Effectiveness of Antipsychotic Combination With Psychosocial Intervention on Outcome of Patients With Schizophrenia - Full Text View

Purpose

Antipsychotic alone is limit to improve the overall outcome of schizophrenia and has a high discontinue rate.To solve these problems, we provide practical and available psychosocial intervention. We hypothesize that there will be significant difference in the overall effectiveness between antipsychotic and antipsychotic combination with psychosocial intervention.

Condition	Intervention	Phase
Schizophrenia	Drug: Chlorpromazine, Sulpiride, Clozapine, Olanzapine, Risperidone, Quetiapine, Aripitrazole Behavioral: psychosocial intervention	Phase IV

MedlinePlus related topics:

Schizophrenia

ChemIDplus related topics:

Risperidone Quetiapine Quetiapine fumarate Olanzapine Clozapine Sulpiride Chlorpromazine Chlorpromazine hydrochloride Benzocaine

U.S. FDA Resources

Study Type:	Interventional
Study Design:	Treatment, Randomized, Open Label, Active Control, Factorial Assignment, Safety/Efficacy Study

Official Title:	Effectiveness of Antipsychotic Combination With Psychosocial Intervention on Outcome of Patients With Schizophrenia:One-Year Follow up.

Further study details as provided by Central South University:

Primary Outcome Measures:

the time to discontinued treatment and the rate of relapse/rehospitalization [ Designated as safety issue: Yes ]

Secondary Outcome Measures:

clinical psychopathology, side effect, compliance, social function, neurocognitive function, quality of life, family/career burden, cost analysis. [ Designated as safety issue: Yes ]

Estimated Enrollment:	1400
Study Start Date:	February 2005
Study Completion Date:	December 2007
Primary Completion Date:	December 2007 (Final data collection date for primary outcome measure)

Arms	Assigned Interventions
1: Active Comparator the comparator arm will only receive one of the seven antipsychotic	Drug: Chlorpromazine, Sulpiride, Clozapine, Olanzapine, Risperidone, Quetiapine, Aripitrazole patient will receive one of the seven study drugs (Chlorpromazine, Sulpiride, Clozapine, Olanzapine, Risperidone, Quetiapine, Aripitrazole) as the maintain treatment. the dose is flexible, is based on the study doctor's judgment.
2: Experimental the experimental group will receive one of the seven study drugs combination with psychosocial intervention	Behavioral: psychosocial intervention the psychosocial interventions include psychoeducaiton, family intervention, skill training, and cognitive-behavioral therapy.

Detailed Description:

The study is designed as a national, multicenter, randomized, naturalistic trial, with research assessors intended to be blind to the intervention status.

We plan to recruit 1400 patients at 10 china sites and randomly assign them to two group. the control group only receive antipsychotic and the study group receive antipsychotic combination with psychosocial intervention. The course is 12 months. Patients use one of the seven study drugs (chlorpromazine, sulpiride, clozapine, olanzapine, risperidone, quetiapine, and aripitrazole)to the maintain treatment. The psychosocial intervention include psychoeducation, family intervention, skills training, and cognitive-behavioral therapy. The primary aim is to delineate differences in the overall effectiveness of the two treatment model.The assessments include the outcome of symptomatology，neurobiology，social psychology，medical economics.

Eligibility

Ages Eligible for Study:	16 Years to 50 Years
Genders Eligible for Study:	Both
Accepts Healthy Volunteers:	No

Criteria

Inclusion Criteria:

Eligible patients were 16 to 50 years of age;
had received a diagnosed of schizophrenia in accordance with criteria set out in the Diagnostic and Statistical Manual of Mental Disorders-fourth edition (DSM-IV);
were confirmed to be clinically stable by the investigator (the total score ≤60 on the Positive and Negative Syndrome Scale [PANSS] or a decrease of fifty percent from acute period in the total score on PANSS)
and taken maintenance treatment with any one of the following seven oral antipsychotics:
- chlorpromazine
- sulpiride clozapine
- risperidone
- olanzapine
- quetiapine
- aripiprazole

Exclusion Criteria:

Patients were excluded if they had received a diagnosis of schizoaffective disorder, mental retardation, or other cognitive disorders;
had a history of serious adverse reactions to the proposed treatment;
were pregnant or breastfeeding; or had a serious and unstable medical condition.
Patients were excluded if they were unable to provide informed consent

Contacts and Locations

Please refer to this study by its ClinicalTrials.gov identifier: NCT00654576

Locations


China, Hunan
	Institute of Mental Health of The Second Xiangya Hospital, Central South University
	changsha, Hunan, China, 410011

Sponsors and Collaborators

Central South University

Shanghai Mental Health Center

Sichuan University

Beijing Anding Hospital

Nanjing Medical University

Jiangxi Mental Hospital

Hunan Mental Hospital

Guangzhou Mental Hospital

Chongqing Metal Institute

Henan Mental Hospital

More Information

Study ID Numbers:	2004BA720A22
First Received:	April 3, 2008
Last Updated:	April 7, 2008
ClinicalTrials.gov Identifier:	NCT00654576
Health Authority:	China: State Food and Drug Administration

Keywords provided by Central South University:

schizophrenia

antipsychotic

outcome

psychosocial intervention

Study placed in the following topic categories:

Sulpiride

Olanzapine

Risperidone

Benzocaine

Chlorpromazine

Serotonin

Schizophrenia

Quetiapine

Dopamine

Mental Disorders

Clozapine

Psychotic Disorders

Schizophrenia and Disorders with Psychotic Features

Additional relevant MeSH terms:

Neurotransmitter Uptake Inhibitors

Neurotransmitter Agents

Tranquilizing Agents

Molecular Mechanisms of Pharmacological Action

Physiological Effects of Drugs

Gastrointestinal Agents

Psychotropic Drugs

Antiemetics

Central Nervous System Depressants

Dopamine Antagonists

Antipsychotic Agents

Serotonin Uptake Inhibitors

Pharmacologic Actions

GABA Antagonists

Serotonin Antagonists

Serotonin Agents

Autonomic Agents

Therapeutic Uses

GABA Agents

Dopamine Agents

Peripheral Nervous System Agents

Antidepressive Agents, Second-Generation

Central Nervous System Agents

Antidepressive Agents

ClinicalTrials.gov processed this record on October 10, 2008

Sponsors and Collaborators:	Central South University Shanghai Mental Health Center Sichuan University Beijing Anding Hospital Nanjing Medical University Jiangxi Mental Hospital Hunan Mental Hospital Guangzhou Mental Hospital Chongqing Metal Institute Henan Mental Hospital
Information provided by:	Central South University
ClinicalTrials.gov Identifier:	NCT00654576