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

Recruiting

• Conditions: Bipolar Disorder; Suicide, Attempted; Suicidal Ideation; Nonsuicidal Self Injury
• Interventions: Drug: Non-lithium medication; Drug: Lithium Carbonate

• Registration Number: NCT06424613
• Lead Sponsor: Peking University

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 dis...

Detailed Description

Not available

Basic Information
|
Recruitment & Eligibility
|
Study & Design
|
Trial Locations

Study Timeline

• Study Start: 2024-04-18
• Status Verified: 2024-05
• Study First Submitted: 2024-05-16
• Study First Submitted QC: 2024-05-16
• Last Update Submitted: 2024-05-16
• Study First Posted: 2024-05-22
• Last Update Posted: 2024-05-22
• Primary Completion: 2024-12-31
• Study Completion: 2024-12-31

Recruitment & Eligibility

• Status: RECRUITING
• Sex: All
• Target Recruitment: 600

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).

Read More

Exclusion Criteria

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

Read More

Study & Design

• Study Type: OBSERVATIONAL
• Study Design: Not specified

Arm && Interventions

Group	Intervention	Description
Non-lithium Group	Non-lithium medication	-
Lithium Group	Lithium Carbonate	-

Primary Outcome Measures

Name	Time	Method
Suicidal ideation	over the past year	Measured using the Columbia Suicide Severity Rating Scale (C-SSRS)

Secondary Outcome Measures

Name	Time	Method
Non-suicidal self-injury	over the past year
Violent and aggressive behaviors	over the past year	measured using the Chinese version of the Buss \& Perry Aggression Questionnaire
Suicidal attempt	over the past year	measured using the Columbia Suicide Severity Rating Scale (C-SSRS)

Trial Locations

Locations (1)

Mental Health Institute of Peking University; 🇨🇳 Beijing, Beijing, China