Clinical trial NCT02850445: 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
Overall status: UNKNOWN
Phase: NA
Conditions: Schizophrenia
Lead sponsor: Guangzhou Psychiatric Hospital
Sponsor class: OTHER_GOV
First posted: 2016-08-01
Enrollment: 170
Sex: ALL
Minimum age (years): 18
Maximum age (years): 50
Standard ages: ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: TREATMENT

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.


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.

Primary outcomes:
measure: Medication nonadherence was assessed in two groups after 12-month follow-up.
timeFrame: One year follow-up
measure: Rehospitalization rate was assessed in two groups after 12-month follow-up.
timeFrame: One year follow-up
measure: Rate of Relapse was assessed in two groups after 12-month follow-up.
timeFrame: One year follow-up
Secondary outcomes:
measure: Improvement of symptoms in each group was assessed by the change of PANSS(Positive and Negative Syndrome Scale) total scale score.
timeFrame: One year follow-up
measure: Improvement of symptoms in each group was assessed by the change of CGI( Clinical Global Impressions) scale score.
timeFrame: One year follow-up
measure: Social functioning in each group was assessed by the change of PSP(Personal and Social Performance)scale score.
timeFrame: One year follow-up
Other outcomes:
Locations:
city: Guangzhou
country: China
facility: Guangzhou psychitric hosptial
state: Guangdong
Study officials:
References:
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.