Sertindole in Asian Patients With Schizophrenia
This study has been completed.
Sponsor:
H. Lundbeck A/S
Information provided by:
H. Lundbeck A/S
ClinicalTrials.gov Identifier:
NCT00864045
First received: March 17, 2009
Last updated: July 12, 2010
Last verified: July 2010
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Purpose
The purpose of this study is to assess the efficacy and safety of sertindole in patients with schizophrenia in Asia.
| Condition | Intervention | Phase |
|---|---|---|
|
Schizophrenia |
Drug: Sertindole Drug: Olanzapine |
Phase 3 |
| Study Type: | Interventional |
| Study Design: | Allocation: Randomized Endpoint Classification: Safety/Efficacy Study Intervention Model: Parallel Assignment Masking: Double Blind (Subject, Investigator) Primary Purpose: Treatment |
| 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 |
Resource links provided by NLM:
Further study details as provided by H. Lundbeck A/S:
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. [ Time Frame: 12 weeks ] [ Designated as safety issue: No ]
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. [ Time Frame: 12 weeks ] [ Designated as safety issue: Yes ]
| Enrollment: | 394 |
| Study Start Date: | March 2007 |
| Study Completion Date: | May 2008 |
| Primary Completion Date: | March 2008 (Final data collection date for primary outcome measure) |
| Arms | Assigned Interventions |
|---|---|
| Experimental: Sertindole |
Drug: Sertindole
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
|
| Active Comparator: Olanzapine |
Drug: Olanzapine
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
|
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.
Eligibility| Ages Eligible for Study: | 18 Years to 65 Years |
| Genders Eligible for Study: | Both |
| Accepts Healthy Volunteers: | No |
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.
Contacts and Locations More Information
No publications provided
| Responsible Party: | H. Lundbeck A/S |
| ClinicalTrials.gov Identifier: | NCT00864045 History of Changes |
| Other Study ID Numbers: | 11286 |
| Study First Received: | March 17, 2009 |
| Last Updated: | July 12, 2010 |
| Health Authority: | China: Food and Drug Administration South Korea: Korea Food and Drug Administration (KFDA) Taiwan: National Bureau of Controlled Drugs |
Additional relevant MeSH terms:
|
Schizophrenia Schizophrenia and Disorders with Psychotic Features Mental Disorders Sertindole Olanzapine Antipsychotic Agents Tranquilizing Agents Central Nervous System Depressants Physiological Effects of Drugs Pharmacologic Actions Central Nervous System Agents |
Therapeutic Uses Psychotropic Drugs Serotonin Uptake Inhibitors Neurotransmitter Uptake Inhibitors Neurotransmitter Agents Molecular Mechanisms of Pharmacological Action Serotonin Agents Antiemetics Autonomic Agents Peripheral Nervous System Agents Gastrointestinal Agents |
ClinicalTrials.gov processed this record on May 22, 2013