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

NCT05667961 | Completed

• 1 other identifier: 2022-TX-007
• Study Type: observational
• Target: 480
• Locations: 1 country
• Sites: 1

Brief Summary

Study objectives:

1. 1.Describe the characteristics of discharged patients with schizophrenia achieving functional remission after drug discontinuation.
2. 2.Establish a prediction model of patients with schizophrenia having good prognosis after drug discontinuation.

Conditions

Schizophrenia

Outcome Measures

Primary Outcomes (2)

• 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 Outcomes (2)

• Symptom assessment dimension 1

  Up to 28 weeks

• Symptom assessment dimension 2

  Up to 28 weeks

Study Arms (4)

the function remitted off-medicine group

* 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

* 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

* 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

* 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

Eligibility Criteria

• Age: 18 Years - 65 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)
• Sampling Method: Probability Sample

Study Population

All participants will be recruited from Shanghai Mental Health Center (SMHC), Shanghai, China

You may qualify if:

• 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.

You may not qualify if:

• 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.

Sponsors & Collaborators

• Shanghai Mental Health Center: lead
• Merck Sharp & Dohme LLC: collaborator

Study Sites (1)

Shanghai Mental Health Center, Shanghai Jiao Tong University School of Medicine

Shanghai, Shanghai Municipality, 200030, China

Location

Related Publications (20)

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• Lu C, Dong Y, Zhai Z, Gao T, Luo M, Feng T, Ma X, Chang D, Chen J, Xue J, Zhao Y, Li X, Shao C, Liu D. Prediction of functional remission in patients with schizophrenia after antipsychotic discontinuation (FURSAD): protocol for a real-world case-control study. BMJ Open. 2024 Dec 27;14(12):e087645. doi: 10.1136/bmjopen-2024-087645.

  PMID: 39732483 DERIVED

MeSH Terms

Conditions

Schizophrenia

Condition Hierarchy (Ancestors)

Schizophrenia Spectrum and Other Psychotic Disorders; Mental Disorders

Study Officials

• Dengtang Liu

  Shanghai Mental Health Center

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: observational
• Observational Model: CASE CONTROL
• Time Perspective: RETROSPECTIVE
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: September 6, 2022
• First Posted: December 29, 2022
• Study Start: September 15, 2022
• Primary Completion: January 31, 2025
• Study Completion: March 31, 2025
• Last Updated: April 25, 2025

Record last verified: 2025-04

Data Sharing

• IPD Sharing: Will not share

Locations

CN (1)