SchizophreniaPhase 3NCT00654706
Efficacy Study Exploring the Effects on Cognition of Sertindole Versus Comparator in Patients With Schizophrenia
A Phase 3 study testing Sertindole and Quetiapine in people with Schizophrenia and Cognition, run by H. Lundbeck A/S at 26 sites in United States.
Trial summary
The objective of this study is to explore the neurocognitive efficacy of Sertindole versus comparator in patients with schizophrenia using the MCCB. Read more about this study
- Who is it for?
- Ages 18 to 55 years
- Conditions the study is for
- Schizophrenia, Cognition
- What is being tested?
- Sertindole and Quetiapine
- Type of treatment
- Pill or oral medicine
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 264 participants
- Where
- 26 sitesUnited States
- Study dates
- Mar 2008to Mar 2010
- 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 55 years
- All sexes
- No healthy volunteers
- Adult
Who may be able to join
- Primary diagnosis of schizophrenia
- Man or woman, aged between 18 and 55 years
Who cannot join
- 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
Show all 9Show fewer
- Significant ECG abnormalities
- Hypokalaemia or hypomagnesaemia
- In concurrent treatment with drugs inhibiting the P450 enzymes system CYP3A
Trial locations and contacts
26 sites in 1 country.
26 sites in 1 country
United States26 sites
US007
Atlanta, Georgia, 30308
US016
Aurora, Colorado, 80045
US023
Austin, Texas, 78754
US012
Baltimore, Maryland, 21204
US013
Brooklyn, New York, 11203
US005
Charlotte, North Carolina, 28211
US024
Chicago, Illinois, 60640
US021
Clementon, New Jersey, 08021
US020
Dallas, Texas, 75235
US004
DeSoto, Texas, 75115
US018
Durham, North Carolina, 27705
US017
Garden Grove, California, 92845
US027
Glen Burnie, Maryland, 21061
US028
Houston, Texas, 77008
US002
Joliet, Illinois, 60435
US019
Lebanon, New Hampshire, 03756
US008
National City, California, 91950
US015
Orange City, Florida, 32763
US001
Pasadena, California, 91107
US022
Philadelphia, Pennsylvania, 19139
US006
Pico Rivera, California, 90660
US011
San Diego, California, 92126
US014
Stanford, California, 94305
US025
Staten Island, New York, 10305
US010
Tampa, Florida, 33613
US026
Torrance, California, 90502
About this study
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)
The objective of this study is to explore the neurocognitive efficacy of Sertindole versus comparator in patients with schizophrenia using the MCCB.
Read the 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.
- Conditions
- Schizophrenia, Cognition
- Being tested
- Sertindole, Quetiapine
- Keywords
- Schizophrenia, Cognition, MATRICS Consensus Cognitive Battery
- Medical subject headings
- Schizophrenia
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
SertindoleDrug
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).
QuetiapineDrug
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).
| Study group | Role | What they receive |
|---|---|---|
| Sertindole | Experimental | Not described Receives: Drug: Sertindole |
| Quetiapine | Active comparator | Not described Receives: Drug: Quetiapine |
What is being measured
The primary outcome is the main question the study is designed to answer.
Neurocognitive effect of treatment based on the overall composite score on the MCCB
Measured: 12 weeks
Secondary outcomes (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
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 posted9 Apr 2008 (estimated)
- Study startMar 2008
- Primary completionJan 2010
- Study completionMar 2010
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
- 264 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
- NCT00654706
- Sponsor's protocol ID
- 11723A
- Status last verified
- May 2014
- First submitted
- 3 Apr 2008
- Last updated
- 28 May 2014
- Results posted
- No
- Data monitoring committee
- No
Publications
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.
PubMed 25583364
Study at a glance
From the registry record, last updated by the sponsor on 28 May 2014. Recruitment status is as the sponsor reported it: confirm with the study team.
- 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)
- ClinicalTrials.gov ID
- NCT00654706
- Acronym / sponsor ID
- 11723A
- Conditions
- Schizophrenia, Cognition
- Keywords
- Schizophrenia, Cognition, MATRICS Consensus Cognitive Battery
- Phase
- Phase 3
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 264 participants (actual)
- Lead sponsor
- H. Lundbeck A/SIndustry (pharma, biotech, devices)
- Study start
- Mar 2008
- Primary completion
- Jan 2010 (actual)
- Study completion
- Mar 2010 (actual)
- First posted
- 9 Apr 2008 (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 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.
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 |
| Quetiapine | Active comparator | Drug: Quetiapine |
Who may qualify
- Ages
- 18 to 55 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult
Key inclusion criteria (2 listed)
- Primary diagnosis of schizophrenia
- Man or woman, aged between 18 and 55 years
Key exclusion criteria (9 listed)
- 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
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 |
|---|---|---|
| SertindoleOnce daily oral dose. Day 1-20: 4-16 mg/day (titration period). Day 21-84: 12, 16 or 20 mg/day (flexible treatment period). | Drug | Sertindole |
| QuetiapineTwice daily oral dose. Day 1-20: 50-500 mg/day (titration period). Day 21-84: 400, 500 or 600 mg/day (flexible treatment period). | Drug | Quetiapine |
Primary outcome
Neurocognitive effect of treatment based on the overall composite score on the MCCB
Time frame: 12 weeks
1 secondary outcome
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
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 28 May 2014.
- Derived from this study: PubMed 25583364Nielsen 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.
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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
26 sites 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 Quetiapine in people with Schizophrenia and Cognition, run by H. Lundbeck A/S at 26 sites in United States.
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 2 inclusion and 9 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 28 May 2014. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 26 sites in United States. 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?
Neurocognitive effect of treatment based on the overall composite score on the MCCB (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 NCT00654706, 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 28 May 2014.