Clinical trial NCT05667961: Predictors of Functional Remission in Discharged Patients With Schizophrenia After Long-term Drug Discontinuation
Official title: Predictors of Functional Remission in Discharged Patients With Schizophrenia After Long-term Drug Discontinuation: a Case-control Study
Study type: OBSERVATIONAL
Overall status: COMPLETED
Conditions: Schizophrenia
Lead sponsor: Shanghai Mental Health Center
Sponsor class: OTHER
Collaborators: name: Merck Sharp & Dohme LLC
First posted: 2022-12-29
Enrollment: 480
Sex: ALL
Minimum age (years): 18
Maximum age (years): 65
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Observational model: CASE_CONTROL
Time perspective: RETROSPECTIVE
Sampling method: PROBABILITY_SAMPLE
Study population: All participants will be recruited from Shanghai Mental Health Center (SMHC), Shanghai, China

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.

Eligibility criteria: 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.

Primary outcomes:
measure: Functional remission dimension 1
timeFrame: Up to 28 weeks
measure: Functional remission dimension 2
timeFrame: Up to 28 weeks
Secondary outcomes:
measure: Symptom assessment dimension 1
timeFrame: Up to 28 weeks
measure: Symptom assessment dimension 2
timeFrame: Up to 28 weeks
Other outcomes:
Locations:
city: Shanghai
country: China
facility: Shanghai Mental Health Center, Shanghai Jiao Tong University School of Medicine
state: Shanghai
Study officials:
affiliation: Shanghai Mental Health Center
name: Dengtang Liu
role: PRINCIPAL_INVESTIGATOR
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