Trial and Follow-up of the Efficacy of Two-stage Integrated Treatment for Chinese Schizophrenia Inpatients

July 29, 2016 updated by: Shenglin She, Guangzhou Psychiatric Hospital

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.

Study Overview

Status

Unknown

Conditions

Intervention / Treatment

Study Type

Interventional

Enrollment (Anticipated)

170

Phase

  • Not Applicable

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Contact

Study Locations

  • China
    • Guangdong
      • Guangzhou, Guangdong, China, 510370
        • Recruiting
        • Guangzhou psychitric hosptial
        • Contact:

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

18 years to 50 years (Adult)

Accepts Healthy Volunteers

No

Genders Eligible for Study

All

Description

Inclusion Criteria:

  • 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.

Exclusion Criteria:

  • 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.

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Primary Purpose: Treatment
  • Allocation: Randomized
  • Interventional Model: Parallel Assignment
  • Masking: Single

Arms and Interventions

Participant Group / Arm
Intervention / Treatment
Experimental: Integrated Treatment
Drug: Olanzapine
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.
Other: Cognitive behavior therapy
Patients with schizophrenia allocated to the Integrated Treatment(IT) group received Cognitive behavioral therapy.
Other: Rehabilitation treatment
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.
Other: Case management
Patients with schizophrenia allocated to the Integrated Treatment(IT) group received Case management.
Active Comparator: antipsychotic medication alone treatment
Drug: Olanzapine
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.

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Measure Description
Time Frame
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
One year follow-up
Rehospitalization rate was assessed in two groups after 12-month follow-up.
Time Frame: One year follow-up
One year follow-up
Rate of Relapse was assessed in two groups after 12-month follow-up.
Time Frame: One year follow-up
One year follow-up

Secondary Outcome Measures

Outcome Measure
Measure Description
Time Frame
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
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).
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
Time course and treatment differences for changes in the CGI( Clinical Global Impressions) was analyzed using Mixed-Effects Model for Repeated-Measures analyses (MMRM).
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
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).
One year follow-up

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Guangzhou Psychiatric Hospital

Publications and helpful links

The person responsible for entering information about the study voluntarily provides these publications. These may be about anything related to the study.

General Publications

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start

January 1, 2012

Primary Completion (Anticipated)

December 1, 2016

Study Registration Dates

First Submitted

July 14, 2016

First Submitted That Met QC Criteria

July 29, 2016

First Posted (Estimate)

August 1, 2016

Study Record Updates

Last Update Posted (Estimate)

August 1, 2016

Last Update Submitted That Met QC Criteria

July 29, 2016

Last Verified

July 1, 2016

More Information

Terms related to this study

Additional Relevant MeSH Terms

Other Study ID Numbers

  • Huiai 2014Y2-00105

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

Clinical Trials on Schizophrenia

Clinical Trials on Olanzapine

Search Similar Trials

Sponsors and Collaborators

Medical Conditions

Drug Interventions

CROs by country

CROs in Türkiye

Conditions

Rare Diseases

Drug Interventions

Dietary Supplements

Sponsor/Collaborators

Locations

3
Subscribe