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

Not Applicable

• Conditions: Schizophrenia
• Interventions: Drug: Olanzapine; Other: Cognitive behavior therapy; Other: Rehabilitation treatment; Other: Case management

• Registration Number: NCT02850445
• Lead Sponsor: Guangzhou Psychiatric Hospital

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.

Detailed Description

Not available

Study Timeline

• Study Start: 2012-01
• Status Verified: 2016-07
• Study First Submitted: 2016-07-14
• Study First Submitted QC: 2016-07-29
• Last Update Submitted: 2016-07-29
• Study First Posted: 2016-08-01
• Last Update Posted: 2016-08-01
• Primary Completion: 2016-12

Recruitment & Eligibility

• Status: UNKNOWN
• Sex: All
• Target Recruitment: 170

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 & Design

• Study Type: INTERVENTIONAL
• Study Design: PARALLEL

Arm && Interventions

Group	Intervention	Description
Integrated Treatment	Olanzapine	-
Integrated Treatment	Cognitive behavior therapy	-
Integrated Treatment	Rehabilitation treatment	-
Integrated Treatment	Case management	-
antipsychotic medication alone treatment	Olanzapine	-

Primary Outcome Measures

Name	Time	Method
Rate of Relapse was assessed in two groups after 12-month follow-up.	One year follow-up
Medication nonadherence was assessed in two groups after 12-month follow-up.	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.	One year follow-up

Secondary Outcome Measures

Name	Time	Method
Improvement of symptoms in each group was assessed by the change of PANSS(Positive and Negative Syndrome Scale) total scale score.	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).
Improvement of symptoms in each group was assessed by the change of CGI( Clinical Global Impressions) scale score.	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).
Social functioning in each group was assessed by the change of PSP(Personal and Social Performance)scale score.	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).

Trial Locations

Locations (1)

Guangzhou psychitric hosptial; 🇨🇳 Guangzhou, Guangdong, China