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

Primary Purpose

Schizophrenia

Status
Not yet recruiting
Phase
Early Phase 1
Locations
Study Type
Interventional
Intervention
Nicotine transdermal patch
Sponsored by
Sir Run Run Shaw Hospital
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional treatment trial for Schizophrenia focused on measuring nicotine transdermal patch, cognitive function, lycolipid metabolism, schizophrenia

Eligibility Criteria

18 Years - undefined (Adult, Older Adult)All SexesDoes not accept healthy volunteers

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.

Sites / Locations

    Arms of the Study

    Arm 1

    Arm 2

    Arm Type

    Experimental

    Placebo Comparator

    Arm Label

    Experimental group

    Control group

    Arm Description

    People with schizophrenic disorders: receiving nicotine transdermal patches.

    People with schizophrenic disorders: receive placebo treatment.

    Outcomes

    Primary Outcome Measures

    Cognitive function of the subject（score）
    In this study, cognitive function is assessed using the Repeatable Battery for the Assessment of Neuropsychological Status（RBANS）. RBANS measures 5 aspects of neuropsychological function: (1) immediate memory (2) visual spatial structure (3) language (4) attention (5) delayed memory.The higher the score on the assessment scale, the better the cognitive function of the subjects.Scale assessments are done once at baseline and at the end of the 2-week follow-up period, for a total of two tests.
    Negative and positive symptoms of the subject（score）
    In this study, negative and positive symptoms in subjects were assessed with Positive and Negative Syndrome Scale（PANSS）.PANSS includes 7 positive scales, 7 negative scales, 16 general psychopathological scales, and 3 supplemental items to assess the risk of attack.The higher the score on the assessment scale, the more severe the subject's symptoms.Scale assessments are done once at baseline and at the end of the 2-week follow-up period, for a total of two tests.
    Serum nicotine metabolic rate （%）
    This study used blood samples from subjects to detect what percentage of nicotine concentrations were available.Subjects were tested once at baseline and after 2 weeks of follow-up, for a total of 2 sessions.
    Structural characteristics of the brain (mm)
    We assessed the brain structure of the subjects by magnetic resonance imaging, once at baseline and once at the end of the 2-week follow-up, for a total of two examinations.We measure how many mm of white matter and gray matter are in the brain.
    The function of the subject's brain （mmol/L）
    We examined the function of the subjects' brains by magnetic resonance imaging, detecting concentrations of metabolites including creatine and creatine phosphate (tCr), glutamate (Glu), inositol (mI), N-acetylbionate (NAA), glycerophosphatecholine (GPC), and glutamic acid and glutamine (Glx).Tests are done at baseline and after 2 weeks of follow-up.
    The blood lipid level of the subject（mmol/L）
    The subjects' blood lipid levels included cholesterol, triglycerides, and lipoprotein alpha, in addition to HDL cholesterol and LDL cholesterol.Subjects were tested once at baseline and after 2 weeks of follow-up, for a total of 2 sessions.

    Secondary Outcome Measures

    The subject's level of depression（score）
    In this study, we used Generalized Anxiety Disorder-7（GAD-7 ）to assess the level of depression in subjects, and the higher the score, the more severe the degree of depression.Scale assessments are done once at baseline and at the end of the 2-week follow-up period, for a total of two tests.
    The subject's level of anxiety （score）
    In this study, we used Patient Health Questionnaire-9 （PHQ-9） to assess subjects' anxiety levels, and the higher the score, the more severe the level of anxiety.Scale assessments are done once at baseline and at the end of the 2-week follow-up period, for a total of two tests.
    The subject's sleep status （score）
    The study used Pittsburgh sleep quality index（PSQI）to assess the sleep status of the subjects, and the higher the score, the worse the sleep quality.Scale assessments are done once at baseline and at the end of the 2-week follow-up period, for a total of two tests.

    Full Information

    First Posted
    February 13, 2022
    Last Updated
    March 19, 2022
    Sponsor
    Sir Run Run Shaw Hospital
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    1. Study Identification

    Unique Protocol Identification Number
    NCT05301660
    Brief Title
    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

    2. Study Status

    Record Verification Date
    March 2022
    Overall Recruitment Status
    Not yet recruiting
    Study Start Date
    March 22, 2022 (Anticipated)
    Primary Completion Date
    February 15, 2023 (Anticipated)
    Study Completion Date
    February 15, 2023 (Anticipated)

    3. Sponsor/Collaborators

    Responsible Party, by Official Title
    Principal Investigator
    Name of the Sponsor
    Sir Run Run Shaw Hospital

    4. Oversight

    Studies a U.S. FDA-regulated Drug Product
    No
    Studies a U.S. FDA-regulated Device Product
    No
    Product Manufactured in and Exported from the U.S.
    No
    Data Monitoring Committee
    No

    5. Study Description

    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).

