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

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

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

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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

Resource links provided by the National Library of Medicine

MedlinePlus related topics: Schizophrenia

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.




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).



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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.

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT02850445


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

Locations
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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
Publications automatically indexed to this study by ClinicalTrials.gov Identifier (NCT Number):
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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    Key Record Dates
Last Update Posted: August 1, 2016
Last Verified: July 2016
Additional relevant MeSH terms:
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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