SchizophreniaPhase 3NCT00864045
Sertindole in Asian Patients With Schizophrenia
A Phase 3 study testing Sertindole and Olanzapine in people with Schizophrenia, run by H. Lundbeck A/S at 1 site in China.
Trial summary
The purpose of this study is to assess the efficacy and safety of sertindole in patients with schizophrenia in Asia. Read more about this study
- Who is it for?
- Ages 18 to 65 years
- Conditions the study is for
- Schizophrenia
- What is being tested?
- Sertindole and Olanzapine
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 394 participants
- Where
- 1 siteChina
- Study dates
- Mar 2007to May 2008
- Phase
- Phase 3
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 to 65 years
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- 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
Who cannot join
- 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
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- 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.
Trial locations and contacts
1 site in 1 country.
About this study
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
The purpose of this study is to assess the efficacy and safety of sertindole in patients with schizophrenia in Asia.
Read the 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.
- Conditions
- Schizophrenia
- Being tested
- Sertindole, Olanzapine
- Medical subject headings
- Schizophrenia
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
SertindoleDrug
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
OlanzapineDrug
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
| Study group | Role | What they receive |
|---|---|---|
| Sertindole | Experimental | Not described Receives: Drug: Sertindole |
| Olanzapine | Active comparator | Not described Receives: Drug: Olanzapine |
What is being measured
The primary outcome is the main question the study is designed to answer.
To evaluate the efficacy of 12 weeks treatment with flexible doses of sertindole in comparison to flexible doses of olanzapine in patients with schizophrenia.
Measured: 12 weeks
Secondary outcomes (1)
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.
Measured: 12 weeks
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted18 Mar 2009 (estimated)
- Study startMar 2007
- Primary completionMar 2008
- Study completionMay 2008
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (1)Papers the sponsor has linked to this study.
- Other trials for SchizophreniaStudies of the same condition, open and under way.
- More trials run by H. Lundbeck A/SThe sponsor's other registered studies.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase 3
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Double blind
- Who is masked
- Participant, Investigator
- Enrolment
- 394 participants (actual)
Sponsor and investigators
- Lead sponsor
- H. Lundbeck A/S
- Sponsor type
- Industry (pharma, biotech, devices)
- Responsible party
- Sponsor
- Investigators
- Email contact via H. Lundbeck A/S, Study director, LundbeckClinicalTrials@lundbeck.com
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT00864045
- Sponsor's protocol ID
- 11286
- Status last verified
- Sep 2013
- First submitted
- 17 Mar 2009
- Last updated
- 20 Sep 2013
- Results posted
- No
- Data monitoring committee
- No
Publications
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.
PubMed 23777311
Study at a glance
From the registry record, last updated by the sponsor on 20 Sep 2013. Recruitment status is as the sponsor reported it: confirm with the study team.
- 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
- ClinicalTrials.gov ID
- NCT00864045
- Acronym / sponsor ID
- 11286
- Conditions
- Schizophrenia
- Phase
- Phase 3
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 394 participants (actual)
- Lead sponsor
- H. Lundbeck A/SIndustry (pharma, biotech, devices)
- Study start
- Mar 2007
- Primary completion
- Mar 2008 (actual)
- Study completion
- May 2008 (actual)
- First posted
- 18 Mar 2009 (estimated)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Double blind (participant, investigator)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Sertindole | Experimental | Drug: Sertindole |
| Olanzapine | Active comparator | Drug: Olanzapine |
Who may qualify
- Ages
- 18 to 65 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (5 listed)
- 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
Key exclusion criteria (10 listed)
- 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)
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| SertindoleSertindole 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 | Drug | Sertindole |
| OlanzapineOlanzapine 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 | Drug | Olanzapine |
Primary outcome
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
1 secondary outcome
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
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 20 Sep 2013.
- Derived from this study: PubMed 23777311Kim 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.
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Email contact via H. Lundbeck A/S study director
LundbeckClinicalTrials@lundbeck.com
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A Phase 3 study testing Sertindole and Olanzapine in people with Schizophrenia, run by H. Lundbeck A/S at 1 site in China.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 5 inclusion and 10 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: finished, as of the sponsor's last update on 20 Sep 2013. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in China. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
What does this phase mean?
Phase 3 studies compare the treatment with the current standard treatment or a placebo in a large group, to confirm how well it works and watch for side effects.
Not every study follows the same path, and some studies (observational studies, device studies) have no phase.
Are results available for this study?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
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). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
On the ClinicalTrials.gov record for NCT00864045, which also lists 1 linked publication.
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 20 Sep 2013.