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

This study has been completed.
Sponsor:
Information provided by (Responsible Party):
H. Lundbeck A/S
ClinicalTrials.gov Identifier:
NCT00654706
First received: April 3, 2008
Last updated: September 13, 2013
Last verified: September 2013
  Purpose

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


Condition Intervention Phase
Schizophrenia
Cognition
Drug: Sertindole
Drug: Quetiapine
Phase 3

Study Type: Interventional
Study Design: Allocation: Randomized
Endpoint Classification: Safety/Efficacy Study
Intervention Model: Parallel Assignment
Masking: Double Blind (Subject, 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)

Resource links provided by NLM:


Further study details as provided by H. Lundbeck A/S:

Primary Outcome Measures:
  • Neurocognitive effect of treatment based on the overall composite score on the MCCB [ Time Frame: 12 weeks ] [ Designated as safety issue: No ]

Secondary Outcome Measures:
  • 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 ] [ Designated as safety issue: Yes ]

Enrollment: 264
Study Start Date: March 2008
Study Completion Date: March 2010
Primary Completion Date: January 2010 (Final data collection date for primary outcome measure)
Arms Assigned Interventions
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).

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.

  Eligibility

Ages Eligible for Study:   18 Years to 55 Years
Genders Eligible for Study:   Both
Accepts Healthy Volunteers:   No
Criteria

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
  Contacts and Locations
Please refer to this study by its ClinicalTrials.gov identifier: NCT00654706

Locations
United States, California
US017
Garden Grove, California, United States, 92845
US008
National City, California, United States, 91950
US001
Pasadena, California, United States, 91107
US006
Pico Rivera, California, United States, 90660
US011
San Diego, California, United States, 92126
US014
Stanford, California, United States, 94305
US026
Torrance, California, United States, 90502
United States, Colorado
US016
Aurora, Colorado, United States, 80045
United States, Florida
US015
Orange City, Florida, United States, 32763
US010
Tampa, Florida, United States, 33613
United States, Georgia
US007
Atlanta, Georgia, United States, 30308
United States, Illinois
US024
Chicago, Illinois, United States, 60640
US002
Joliet, Illinois, United States, 60435
United States, Maryland
US012
Baltimore, Maryland, United States, 21204
US027
Glen Burnie, Maryland, United States, 21061
United States, New Hampshire
US019
Lebanon, New Hampshire, United States, 03756
United States, New Jersey
US021
Clementon, New Jersey, United States, 08021
United States, New York
US013
Brooklyn, New York, United States, 11203
US025
Staten Island, New York, United States, 10305
United States, North Carolina
US005
Charlotte, North Carolina, United States, 28211
US018
Durham, North Carolina, United States, 27705
United States, Pennsylvania
US022
Philadelphia, Pennsylvania, United States, 19139
United States, Texas
US023
Austin, Texas, United States, 78754
US020
Dallas, Texas, United States, 75235
US004
Desoto, Texas, United States, 75115
US028
Houston, Texas, United States, 77008
Sponsors and Collaborators
H. Lundbeck A/S
Investigators
Study Director: Email contact via H. Lundbeck A/S LundbeckClinicalTrials@lundbeck.com
  More Information

No publications provided

Responsible Party: H. Lundbeck A/S
ClinicalTrials.gov Identifier: NCT00654706     History of Changes
Other Study ID Numbers: 11723A
Study First Received: April 3, 2008
Last Updated: September 13, 2013
Health Authority: United States: Food and Drug Administration
United States: Institutional Review Board

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

Additional relevant MeSH terms:
Schizophrenia
Schizophrenia and Disorders with Psychotic Features
Mental Disorders
Sertindole
Quetiapine
Antipsychotic Agents
Tranquilizing Agents
Central Nervous System Depressants
Physiological Effects of Drugs
Pharmacologic Actions
Central Nervous System Agents
Therapeutic Uses
Psychotropic Drugs

ClinicalTrials.gov processed this record on April 17, 2014