SchizophreniaPhase 4NCT00418873
Zotepine Versus Risperidone in Aggressive Schizophrenic Patients of Acute Ward
A Phase 4 study testing Zotepine and Risperidone in people with Schizophrenia, run by Astellas Pharma Inc at 4 sites in Taiwan.
Trial summary
The purpose of this study is to compare the efficacy and tolerability of zotepine versus Risperidone in aggressive schizophrenic patients. Read more about this study
- Who is it for?
- Ages 18 to 65 years
- Conditions the study is for
- Schizophrenia
- What is being tested?
- Zotepine and Risperidone
- Type of treatment
- Pill or oral medicine
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 39 participants
- Where
- 4 sitesTaiwan
- Study dates
- Mar 2007to Dec 2009
- 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 65 years
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- Aged 18 to 65 years, male or female
- In-patients suffering from schizophrenia according to DSM-IV diagnostic criteria with PANSS total score of greater than or equal to 60.
- Patients with PANSS-EC total score of greater than or equal to 14 and with at least one PANSS-EC symptom score greater than or equal to 4
Who cannot join
- Patients with history of seizure or with alcohol or substance abuse in the last 6 months
- Diabetes, Parkinson's disease or phaeochromocytoma
- Patients with hypertension and current use of antihypertensive agents
- Women who are pregnant, lactating or intend to become pregnant during the study period
- Poor response to two different antipsychotics in full dose and full course or use of clozapine previously
- Renal, hepatic, haematologic disease or other conditions may not suitable for the study based on investigator's evaluation
Trial locations and contacts
4 sites in 1 country.
Taiwan4 sites
Study site
Bali, Taipei, 249
Study site
Taipei, 110
Study site
Taipei, 114
Study site
Taoyuan, 330
About this study
Official title: A Multi-centre Comparative Study to Evaluate the Anti-aggression Effect and Safety of Zotepine Versus Risperidone in Aggressive Schizophrenic Patients of Acute Ward
The purpose of this study is to compare the efficacy and tolerability of zotepine versus Risperidone in aggressive schizophrenic patients.
- Conditions
- Schizophrenia
- Being tested
- Zotepine, Risperidone
- Keywords
- schizophrenia, zotepine, risperidone, second generation antipsychotic
- Medical subject headings
- Schizophrenia
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
ZotepineDrug
Also called Lodopin®, Zoleptil®, Nipolept®
Oral
RisperidoneDrug
Also called Risperdal®
Oral
| Study group | Role | What they receive |
|---|---|---|
| 1. Zotepine | Experimental | Not described Receives: Drug: Zotepine |
| 2. Risperidone | Active comparator | Not described Receives: Drug: Risperidone |
What is being measured
The primary outcome is the main question the study is designed to answer.
Change from baseline in aggression behavior assessed using the Positive and Negative Syndrome Scale Excited Component (PANSS-EC) score.
Measured: 6 Weeks
Secondary outcomes (2)
Change from baseline on the total score of Positive and Negative Syndrome Scale
Measured: 6 Weeks
Change from baseline on Clinical Global Impression (CGI)
Measured: 6 Weeks
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted5 Jan 2007 (estimated)
- Study startMar 2007
- Primary completionDec 2009
- Study completionDec 2009
Why it stopped: Study was stopped due to difficulty in patient enrollment
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.
- 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
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Enrolment
- 39 participants (actual)
Sponsor and investigators
- Lead sponsor
- Astellas Pharma Inc
- Sponsor type
- Industry (pharma, biotech, devices)
- Collaborators
- Astellas Pharma Taiwan, Inc.
- Investigators
- Chang-Jer Tsai, Principal investigator, Taipei City Hospital
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT00418873
- Sponsor's protocol ID
- LPRIS-0601-TW
- Status last verified
- Apr 2010
- First submitted
- 3 Jan 2007
- Last updated
- 16 Apr 2010
- Results posted
- No
- Data monitoring committee
- No
Publications
Chan HY, Lin AS, Chen KP, Cheng JS, Chen YY, Tsai CJ. An open-label, randomized, controlled trial of zotepine and risperidone for acutely ill, hospitalized, schizophrenic patients with symptoms of agitation. J Clin Psychopharmacol. 2013 Dec;33(6):747-52. doi: 10.1097/JCP.0b013e31829e8168.
