NCT05301660

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.

Trial Health

35
At Risk

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Trial has exceeded expected completion date
Enrollment
80

participants targeted

Target at P75+ for early_phase_1 schizophrenia

Timeline
Completed

Started Mar 2022

Shorter than P25 for early_phase_1 schizophrenia

Status
unknown

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

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Study Timeline

Key milestones and dates

First Submitted

Initial submission to the registry

February 13, 2022

Completed
1 month until next milestone

Study Start

First participant enrolled

March 22, 2022

Completed
9 days until next milestone

First Posted

Study publicly available on registry

March 31, 2022

Completed
11 months until next milestone

Primary Completion

Last participant's last visit for primary outcome

February 15, 2023

Completed
Same day until next milestone

Study Completion

Last participant's last visit for all outcomes

February 15, 2023

Completed
Last Updated

March 31, 2022

Status Verified

March 1, 2022

Enrollment Period

11 months

First QC Date

February 13, 2022

Last Update Submit

March 19, 2022

Conditions

Schizophrenia

Keywords

nicotine transdermal patchcognitive functionlycolipid metabolismschizophrenia

Outcome Measures

Primary Outcomes (6)

  • 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.

    30-40 minutes

  • 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.

    30-40 minutes

  • 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.

    40 minutes

  • 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.

    30 minutes

  • 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.

    30 minutes

  • 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.

    1 hour

Secondary Outcomes (3)

  • The subject's level of depression（score）

    5-10 minutes

  • The subject's level of anxiety （score）

    5-10 minutes

  • The subject's sleep status （score）

    10-15 minutes

Study Arms (2)

Experimental group

EXPERIMENTAL

People with schizophrenic disorders: receiving nicotine transdermal patches.

Drug: Nicotine transdermal patch

Control group

PLACEBO COMPARATOR

People with schizophrenic disorders: receive placebo treatment.

Drug: Nicotine transdermal patch

Interventions

Nicotine transdermal patchDRUG

14 mg / tablet, one tablet a day, attached to the patient's back for 8 weeks

Also known as: nicotinell
Control groupExperimental group

Eligibility Criteria

Age18 Years+
Sexall
Healthy VolunteersNo
Age GroupsAdult (18-64), Older Adult (65+)

You may qualify if:

  • 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.

You may not qualify if:

  • 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.

Contact the study team to confirm eligibility.

Sponsors & Collaborators

MeSH Terms

Conditions

Schizophrenia

Interventions

Tobacco Use Cessation DevicesNicotine

Condition Hierarchy (Ancestors)

Schizophrenia Spectrum and Other Psychotic DisordersMental Disorders

Intervention Hierarchy (Ancestors)

TherapeuticsSolanaceous AlkaloidsAlkaloidsHeterocyclic CompoundsPyridinesHeterocyclic Compounds, 1-Ring

Study Design

Study Type
interventional
Phase
early phase 1
Allocation
RANDOMIZED
Masking
QUADRUPLE
Who Masked
PARTICIPANT, CARE PROVIDER, INVESTIGATOR, OUTCOMES ASSESSOR
Purpose
TREATMENT
Intervention Model
PARALLEL
Sponsor Type
OTHER
Responsible Party
PRINCIPAL INVESTIGATOR
PI Title
Deputy Chief Physician

Study Record Dates

First Submitted

February 13, 2022

First Posted

March 31, 2022

Study Start

March 22, 2022

Primary Completion

February 15, 2023

Study Completion

February 15, 2023

Last Updated

March 31, 2022

Record last verified: 2022-03