGI-S, CDSS and GAF scores; QLS and UPSA total and subscale scores; ECGs		12 weeks	Yes