    6. Conditions and Keywords

    Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
    Schizophrenia
    Keywords
    nicotine transdermal patch, cognitive function, lycolipid metabolism, schizophrenia

    7. Study Design

    Primary Purpose
    Treatment
    Study Phase
    Early Phase 1
    Interventional Study Model
    Parallel Assignment
    Masking
    ParticipantCare ProviderInvestigatorOutcomes Assessor
    Allocation
    Randomized
    Enrollment
    80 (Anticipated)

    8. Arms, Groups, and Interventions

    Arm Title
    Experimental group
    Arm Type
    Experimental
    Arm Description
    People with schizophrenic disorders: receiving nicotine transdermal patches.
    Arm Title
    Control group
    Arm Type
    Placebo Comparator
    Arm Description
    People with schizophrenic disorders: receive placebo treatment.
    Intervention Type
    Drug
    Intervention Name(s)
    Nicotine transdermal patch
    Other Intervention Name(s)
    nicotinell
    Intervention Description
    14 mg / tablet, one tablet a day, attached to the patient's back for 8 weeks
    Primary Outcome Measure Information:
    Title
    Cognitive function of the subject（score）
    Description
    In this study, cognitive function is assessed using the Repeatable Battery for the Assessment of Neuropsychological Status（RBANS）. RBANS measures 5 aspects of neuropsychological function: (1) immediate memory (2) visual spatial structure (3) language (4) attention (5) delayed memory.The higher the score on the assessment scale, the better the cognitive function of the subjects.Scale assessments are done once at baseline and at the end of the 2-week follow-up period, for a total of two tests.
    Time Frame
    30-40 minutes
    Title
    Negative and positive symptoms of the subject（score）
    Description
    In this study, negative and positive symptoms in subjects were assessed with Positive and Negative Syndrome Scale（PANSS）.PANSS includes 7 positive scales, 7 negative scales, 16 general psychopathological scales, and 3 supplemental items to assess the risk of attack.The higher the score on the assessment scale, the more severe the subject's symptoms.Scale assessments are done once at baseline and at the end of the 2-week follow-up period, for a total of two tests.
    Time Frame
    30-40 minutes
    Title
    Serum nicotine metabolic rate （%）
    Description
    This study used blood samples from subjects to detect what percentage of nicotine concentrations were available.Subjects were tested once at baseline and after 2 weeks of follow-up, for a total of 2 sessions.
    Time Frame
    40 minutes
    Title
    Structural characteristics of the brain (mm)
    Description
    We assessed the brain structure of the subjects by magnetic resonance imaging, once at baseline and once at the end of the 2-week follow-up, for a total of two examinations.We measure how many mm of white matter and gray matter are in the brain.
    Time Frame
    30 minutes
    Title
    The function of the subject's brain （mmol/L）
    Description
    We examined the function of the subjects' brains by magnetic resonance imaging, detecting concentrations of metabolites including creatine and creatine phosphate (tCr), glutamate (Glu), inositol (mI), N-acetylbionate (NAA), glycerophosphatecholine (GPC), and glutamic acid and glutamine (Glx).Tests are done at baseline and after 2 weeks of follow-up.
    Time Frame
    30 minutes
    Title
    The blood lipid level of the subject（mmol/L）
    Description
    The subjects' blood lipid levels included cholesterol, triglycerides, and lipoprotein alpha, in addition to HDL cholesterol and LDL cholesterol.Subjects were tested once at baseline and after 2 weeks of follow-up, for a total of 2 sessions.
    Time Frame
    1 hour
    Secondary Outcome Measure Information:
    Title
    The subject's level of depression（score）
    Description
    In this study, we used Generalized Anxiety Disorder-7（GAD-7 ）to assess the level of depression in subjects, and the higher the score, the more severe the degree of depression.Scale assessments are done once at baseline and at the end of the 2-week follow-up period, for a total of two tests.
    Time Frame
    5-10 minutes
    Title
    The subject's level of anxiety （score）
    Description
    In this study, we used Patient Health Questionnaire-9 （PHQ-9） to assess subjects' anxiety levels, and the higher the score, the more severe the level of anxiety.Scale assessments are done once at baseline and at the end of the 2-week follow-up period, for a total of two tests.
    Time Frame
    5-10 minutes
    Title
    The subject's sleep status （score）
    Description
    The study used Pittsburgh sleep quality index（PSQI）to assess the sleep status of the subjects, and the higher the score, the worse the sleep quality.Scale assessments are done once at baseline and at the end of the 2-week follow-up period, for a total of two tests.
    Time Frame
    10-15 minutes

    10. Eligibility

    Sex
    All
    Minimum Age & Unit of Time
    18 Years
    Accepts Healthy Volunteers
    No
    Eligibility Criteria
    Inclusion Criteria: Using the DSM-V International Neuropsychiatric Jane's Interview Questionnaire (M.I.N.I.); Meet the DSM-V symptom criteria for the diagnosis of schizophrenia; Course of illness for 5 years and less; The cumulative number of cigarettes smoked in the past is less than 100; Lower secondary school or above education level; Han Chinese; years old≥ 18 years old; Right hand; Voluntarily join the study and sign an informed consent form. Exclusion Criteria: 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; Have a history of cerebral organic diseases or head injury; have a history of alcohol and drug dependence; history of impaired consciousness for more than 5 minutes; History of endocrine diseases such as thyroid dysfunction and diabetes mellitus; Those who have serious abnormalities in blood picture, heart, liver and kidney function after examination; pregnant and nursing women; people who have been treated with electroconvulsiveness; There are contraindications to magnetic resonance.

    12. IPD Sharing Statement

    Learn more about this trial

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

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