SchizophreniaPhase 4NCT02021201
The Effect of Sertindole and Risperidone on Endophenotypic Markers of Schizophrenia
A Phase 4 study testing risperidone and Sertindole in people with Schizophrenia, run by Birte Glenthoj at 1 site in Denmark.
Trial summary
This comparison is made between the effects of sertindole and risperidone on vulnerability indicators in schizophrenia. More specifically: the effects of these two antipsychotic compounds on basic processing of incoming information is studied. Read more about this study
- Who is it for?
- Ages 18 to 55 years, men onlyHealthy volunteers can take part
- Conditions the study is for
- Schizophrenia
- What is being tested?
- risperidone and Sertindole
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 1 participants
- Where
- 1 siteDenmark
- Study dates
- Jul 2008to Jul 2013
- Phase
- Phase 4
- 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
- Men only
- Healthy volunteers accepted
- Adult
Who may be able to join
- Healthy controls:
- matched by age (+/- 2 years), gender and parental socioeconomic status to patients with schizophrenia.
- age between 18-55 years
- male
- physically and mentally healthy and no daily intake of medicine
- no current substance abuse
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- Patients:
- patients who fulfill both ICD-10 and DSM IV diagnostic criteria for schizophrenia.
- age between 18-55 years
- male
- patients who need a change in their medication
- diagnosed with schizophrenia within the last 10 years
- not formerly treated with risperidone (Risperdal) or sertindole (Serdolect) where treatment was stopped because of side effects or lack of effect
- physically healthy
- no current substance abuse
Who cannot join
- Controls:
- a history of mental illness in the first degree relatives
- hearing disabilities
- head injury accompanied by unconsciousness for more than 5 min.
- physical illness with a need of daily intake of medicine
- positive screening for drugs of abuse at baseline.
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- Patients:
- head injury accompanied by unconsciousness for more than 5 min.
- serious medical conditions (more specific: brain diseases and diseases which cause a daily intake of medicine, heart, liver or kidney diseases, diabetes and prolongation of the QTc-interval (or a family history of such) and patients with phenylketonuri)
- abuse of alcohol or medication/ narcotics during the last 6 months or positive screening for drugs of abuse at baseline.
- former treatment with risperidone (Risperdal) or sertindole (Serdolect) where treatment was stopped because of side effects or lack of effect
- hearing disability
- allergy towards the content in the medicine used in the study
- bradycardia (pulse under 50 beats per minute) and QTc>450 ms
Trial locations and contacts
1 site in 1 country.
Denmark1 site
Center for Neuropsychiatric Schizophrenia Research, University of Copenhagen, Psychiatric Center Glostrup
Glostrup Municipality, DK-2600
About this study
Official title: The Effect of Sertindole and Risperidone on Endophenotypic Markers of Schizophrenia, a Comparative Study
This comparison is made between the effects of sertindole and risperidone on vulnerability indicators in schizophrenia. More specifically: the effects of these two antipsychotic compounds on basic processing of incoming information is studied. The investigators expect that the newer antipsychotic sertindole to be more effective in restoring information processing in schizophrenia patients than risperidone.
Read the detailed description
The study is has a so-called double blind, randomized - yet balanced - cross-over design, in which 24 male patients with schizophrenia are included. After inclusion in the study, patients will be assessed in a test-battery, in which psychophysiological parameters of their basic information capabilities are quantified. Following this, the patients will be treated with either risperidone or sertindole for a period of 10 weeks, after which they will cross-over to the other treatment (the order of treatments is randomized (and balanced)). The battery of tests is repeated after the first and second treatment period. In addition, a second test-battery will be performed at these follow-up intervals, to assess neuropsychological parameters of information processing. To evaluate the extend of the treatment effects, the patients will be matched (age, gender, parental socioeconomic status) to 24 healthy controls.
- Conditions
- Schizophrenia
- Being tested
- risperidone, Sertindole
- Medical subject headings
- Schizophrenia
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
risperidoneDrug
Also called Risperdal
Patients with schizophrenia will be treated for 10 weeks treatment with risperidone
SertindoleDrug
Also called Serdolect
Patients with schizophrenia will be treated for 10 weeks treatment with serindole
| Study group | Role | What they receive |
|---|---|---|
| 1 | Experimental | Patients with schizophrenia will be treated with risperidone or sertindole for a period of 10 weeks, after which they will cross-over for an additional treatment of 10 weeks with the other compound Receives: Drug: risperidone; Drug: Sertindole |
| 2 | Experimental | Patients with schizophrenia will be treated with risperidone or sertindole for a period of 10 weeks, after which they will cross-over for an additional treatment of 10 weeks with the other compound Receives: Drug: risperidone; Drug: Sertindole |
What is being measured
The primary outcome is the main question the study is designed to answer.
Psychophysiological parameters sensory gating
Measured: baseline, after ten weeks and after 20 weeks
Secondary outcomes (2)
Psychophysiological parameters of selective attention
Measured: Baseline, 10 weeks and 20 weeks after treatment
Neurocognitive parameters of amongst others executive functioning, attention, and reaction time
Measured: 10 weeks and 20 weeks after treatment
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted27 Dec 2013 (estimated)
- Study startJul 2008
- Primary completionJul 2013
- Study completionJul 2013
Why it stopped: No suitable patients could be recruited in the available time period
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for SchizophreniaStudies of the same condition, open and under way.
- 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 4
- Primary purpose
- Basic science
- Allocation
- Randomised
- Intervention model
- Crossover
- Masking
- Quadruple blind
- Who is masked
- Participant, Care provider, Investigator, Outcomes assessor
- Enrolment
- 1 participants (actual)
Sponsor and investigators
- Lead sponsor
- Birte Glenthoj
- Sponsor type
- University, hospital or other
- Collaborators
- Icahn School of Medicine at Mount Sinai
- Responsible party
- Sponsor-investigator, Birte Glenthoj, University of Copenhagen
- Investigators
- Birte Y Glenthoj, PhD, Study director, Center for Neuropsychiatric Schizophrenia Research, University of Copenhagen, Psychiatric Center GlostrupBob Oranje, PhD, Principal investigator, Center for Neuropsychiatric Schizophrenia Research, University of Copenhagen, Psychiatric Center GlostrupBirgitte Fagerlund, PhD, Principal investigator, Center for Neuropsychiatric Schizophrenia Research, University of Copenhagen, Psychiatric Center GlostrupRita S Godske, MD, Principal investigator, Center for Neuropsychiatric Schizophrenia Research, University of Copenhagen, Psychiatric Center Glostrup
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT02021201
- Sponsor's protocol ID
- H-A-2008-062
- Status last verified
- Mar 2020
- First submitted
- 19 Sep 2011
- Last updated
- 26 Mar 2020
- Results posted
- No
- Data monitoring committee
- Yes
Study at a glance
From the registry record, last updated by the sponsor on 26 Mar 2020. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- The Effect of Sertindole and Risperidone on Endophenotypic Markers of Schizophrenia, a Comparative Study
- ClinicalTrials.gov ID
- NCT02021201
- Acronym / sponsor ID
- H-A-2008-062
- Conditions
- Schizophrenia
- Phase
- Phase 4
- Study type
- Interventional
- Recruitment status
- TerminatedReason stopped: No suitable patients could be recruited in the available time period
- Enrolment
- 1 participants (actual)
- Lead sponsor
- Birte GlenthojUniversity, hospital or other
- Collaborators
- Icahn School of Medicine at Mount Sinai
- Study start
- Jul 2008
- Primary completion
- Jul 2013 (actual)
- Study completion
- Jul 2013 (actual)
- First posted
- 27 Dec 2013 (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.
This comparison is made between the effects of sertindole and risperidone on vulnerability indicators in schizophrenia. More specifically: the effects of these two antipsychotic compounds on basic processing of incoming information is studied. The investigators expect that the newer antipsychotic sertindole to be more effective in restoring information processing in schizophrenia patients than risperidone.
Detailed description
The study is has a so-called double blind, randomized - yet balanced - cross-over design, in which 24 male patients with schizophrenia are included. After inclusion in the study, patients will be assessed in a test-battery, in which psychophysiological parameters of their basic information capabilities are quantified. Following this, the patients will be treated with either risperidone or sertindole for a period of 10 weeks, after which they will cross-over to the other treatment (the order of treatments is randomized (and balanced)). The battery of tests is repeated after the first and second treatment period. In addition, a second test-battery will be performed at these follow-up intervals, to assess neuropsychological parameters of information processing. To evaluate the extend of the treatment effects, the patients will be matched (age, gender, parental socioeconomic status) to 24 healthy controls.
Study design
- Primary purpose
- Basic science
- Allocation
- Randomised
- Intervention model
- Crossover
- Masking
- Quadruple blind (participant, care provider, investigator, outcomes assessor)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| 1 | Experimental | Drug: risperidone, Drug: SertindolePatients with schizophrenia will be treated with risperidone or sertindole for a period of 10 weeks, after which they will cross-over for an additional treatment of 10 weeks with the other compound |
| 2 | Experimental | Drug: risperidone, Drug: SertindolePatients with schizophrenia will be treated with risperidone or sertindole for a period of 10 weeks, after which they will cross-over for an additional treatment of 10 weeks with the other compound |
Who may qualify
- Ages
- 18 to 55 years
- Sex
- Male only
- Healthy volunteers
- Accepted
- Age groups
- Adult
Key inclusion criteria (15 listed)
- matched by age (+/- 2 years), gender and parental socioeconomic status to patients with schizophrenia.
- age between 18-55 years
- male
- physically and mentally healthy and no daily intake of medicine
- no current substance abuse
Key exclusion criteria (14 listed)
- a history of mental illness in the first degree relatives
- hearing disabilities
- head injury accompanied by unconsciousness for more than 5 min.
- physical illness with a need of daily intake of medicine
- positive screening for drugs of abuse at baseline.
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 |
|---|---|---|
| risperidoneAlso: RisperdalPatients with schizophrenia will be treated for 10 weeks treatment with risperidone | Drug | 1, 2 |
| SertindoleAlso: SerdolectPatients with schizophrenia will be treated for 10 weeks treatment with serindole | Drug | 1, 2 |
Primary outcome
Psychophysiological parameters sensory gating
Time frame: baseline, after ten weeks and after 20 weeks
2 secondary outcomes
Psychophysiological parameters of selective attention
Time frame: Baseline, 10 weeks and 20 weeks after treatment
Neurocognitive parameters of amongst others executive functioning, attention, and reaction time
Time frame: 10 weeks and 20 weeks after treatment
Results and safety
The study was stopped early (reason given: No suitable patients could be recruited in the available time period). Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 26 Mar 2020.
- Homepage of our organizationLink provided by the sponsor.
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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.
Birte Y Glenthoj, PhD study director
Center for Neuropsychiatric Schizophrenia Research, University of Copenhagen, Psychiatric Center Glostrup
Bob Oranje, PhD principal investigator
Center for Neuropsychiatric Schizophrenia Research, University of Copenhagen, Psychiatric Center Glostrup
Birgitte Fagerlund, PhD principal investigator
Center for Neuropsychiatric Schizophrenia Research, University of Copenhagen, Psychiatric Center Glostrup
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A Phase 4 study testing risperidone and Sertindole in people with Schizophrenia, run by Birte Glenthoj at 1 site in Denmark.
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 15 inclusion and 14 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: stopped early, as of the sponsor's last update on 26 Mar 2020. 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 Denmark. 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 4 studies take place after a treatment is approved, to learn more about its long-term benefits and risks in everyday use.
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 was stopped early (reason given: No suitable patients could be recruited in the available time period). Results are not available in the source record.
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?
Psychophysiological parameters sensory gating (time frame: baseline, after ten weeks and after 20 weeks). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
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 26 Mar 2020.