Efficacy Study Exploring the Effects on Cognition of Sertindole Versus Comparator in Patients With Schizophrenia
NCT ID: NCT00654706
Last Updated: 2014-05-28
Study Results
The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.
Basic Information
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COMPLETED
PHASE3
264 participants
INTERVENTIONAL
2008-03-31
2010-03-31
Brief Summary
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Detailed Description
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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 Prior antipsychotic medication will be withdrawn (down-tapered) and patients will be randomly assigned to one of the study drugs.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.
Conditions
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Study Design
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RANDOMIZED
PARALLEL
TREATMENT
DOUBLE
Study Groups
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Sertindole
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
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).
Interventions
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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).
Eligibility Criteria
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Inclusion Criteria
* Man or woman, aged between 18 and 55 years
Exclusion Criteria
* 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
18 Years
55 Years
ALL
No
Sponsors
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H. Lundbeck A/S
INDUSTRY
Responsible Party
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Principal Investigators
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Locations
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US017
Garden Grove, California, United States
US008
National City, California, United States
US001
Pasadena, California, United States
US006
Pico Rivera, California, United States
US011
San Diego, California, United States
US014
Stanford, California, United States
US026
Torrance, California, United States
US016
Aurora, Colorado, United States
US015
Orange City, Florida, United States
US010
Tampa, Florida, United States
US007
Atlanta, Georgia, United States
US024
Chicago, Illinois, United States
US002
Joliet, Illinois, United States
US012
Baltimore, Maryland, United States
US027
Glen Burnie, Maryland, United States
US019
Lebanon, New Hampshire, United States
US021
Clementon, New Jersey, United States
US013
Brooklyn, New York, United States
US025
Staten Island, New York, United States
US005
Charlotte, North Carolina, United States
US018
Durham, North Carolina, United States
US022
Philadelphia, Pennsylvania, United States
US023
Austin, Texas, United States
US020
Dallas, Texas, United States
US004
DeSoto, Texas, United States
US028
Houston, Texas, United States
Countries
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References
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Nielsen J, Matz J, Mittoux A, Polcwiartek C, Struijk JJ, Toft E, Kanters JK, Graff C. Cardiac effects of sertindole and quetiapine: analysis of ECGs from a randomized double-blind study in patients with schizophrenia. Eur Neuropsychopharmacol. 2015 Mar;25(3):303-11. doi: 10.1016/j.euroneuro.2014.12.005. Epub 2015 Jan 3.
Other Identifiers
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11723A
Identifier Type: -
Identifier Source: org_study_id
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