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

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.

Study Overview

• Status: Recruiting
• Conditions: Bipolar Disorder; Suicidal Ideation; Suicide, Attempted; Nonsuicidal Self Injury
• Intervention / Treatment: Drug: Lithium Carbonate; Drug: Non-lithium medication

• Study Type: Observational
• Enrollment (Estimated): 600

Contacts and Locations

• Study Contact: Name: Xin Yu; Phone Number: 86-10-82801999; Email: yuxin@bjmu.edu.cn
• Study Contact Backup: Name: Ni Xu; Email: nixu@bjmu.edu.cn

Study Locations

• China
  • Beijing
    • Beijing, Beijing, China, 100191
      • Recruiting
      • Mental Health Institute of Peking University
      • Contact: Xin Yu, Professor; Phone Number: 86-10-82801999; Email: yuxin@bjmu.edu.cn

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: Child; Adult
• Accepts Healthy Volunteers: No

• Sampling Method: Non-Probability Sample

Study Population

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

Description

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.

Study Plan

How is the study designed?

Number of groups / cohorts

2

Cohorts and Interventions

Group / Cohort	Intervention / Treatment
Lithium Group	Drug: 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	Drug: Non-lithium medication; No history of lithium use within the past year

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Suicidal ideation	Measured using the Columbia Suicide Severity Rating Scale (C-SSRS)	over the past year

Secondary Outcome Measures

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

Other Outcome Measures

Outcome Measure	Measure Description	Time Frame
Depressive symptoms	measured by Beck Depression Inventory	over the past two weeks
Mood symptoms	measured by Mood Disorder Questionnaire	over the past year

Collaborators and Investigators

• Sponsor: Peking University
• Collaborators: Jiangsu Nhwa Pharmaceutical Co., Ltd.

Study record dates

Study Major Dates

• Study Start (Actual): April 18, 2024
• Primary Completion (Estimated): December 31, 2024
• Study Completion (Estimated): December 31, 2024

Study Registration Dates

• First Submitted: May 16, 2024
• First Submitted That Met QC Criteria: May 16, 2024
• First Posted (Actual): May 22, 2024

Study Record Updates

• Last Update Posted (Actual): May 22, 2024
• Last Update Submitted That Met QC Criteria: May 16, 2024
• Last Verified: May 1, 2024

More Information

Terms related to this study

• Keywords: Suicide; Bipolar disorder; Lithium; Nonsuicidal Self Injury
• Additional Relevant MeSH Terms: Behavioral Symptoms; Mental Disorders; Mood Disorders; Bipolar and Related Disorders; Bipolar Disorder; Suicide; Suicidal Ideation; Suicide, Attempted; Self-Injurious Behavior; Physiological Effects of Drugs; Molecular Mechanisms of Pharmacological Action; Central Nervous System Depressants; Enzyme Inhibitors; Tranquilizing Agents; Psychotropic Drugs; Antidepressive Agents; Antimanic Agents; Lithium Carbonate
• Other Study ID Numbers: F2023-12-20-4-1

Plan for Individual participant data (IPD)

• Plan to Share Individual Participant Data (IPD)?: NO

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: No