Clinical trial NCT05301660: Effect of Nicotine Transdermal Patch on Cognitive Function and Glycolipid Metabolism in Non-smoking Schizophrenia
Official title: Effect of Nicotine Transdermal Patch on Cognitive Function and Glycolipid Metabolism in Non-smoking Patients With Schizophrenia
Study type: INTERVENTIONAL
Overall status: UNKNOWN
Phase: EARLY_PHASE1
Conditions: Schizophrenia
Keywords: nicotine transdermal patch
cognitive function
lycolipid metabolism
schizophrenia
Lead sponsor: Sir Run Run Shaw Hospital
Sponsor class: OTHER
First posted: 2022-03-31
Enrollment: 80
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: TREATMENT

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).

Eligibility criteria: Inclusion Criteria:

1. Using the DSM-V International Neuropsychiatric Jane's Interview Questionnaire (M.I.N.I.);
2. Meet the DSM-V symptom criteria for the diagnosis of schizophrenia;
3. Course of illness for 5 years and less;
4. The cumulative number of cigarettes smoked in the past is less than 100;
5. Lower secondary school or above education level;
6. Han Chinese;
7. years old≥ 18 years old;
8. Right hand;
9. Voluntarily join the study and sign an informed consent form.

Exclusion Criteria:

1. Schizophoratic disorder, bipolar disorder, mental retardation, anxiety spectrum disorder, psychotic disorder caused by drugs, alcohol and other psychoactive substances that meet the diagnostic criteria of DSM-V;
2. Have a history of cerebral organic diseases or head injury;
3. have a history of alcohol and drug dependence;
4. history of impaired consciousness for more than 5 minutes;
5. History of endocrine diseases such as thyroid dysfunction and diabetes mellitus;
6. Those who have serious abnormalities in blood picture, heart, liver and kidney function after examination;
7. pregnant and nursing women;
8. people who have been treated with electroconvulsiveness;
9. There are contraindications to magnetic resonance.

Primary outcomes:
measure: Cognitive function of the subject（score）
timeFrame: 30-40 minutes
measure: Negative and positive symptoms of the subject（score）
timeFrame: 30-40 minutes
measure: Serum nicotine metabolic rate （%）
timeFrame: 40 minutes
measure: Structural characteristics of the brain (mm)
timeFrame: 30 minutes
measure: The function of the subject's brain （mmol/L）
timeFrame: 30 minutes
measure: The blood lipid level of the subject（mmol/L）
timeFrame: 1 hour
Secondary outcomes:
measure: The subject's level of depression（score）
timeFrame: 5-10 minutes
measure: The subject's level of anxiety （score）
timeFrame: 5-10 minutes
measure: The subject's sleep status （score）
timeFrame: 10-15 minutes
Other outcomes:
Locations:
Study officials:
References: