NCT05301660

Effect of Nicotine Transdermal Patch on Cognitive Function and Glycolipid Metabolism in Non-smoking Schizophrenia

Effect of Nicotine Transdermal Patch on Cognitive Function and Glycolipid Metabolism in Non-smoking Patients With Schizophrenia

• Status: Unknown
• Phase: EARLY_Phase 1
• Study type: Interventional
• Enrollment: 80 (estimated)
• Sponsor: Sir Run Run Shaw Hospital · Academic / Other
• Sex: All
• Age: 18 Years
• Healthy volunteers: Not accepted

Summary

Schizophrenia is a group of severe mental disorders of unknown etiology, with significant abnormalities in mental activities such as cognition, thinking, emotion, and behavior, and lead to obvious occupational and social function damage. At present, many studies have found that nicotine and cognitive function changes are related, and many studies have carried out a series of explorations for patients with schizophrenia, but there is no study on the mechanism of nicotine on cognitive function in patients with schizophrenia through changes in glycolipid metabolism, and this study intends to explore whether nicotine participates in the cognitive changes of patients with schizophrenia by regulating glycolipid metabolism, which is conducive to the in-depth study of the mechanism of cognitive function change in schizophrenia, in order to find an effective way to improve the cognitive function of schizophrenia.

Detailed description

The project plans to include 80 non-smoking patients with schizophrenia. If you meet the study enrollment requirements and agree to participate in the study, we will number you and establish a medical record file. During the course of the study, you will be randomly grouped. The intervention group received nicotine transdermal patch (14 mg/tablet) one tablet per day, while the placebo group received a similar-looking placebo patch for a period of 8 weeks. The study was designed to be double-blind, meaning that neither you nor the investigator knew your group until the study was completed. Before and after treatment, you will need to cooperate with the questionnaire assessment, which includes: the subject's general demographic information, medical history, smoking status, nicotine dependence, cognitive function using MCCB (MATRICS Consensus Cognitive Battery) assessment, symptom severity panss (PANSS) assessment, Symptoms of depression and anxiety were assessed using GAD-7 (Generalized Anxiety Disorder) and PHQ-9 (Patient Health Questionnaire-9, PHQ-9).

Conditions

• Schizophrenia

Interventions

Type	Name	Description
DRUG	Nicotine transdermal patch	14 mg / tablet, one tablet a day, attached to the patient's back for 8 weeks

Timeline

• Start date: 2022-03-22
• Primary completion: 2023-02-15
• Completion: 2023-02-15
• First posted: 2022-03-31
• Last updated: 2022-03-31