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

Completed

• Conditions: Schizophrenia

• Registration Number: NCT05667961
• Lead Sponsor: Shanghai Mental Health Center

Brief Summary

Study objectives:

1. Describe the characteristics of discharged patients with schizophrenia achieving functional remission after drug discontinuation.

2. Establish a prediction model of patients with schizophrenia having good prognosis after drug discontinuation.

Detailed Description

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.

Study Timeline

• Study First Submitted: 2022-09-06
• Study Start: 2022-09-15
• Study First Submitted QC: 2022-12-28
• Study First Posted: 2022-12-29
• Primary Completion: 2025-01-31
• Study Completion: 2025-03-31
• Status Verified: 2025-04
• Last Update Submitted: 2025-04-22
• Last Update Posted: 2025-04-25

Recruitment & Eligibility

• Status: COMPLETED
• Sex: All
• Target Recruitment: 480

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.

Study & Design

• Study Type: OBSERVATIONAL
• Study Design: Not specified

Primary Outcome Measures

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

Secondary Outcome Measures

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

Trial Locations

Locations (1)

Shanghai Mental Health Center, Shanghai Jiao Tong University School of Medicine; 🇨🇳 Shanghai, Shanghai, China