SchizophreniaNCT02850445
Trial and Follow-up of the Efficacy of Two-stage Integrated Treatment for Chinese Schizophrenia Inpatients
A study testing Olanzapine, Cognitive behavior therapy and Rehabilitation treatment in people with Schizophrenia, run by Guangzhou Psychiatric Hospital at 1 site in China.
Trial summary
Regular psychosocial intervention combined with antipsychotic drugs, compared with usual medication alone treatments, can reduce psychiatric symptoms and improve quality of life in patients with schizophrenia. Read more about this study
- Who is it for?
- Ages 18 to 50 years
- Conditions the study is for
- Schizophrenia
- What is being tested?
- Olanzapine, Cognitive behavior therapy and Rehabilitation treatment
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 170 participants
- Where
- 1 siteChina
- Study dates
- Jan 2012to Dec 2016
- 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 18 to 50 years
- All sexes
- No healthy volunteers
- Adult
Who may be able to join
- Diagnosed with the Structured Clinical Interview for DSM-IV (SCID-DSM-IV) (First et al., 1996), were recruited from inpatient psychiatric ward. Patients with diagnoses of schizoaffective or other psychotic disorders were not included.
- Additional inclusion criteria for participants were aged between 18 and 50 years with education of more than 9 years, and
- PANSS (Positive and Negative Syndrome Scale) total scores of more than 60.
Who cannot join
- Diagnosed with a serious and unstable medical condition including abuse and/or dependence of alcohol and/or drugs;
- Pregnant or breastfeeding;
- Under a treatment of clozapine with a dose of more than 200 mg/day,
- Had a treatment of the electroconvulsive therapy (ECT) or modified electroconvulsive therapy within 6 months(MECT) within the past six months.
Trial locations and contacts
1 site in 1 country.
China1 site, 1 recruiting
- Recruiting
Guangzhou psychitric hosptial
Guangzhou, Guangdong, 510370
Yingjun Zheng, Phd,Md, +8618998303126, brainzheng@163.com
About this study
Official title: Effects of Integrated Treatment for Chinese Patients With Schizophrenia: 1-year Follow-up
Regular psychosocial intervention combined with antipsychotic drugs, compared with usual medication alone treatments, can reduce psychiatric symptoms and improve quality of life in patients with schizophrenia. However, it's expensive, time-consuming, and sometimes inconvenient for patients and their family members in developing areas where the number of well-trained therapist remains limited in local psychiatric settings. The investigators aimed to establish an efficient model of integrated treatment (IT) for patients with schizophrenia. The procedure contains two stages: a centralized treatment during hospitalization and the following consolidation treatments with long intervals.
- Conditions
- Schizophrenia
- Being tested
- Olanzapine, Cognitive behavior therapy, Rehabilitation treatment, Case management
- Medical subject headings
- Schizophrenia
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
OlanzapineDrug
All patients with schizophrenia were under medication treatment at the baseline. Individualized plan of antipsychotic medication for the patients were determined by psychiatrist who were blind to the group allocation. Medications could be changed at any time during the course of the study if the change was clinically warranted, the drug can also be any other antipsychotic medication.
Cognitive behavior therapyOther
Patients with schizophrenia allocated to the Integrated Treatment(IT) group received Cognitive behavioral therapy.
Rehabilitation treatmentOther
Rehabilitation treatment include three modules: medication management, symptom management, and social kill training. Patients with schizophrenia allocated to the Integrated Treatment(IT) group received Rehabilitation treatment therapy.
Case managementOther
Patients with schizophrenia allocated to the Integrated Treatment(IT) group received Case management.
| Study group | Role | What they receive |
|---|---|---|
| Integrated Treatment | Experimental | Not described Receives: Drug: Olanzapine; Other: Cognitive behavior therapy; Other: Rehabilitation treatment; Other: Case management |
| antipsychotic medication alone treatment | Active comparator | Not described Receives: Drug: Olanzapine |
What is being measured
The primary outcome is the main question the study is designed to answer.
Medication nonadherence was assessed in two groups after 12-month follow-up.
Medication non-adherence was defined as a failure to take medication for one week or longer
Measured: One year follow-up
Rehospitalization rate was assessed in two groups after 12-month follow-up.
Measured: One year follow-up
Rate of Relapse was assessed in two groups after 12-month follow-up.
Measured: One year follow-up
Secondary outcomes (3)
Improvement of symptoms in each group was assessed by the change of PANSS(Positive and Negative Syndrome Scale) total scale score.
Time course and treatment differences for changes in the PANSS( Positive and Negative Syndrome Scale) was analyzed using Mixed-Effects Model for Repeated-Measures analyses (MMRM).
Measured: One year follow-up
Improvement of symptoms in each group was assessed by the change of CGI( Clinical Global Impressions) scale score.
Time course and treatment differences for changes in the CGI( Clinical Global Impressions) was analyzed using Mixed-Effects Model for Repeated-Measures analyses (MMRM).
Measured: One year follow-up
Social functioning in each group was assessed by the change of PSP(Personal and Social Performance)scale score.
Time course and treatment differences for changes in the PSP(Personal and Social Performance) were analyzed using Mixed-Effects Model for Repeated-Measures analyses (MMRM).
