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

Primary Purpose

Schizophrenia

Status
Unknown status
Phase
Not Applicable
Locations
China
Study Type
Interventional
Intervention
Olanzapine
Cognitive behavior therapy
Rehabilitation treatment
Case management
Sponsored by
Guangzhou Psychiatric Hospital
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional treatment trial for Schizophrenia

Eligibility Criteria

18 Years - 50 Years (Adult)All SexesDoes not accept healthy volunteers

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.

Sites / Locations

  • Guangzhou psychitric hosptialRecruiting

Arms of the Study

Arm 1

Arm 2

Arm Type

Experimental

Active Comparator

Arm Label

Integrated Treatment

antipsychotic medication alone treatment

Arm Description

Outcomes

Primary Outcome Measures

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
Rehospitalization rate was assessed in two groups after 12-month follow-up.
Rate of Relapse was assessed in two groups after 12-month follow-up.

Secondary Outcome Measures

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).
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).
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).

Full Information

First Posted
July 14, 2016
Last Updated
July 29, 2016
Sponsor
Guangzhou Psychiatric Hospital
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1. Study Identification

Unique Protocol Identification Number
NCT02850445
Brief Title
Trial and Follow-up of the Efficacy of Two-stage Integrated Treatment for Chinese Schizophrenia Inpatients
Official Title
Effects of Integrated Treatment for Chinese Patients With Schizophrenia: 1-year Follow-up
Study Type
Interventional

2. Study Status

Record Verification Date
July 2016
Overall Recruitment Status
Unknown status
Study Start Date
January 2012 (undefined)
Primary Completion Date
December 2016 (Anticipated)
Study Completion Date
undefined (undefined)

3. Sponsor/Collaborators

Responsible Party, by Official Title
Principal Investigator
Name of the Sponsor
Guangzhou Psychiatric Hospital

4. Oversight

5. Study Description

Brief 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. 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.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Schizophrenia

7. Study Design

Primary Purpose
Treatment
Study Phase
Not Applicable
Interventional Study Model
Parallel Assignment
Masking
Outcomes Assessor
Allocation
Randomized
Enrollment
170 (Anticipated)

8. Arms, Groups, and Interventions

Arm Title
Integrated Treatment
Arm Type
Experimental
Arm Title
antipsychotic medication alone treatment
Arm Type
Active Comparator
Intervention Type
Drug
Intervention Name(s)
Olanzapine
Intervention Description
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.
Intervention Type
Other
Intervention Name(s)
Cognitive behavior therapy
Intervention Description
Patients with schizophrenia allocated to the Integrated Treatment(IT) group received Cognitive behavioral therapy.
Intervention Type
Other
Intervention Name(s)
Rehabilitation treatment
Intervention Description
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.
Intervention Type
Other
Intervention Name(s)
Case management
Intervention Description
Patients with schizophrenia allocated to the Integrated Treatment(IT) group received Case management.
Primary Outcome Measure Information:
Title
Medication nonadherence was assessed in two groups after 12-month follow-up.
Description
Medication non-adherence was defined as a failure to take medication for one week or longer
Time Frame
One year follow-up
Title
Rehospitalization rate was assessed in two groups after 12-month follow-up.
Time Frame
One year follow-up
Title
Rate of Relapse was assessed in two groups after 12-month follow-up.
Time Frame
One year follow-up
Secondary Outcome Measure Information:
Title
Improvement of symptoms in each group was assessed by the change of PANSS(Positive and Negative Syndrome Scale) total scale score.
Description
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).
Time Frame
One year follow-up
Title
Improvement of symptoms in each group was assessed by the change of CGI( Clinical Global Impressions) scale score.
Description
Time course and treatment differences for changes in the CGI( Clinical Global Impressions) was analyzed using Mixed-Effects Model for Repeated-Measures analyses (MMRM).
Time Frame
One year follow-up
Title
Social functioning in each group was assessed by the change of PSP(Personal and Social Performance)scale score.
Description
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).
Time Frame
One year follow-up

10. Eligibility

Sex
All
Minimum Age & Unit of Time
18 Years
Maximum Age & Unit of Time
50 Years
Accepts Healthy Volunteers
No
Eligibility Criteria
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.
Central Contact Person:
First Name & Middle Initial & Last Name or Official Title & Degree
Yingjun Zheng, MD,PhD
Phone
+8618998303126
Email
brainzheng@163.com
Facility Information:
Facility Name
Guangzhou psychitric hosptial
City
Guangzhou
State/Province
Guangdong
ZIP/Postal Code
510370
Country
China
Individual Site Status
Recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Yingjun Zheng, Phd,Md
Phone
+8618998303126
Email
brainzheng@163.com

12. IPD Sharing Statement

Citations:
PubMed Identifier
28463714
Citation
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.
Results Reference
derived

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

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