SchizophreniaPhase 4ACPIOSNCT00654576

Effectiveness of Antipsychotic Combination With Psychosocial Intervention on Outcome of Patients With Schizophrenia

A Phase 4 study testing Chlorpromazine, Sulpiride, Clozapine, Olanzapine, Risperidone, Quetiapine, Aripitrazole and psychosocial intervention in people with Schizophrenia, run by Central South University at 1 site in China.

Completed

Finished. The study has ended and is not enrolling. Results may be posted on the official record.

Official record

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Trial summary

Who is it for?: Ages 16 to 50 years
Conditions the study is for: Schizophrenia
What is being tested?: Chlorpromazine, Sulpiride, Clozapine, Olanzapine, Risperidone, Quetiapine, Aripitrazole and psychosocial intervention
Type of treatment: Lifestyle or therapy programme
Could I receive a placebo?: No, everyone receives an active treatment
How many people: 1,400 participants
Where: 1 siteChina
Study dates: Feb 2005to Dec 2007
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 16 to 50 years
All sexes
No healthy volunteers
Child, Adult

Who may be able to join

Eligible patients were 16 to 50 years of age;
had received a diagnosed of schizophrenia in accordance with criteria set out in the Diagnostic and Statistical Manual of Mental Disorders-fourth edition (DSM-IV);
were confirmed to be clinically stable by the investigator (the total score ≤60 on the Positive and Negative Syndrome Scale [PANSS] or a decrease of fifty percent from acute period in the total score on PANSS)
and taken maintenance treatment with any one of the following seven oral antipsychotics:
chlorpromazine
sulpiride clozapine

Show all 10Show fewer

risperidone
olanzapine
quetiapine
aripiprazole

Who cannot join

Patients were excluded if they had received a diagnosis of schizoaffective disorder, mental retardation, or other cognitive disorders;
had a history of serious adverse reactions to the proposed treatment;
were pregnant or breastfeeding; or had a serious and unstable medical condition.
Patients were excluded if they were unable to provide informed consent

Trial locations and contacts

1 site in 1 country.

China1 site

Institute of Mental Health of The Second Xiangya Hospital, Central South University
Changsha, Hunan, 410011

Other trials in China

About this study

Official title: Effectiveness of Antipsychotic Combination With Psychosocial Intervention on Outcome of Patients With Schizophrenia:One-Year Follow up.

Antipsychotic alone is limit to improve the overall outcome of schizophrenia and has a high discontinue rate.To solve these problems, we provide practical and available psychosocial intervention. We hypothesize that there will be significant difference in the overall effectiveness between antipsychotic and antipsychotic combination with psychosocial intervention.

Read the detailed description

The study is designed as a national, multicenter, randomized, naturalistic trial, with research assessors intended to be blind to the intervention status.

We plan to recruit 1400 patients at 10 china sites and randomly assign them to two group. the control group only receive antipsychotic and the study group receive antipsychotic combination with psychosocial intervention. The course is 12 months. Patients use one of the seven study drugs (chlorpromazine, sulpiride, clozapine, olanzapine, risperidone, quetiapine, and aripitrazole)to the maintain treatment. The psychosocial intervention include psychoeducation, family intervention, skills training, and cognitive-behavioral therapy. The primary aim is to delineate differences in the overall effectiveness of the two treatment model.The assessments include the outcome of symptomatology，neurobiology，social psychology，medical economics.

Conditions: Schizophrenia
Being tested: Chlorpromazine, Sulpiride, Clozapine, Olanzapine, Risperidone, Quetiapine, Aripitrazole, psychosocial intervention
Keywords: schizophrenia, antipsychotic, outcome, psychosocial intervention
Medical subject headings: Schizophrenia

What participants receive

What participants receive. In a randomised study each person is assigned to one group by chance.

Chlorpromazine, Sulpiride, Clozapine, Olanzapine, Risperidone, Quetiapine, AripitrazoleDrug
patient will receive one of the seven study drugs (Chlorpromazine, Sulpiride, Clozapine, Olanzapine, Risperidone, Quetiapine, Aripitrazole) as the maintain treatment. the dose is flexible, is based on the study doctor's judgment.
psychosocial interventionBehavioural
the psychosocial interventions include psychoeducaiton, family intervention, skill training, and cognitive-behavioral therapy.

