SchizophreniaNCT01057849
Standard Comprehensive Intervention to Treat First-episode Schizophrenia
A study testing risperidone, olanzapine and Aripiprazole in people with Schizophrenia, run by Peking University at 6 sites in China.
Trial summary
Schizophrenia is not a curable but a treatable disease by antipsychotics. Kinds of atypical antipsychotics are widely used since 1990s' in China. Although their efficacy for acute phase are all better than typicals, individulized regimen of them for first-episode schizophrenia and their effectiveness in real… Read more about this study
- Who is it for?
- Ages 16 to 45 yearsHealthy volunteers can take part
- Conditions the study is for
- Schizophrenia
- What is being tested?
- risperidone, olanzapine and Aripiprazole
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 600 participants
- Where
- 6 sitesChina
- Study dates
- Sep 2008to Mar 2011
- Phase
- Interventional
- 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 16 to 45 years
- All sexes
- Healthy volunteers accepted
- Child, Adult
Who may be able to join
- schizophrenic patients diagnosed with DSM-IV criteria by SCID-I.
- age between 16-45 years old
- with disease course less than 3 years and during their first episode
- without receiving systematic antipsychotic treatment less than 1 month
Who cannot join
- organic disease or unstable physical diseases.
- brain trauma with loss of consciousness more than 1 hour
- current substance misuse (in 3 months) or any substance dependence.
- pregnant women.
- patients with severe suicidal imaginations or behavior.
- mental retardation
- contradict to the study drugs
Trial locations and contacts
6 sites in 1 country.
6 sites in 1 country
China6 sites, 6 recruiting
- Recruiting
Beijing Anding Hospital
Beijing, Beijing Municipality, 100000
Yan Zhou, pretty_zhouyan@126.com
Chuanyue Wang, M.D.
- Recruiting
Beijing Huilongguan Hospital
Beijing, Beijing Municipality, 100000
Song Chen, M.D., asongsi@gmail.com
Fude Yang, M.D.
- Recruiting
Zhongnan University Xiangya Second Hospital
Changsha, Hunan, 410000
Maorong Hu, M.D., maron13@126.com
Jingping Zhao, M.D.
- Recruiting
Sichuan University Huaxi Hospital
Chengdu, Sichuan, 610000
Shanming Liu, M.D., lciauo@sina.com
Hong Deng, M.D.
- Recruiting
Peking University Institute of Mental Health
Haidian District, Beijing Municipality, 100191
Yanbo Yuan, M.D., +86-10-82806157, yuanyb@gmail.com
Yanbo Yuan, M.D.
- Recruiting
Shanghai Mental Health Center
Shanghai, Shanghai Municipality, 200030
Liu, M.D., lnmilk-1982@126.com
Zheng Lu, M.D.
About this study
Official title: Sequenced Atypical Antipsychotics Therapy With Intensive or Basic Psychosocial Intervention for First-episode Schizophrenia: An Effectiveness Study
Schizophrenia is not a curable but a treatable disease by antipsychotics. Kinds of atypical antipsychotics are widely used since 1990s' in China. Although their efficacy for acute phase are all better than typicals, individulized regimen of them for first-episode schizophrenia and their effectiveness in real naturalistic clinical settings still remain unclear. And those patients also need more comprehensive intervention such as psychosocial programs to improve their function. This protocol is to conduct a study in several sites of China to investigate the effectiveness of comprehensive intervention combining sequenced atypical antipsychotic therapy and intensive psychosocial intervention for first-episode schizophrenic patients. In addition, this protocol also aims at collecting such information as molecular genetics, neurochemical test, neucognitive performance and neuroimaging for outcome analysis.
- Conditions
- Schizophrenia
- Being tested
- risperidone, olanzapine, Aripiprazole
- Keywords
- schizophrenia, first episode, atypical antipsychotics, psychosocial intervention, outcome, effectiveness
- Medical subject headings
- Schizophrenia
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
risperidoneDrug
3-6 mg per day
olanzapineDrug
5-20 mg per day
AripiprazoleDrug
10-30 mg per day
| Study group | Role | What they receive |
|---|---|---|
| Risperidone, Intensive | Experimental | risperidone and intensive psychosocial intervention Receives: Drug: risperidone |
| risperidone, basic | Active comparator | risperidone and basic psychosocial support Receives: Drug: risperidone |
| olanzapine, intensive | Experimental | olanzapine and intensive psychosocial intervention Receives: Drug: olanzapine |
| olanzapine, basic | Active comparator | olanzapine and basic psychosocial support Receives: Drug: olanzapine |
| aripiprazole, intensive | Experimental | aripiprazole and intensive psychosocial intervention Receives: Drug: Aripiprazole |
| aripiprazole, basiv | Active comparator | aripiprazole and basic psychosocial support Receives: Drug: Aripiprazole |
What is being measured
The primary outcome is the main question the study is designed to answer.
the time the patients remain stable
Measured: 1 year
Secondary outcomes (1)
Scoring of PANSS and PSP
Measured: 1 year
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted27 Jan 2010 (estimated)
- Study startSep 2008
- Primary completionMar 2011 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (4)Papers the sponsor has linked to this study.
- Other trials for SchizophreniaStudies of the same condition, open and under way.
- More trials run by Peking UniversityThe 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 N/A
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Enrolment
- 600 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Peking University
- Sponsor type
- University, hospital or other
- Collaborators
- Ministry of Science and Technology of the People´s Republic of China
- Investigators
- Xin Yu, M.D., Principal investigator, Peking University Institute of Mental Health
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT01057849
- Sponsor's protocol ID
- 2007BAI17B04
- Status last verified
- Sep 2008
- First submitted
- 26 Jan 2010
- Last updated
- 27 Jan 2010
- Results posted
- No
- Data monitoring committee
- Yes
Publications
Yin X, Zhou T, Huang B, Lu Z, Gao T, Guo X, Hu W, Ji Y, Wang X, Zheng Y, Yu X, Pu C. Trajectory analysis of BMI increase induced by second-generation antipsychotics in first-episode schizophrenia: a secondary analysis based on CNFEST***. Schizophrenia (Heidelb). 2025 Dec 4;12(1):7. doi: 10.1038/s41537-025-00710-1.
PubMed 41345405Dai N, Huang B, Gao T, Zheng Y, Shi C, Pu C, Yu X. Initial attitudes toward a drug predict medication adherence in first-episode patients with schizophrenia: a 1-year prospective study in China. BMC Psychiatry. 2023 Dec 5;23(1):907. doi: 10.1186/s12888-023-05419-y.
PubMed 38053101Cheng Z, Yuan Y, Han X, Yang L, Zeng X, Yang F, Lu Z, Wang C, Deng H, Zhao J, Yu X. Which Subgroup of First-Episode Schizophrenia Patients Can Remit During the First Year of Antipsychotic Treatment? Front Psychiatry. 2020 Jun 19;11:566. doi: 10.3389/fpsyt.2020.00566. eCollection 2020.
PubMed 32636771Han X, Yuan YB, Yu X, Zhao JP, Wang CY, Lu Z, Yang FD, Dong H, Wu YF, Ungvari GS, Xiang YT, Chiu HF. The Chinese First-Episode Schizophrenia Trial: background and study design. East Asian Arch Psychiatry. 2014 Dec;24(4):169-73.
PubMed 25482837
Study at a glance
From the registry record, last updated by the sponsor on 27 Jan 2010. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Sequenced Atypical Antipsychotics Therapy With Intensive or Basic Psychosocial Intervention for First-episode Schizophrenia: An Effectiveness Study
- ClinicalTrials.gov ID
- NCT01057849
- Acronym / sponsor ID
- 2007BAI17B04
- Conditions
- Schizophrenia
- Keywords
- schizophrenia, first episode, atypical antipsychotics, psychosocial intervention, outcome, effectiveness
- Study type
- Interventional
- Recruitment status
- Unknown status
- Enrolment
- 600 participants (estimated)
- Lead sponsor
- Peking UniversityUniversity, hospital or other
- Collaborators
- Ministry of Science and Technology of the People´s Republic of China
- Study start
- Sep 2008
- Primary completion
- Mar 2011 (estimated)
- First posted
- 27 Jan 2010 (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.
Schizophrenia is not a curable but a treatable disease by antipsychotics. Kinds of atypical antipsychotics are widely used since 1990s' in China. Although their efficacy for acute phase are all better than typicals, individulized regimen of them for first-episode schizophrenia and their effectiveness in real naturalistic clinical settings still remain unclear. And those patients also need more comprehensive intervention such as psychosocial programs to improve their function. This protocol is to conduct a study in several sites of China to investigate the effectiveness of comprehensive intervention combining sequenced atypical antipsychotic therapy and intensive psychosocial intervention for first-episode schizophrenic patients. In addition, this protocol also aims at collecting such information as molecular genetics, neurochemical test, neucognitive performance and neuroimaging for outcome analysis.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Number of arms
- 6
| Arm | Type | Receives |
|---|---|---|
| Risperidone, Intensive | Experimental | Drug: risperidonerisperidone and intensive psychosocial intervention |
| risperidone, basic | Active comparator | Drug: risperidonerisperidone and basic psychosocial support |
| olanzapine, intensive | Experimental | Drug: olanzapineolanzapine and intensive psychosocial intervention |
| olanzapine, basic | Active comparator | Drug: olanzapineolanzapine and basic psychosocial support |
| aripiprazole, intensive | Experimental | Drug: Aripiprazolearipiprazole and intensive psychosocial intervention |
| aripiprazole, basiv | Active comparator | Drug: Aripiprazolearipiprazole and basic psychosocial support |
Who may qualify
- Ages
- 16 to 45 years
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Child, Adult
Key inclusion criteria (4 listed)
- schizophrenic patients diagnosed with DSM-IV criteria by SCID-I.
- age between 16-45 years old
- with disease course less than 3 years and during their first episode
- without receiving systematic antipsychotic treatment less than 1 month
Key exclusion criteria (7 listed)
- organic disease or unstable physical diseases.
- brain trauma with loss of consciousness more than 1 hour
- current substance misuse (in 3 months) or any substance dependence.
- pregnant women.
- patients with severe suicidal imaginations or behavior.
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 |
|---|---|---|
| risperidone3-6 mg per day | Drug | Risperidone, Intensive, risperidone, basic |
| olanzapine5-20 mg per day | Drug | olanzapine, basic, olanzapine, intensive |
| Aripiprazole10-30 mg per day | Drug | aripiprazole, basiv, aripiprazole, intensive |
Primary outcome
the time the patients remain stable
Time frame: 1 year
1 secondary outcome
Scoring of PANSS and PSP
Time frame: 1 year
Results and safety
Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 27 Jan 2010.
- Derived from this study: PubMed 41345405Yin X, Zhou T, Huang B, Lu Z, Gao T, Guo X, Hu W, Ji Y, Wang X, Zheng Y, Yu X, Pu C. Trajectory analysis of BMI increase induced by second-generation antipsychotics in first-episode schizophrenia: a secondary analysis based on CNFEST***. Schizophrenia (Heidelb). 2025 Dec 4;12(1):7. doi: 10.1038/s41537-025-00710-1.
- Derived from this study: PubMed 38053101Dai N, Huang B, Gao T, Zheng Y, Shi C, Pu C, Yu X. Initial attitudes toward a drug predict medication adherence in first-episode patients with schizophrenia: a 1-year prospective study in China. BMC Psychiatry. 2023 Dec 5;23(1):907. doi: 10.1186/s12888-023-05419-y.
- Derived from this study: PubMed 32636771Cheng Z, Yuan Y, Han X, Yang L, Zeng X, Yang F, Lu Z, Wang C, Deng H, Zhao J, Yu X. Which Subgroup of First-Episode Schizophrenia Patients Can Remit During the First Year of Antipsychotic Treatment? Front Psychiatry. 2020 Jun 19;11:566. doi: 10.3389/fpsyt.2020.00566. eCollection 2020.
- Derived from this study: PubMed 25482837Han X, Yuan YB, Yu X, Zhao JP, Wang CY, Lu Z, Yang FD, Dong H, Wu YF, Ungvari GS, Xiang YT, Chiu HF. The Chinese First-Episode Schizophrenia Trial: background and study design. East Asian Arch Psychiatry. 2014 Dec;24(4):169-73.
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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.
Xin Yu, M.D. principal investigator
Peking University Institute of Mental Health
6 sites in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing risperidone, olanzapine and Aripiprazole in people with Schizophrenia, run by Peking University at 6 sites 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 7 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 Jan 2010. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 6 sites 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.
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 Yanbo Yuan, M.D. (+8613910821507, yuanyb@gmail.com), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
the time the patients remain stable (time frame: 1 year). 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 NCT01057849, which also lists 4 linked publications.
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 Jan 2010.