PubMed 24100785
Study at a glance
From the registry record, last updated by the sponsor on 16 Apr 2010. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- A Multi-centre Comparative Study to Evaluate the Anti-aggression Effect and Safety of Zotepine Versus Risperidone in Aggressive Schizophrenic Patients of Acute Ward
- ClinicalTrials.gov ID
- NCT00418873
- Acronym / sponsor ID
- LPRIS-0601-TW
- Conditions
- Schizophrenia
- Keywords
- schizophrenia, zotepine, risperidone, second generation antipsychotic
- Phase
- Phase 4
- Study type
- Interventional
- Recruitment status
- TerminatedReason stopped: Study was stopped due to difficulty in patient enrollment
- Enrolment
- 39 participants (actual)
- Lead sponsor
- Astellas Pharma IncIndustry (pharma, biotech, devices)
- Collaborators
- Astellas Pharma Taiwan, Inc.
- Study start
- Mar 2007
- Primary completion
- Dec 2009 (actual)
- Study completion
- Dec 2009 (actual)
- First posted
- 5 Jan 2007 (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 compare the efficacy and tolerability of zotepine versus Risperidone in aggressive schizophrenic patients.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| 1. Zotepine | Experimental | Drug: Zotepine |
| 2. Risperidone | Active comparator | Drug: Risperidone |
Who may qualify
- Ages
- 18 to 65 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (3 listed)
- Aged 18 to 65 years, male or female
- In-patients suffering from schizophrenia according to DSM-IV diagnostic criteria with PANSS total score of greater than or equal to 60.
- Patients with PANSS-EC total score of greater than or equal to 14 and with at least one PANSS-EC symptom score greater than or equal to 4
Key exclusion criteria (6 listed)
- Patients with history of seizure or with alcohol or substance abuse in the last 6 months
- Diabetes, Parkinson's disease or phaeochromocytoma
- Patients with hypertension and current use of antihypertensive agents
- Women who are pregnant, lactating or intend to become pregnant during the study period
- Poor response to two different antipsychotics in full dose and full course or use of clozapine previously
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 |
|---|---|---|
| ZotepineAlso: Lodopin®, Zoleptil®, Nipolept®Oral | Drug | 1. Zotepine |
| RisperidoneAlso: Risperdal®Oral | Drug | 2. Risperidone |
Primary outcome
Change from baseline in aggression behavior assessed using the Positive and Negative Syndrome Scale Excited Component (PANSS-EC) score.
Time frame: 6 Weeks
2 secondary outcomes
Change from baseline on the total score of Positive and Negative Syndrome Scale
Time frame: 6 Weeks
Change from baseline on Clinical Global Impression (CGI)
Time frame: 6 Weeks
Results and safety
The study was stopped early (reason given: Study was stopped due to difficulty in patient enrollment). Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 16 Apr 2010.
- Derived from this study: PubMed 24100785Chan HY, Lin AS, Chen KP, Cheng JS, Chen YY, Tsai CJ. An open-label, randomized, controlled trial of zotepine and risperidone for acutely ill, hospitalized, schizophrenic patients with symptoms of agitation. J Clin Psychopharmacol. 2013 Dec;33(6):747-52. doi: 10.1097/JCP.0b013e31829e8168.
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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.
Chang-Jer Tsai principal investigator
Taipei City Hospital
4 sites in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A Phase 4 study testing Zotepine and Risperidone in people with Schizophrenia, run by Astellas Pharma Inc at 4 sites in Taiwan.
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 3 inclusion and 6 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 16 Apr 2010. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 4 sites in Taiwan. 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: Study was stopped due to difficulty in patient enrollment). 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?
Change from baseline in aggression behavior assessed using the Positive and Negative Syndrome Scale Excited Component (PANSS-EC) score. (time frame: 6 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 NCT00418873, 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 16 Apr 2010.