Clinical trial NCT06424613: Effects of Lithium on Suicide Prevention in Adolescents and Young Adults With Bipolar Disorder in China
Official title: Investigating the Effects of Lithium Carbonate on Suicide and Self-harm in Adolescents and Young Adults With Bipolar Disorder in China
Study type: OBSERVATIONAL
Overall status: RECRUITING
Conditions: Bipolar Disorder
Suicidal Ideation
Suicide, Attempted
Nonsuicidal Self Injury
Keywords: Lithium
Bipolar disorder
Suicide
Nonsuicidal Self Injury
Lead sponsor: Peking University
Sponsor class: OTHER
Collaborators: name: Jiangsu Nhwa Pharmaceutical Co., Ltd.
First posted: 2024-05-22
Enrollment: 600
Sex: ALL
Minimum age (years): 12
Maximum age (years): 45
Standard ages: CHILD
ADULT
Accepts healthy volunteers: no
Observational model: COHORT
Time perspective: RETROSPECTIVE
Sampling method: NON_PROBABILITY_SAMPLE
Study population: Individuals with bipolar disorder ranged in age from 12 to 45 years

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.


Eligibility criteria: Inclusion Criteria:

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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.

Primary outcomes:
measure: Suicidal ideation
timeFrame: over the past year
Secondary outcomes:
measure: Suicidal attempt
timeFrame: over the past year
measure: Non-suicidal self-injury
timeFrame: over the past year
measure: Violent and aggressive behaviors
timeFrame: over the past year
Other outcomes:
measure: Depressive symptoms
timeFrame: over the past two weeks
measure: Mood symptoms
timeFrame: over the past year
Locations:
city: Beijing
country: China
facility: Mental Health Institute of Peking University
state: Beijing
Study officials:
References: