SchizophreniaPhase 3NCT02453893
Risperidone-controlled,Multicentre Clinical Trial of Iloperidone in Patients With Schizophrenia
A Phase 3 study testing Iloperidone and Risperidone in people with Schizophrenia, run by CSPC ZhongQi Pharmaceutical Technology Co., Ltd. at 1 site in China.
Trial summary
This research is a Randomized, double-blind, risperidone-controlled, multicenter clinical study. Chinese subjects with Ischemic Schizophrenia. Read more about this study
- Who is it for?
- Ages 18 to 65 years
- Conditions the study is for
- Schizophrenia
- What is being tested?
- Iloperidone and Risperidone
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 288 participants
- Where
- 1 siteChina
- Study dates
- Nov 2013to Jun 2015
- 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
- men and women aged 18 to 65 years with schizophrenia;
- PANSS total score of at least 70 at screening and baseline;
- at least 2 more than 4 points in 7 of PANSS-P;
- informed consent.
Who cannot join
- allergy with iloperidone or risperidone;
- psychotic symptoms failing to improve after sufficient exposure to 2 antipsychotic treatment;
- any other primary Axis 1 psychiatric diagnosis;
- a history of alcohol or drug dependence in recent 1 year;
- at imminent risk of harm to self or others;
- systolic blood pressure≤90mmHg。
Trial locations and contacts
1 site in 1 country.
Wang yu mei, master contact
China1 site, 1 recruiting
- Recruiting
Shanghai Mental Health Center
Shanghai, Shanghai Municipality, 200030
Li Hua fang, Ph.D, 86-021-34773128
About this study
Official title: Double-blind,Double-simulation,Risperidone-controlled,Multicentre Clinical Trial of Iloperidone in Patients With Schizophrenia
This research is a Randomized, double-blind, risperidone-controlled, multicenter clinical study. Chinese subjects with Ischemic Schizophrenia.
Read the detailed description
Subjects will randomly enter into one of two groups,the period of treatment is 8 weeks.
- Conditions
- Schizophrenia
- Being tested
- Iloperidone, Risperidone
- Keywords
- Iloperidone, Risperidone, PANSS
- Medical subject headings
- Schizophrenia
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
IloperidoneDrug
RisperidoneDrug
| Study group | Role | What they receive |
|---|---|---|
| oral iloperidone | Experimental | 2~12mg/day for 2 weeks,12~24mg/day for 6 weeks. Receives: Drug: Iloperidone |
| oral risperidone | Active comparator | 1~3mg/day for 2 weeks,3~6mg/day for 6 weeks. Receives: Drug: Risperidone |
What is being measured
The primary outcome is the main question the study is designed to answer.
the score of Positive and Negative syndrome scale to evaluation the severity of schizophrenia
Measured: 8 weeks
Secondary outcomes (2)
the score of clinical global impressions to evaluation the severity of illness
Measured: 8 weeks
the score of clinical global impressions to evaluation the improvement of illness
Measured: 8 weeks
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted27 May 2015 (estimated)
- Study startNov 2013
- Primary completionJun 2015 (estimated)
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.
- More trials run by CSPC ZhongQi Pharmaceutical Technology 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 3
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Triple blind
- Who is masked
- Participant, Care provider, Investigator
- Enrolment
- 288 participants (estimated)
Sponsor and investigators
- Lead sponsor
- CSPC ZhongQi Pharmaceutical Technology Co., Ltd.
- Sponsor type
- Industry (pharma, biotech, devices)
- Responsible party
- Sponsor
- Investigators
- Li hua fang, Ph.D, Study director, Shanghai Mental Health Center
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT02453893
- Sponsor's protocol ID
- CSPC-HC103/PRO/Ⅱ
- Status last verified
- Mar 2015
- First submitted
- 19 May 2015
- Last updated
- 27 May 2015
- Results posted
- No
- Data monitoring committee
- No
Study at a glance
From the registry record, last updated by the sponsor on 27 May 2015. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Double-blind,Double-simulation,Risperidone-controlled,Multicentre Clinical Trial of Iloperidone in Patients With Schizophrenia
- ClinicalTrials.gov ID
- NCT02453893
- Acronym / sponsor ID
- CSPC-HC103/PRO/Ⅱ
- Conditions
- Schizophrenia
- Keywords
- Iloperidone, Risperidone, PANSS
- Phase
- Phase 3
- Study type
- Interventional
- Recruitment status
- Unknown status
- Enrolment
- 288 participants (estimated)
- Lead sponsor
- CSPC ZhongQi Pharmaceutical Technology Co., Ltd.Industry (pharma, biotech, devices)
- Study start
- Nov 2013
- Primary completion
- Jun 2015 (estimated)
- First posted
- 27 May 2015 (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 research is a Randomized, double-blind, risperidone-controlled, multicenter clinical study. Chinese subjects with Ischemic Schizophrenia.
Detailed description
Subjects will randomly enter into one of two groups,the period of treatment is 8 weeks.
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 |
|---|---|---|
| oral iloperidone | Experimental | Drug: Iloperidone2~12mg/day for 2 weeks,12~24mg/day for 6 weeks. |
| oral risperidone | Active comparator | Drug: Risperidone1~3mg/day for 2 weeks,3~6mg/day for 6 weeks. |
Who may qualify
- Ages
- 18 to 65 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (4 listed)
- men and women aged 18 to 65 years with schizophrenia;
- PANSS total score of at least 70 at screening and baseline;
- at least 2 more than 4 points in 7 of PANSS-P;
- informed consent.
Key exclusion criteria (6 listed)
- allergy with iloperidone or risperidone;
- psychotic symptoms failing to improve after sufficient exposure to 2 antipsychotic treatment;
- any other primary Axis 1 psychiatric diagnosis;
- a history of alcohol or drug dependence in recent 1 year;
- at imminent risk of harm to self or others;
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 |
|---|---|---|
| Iloperidone | Drug | oral iloperidone |
| Risperidone | Drug | oral risperidone |
Primary outcome
the score of Positive and Negative syndrome scale to evaluation the severity of schizophrenia
Time frame: 8 weeks
2 secondary outcomes
the score of clinical global impressions to evaluation the severity of illness
Time frame: 8 weeks
the score of clinical global impressions to evaluation the improvement of illness
Time frame: 8 weeks
Results and safety
Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 27 May 2015.
Related trials for Schizophrenia
RecruitingPhase 3
A Study to Evaluate the Long-term Safety and Tolerability of Xanomeline and Trospium Chloride for the Treatment of Psychiatric Disorders in Children and Adolescents
Schizophrenia, Autism-Related Irritability
Not yet recruiting
Deep Brain Stimulation for Treatment-Resistant Schizophrenia
Treatment Resistant Disorders
Not yet recruitingObservational study
Sleep Monitoring for Early Detection of Relapse in People With Schizophrenia or Bipolar Disorder Receiving Usual Treatment
Bipolar Disorder (BD), SCHIZOPHRENIA 1 (Disorder)
Not yet recruitingPhase 1
Pharmacokinetics and Relative Bioavailability of Intranasal vs Intramuscular Olanzapine in Healthy Adult Participants
Healthy Adult Participants
Active, not recruiting
Designing and Evaluating a Classroom-Based Mental Health Programme for Adolescents.
Mental Health Promotion
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.
Wang yu mei, master contact
Li hua fang, Ph.D study director
Shanghai Mental Health Center
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 Iloperidone and Risperidone in people with Schizophrenia, run by CSPC ZhongQi Pharmaceutical Technology 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 4 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: status not confirmed, as of the sponsor's last update on 27 May 2015. 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?
Results are not available in the source record.
How can a doctor refer a patient or contact the research team?
Contact Wang yu mei, master (86-311-67808816), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
the score of Positive and Negative syndrome scale to evaluation the severity of schizophrenia (time frame: 8 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 27 May 2015.