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

Completed · Phase 3

Conditions studied: Schizophrenia, Cognition

In brief

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

Key facts

Study ID

NCT00654706

Run by

H. Lundbeck A/S

People needed

264

Starts

2008-03-01

Expected to finish

2010-03-01

Last updated by the study team

2014-05-28

Who can join

Age: 18 and older, up to 55. Sex: any. Healthy volunteers: not accepted.

You may qualify if…

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

You may not qualify if…

• 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

Where it is running

• 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

Full record on ClinicalTrials.gov

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