Effects of Lithium on Suicide Prevention in Adolescents and Young Adults With Bipolar Disorder in China
NCT ID: NCT06424613
Last Updated: 2024-05-22
Study Results
The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.
Basic Information
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RECRUITING
600 participants
OBSERVATIONAL
2024-04-18
2024-12-31
Brief Summary
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Detailed Description
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Conditions
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Study Design
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COHORT
RETROSPECTIVE
Study Groups
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Lithium Group
Lithium Carbonate
Participants must have been prescribed lithium for the past year and demonstrate at least 80% adherence to their lithium medication regimen during the first six months of the study period.
Non-lithium Group
Non-lithium medication
No history of lithium use within the past year
Interventions
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Lithium Carbonate
Participants must have been prescribed lithium for the past year and demonstrate at least 80% adherence to their lithium medication regimen during the first six months of the study period.
Non-lithium medication
No history of lithium use within the past year
Eligibility Criteria
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Inclusion Criteria
1 For Lithium group
1. Aged 12-45 years (adolescents 12-17, young adults 18-45).
2. Diagnosed with bipolar disorder using the the Mini-International Neuropsychiatric Interview (M.I.N.I.) (M.I.N.I.; version 5.0) based on Diagnostic and Statistical Manual of Mental Disorders, 4th Edition (DSM-IV) criteria.
3. Adolescents diagnosed using the M.I.N.I. Kid version.
4. Lithium medication adherence of at least 80% in the first six months over the past year.
5. Not in an acute phase of illness.
6. Patient or guardian able to participate in assessment interviews.
7. Informed consent signed by participants and guardians (for adolescents).
2 for Non-lithium group
1. Aged 12-45 years (adolescents 12-17, young adults 18-45).
2. Diagnosed with bipolar disorder using the Mini-International Neuropsychiatric Interview (M.I.N.I.; version 5.0) based on DSM-IV criteria.
3. Adolescents diagnosed using the M.I.N.I. Kid version.
4. No lithium use over the past year.
5. Not in an acute phase of illness.
6. Patient or guardian able to participate in assessment interviews.
7. Informed consent signed by participants and guardians (for adolescents).
Exclusion Criteria
2. Severe cognitive impairments, including developmental delays or dementia.
12 Years
45 Years
ALL
No
Sponsors
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Jiangsu Nhwa Pharmaceutical Co., Ltd.
INDUSTRY
Peking University
OTHER
Responsible Party
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Locations
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Mental Health Institute of Peking University
Beijing, Beijing Municipality, China
Countries
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Central Contacts
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Facility Contacts
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Other Identifiers
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F2023-12-20-4-1
Identifier Type: -
Identifier Source: org_study_id
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