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Effects of Lithium on Suicide Prevention in Adolescents and Young Adults With Bipolar Disorder in China

Investigating the Effects of Lithium Carbonate on Suicide and Self-harm in Adolescents and Young Adults With Bipolar Disorder in China

Status
Recruiting
Phases
Unknown
Study type
Observational
Source
ClinicalTrials.gov
Registry ID
NCT06424613
Enrollment
600
Registered
2024-05-22
Start date
2024-04-18
Completion date
2024-12-31
Last updated
2024-05-22

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

Bipolar Disorder, Nonsuicidal Self Injury, Suicidal Ideation, Suicide, Attempted

Keywords

Lithium, Bipolar disorder, Suicide, Nonsuicidal Self Injury

Brief summary

This study aims to use a retrospective cohort approach to explore the impact of lithium carbonate on suicide and self-harm related events among adolescents and young adults with bipolar disorder in China.The primary objective of this study is to investigate the effects of lithium carbonate on suicidal ideation in adolescents and young adults with bipolar disorder in China. Secondary objectives include exploring its effects on preventing suicide attempts, non-suicidal self-injury, and aggressive behaviors in this population.

Interventions

DRUGLithium 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.

DRUGNon-lithium medication

No history of lithium use within the past year

Sponsors

Jiangsu Nhwa Pharmaceutical Co., Ltd.
CollaboratorINDUSTRY
Peking University
Lead SponsorOTHER

Study design

Observational model
COHORT
Time perspective
RETROSPECTIVE

Eligibility

Sex/Gender
ALL
Age
12 Years to 45 Years
Healthy volunteers
No

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

1. Severe physical illness or active substance abuse. 2. Severe cognitive impairments, including developmental delays or dementia.

Design outcomes

Primary

MeasureTime frameDescription
Suicidal ideationover the past yearMeasured using the Columbia Suicide Severity Rating Scale (C-SSRS)

Secondary

MeasureTime frameDescription
Suicidal attemptover the past yearmeasured using the Columbia Suicide Severity Rating Scale (C-SSRS)
Non-suicidal self-injuryover the past year
Violent and aggressive behaviorsover the past yearmeasured using the Chinese version of the Buss & Perry Aggression Questionnaire

Other

MeasureTime frameDescription
Depressive symptomsover the past two weeksmeasured by Beck Depression Inventory
Mood symptomsover the past yearmeasured by Mood Disorder Questionnaire

Countries

China

Contacts

Primary ContactXin Yu
yuxin@bjmu.edu.cn86-10-82801999
Backup ContactNi Xu
nixu@bjmu.edu.cn

Outcome results

None listed

Source: ClinicalTrials.gov · Data processed: Feb 4, 2026