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

Bipolar Disorder Clinical Trial

Official title:

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

Clinical Trial Details — Status: Recruiting

Administrative data

• NCT number: NCT06424613
• Other study ID #: F2023-12-20-4-1
• Status: Recruiting
• Start date: April 18, 2024
• Est. completion date: December 31, 2024

Study information

• Verified date: May 2024
• Source: Peking University
• Contact: Xin Yu
• Phone: 86-10-82801999
• Email: yuxin[@]bjmu.edu.cn
• Is FDA regulated: No
• Study type: Observational

Clinical Trial 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.

Recruitment information / eligibility

• Status: Recruiting
• Enrollment: 600
• Est. completion date: December 31, 2024
• Est. primary completion date: December 31, 2024
• Accepts healthy volunteers: No
• Gender: All
• Age group: 12 Years to 45 Years

Eligibility

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.

Related Conditions & MeSH terms

• Bipolar Disorder
• Nonsuicidal Self Injury
• Self-Injurious Behavior
• Suicidal Ideation
• Suicide
• Suicide, Attempted

Intervention

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 medication
No history of lithium use within the past year

Locations

Country	Name	City	State
China	Mental Health Institute of Peking University	Beijing	Beijing

Sponsors (2)

Lead Sponsor	Collaborator
Peking University	Jiangsu Nhwa Pharmaceutical Co., Ltd.

Country where clinical trial is conducted

China, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Other	Depressive symptoms	measured by Beck Depression Inventory	over the past two weeks
Other	Mood symptoms	measured by Mood Disorder Questionnaire	over the past year
Primary	Suicidal ideation	Measured using the Columbia Suicide Severity Rating Scale (C-SSRS)	over the past year
Secondary	Suicidal attempt	measured using the Columbia Suicide Severity Rating Scale (C-SSRS)	over the past year
Secondary	Non-suicidal self-injury		over the past year
Secondary	Violent and aggressive behaviors	measured using the Chinese version of the Buss & Perry Aggression Questionnaire	over the past year