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| Sponsored by: |
H. Lundbeck A/S |
|---|---|
| Information provided by: | H. Lundbeck A/S |
| ClinicalTrials.gov Identifier: | NCT00654706 |
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 III |
| Study Type: | Interventional |
| Study Design: | Treatment, Randomized, Double Blind (Subject, Investigator), Parallel Assignment, Safety/Efficacy Study |
| 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) |
| Estimated Enrollment: | 260 |
| Study Start Date: | March 2008 |
| Estimated Study Completion Date: | June 2009 |
| Estimated Primary Completion Date: | May 2009 (Final data collection date for primary outcome measure) |
| Arms | Assigned Interventions |
|---|---|
| 1: Experimental |
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).
|
| 2: Active Comparator |
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).
|
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 |
Inclusion Criteria:
Exclusion Criteria:
Contacts and Locations| Contact: Email contact via H. Lundbeck A/S | LundbeckClinicalTrials@lundbeck.com |
| United States, California | |
| US006 | Recruiting |
| Pico Rivera, California, United States, 90660 | |
| US001 | Recruiting |
| Pasadena, California, United States, 91107 | |
| US008 | Recruiting |
| National City, California, United States, 91950 | |
| US011 | Recruiting |
| San Diego, California, United States, 92126 | |
| US017 | Recruiting |
| Garden Grove, California, United States, 92845 | |
| United States, Florida | |
| US010 | Recruiting |
| Tampa, Florida, United States, 33613 | |
| US015 | Recruiting |
| Orange City, Florida, United States, 32763 | |
| United States, Georgia | |
| US007 | Recruiting |
| Atlanta, Georgia, United States, 30308 | |
| United States, Illinois | |
| US002 | Recruiting |
| Joliet, Illinois, United States, 60435 | |
| United States, Maryland | |
| US012 | Recruiting |
| Baltimore, Maryland, United States, 21204 | |
| United States, New Jersey | |
| US021 | Recruiting |
| Clementon, New Jersey, United States, 08021 | |
| United States, Texas | |
| US004 | Recruiting |
| Desoto, Texas, United States, 75115 | |
| Study Director: | Email contact via H. Lundbeck A/S | LundbeckClinicalTrials@lundbeck.com |
More Information
| Responsible Party: | H. Lundbeck A/S ( H. Lundbeck A/S ) |
| Study ID Numbers: | 11723A |
| Study First Received: | April 3, 2008 |
| Last Updated: | April 16, 2009 |
| ClinicalTrials.gov Identifier: | NCT00654706 History of Changes |
| Health Authority: | United States: Food and Drug Administration; United States: Institutional Review Board |
|
Schizophrenia Cognition MATRICS Consensus Cognitive Battery |
|
Schizophrenia Quetiapine Tranquilizing Agents Mental Disorders Psychotropic Drugs |
Central Nervous System Depressants Psychotic Disorders Sertindole Antipsychotic Agents Schizophrenia and Disorders with Psychotic Features |
|
Tranquilizing Agents Physiological Effects of Drugs Psychotropic Drugs Central Nervous System Depressants Antipsychotic Agents Pharmacologic Actions Schizophrenia |
Quetiapine Mental Disorders Therapeutic Uses Sertindole Central Nervous System Agents Schizophrenia and Disorders with Psychotic Features |
