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

NCT06424613 | Recruiting

• 1 other identifier: F2023-12-20-4-1
• Study Type: observational
• Target: 600
• Locations: 1 country
• Sites: 1

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.

Conditions

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

Keywords

Lithium; Bipolar disorder; Suicide; Nonsuicidal Self Injury

Outcome Measures

Primary Outcomes (1)

• Suicidal ideation

  Measured using the Columbia Suicide Severity Rating Scale (C-SSRS)

  over the past year

Secondary Outcomes (3)

• Suicidal attempt

  over the past year

• Non-suicidal self-injury

  over the past year

• Violent and aggressive behaviors

  over the past year

Other Outcomes (2)

• Depressive symptoms

  over the past two weeks

• Mood symptoms

  over the past year

Study Arms (2)

Lithium Group

Drug: Lithium Carbonate

Non-lithium Group

Drug: Non-lithium medication

Interventions

Lithium Carbonate DRUG

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.

Lithium Group

Non-lithium medication DRUG

No history of lithium use within the past year

Non-lithium Group

Eligibility Criteria

• Age: 12 Years - 45 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Child (0-17), Adult (18-64)
• Sampling Method: Non-Probability Sample

Study Population

Individuals with bipolar disorder ranged in age from 12 to 45 years

You may qualify if:

• For Lithium group
• Aged 12-45 years (adolescents 12-17, young adults 18-45).
• 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.
• Adolescents diagnosed using the M.I.N.I. Kid version.
• Lithium medication adherence of at least 80% in the first six months over the past year.
• Not in an acute phase of illness.
• Patient or guardian able to participate in assessment interviews.
• Informed consent signed by participants and guardians (for adolescents).
• for Non-lithium group
• Aged 12-45 years (adolescents 12-17, young adults 18-45).
• Diagnosed with bipolar disorder using the Mini-International Neuropsychiatric Interview (M.I.N.I.; version 5.0) based on DSM-IV criteria.
• Adolescents diagnosed using the M.I.N.I. Kid version.
• No lithium use over the past year.
• Not in an acute phase of illness.
• Patient or guardian able to participate in assessment interviews.

You may not qualify if:

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

Sponsors & Collaborators

• Peking University: lead
• Jiangsu Nhwa Pharmaceutical Co., Ltd.: collaborator

Study Sites (1)

Mental Health Institute of Peking University

Beijing, Beijing Municipality, 100191, China

RECRUITING

MeSH Terms

Conditions

Bipolar Disorder; Suicidal Ideation; Suicide, Attempted; Self-Injurious Behavior; Suicide

Interventions

Lithium Carbonate

Condition Hierarchy (Ancestors)

Bipolar and Related Disorders; Mood Disorders; Mental Disorders; Behavioral Symptoms; Behavior

Intervention Hierarchy (Ancestors)

Carbonates; Alkalies; Inorganic Chemicals; Carbonic Acid; Carbon Compounds, Inorganic; Lithium Compounds

Central Study Contacts

Xin Yu

CONTACT

86-10-82801999; yuxin@bjmu.edu.cn

Ni Xu

CONTACT

nixu@bjmu.edu.cn

Study Design

• Study Type: observational
• Observational Model: COHORT
• Time Perspective: RETROSPECTIVE
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: May 16, 2024
• First Posted: May 22, 2024
• Study Start: April 18, 2024
• Primary Completion: December 31, 2024
• Study Completion: December 31, 2024
• Last Updated: May 22, 2024

Record last verified: 2024-05

Data Sharing

• IPD Sharing: Will not share

Locations

CN (1)