SchizophreniaPhase 2NCT01623713
Efficacy and Safety Study of Iloperidone Virus Risperidone to Treat Schizophrenia
A Phase 2 study testing iloperidone and Risperidone in people with Schizophrenia and Iloperidone, run by Jiangsu Hansoh Pharmaceutical Co., Ltd. at 1 site in China.
Trial summary
The purpose of this study is to determine whether iloperidone is effective in the treatment of Schizophrenia. Read more about this study
- Who is it for?
- Ages 18 to 65 years
- Conditions the study is for
- Schizophrenia, Iloperidone, Efficacy
- What is being tested?
- iloperidone and Risperidone
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 260 participants
- Where
- 1 siteChina
- Study dates
- Jun 2012to Nov 2013
- Phase
- Phase 2
- 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
- Men or women ages 18-65 years old.
- DSM-IV diagnosis of schizophrenia.
- PANSS≥70.
- Of the 7 PANSS positive symptom subscale, at least two score ≥ 4 points.
- Written informed consent.
Who cannot join
- Pregnant or nursing (lactating) women, or women who plan on conceiving during the course of the study.
- Clinically significant disease of the heart,kidneys,liver,hematonosis or endocrine system.
Trial locations and contacts
1 site in 1 country.
China1 site
Sixth Hospital of Peking University
Beijing, Beijing Municipality, 100191
About this study
Official title: A Randomized, Double-Blind, Active-Controlled, Multicenter Study to Evaluate Efficacy and Safety Study of Iloperidone Virus Risperidone to Treat Schizophrenia
The purpose of this study is to determine whether iloperidone is effective in the treatment of Schizophrenia.
- Conditions
- Schizophrenia, Iloperidone, Efficacy
- Being tested
- iloperidone, Risperidone
- Keywords
- schizophrenia, iloperidone, Risperidone, Efficacy, Safety
- Medical subject headings
- Schizophrenia
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
iloperidoneDrug
Iloperidone is being development as a treatment of schizophrenia. This trial will verify the safety and efficacy of iloperidone in patients with schizophrenia.
RisperidoneDrug
Risperidone is used for the treatment of schizophrenia.Risperidone is unique among most other atypicals in that it has high affinity for the D2 receptor whereas most other atypicals have 'loose binding' of the D2 receptor. It has actions at several 5-HT (serotonin) receptor subtypes.
| Study group | Role | What they receive |
|---|---|---|
| Risperidone | Active comparator | Not described Receives: Drug: Risperidone |
| iloperidone | Experimental | Not described Receives: Drug: iloperidone |
What is being measured
The primary outcome is the main question the study is designed to answer.
Positive and Negative Symptom Scale(PANSS)-Total Score
Measured: 6 weeks
Secondary outcomes (4)
Effective percentage(PANSS score reduce rate≥50%)
Measured: 6 weeks
Change in scores from baseline to end point assessment on the PANSS Positive subscale (PANSS-P)
Measured: 6 weeks
Change in scores from baseline to end point assessment on the PANSS Negative subscale (PANSS-N)
Measured: 6 weeks
Change in scores from baseline to end point assessment on the PANSS General Psychopathology subscale(PANSS-GP)
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 posted20 Jun 2012 (estimated)
- Study startJun 2012
- Primary completionOct 2013
- Study completionNov 2013
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 Jiangsu Hansoh Pharmaceutical Co., Ltd.The 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 2
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Triple blind
- Who is masked
- Participant, Care provider, Investigator
- Enrolment
- 260 participants (actual)
Sponsor and investigators
- Lead sponsor
- Jiangsu Hansoh Pharmaceutical Co., Ltd.
- Sponsor type
- Industry (pharma, biotech, devices)
- Responsible party
- Sponsor
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT01623713
- Sponsor's protocol ID
- YPLT20111123
- Status last verified
- Nov 2013
- First submitted
- 17 Jun 2012
- Last updated
- 19 Nov 2013
- Results posted
- No
- Data monitoring committee
- Yes
Publications
Lieberman JA, Stroup TS, McEvoy JP, Swartz MS, Rosenheck RA, Perkins DO, Keefe RS, Davis SM, Davis CE, Lebowitz BD, Severe J, Hsiao JK; Clinical Antipsychotic Trials of Intervention Effectiveness (CATIE) Investigators. Effectiveness of antipsychotic drugs in patients with chronic schizophrenia. N Engl J Med. 2005 Sep 22;353(12):1209-23. doi: 10.1056/NEJMoa051688. Epub 2005 Sep 19.
PubMed 16172203
Study at a glance
From the registry record, last updated by the sponsor on 19 Nov 2013. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- A Randomized, Double-Blind, Active-Controlled, Multicenter Study to Evaluate Efficacy and Safety Study of Iloperidone Virus Risperidone to Treat Schizophrenia
- ClinicalTrials.gov ID
- NCT01623713
- Acronym / sponsor ID
- YPLT20111123
- Conditions
- Schizophrenia, Iloperidone, Efficacy
- Keywords
- schizophrenia, iloperidone, Risperidone, Efficacy, Safety
- Phase
- Phase 2
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 260 participants (actual)
- Lead sponsor
- Jiangsu Hansoh Pharmaceutical Co., Ltd.Industry (pharma, biotech, devices)
- Study start
- Jun 2012
- Primary completion
- Oct 2013 (actual)
- Study completion
- Nov 2013 (actual)
- First posted
- 20 Jun 2012 (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 determine whether iloperidone is effective in the treatment of Schizophrenia.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Triple blind (participant, care provider, investigator)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Risperidone | Active comparator | Drug: Risperidone |
| iloperidone | Experimental | Drug: iloperidone |
Who may qualify
- Ages
- 18 to 65 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (5 listed)
- Men or women ages 18-65 years old.
- DSM-IV diagnosis of schizophrenia.
- PANSS≥70.
- Of the 7 PANSS positive symptom subscale, at least two score ≥ 4 points.
- Written informed consent.
Key exclusion criteria (2 listed)
- Pregnant or nursing (lactating) women, or women who plan on conceiving during the course of the study.
- Clinically significant disease of the heart,kidneys,liver,hematonosis or endocrine system.
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 |
|---|---|---|
| iloperidoneIloperidone is being development as a treatment of schizophrenia. This trial will verify the safety and efficacy of iloperidone in patients with schizophrenia. | Drug | iloperidone |
| RisperidoneRisperidone is used for the treatment of schizophrenia.Risperidone is unique among most other atypicals in that it has high affinity for the D2 receptor whereas most other atypicals have 'loose binding' of the D2 receptor. It has actions at several 5-HT (serotonin) receptor subtypes. | Drug | Risperidone |
Primary outcome
Positive and Negative Symptom Scale(PANSS)-Total Score
Time frame: 6 weeks
4 secondary outcomes
Effective percentage(PANSS score reduce rate≥50%)
Time frame: 6 weeks
Change in scores from baseline to end point assessment on the PANSS Positive subscale (PANSS-P)
Time frame: 6 weeks
Change in scores from baseline to end point assessment on the PANSS Negative subscale (PANSS-N)
Time frame: 6 weeks
Change in scores from baseline to end point assessment on the PANSS General Psychopathology subscale(PANSS-GP)
Time frame: 6 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 19 Nov 2013.
- Background: PubMed 16172203Lieberman JA, Stroup TS, McEvoy JP, Swartz MS, Rosenheck RA, Perkins DO, Keefe RS, Davis SM, Davis CE, Lebowitz BD, Severe J, Hsiao JK; Clinical Antipsychotic Trials of Intervention Effectiveness (CATIE) Investigators. Effectiveness of antipsychotic drugs in patients with chronic schizophrenia. N Engl J Med. 2005 Sep 22;353(12):1209-23. doi: 10.1056/NEJMoa051688. Epub 2005 Sep 19.
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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.
The record lists no contact. Use the official record to reach the sponsor.
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A Phase 2 study testing iloperidone and Risperidone in people with Schizophrenia and Iloperidone, run by Jiangsu Hansoh Pharmaceutical Co., Ltd. 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 2 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 19 Nov 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 2 studies give the treatment to a larger group to see whether it has the intended effect and to keep checking safety.
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?
Positive and Negative Symptom Scale(PANSS)-Total 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 NCT01623713, 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 19 Nov 2013.