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

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

Status

Completed

Phases

Unknown

Study type

Observational

Source

ClinicalTrials.gov

Registry ID

NCT05667961

Enrollment

480

Registered

2022-12-29

Start date

2022-09-15

Completion date

2025-03-31

Last updated

2025-04-25

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

Schizophrenia

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.

Interventions

None listed

Study design

Observational model

CASE_CONTROL

Time perspective

RETROSPECTIVE

Eligibility

Sex/Gender

ALL

Age

18 Years to 65 Years

Healthy volunteers

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.

Design outcomes

Primary

Measure	Time frame	Description
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

Measure	Time frame	Description
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.
Symptom assessment dimension 2	Up to 28 weeks	Clinical Global Impression (CGI), score from 1 to 7. High score indicates severe symptoms.

Countries

China

Outcome results