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
Verified date | May 2024 |
Source | Peking University |
Contact | Xin Yu |
Phone | 86-10-82801999 |
yuxin[@]bjmu.edu.cn | |
Is FDA regulated | No |
Health authority | |
Study type | Observational |
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.
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. |
Country | Name | City | State |
---|---|---|---|
China | Mental Health Institute of Peking University | Beijing | Beijing |
Lead Sponsor | Collaborator |
---|---|
Peking University | Jiangsu Nhwa Pharmaceutical Co., Ltd. |
China,
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 |
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