Study groups in NCT00654576
Study group	Role	What they receive
1	Active comparator	the comparator arm will only receive one of the seven antipsychotic Receives: Drug: Chlorpromazine, Sulpiride, Clozapine, Olanzapine, Risperidone, Quetiapine, Aripitrazole
2	Experimental	the experimental group will receive one of the seven study drugs combination with psychosocial intervention Receives: Behavioral: psychosocial intervention

What is being measured

The primary outcome is the main question the study is designed to answer.

the time to discontinued treatment and the rate of relapse/rehospitalization

Secondary outcomes (1)

clinical psychopathology, side effect, compliance, social function, neurocognitive function, quality of life, family/career burden, cost analysis.

Timeline

From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.

Feb 2005Dec 2007

First posted8 Apr 2008 (estimated)
Study startFeb 2005
Primary completionDec 2007
Study completionDec 2007

Resources

Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
Publications (3)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: Factorial
Masking: None (open label)
Enrolment: 1,400 participants (estimated)

IDs, dates and publications

ClinicalTrials.gov ID: NCT00654576
Sponsor's protocol ID: 2004BA720A22
Acronym: ACPIOS
Status last verified: Apr 2008
First submitted: 3 Apr 2008
Last updated: 8 Apr 2008
Results posted: No
Data monitoring committee: Yes

Publications

Zhang Z, Zhai J, Wei Q, Qi J, Guo X, Zhao J. Cost-effectiveness analysis of psychosocial intervention for early stage schizophrenia in China: a randomized, one-year study. BMC Psychiatry. 2014 Jul 26;14:212. doi: 10.1186/s12888-014-0212-0.
PubMed 25064681
Guo X, Fang M, Zhai J, Wang B, Wang C, Hu B, Sun X, Lv L, Lu Z, Ma C, Guo T, Xie S, Twamley EW, Jin H, Zhao J. Effectiveness of maintenance treatments with atypical and typical antipsychotics in stable schizophrenia with early stage: 1-year naturalistic study. Psychopharmacology (Berl). 2011 Aug;216(4):475-84. doi: 10.1007/s00213-011-2242-3. Epub 2011 Mar 3.
PubMed 21369751
Guo X, Zhai J, Liu Z, Fang M, Wang B, Wang C, Hu B, Sun X, Lv L, Lu Z, Ma C, He X, Guo T, Xie S, Wu R, Xue Z, Chen J, Twamley EW, Jin H, Zhao J. Effect of antipsychotic medication alone vs combined with psychosocial intervention on outcomes of early-stage schizophrenia: A randomized, 1-year study. Arch Gen Psychiatry. 2010 Sep;67(9):895-904. doi: 10.1001/archgenpsychiatry.2010.105.
PubMed 20819983

Want to know more?

The sponsor has not listed a contact. The official record may have more details.

Talk to your doctor first and take this page with you. Only the study team can confirm whether you can join.

Questions to ask the study team

What is the study trying to find out?
What would I need to do, and how often would I visit?
Could I receive a placebo instead of the treatment?
What are the possible risks and benefits for me?
Will it cost me anything? Are travel or time paid for?
Can I keep seeing my own doctor during the study?
What happens when the study ends?

See locations

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All Schizophrenia trials

Study at a glance

From the registry record, last updated by the sponsor on 8 Apr 2008. Recruitment status is as the sponsor reported it: confirm with the study team.

Official title: Effectiveness of Antipsychotic Combination With Psychosocial Intervention on Outcome of Patients With Schizophrenia:One-Year Follow up.
ClinicalTrials.gov ID: NCT00654576
Acronym / sponsor ID: ACPIOS / 2004BA720A22
Conditions: Schizophrenia
Keywords: schizophrenia, antipsychotic, outcome, psychosocial intervention
Phase: Phase 4
Study type: Interventional
Recruitment status: Completed
Enrolment: 1,400 participants (estimated)
Lead sponsor: Central South UniversityUniversity, hospital or other
Collaborators: Shanghai Mental Health Center, Sichuan University, Capital Medical University, Nanjing Medical University, Jiangxi Mental Hospital, Hunan Mental Hospital, Guangzhou Mental Hospital, Chongqing Metal Institute, Henan Mental Hospital
Study start: Feb 2005
Primary completion: Dec 2007 (actual)
Study completion: Dec 2007 (actual)
First posted: 8 Apr 2008 (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.

