Ignite Creation Date:
2025-12-25 @ 2:10 AM
Ignite Modification Date:
2025-12-25 @ 2:10 AM
Study NCT ID:
NCT05301660
Status:
UNKNOWN
Last Update Posted:
2022-03-31
First Post:
2022-02-13
Is NOT Gene Therapy:
False
Has Adverse Events:
False
Brief Title:
Effect of Nicotine Transdermal Patch on Cognitive Function and Glycolipid Metabolism in Non-smoking Schizophrenia
Sponsor:
Sir Run Run Shaw Hospital
Organization:
Study Overview
Official Title:
Effect of Nicotine Transdermal Patch on Cognitive Function and Glycolipid Metabolism in Non-smoking Patients With Schizophrenia
Status:
UNKNOWN
Status Verified Date:
2022-03
Last Known Status:
NOT_YET_RECRUITING
Delayed Posting:
No
If Stopped, Why?:
Not Stopped
Has Expanded Access:
False
If Expanded Access, NCT#:
N/A
Has Expanded Access, NCT# Status:
N/A
Acronym:
None
Brief 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).
Study Oversight
Has Oversight DMC:
False
Is a FDA Regulated Drug?:
False
Is a FDA Regulated Device?:
False
Is an Unapproved Device?:
None
Is a PPSD?:
None
Is a US Export?:
False
Is an FDA AA801 Violation?: