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

Peking University

Status: Enrolling

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

Treatments: Drug: Non-lithium medication; Drug: Lithium Carbonate

Study type: Observational

Funder types: Other; Industry

Identifiers

NCT06424613

F2023-12-20-4-1

Details and patient eligibility

About

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.

Enrollment: 600 estimated patients

Sex: All

Ages: 12 to 45 years old

Volunteers: No Healthy Volunteers

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.

Trial design

600 participants in 2 patient groups

Lithium Group

Treatment:

Drug: Lithium Carbonate

Non-lithium Group

Treatment:

Drug: Non-lithium medication