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

Shanghai Mental Health Center

Status: Completed

Conditions: Schizophrenia

Study type: Observational

Funder types: Other; Industry

Identifiers

NCT05667961

2022-TX-007

Details and patient eligibility

About

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.

Full 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.

Enrollment: 480 patients

Sex: All

Ages: 18 to 65 years old

Volunteers: No 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.

Trial design

480 participants in 4 patient groups

the function remitted off-medicine group

Description:

* 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

Description:

* 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

Description:

* 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

Description:

* 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