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

Sponsor
H. Lundbeck A/S (Industry)
Overall Status
Completed
CT.gov ID
NCT00654706
Collaborator
(none)
264
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Study Details

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.

Condition or Disease Intervention/Treatment Phase
Phase 3

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 Prior antipsychotic medication will be withdrawn (down-tapered) and patients will be randomly assigned to one of the study drugs.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.

Study Design

Study Type:
Interventional
Actual Enrollment :
264 participants
Allocation:
Randomized
Intervention Model:
Parallel Assignment
Masking:
Double (Participant, Investigator)
Primary Purpose:
Treatment
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 Start Date :
Mar 1, 2008
Actual Primary Completion Date :
Jan 1, 2010
Actual Study Completion Date :
Mar 1, 2010

Arms and Interventions

Arm Intervention/Treatment
Experimental: Sertindole

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).

Active Comparator: Quetiapine

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).

Outcome Measures

Primary Outcome Measures

  1. Neurocognitive effect of treatment based on the overall composite score on the MCCB [12 weeks]

Secondary Outcome Measures

  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]

Eligibility Criteria

Criteria

Ages Eligible for Study:
18 Years to 55 Years
Sexes Eligible for Study:
All
Accepts Healthy Volunteers:
No
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

Contacts and Locations

Locations

Site City State Country Postal Code
1 US017 Garden Grove California United States 92845
2 US008 National City California United States 91950
3 US001 Pasadena California United States 91107
4 US006 Pico Rivera California United States 90660
5 US011 San Diego California United States 92126
6 US014 Stanford California United States 94305
7 US026 Torrance California United States 90502
8 US016 Aurora Colorado United States 80045
9 US015 Orange City Florida United States 32763
10 US010 Tampa Florida United States 33613
11 US007 Atlanta Georgia United States 30308
12 US024 Chicago Illinois United States 60640
13 US002 Joliet Illinois United States 60435
14 US012 Baltimore Maryland United States 21204
15 US027 Glen Burnie Maryland United States 21061
16 US019 Lebanon New Hampshire United States 03756
17 US021 Clementon New Jersey United States 08021
18 US013 Brooklyn New York United States 11203
19 US025 Staten Island New York United States 10305
20 US005 Charlotte North Carolina United States 28211
21 US018 Durham North Carolina United States 27705
22 US022 Philadelphia Pennsylvania United States 19139
23 US023 Austin Texas United States 78754
24 US020 Dallas Texas United States 75235
25 US004 Desoto Texas United States 75115
26 US028 Houston Texas United States 77008

Sponsors and Collaborators

  • H. Lundbeck A/S

Investigators

  • Study Director: Email contact via H. Lundbeck A/S, LundbeckClinicalTrials@lundbeck.com

Study Documents (Full-Text)

None provided.

More Information

Publications

None provided.
Responsible Party:
H. Lundbeck A/S
ClinicalTrials.gov Identifier:
NCT00654706
Other Study ID Numbers:
  • 11723A
First Posted:
Apr 9, 2008
Last Update Posted:
May 28, 2014
Last Verified:
May 1, 2014
Keywords provided by H. Lundbeck A/S
Additional relevant MeSH terms:

Study Results

No Results Posted as of May 28, 2014