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

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details. Identifier: NCT00654706
Recruitment Status : Completed
First Posted : April 9, 2008
Last Update Posted : May 28, 2014
Information provided by (Responsible Party):
H. Lundbeck A/S

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

Condition or disease Intervention/treatment Phase
Schizophrenia Cognition Drug: Sertindole Drug: Quetiapine Phase 3

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 Prior antipsychotic medication will be withdrawn (down-tapered) and patients will be randomly assigned to one of the study drugs.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

Study Type : Interventional  (Clinical Trial)
Actual Enrollment : 264 participants
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Double (Participant, Investigator)
Primary Purpose: Treatment
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)
Study Start Date : March 2008
Actual Primary Completion Date : January 2010
Actual Study Completion Date : March 2010

Resource links provided by the National Library of Medicine

MedlinePlus related topics: Schizophrenia

Arm Intervention/treatment
Experimental: Sertindole 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).

Active Comparator: Quetiapine Drug: 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).

Primary Outcome Measures :
  1. Neurocognitive effect of treatment based on the overall composite score on the MCCB [ Time Frame: 12 weeks ]

Secondary Outcome Measures :
  1. 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 [ Time Frame: 12 weeks ]

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Ages Eligible for Study:   18 Years to 55 Years   (Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No

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

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its identifier (NCT number): NCT00654706

United States, California
Garden Grove, California, United States, 92845
National City, California, United States, 91950
Pasadena, California, United States, 91107
Pico Rivera, California, United States, 90660
San Diego, California, United States, 92126
Stanford, California, United States, 94305
Torrance, California, United States, 90502
United States, Colorado
Aurora, Colorado, United States, 80045
United States, Florida
Orange City, Florida, United States, 32763
Tampa, Florida, United States, 33613
United States, Georgia
Atlanta, Georgia, United States, 30308
United States, Illinois
Chicago, Illinois, United States, 60640
Joliet, Illinois, United States, 60435
United States, Maryland
Baltimore, Maryland, United States, 21204
Glen Burnie, Maryland, United States, 21061
United States, New Hampshire
Lebanon, New Hampshire, United States, 03756
United States, New Jersey
Clementon, New Jersey, United States, 08021
United States, New York
Brooklyn, New York, United States, 11203
Staten Island, New York, United States, 10305
United States, North Carolina
Charlotte, North Carolina, United States, 28211
Durham, North Carolina, United States, 27705
United States, Pennsylvania
Philadelphia, Pennsylvania, United States, 19139
United States, Texas
Austin, Texas, United States, 78754
Dallas, Texas, United States, 75235
Desoto, Texas, United States, 75115
Houston, Texas, United States, 77008
Sponsors and Collaborators
H. Lundbeck A/S
Study Director: Email contact via H. Lundbeck A/S

Publications automatically indexed to this study by Identifier (NCT Number):
Responsible Party: H. Lundbeck A/S Identifier: NCT00654706     History of Changes
Other Study ID Numbers: 11723A
First Posted: April 9, 2008    Key Record Dates
Last Update Posted: May 28, 2014
Last Verified: May 2014

Keywords provided by H. Lundbeck A/S:
MATRICS Consensus Cognitive Battery

Additional relevant MeSH terms:
Schizophrenia Spectrum and Other Psychotic Disorders
Mental Disorders
Quetiapine Fumarate
Antipsychotic Agents
Tranquilizing Agents
Central Nervous System Depressants
Physiological Effects of Drugs
Psychotropic Drugs