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Sertindole in Asian Patients With Schizophrenia

Primary Purpose

Schizophrenia

Status

Completed

Phase

Phase 3

Locations

China

Study Type

Interventional

Intervention

Sertindole

Olanzapine

About this trial

This is an interventional treatment trial for Schizophrenia

Eligibility Criteria

18 Years - 65 Years (Adult, Older Adult)All SexesDoes not accept healthy volunteers

Inclusion Criteria:

Male and female patients, aged 18-65 years (extremes included), suffering from schizophrenia
Positive and Negative Syndrome Scales (PANSS) total score between 60 and 120 (extremes included) at screening and baseline
Based on the patient's clinical status, an antipsychotic treatment is indicated
Otherwise healthy
Female patients of non-childbearing potential, or non-pregnant, not breast-feeding women of childbearing potential, using adequate birth control methods

Exclusion Criteria:

Current Axis I primary psychiatric diagnosis other than schizophrenia
Has never before received antipsychotic drugs
Has received a depot antipsychotic medication within less than one dose interval prior to Screening
History of clinically significant cardiovascular disease, congestive heart failure, cardiac hypertrophy, arrhythmia or bradycardia (<50 beats per minute)
Congenital long QT syndrome or a family history of this disease, or in patients with known acquired QT interval prolongation (QTc above 450 msec in males and 470 msec in females at Screening)
Significant risk of suicide and/or violent behaviour
Known history of narrow angle glaucoma
Substance or alcohol abuse, current alcohol dependence
Use of disallowed concomitant medication

Other protocol-defined inclusion and exclusion criteria may apply.

Sites / Locations

CN001

Arms of the Study

Arm 1

Arm 2

Arm Type

Experimental

Active Comparator

Arm Label

Sertindole

Olanzapine

Arm Description

Outcomes

Primary Outcome Measures

To evaluate the efficacy of 12 weeks treatment with flexible doses of sertindole in comparison to flexible doses of olanzapine in patients with schizophrenia.

Secondary Outcome Measures

To evaluate the safety and tolerability of 12 weeks treatment with flexible doses of sertindole in comparison to flexible doses of olanzapine in patients with schizophrenia.

Full Information

NCT ID

NCT00864045

First Posted

March 17, 2009

Last Updated

September 19, 2013

Sponsor

H. Lundbeck A/S

1. Study Identification

Unique Protocol Identification Number

NCT00864045

Brief Title

Sertindole in Asian Patients With Schizophrenia

Official Title

A Randomised, Double-blind, Parallel-group, Flexible-dose Trial Evaluating the Efficacy and Safety of 12 Weeks of Treatment With Sertindole or Olanzapine in Patients With Schizophrenia in Asia

Study Type

Interventional

2. Study Status

Record Verification Date

September 2013

Overall Recruitment Status

Completed

Study Start Date

March 2007 (undefined)

Primary Completion Date

March 2008 (Actual)

Study Completion Date

May 2008 (Actual)

3. Sponsor/Collaborators

Responsible Party, by Official Title

Sponsor

Name of the Sponsor

H. Lundbeck A/S

4. Oversight

Data Monitoring Committee

5. Study Description

Brief Summary

The purpose of this study is to assess the efficacy and safety of sertindole in patients with schizophrenia in Asia.

Detailed Description

This study is the first randomised clinical trial performed in Asia with sertindole, aiming at comparing sertindole efficacy and safety to that of another atypical antipsychotic. Sertindole is a limbic-selective antipsychotic agent with a unique neuropharmacological profile. Sertindole has shown significant improvements relative to placebo against both positive and negative symptoms of schizophrenia (measured by PANSS total, PANSS negative and positive subscale scores). It is well tolerated and shows placebo-level incidence of extrapyramidal symptoms (EPS). Sertindole is associated with a dose-dependent increase in the QT interval, but this does not translate into an excess mortality with sertindole relative to that of other recently developed antipsychotics in their respective clinical development programmes.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study

Schizophrenia

7. Study Design

Primary Purpose

Treatment

Study Phase

Phase 3

Interventional Study Model

Parallel Assignment

Masking

ParticipantInvestigator

Allocation

Randomized

Enrollment

394 (Actual)

8. Arms, Groups, and Interventions

Arm Title

Sertindole

Arm Type

Experimental

Arm Title

Olanzapine

Arm Type

Active Comparator

Intervention Type

Drug

Intervention Name(s)

Sertindole

Intervention Description

Sertindole flexible doses per os, 12, 16 or 20mg/day according to response and tolerability, initially up-titrated from 4mg/day to target dose 16mg/day within the first 16 days

Intervention Type

Drug

Intervention Name(s)

Olanzapine

Intervention Description

Olanzapine flexible doses per os, 10, 15 or 20mg/day according to response and tolerability, initially up-titrated from 10mg/day to target dose 15mg/day within the first 16 days

Primary Outcome Measure Information:

Title

To evaluate the efficacy of 12 weeks treatment with flexible doses of sertindole in comparison to flexible doses of olanzapine in patients with schizophrenia.

Time Frame

12 weeks

Secondary Outcome Measure Information:

Title

To evaluate the safety and tolerability of 12 weeks treatment with flexible doses of sertindole in comparison to flexible doses of olanzapine in patients with schizophrenia.

Time Frame

12 weeks

10. Eligibility

Sex

All

Minimum Age & Unit of Time

18 Years

Maximum Age & Unit of Time

65 Years

Accepts Healthy Volunteers

Eligibility Criteria

Inclusion Criteria: Male and female patients, aged 18-65 years (extremes included), suffering from schizophrenia Positive and Negative Syndrome Scales (PANSS) total score between 60 and 120 (extremes included) at screening and baseline Based on the patient's clinical status, an antipsychotic treatment is indicated Otherwise healthy Female patients of non-childbearing potential, or non-pregnant, not breast-feeding women of childbearing potential, using adequate birth control methods Exclusion Criteria: Current Axis I primary psychiatric diagnosis other than schizophrenia Has never before received antipsychotic drugs Has received a depot antipsychotic medication within less than one dose interval prior to Screening History of clinically significant cardiovascular disease, congestive heart failure, cardiac hypertrophy, arrhythmia or bradycardia (<50 beats per minute) Congenital long QT syndrome or a family history of this disease, or in patients with known acquired QT interval prolongation (QTc above 450 msec in males and 470 msec in females at Screening) Significant risk of suicide and/or violent behaviour Known history of narrow angle glaucoma Substance or alcohol abuse, current alcohol dependence Use of disallowed concomitant medication Other protocol-defined inclusion and exclusion criteria may apply.

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

CN001

City

Beijing

ZIP/Postal Code

300074

Country

China

12. IPD Sharing Statement

Citations:

PubMed Identifier

23777311

Citation

Kim EY, Chang SM, Shim JC, Joo EJ, Kim JJ, Kim YS, Ahn YM. Long-term effectiveness of flexibly dosed paliperidone extended-release: comparison among patients with schizophrenia switching from risperidone and other antipsychotic agents. Curr Med Res Opin. 2013 Oct;29(10):1231-40. doi: 10.1185/03007995.2013.816277. Epub 2013 Jul 16.

Results Reference

derived

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Sertindole in Asian Patients With Schizophrenia

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