Detailed description

The study is designed as a national, multicenter, randomized, naturalistic trial, with research assessors intended to be blind to the intervention status.

Study design

Primary purpose: Treatment
Allocation: Randomised
Intervention model: Factorial
Masking: None (open label)
Number of arms: 2

Arm	Type	Receives
1	Active comparator	Drug: Chlorpromazine, Sulpiride, Clozapine, Olanzapine, Risperidone, Quetiapine, Aripitrazolethe comparator arm will only receive one of the seven antipsychotic
2	Experimental	Behavioral: psychosocial interventionthe experimental group will receive one of the seven study drugs combination with psychosocial intervention

Who may qualify

Ages: 16 to 50 years
Sex: All
Healthy volunteers: Not accepted
Age groups: Child, Adult

Key inclusion criteria (10 listed)

Eligible patients were 16 to 50 years of age;
had received a diagnosed of schizophrenia in accordance with criteria set out in the Diagnostic and Statistical Manual of Mental Disorders-fourth edition (DSM-IV);
were confirmed to be clinically stable by the investigator (the total score ≤60 on the Positive and Negative Syndrome Scale [PANSS] or a decrease of fifty percent from acute period in the total score on PANSS)
and taken maintenance treatment with any one of the following seven oral antipsychotics:

Key exclusion criteria (4 listed)

Patients were excluded if they had received a diagnosis of schizoaffective disorder, mental retardation, or other cognitive disorders;
had a history of serious adverse reactions to the proposed treatment;
were pregnant or breastfeeding; or had a serious and unstable medical condition.
Patients were excluded if they were unable to provide informed consent

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
Chlorpromazine, Sulpiride, Clozapine, Olanzapine, Risperidone, Quetiapine, Aripitrazolepatient will receive one of the seven study drugs (Chlorpromazine, Sulpiride, Clozapine, Olanzapine, Risperidone, Quetiapine, Aripitrazole) as the maintain treatment. the dose is flexible, is based on the study doctor's judgment.	Drug	1
psychosocial interventionthe psychosocial interventions include psychoeducaiton, family intervention, skill training, and cognitive-behavioral therapy.	Behavioural	2

Primary outcome

the time to discontinued treatment and the rate of relapse/rehospitalization

1 secondary outcome

clinical psychopathology, side effect, compliance, social function, neurocognitive function, quality of life, family/career burden, cost analysis.

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 8 Apr 2008.
Derived from this study: PubMed 25064681Zhang Z, Zhai J, Wei Q, Qi J, Guo X, Zhao J. Cost-effectiveness analysis of psychosocial intervention for early stage schizophrenia in China: a randomized, one-year study. BMC Psychiatry. 2014 Jul 26;14:212. doi: 10.1186/s12888-014-0212-0.
Derived from this study: PubMed 21369751Guo X, Fang M, Zhai J, Wang B, Wang C, Hu B, Sun X, Lv L, Lu Z, Ma C, Guo T, Xie S, Twamley EW, Jin H, Zhao J. Effectiveness of maintenance treatments with atypical and typical antipsychotics in stable schizophrenia with early stage: 1-year naturalistic study. Psychopharmacology (Berl). 2011 Aug;216(4):475-84. doi: 10.1007/s00213-011-2242-3. Epub 2011 Mar 3.
Derived from this study: PubMed 20819983Guo X, Zhai J, Liu Z, Fang M, Wang B, Wang C, Hu B, Sun X, Lv L, Lu Z, Ma C, He X, Guo T, Xie S, Wu R, Xue Z, Chen J, Twamley EW, Jin H, Zhao J. Effect of antipsychotic medication alone vs combined with psychosocial intervention on outcomes of early-stage schizophrenia: A randomized, 1-year study. Arch Gen Psychiatry. 2010 Sep;67(9):895-904. doi: 10.1001/archgenpsychiatry.2010.105.

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Not yet recruiting
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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
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Designing and Evaluating a Classroom-Based Mental Health Programme for Adolescents.
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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?

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 10 inclusion and 4 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 8 Apr 2008. 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 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 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?

the time to discontinued treatment and the rate of relapse/rehospitalization. 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 NCT00654576, which also lists 3 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 8 Apr 2008.