Measured: One year follow-up
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted1 Aug 2016 (estimated)
- Study startJan 2012
- Primary completionDec 2016 (estimated)
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 N/A
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Single blind
- Who is masked
- Outcomes assessor
- Enrolment
- 170 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Guangzhou Psychiatric Hospital
- Sponsor type
- Other government
- Responsible party
- Principal investigator, Shenglin She, Guangzhou Psychiatric Hospital
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT02850445
- Sponsor's protocol ID
- Huiai 2014Y2-00105
- Status last verified
- Jul 2016
- First submitted
- 14 Jul 2016
- Last updated
- 1 Aug 2016
- Results posted
- No
Publications
She S, Deng Y, Chen Y, Wu C, Yi W, Lu X, Chen X, Li J, Li R, Zhang J, Xiao D, Wu H, Ning Y, Zheng Y. Two-stage integrated care versus antipsychotic medication alone on outcomes of schizophrenia: One-year randomized controlled trial and follow-up. Psychiatry Res. 2017 Aug;254:164-172. doi: 10.1016/j.psychres.2017.04.054. Epub 2017 Apr 25.
PubMed 28463714
Study at a glance
From the registry record, last updated by the sponsor on 1 Aug 2016. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Effects of Integrated Treatment for Chinese Patients With Schizophrenia: 1-year Follow-up
- ClinicalTrials.gov ID
- NCT02850445
- Acronym / sponsor ID
- Huiai 2014Y2-00105
- Conditions
- Schizophrenia
- Study type
- Interventional
- Recruitment status
- Unknown status
- Enrolment
- 170 participants (estimated)
- Lead sponsor
- Guangzhou Psychiatric HospitalOther government
- Study start
- Jan 2012
- Primary completion
- Dec 2016 (estimated)
- First posted
- 1 Aug 2016 (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.
Regular psychosocial intervention combined with antipsychotic drugs, compared with usual medication alone treatments, can reduce psychiatric symptoms and improve quality of life in patients with schizophrenia. However, it's expensive, time-consuming, and sometimes inconvenient for patients and their family members in developing areas where the number of well-trained therapist remains limited in local psychiatric settings. The investigators aimed to establish an efficient model of integrated treatment (IT) for patients with schizophrenia. The procedure contains two stages: a centralized treatment during hospitalization and the following consolidation treatments with long intervals.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Single blind (outcomes assessor)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Integrated Treatment | Experimental | Drug: Olanzapine, Other: Cognitive behavior therapy, Other: Rehabilitation treatment, Other: Case management |
| antipsychotic medication alone treatment | Active comparator | Drug: Olanzapine |
Who may qualify
- Ages
- 18 to 50 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult
Key inclusion criteria (3 listed)
- Diagnosed with the Structured Clinical Interview for DSM-IV (SCID-DSM-IV) (First et al., 1996), were recruited from inpatient psychiatric ward. Patients with diagnoses of schizoaffective or other psychotic disorders were not included.
- Additional inclusion criteria for participants were aged between 18 and 50 years with education of more than 9 years, and
- PANSS (Positive and Negative Syndrome Scale) total scores of more than 60.
Key exclusion criteria (4 listed)
- Diagnosed with a serious and unstable medical condition including abuse and/or dependence of alcohol and/or drugs;
- Pregnant or breastfeeding;
- Under a treatment of clozapine with a dose of more than 200 mg/day,
- Had a treatment of the electroconvulsive therapy (ECT) or modified electroconvulsive therapy within 6 months(MECT) within the past six months.
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 |
|---|---|---|
| OlanzapineAll patients with schizophrenia were under medication treatment at the baseline. Individualized plan of antipsychotic medication for the patients were determined by psychiatrist who were blind to the group allocation. Medications could be changed at any time during the course of the study if the change was clinically warranted, the drug can also be any other antipsychotic medication. | Drug | Integrated Treatment, antipsychotic medication alone treatment |
| Cognitive behavior therapyPatients with schizophrenia allocated to the Integrated Treatment(IT) group received Cognitive behavioral therapy. | Other | Integrated Treatment |
| Rehabilitation treatmentRehabilitation treatment include three modules: medication management, symptom management, and social kill training. Patients with schizophrenia allocated to the Integrated Treatment(IT) group received Rehabilitation treatment therapy. | Other | Integrated Treatment |
| Case managementPatients with schizophrenia allocated to the Integrated Treatment(IT) group received Case management. | Other | Integrated Treatment |
Primary outcome
Medication nonadherence was assessed in two groups after 12-month follow-up.
Time frame: One year follow-up
Medication non-adherence was defined as a failure to take medication for one week or longer
Rehospitalization rate was assessed in two groups after 12-month follow-up.
Time frame: One year follow-up
Rate of Relapse was assessed in two groups after 12-month follow-up.
Time frame: One year follow-up
3 secondary outcomes
Improvement of symptoms in each group was assessed by the change of PANSS(Positive and Negative Syndrome Scale) total scale score.
Time frame: One year follow-up
Improvement of symptoms in each group was assessed by the change of CGI( Clinical Global Impressions) scale score.
Time frame: One year follow-up
Social functioning in each group was assessed by the change of PSP(Personal and Social Performance)scale score.
Time frame: One year follow-up
Results and safety
Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 1 Aug 2016.
- Derived from this study: PubMed 28463714She S, Deng Y, Chen Y, Wu C, Yi W, Lu X, Chen X, Li J, Li R, Zhang J, Xiao D, Wu H, Ning Y, Zheng Y. Two-stage integrated care versus antipsychotic medication alone on outcomes of schizophrenia: One-year randomized controlled trial and follow-up. Psychiatry Res. 2017 Aug;254:164-172. doi: 10.1016/j.psychres.2017.04.054. Epub 2017 Apr 25.
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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.
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Olanzapine, Cognitive behavior therapy and Rehabilitation treatment in people with Schizophrenia, run by Guangzhou Psychiatric Hospital 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 3 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: status not confirmed, as of the sponsor's last update on 1 Aug 2016. 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.
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 Yingjun Zheng, MD,PhD (+8618998303126, brainzheng@163.com), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Medication nonadherence was assessed in two groups after 12-month follow-up. (time frame: One year follow-up). The study lists 3 primary outcomes in all. 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 NCT02850445, 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 1 Aug 2016.