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OpenTrials
Completed

NCT Number: NCT05667961

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

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.

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Key information

Conditions

Schizophrenia Mental Disorders Schizophrenia Spectrum and Other Psychotic Disorders

Age range

18 year–65 year

Sex eligibility

All sexes

Study type

Observational

Primary location

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

Shanghai, Shanghai Municipality, 200030, China

About this study

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.

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

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.

Treatment and study plan

Primary outcomes

  1. Functional remission dimension 1

    Time frame: 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.

  2. Functional remission dimension 2

    Time frame: Up to 28 weeks

    Functional Remission of General Schizophrenia Scale (FROGS), scale from 19 to 95. Higher score indicates better functional remission.

Secondary outcomes

  1. Symptom assessment dimension 1

    Time frame: Up to 28 weeks

    the Positive and Negative Syndrome Scale (PANSS), score from 30 to 210. High score indicates severe symptoms.

  2. Symptom assessment dimension 2

    Time frame: Up to 28 weeks

    Clinical Global Impression (CGI), score from 1 to 7. High score indicates severe symptoms.

Sponsors and collaborators

Lead sponsor

Shanghai Mental Health Center

Other

Collaborators

  • Merck Sharp & Dohme LLC

Registry information

Official study title

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

Important dates

Study start
2022
Primary completion
2025
Study completion
2025
First posted
Dec 29, 2022
Registry last updated
Apr 25, 2025

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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