Predictors of Functional Remission in Discharged Patients With Schizophrenia After Long-term Drug Discontinuation

Study Overview
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Brief Summary
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Study objectives: Describe the characteristics of discharged patients with schizophrenia achieving functional remission after drug discontinuation. Establish a prediction model of patients with schizophrenia having good prognosis after drug discontinuation.

Detailed Description
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There are 2 clinically important and urgent questions to be explored in this study: 1. Who is more likely to benefit from guided drug reduction or discontinuation? How to design an individualized treatment plan which can balance the risk of relapse and side-effects from antipsychotics? 2. What are the predictors of functional remission in patients with schizophrenia after drug discontinuation? This will be the first related study to be conducted in China.

Official Title
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Predictors of Functional Remission in Discharged Patients With Schizophrenia After Long-term Drug Discontinuation: a Case-control Study

Conditions
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Schizophrenia

Participation Criteria
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Eligibility Criteria
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Inclusion Criteria: Patients who met the diagnostic criteria of the International Classification of diseases, 10th edition (ICD-10) for a diagnosis of schizophrenia; Aged between 18 to 65 years old at time of investigation; Hospitalized in Shanghai Mental Health Center any time from the year 2013 to 2018; Informed consent. Exclusion Criteria: Patients with neurological diseases, severe somatic diseases, psychoactive substance abuse, mental retardation, agitation, stupor, or risk of suicide, and female patients who are pregnant or breast-feeding, will be excluded from the study.

Ages Eligible for Study
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Minimum Age: 18 Years
Maximum Age: 65 Years

Sexes Eligible for Study
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All

Accepts Healthy Volunteers
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No

Study Plan
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How is the study designed?
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Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| the function remitted off-medicine group<br>Off-medicine definition: Continuous antipsychotic maintenance therapy for at least two years before drug discontinuation and drug discontinuation of all reasons (treatment benefits, adverse events, socioeconomic difficulties, migration, stigma, etc.) for at least one year; Function remitted definition: Meet the criteria of functional remission in both WHOQoL-BREF (overall points ≥ 60) and FROGS (social functioning dimension points ≥ 33, daily life dimension points ≥ 12, and treatment dimension points ≥ 12) | |
| the function not-remitted off-medicine group<br>Off-medicine definition: Continuous antipsychotic maintenance therapy for at least two years before drug discontinuation and drug discontinuation of all reasons (treatment benefits, adverse events, socioeconomic difficulties, migration, stigma, etc.) for at least one year; Function not-remitted definition: Fail to meet the criteria of functional remission in both WHOQoL-BREF and FROGS | |
| the function remitted on-medicine group<br>On-medicine definition: Continuous antipsychotic maintenance therapy during the time this study is conducted Function remitted definition: Meet the criteria of functional remission in both WHOQoL-BREF and FROGS | |
| the function not-remitted on-medicine group<br>On-medicine definition: Continuous antipsychotic maintenance therapy during the time this study is conducted Function not-remitted definition: Fail to meet the criteria of functional remission in both WHOQoL-BREF and FROGS | |

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Functional remission dimension 1 | World Health Organization Quality of Life abbreviated version（WHOQoL-BREF), score from 26 to 130. Higher score indicates better functional remission. | Up to 28 weeks | 
| Functional remission dimension 2 | Functional Remission of General Schizophrenia Scale (FROGS), scale from 19 to 95. Higher score indicates better functional remission. | Up to 28 weeks | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Symptom assessment dimension 1 | the Positive and Negative Syndrome Scale (PANSS), score from 30 to 210. High score indicates severe symptoms. | Up to 28 weeks | 
| Symptom assessment dimension 2 | Clinical Global Impression (CGI), score from 1 to 7. High score indicates severe symptoms. | Up to 28 weeks |