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

• ClinicalTrials.gov Identifier: NCT02850445
• Recruitment Status: Unknown
• First Posted: August 1, 2016
• Last Update Posted: August 1, 2016
• Sponsor: Guangzhou Psychiatric Hospital
• Information provided by (Responsible Party): Shenglin She, Guangzhou Psychiatric Hospital

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.

Condition or disease	Intervention/treatment	Phase
Schizophrenia	Drug: Olanzapine; Other: Cognitive behavior therapy; Other: Rehabilitation treatment; Other: Case management	Not Applicable

Study Design

• Study Type: Interventional (Clinical Trial)
• Estimated Enrollment: 170 participants
• Allocation: Randomized
• Intervention Model: Parallel Assignment
• Masking: Single (Outcomes Assessor)
• Primary Purpose: Treatment
• Official Title: Effects of Integrated Treatment for Chinese Patients With Schizophrenia: 1-year Follow-up
• Study Start Date: January 2012
• Estimated Primary Completion Date: December 2016

Arms and Interventions

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.

Outcome Measures

Primary Outcome Measures :

1. 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
2. Rehospitalization rate was assessed in two groups after 12-month follow-up. [ Time Frame: One year follow-up ]
3. Rate of Relapse was assessed in two groups after 12-month follow-up. [ Time Frame: One year follow-up ]

Secondary Outcome Measures :

1. 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).
2. 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).
3. 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).

Eligibility Criteria

• Ages Eligible for Study: 18 Years to 50 Years (Adult)
• Sexes Eligible for Study: All
• Accepts Healthy Volunteers: No

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.

Contacts and Locations

Contacts

Contact: Yingjun Zheng, MD,PhD; +8618998303126; brainzheng@163.com

Locations

China, Guangdong

Guangzhou psychitric hosptial; Recruiting

Guangzhou, Guangdong, China, 510370

Contact: Yingjun Zheng, Phd,Md +8618998303126 brainzheng@163.com

Sponsors and Collaborators

Guangzhou Psychiatric Hospital

More Information

Publications automatically indexed to this study by ClinicalTrials.gov Identifier (NCT Number):

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.

• Responsible Party: Shenglin She, Clinical Professor, Guangzhou Psychiatric Hospital
• ClinicalTrials.gov Identifier: NCT02850445
• Other Study ID Numbers: Huiai 2014Y2-00105
• First Posted: August 1, 2016
• Last Update Posted: August 1, 2016
• Last Verified: July 2016

Additional relevant MeSH terms:

Schizophrenia; Schizophrenia Spectrum and Other Psychotic Disorders; Mental Disorders; Olanzapine; Antiemetics; Autonomic Agents; Peripheral Nervous System Agents; Physiological Effects of Drugs; Gastrointestinal Agents; Antipsychotic Agents; Tranquilizing Agents; Central Nervous System Depressants; Psychotropic Drugs; Serotonin Uptake Inhibitors; Neurotransmitter Uptake Inhibitors; Membrane Transport Modulators; Molecular Mechanisms of Pharmacological Action; Neurotransmitter Agents; Serotonin Agents