Efficacy Study Exploring the Effects on Cognition of Sertindole Versus Comparator in Patients With Schizophrenia
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)
1 other identifier
interventional
264
1 country
26
Brief Summary
The objective of this study is to explore the neurocognitive efficacy of Sertindole versus comparator in patients with schizophrenia using the MCCB.
Trial Health
Trial Health Score
Automated assessment based on enrollment pace, timeline, and geographic reach
participants targeted
Target at P25-P50 for phase_3 schizophrenia
Started Mar 2008
26 active sites
Health score is calculated from publicly available data and should be used for screening purposes only.
Trial Relationships
Click on a node to explore related trials.
Study Timeline
Key milestones and dates
Study Start
First participant enrolled
March 1, 2008
CompletedFirst Submitted
Initial submission to the registry
April 3, 2008
CompletedFirst Posted
Study publicly available on registry
April 9, 2008
CompletedPrimary Completion
Last participant's last visit for primary outcome
January 1, 2010
CompletedStudy Completion
Last participant's last visit for all outcomes
March 1, 2010
CompletedMay 28, 2014
May 1, 2014
1.8 years
April 3, 2008
May 14, 2014
Conditions
Keywords
Outcome Measures
Primary Outcomes (1)
Neurocognitive effect of treatment based on the overall composite score on the MCCB
12 weeks
Secondary Outcomes (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
12 weeks
Study Arms (2)
Sertindole
EXPERIMENTALQuetiapine
ACTIVE COMPARATORInterventions
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).
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
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
Contact the study team to confirm eligibility.
Sponsors & Collaborators
- H. Lundbeck A/Slead
Study Sites (26)
US017
Garden Grove, California, 92845, United States
US008
National City, California, 91950, United States
US001
Pasadena, California, 91107, United States
US006
Pico Rivera, California, 90660, United States
US011
San Diego, California, 92126, United States
US014
Stanford, California, 94305, United States
US026
Torrance, California, 90502, United States
US016
Aurora, Colorado, 80045, United States
US015
Orange City, Florida, 32763, United States
US010
Tampa, Florida, 33613, United States
US007
Atlanta, Georgia, 30308, United States
US024
Chicago, Illinois, 60640, United States
US002
Joliet, Illinois, 60435, United States
US012
Baltimore, Maryland, 21204, United States
US027
Glen Burnie, Maryland, 21061, United States
US019
Lebanon, New Hampshire, 03756, United States
US021
Clementon, New Jersey, 08021, United States
US013
Brooklyn, New York, 11203, United States
US025
Staten Island, New York, 10305, United States
US005
Charlotte, North Carolina, 28211, United States
US018
Durham, North Carolina, 27705, United States
US022
Philadelphia, Pennsylvania, 19139, United States
US023
Austin, Texas, 78754, United States
US020
Dallas, Texas, 75235, United States
US004
DeSoto, Texas, 75115, United States
US028
Houston, Texas, 77008, United States
Related Publications (1)
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.
PMID: 25583364DERIVED
MeSH Terms
Conditions
Interventions
Condition Hierarchy (Ancestors)
Intervention Hierarchy (Ancestors)
Study Officials
- STUDY DIRECTOR
Email contact via H. Lundbeck A/S
LundbeckClinicalTrials@lundbeck.com
Study Design
- Study Type
- interventional
- Phase
- phase 3
- Allocation
- RANDOMIZED
- Masking
- DOUBLE
- Who Masked
- PARTICIPANT, INVESTIGATOR
- Purpose
- TREATMENT
- Intervention Model
- PARALLEL
- Sponsor Type
- INDUSTRY
- Responsible Party
- SPONSOR
Study Record Dates
First Submitted
April 3, 2008
First Posted
April 9, 2008
Study Start
March 1, 2008
Primary Completion
January 1, 2010
Study Completion
March 1, 2010
Last Updated
May 28, 2014
Record last verified: 2014-05