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

Schizophrenia Clinical Trial

Official title:

Effects of Integrated Treatment for Chinese Patients With Schizophrenia: 1-year Follow-up

Clinical Trial Details — Status: Recruiting

Administrative data

• NCT number: NCT02850445
• Other study ID #: Huiai 2014Y2-00105
• Status: Recruiting
• Phase: N/A
• First received: July 14, 2016
• Last updated: July 29, 2016
• Start date: January 2012

Study information

• Verified date: July 2016
• Source: Guangzhou Psychiatric Hospital
• Contact: Yingjun Zheng, MD,PhD
• Phone: +8618998303126
• Email: brainzheng[@]163.com
• Is FDA regulated: No
• Health authority: China: Health and family planning Commisson of Guangzhou Municipality
• Study type: Interventional

Clinical 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. 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.

Recruitment information / eligibility

• Status: Recruiting
• Enrollment: 170
• Est. primary completion date: December 2016
• Accepts healthy volunteers: No
• Gender: Both
• Age group: 18 Years to 50 Years

Eligibility

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

Allocation: Randomized, Endpoint Classification: Safety/Efficacy Study, Intervention Model: Parallel Assignment, Masking: Single Blind (Outcomes Assessor), Primary Purpose: Treatment

Related Conditions & MeSH terms

• Schizophrenia

Intervention

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.
• 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.
• Case management
Patients with schizophrenia allocated to the Integrated Treatment(IT) group received Case management.

Locations

Country	Name	City	State
China	Guangzhou psychitric hosptial	Guangzhou	Guangdong

Sponsors (1)

Lead Sponsor	Collaborator
Guangzhou Psychiatric Hospital

Country where clinical trial is conducted

China, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	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	One year follow-up	No
Primary	Rehospitalization rate was assessed in two groups after 12-month follow-up.		One year follow-up	No
Primary	Rate of Relapse was assessed in two groups after 12-month follow-up.		One year follow-up	No
Secondary	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).	One year follow-up	No
Secondary	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).	One year follow-up	No
Secondary	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).	One year follow-up	No