Efficacy Study Exploring the Effects on Cognition of Sertindole Versus Comparator in Patients With Schizophrenia
Primary Purpose
Schizophrenia, Cognition
Status
Completed
Phase
Phase 3
Locations
United States
Study Type
Interventional
Intervention
Sertindole
Quetiapine
Sponsored by
About this trial
This is an interventional treatment trial for Schizophrenia focused on measuring Schizophrenia, Cognition, MATRICS Consensus Cognitive Battery
Eligibility 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
Sites / Locations
- US017
- US008
- US001
- US006
- US011
- US014
- US026
- US016
- US015
- US010
- US007
- US024
- US002
- US012
- US027
- US019
- US021
- US013
- US025
- US005
- US018
- US022
- US023
- US020
- US004
- US028
Arms of the Study
Arm 1
Arm 2
Arm Type
Experimental
Active Comparator
Arm Label
Sertindole
Quetiapine
Arm Description
Outcomes
Primary Outcome Measures
Neurocognitive effect of treatment based on the overall composite score on the MCCB
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
Full Information
1. Study Identification
Unique Protocol Identification Number
NCT00654706
Brief Title
Efficacy Study Exploring the Effects on Cognition of Sertindole Versus Comparator in Patients With Schizophrenia
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)
Study Type
Interventional
2. Study Status
Record Verification Date
May 2014
Overall Recruitment Status
Completed
Study Start Date
March 2008 (undefined)
Primary Completion Date
January 2010 (Actual)
Study Completion Date
March 2010 (Actual)
3. Sponsor/Collaborators
Responsible Party, by Official Title
Sponsor
Name of the Sponsor
H. Lundbeck A/S
4. Oversight
Data Monitoring Committee
No
5. Study Description
Brief Summary
The objective of this study is to explore the neurocognitive efficacy of Sertindole versus comparator in patients with schizophrenia using the MCCB.
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.
6. Conditions and Keywords
Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Schizophrenia, Cognition
Keywords
Schizophrenia, Cognition, MATRICS Consensus Cognitive Battery
7. Study Design
Primary Purpose
Treatment
Study Phase
Phase 3
Interventional Study Model
Parallel Assignment
Masking
ParticipantInvestigator
Allocation
Randomized
Enrollment
264 (Actual)
8. Arms, Groups, and Interventions
Arm Title
Sertindole
Arm Type
Experimental
Arm Title
Quetiapine
Arm Type
Active Comparator
Intervention Type
Drug
Intervention Name(s)
Sertindole
Intervention Description
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).
Intervention Type
Drug
Intervention Name(s)
Quetiapine
Intervention Description
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).
Primary Outcome Measure Information:
Title
Neurocognitive effect of treatment based on the overall composite score on the MCCB
Time Frame
12 weeks
Secondary Outcome Measure Information:
Title
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
10. Eligibility
Sex
All
Minimum Age & Unit of Time
18 Years
Maximum Age & Unit of Time
55 Years
Accepts Healthy Volunteers
No
Eligibility 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
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Email contact via H. Lundbeck A/S
Organizational Affiliation
LundbeckClinicalTrials@lundbeck.com
Official's Role
Study Director
Facility Information:
Facility Name
US017
City
Garden Grove
State/Province
California
ZIP/Postal Code
92845
Country
United States
Facility Name
US008
City
National City
State/Province
California
ZIP/Postal Code
91950
Country
United States
Facility Name
US001
City
Pasadena
State/Province
California
ZIP/Postal Code
91107
Country
United States
Facility Name
US006
City
Pico Rivera
State/Province
California
ZIP/Postal Code
90660
Country
United States
Facility Name
US011
City
San Diego
State/Province
California
ZIP/Postal Code
92126
Country
United States
Facility Name
US014
City
Stanford
State/Province
California
ZIP/Postal Code
94305
Country
United States
Facility Name
US026
City
Torrance
State/Province
California
ZIP/Postal Code
90502
Country
United States
Facility Name
US016
City
Aurora
State/Province
Colorado
ZIP/Postal Code
80045
Country
United States
Facility Name
US015
City
Orange City
State/Province
Florida
ZIP/Postal Code
32763
Country
United States
Facility Name
US010
City
Tampa
State/Province
Florida
ZIP/Postal Code
33613
Country
United States
Facility Name
US007
City
Atlanta
State/Province
Georgia
ZIP/Postal Code
30308
Country
United States
Facility Name
US024
City
Chicago
State/Province
Illinois
ZIP/Postal Code
60640
Country
United States
Facility Name
US002
City
Joliet
State/Province
Illinois
ZIP/Postal Code
60435
Country
United States
Facility Name
US012
City
Baltimore
State/Province
Maryland
ZIP/Postal Code
21204
Country
United States
Facility Name
US027
City
Glen Burnie
State/Province
Maryland
ZIP/Postal Code
21061
Country
United States
Facility Name
US019
City
Lebanon
State/Province
New Hampshire
ZIP/Postal Code
03756
Country
United States
Facility Name
US021
City
Clementon
State/Province
New Jersey
ZIP/Postal Code
08021
Country
United States
Facility Name
US013
City
Brooklyn
State/Province
New York
ZIP/Postal Code
11203
Country
United States
Facility Name
US025
City
Staten Island
State/Province
New York
ZIP/Postal Code
10305
Country
United States
Facility Name
US005
City
Charlotte
State/Province
North Carolina
ZIP/Postal Code
28211
Country
United States
Facility Name
US018
City
Durham
State/Province
North Carolina
ZIP/Postal Code
27705
Country
United States
Facility Name
US022
City
Philadelphia
State/Province
Pennsylvania
ZIP/Postal Code
19139
Country
United States
Facility Name
US023
City
Austin
State/Province
Texas
ZIP/Postal Code
78754
Country
United States
Facility Name
US020
City
Dallas
State/Province
Texas
ZIP/Postal Code
75235
Country
United States
Facility Name
US004
City
Desoto
State/Province
Texas
ZIP/Postal Code
75115
Country
United States
Facility Name
US028
City
Houston
State/Province
Texas
ZIP/Postal Code
77008
Country
United States
12. IPD Sharing Statement
Citations:
PubMed Identifier
25583364
Citation
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.
Results Reference
derived
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Efficacy Study Exploring the Effects on Cognition of Sertindole Versus Comparator in Patients With Schizophrenia
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