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

Guangzhou Psychiatric Hospital

Status: Unknown

Conditions: Schizophrenia

Treatments: Drug: Olanzapine; Other: Case management; Other: Cognitive behavior therapy; Other: Rehabilitation treatment

Study type: Interventional

Funder types: Other

Identifiers

NCT02850445

Huiai 2014Y2-00105

Details and patient eligibility

About

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.

Enrollment: 170 estimated patients

Sex: All

Ages: 18 to 50 years old

Volunteers: No 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.

Trial design

Primary purpose: Treatment

Allocation: Randomized

Interventional model: Parallel Assignment

Masking: Single Blind

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170 participants in 2 patient groups

Integrated Treatment

Experimental group

Treatment:

Drug: Olanzapine

Other: Cognitive behavior therapy

Other: Case management

Other: Rehabilitation treatment

antipsychotic medication alone treatment

Active Comparator group

Treatment:

Drug: Olanzapine