Bipolar DisorderNCT06424613
Effects of Lithium on Suicide Prevention in Adolescents and Young Adults With Bipolar Disorder in China
An observational study of Bipolar Disorder and Suicidal Ideation, run by Peking University at 1 site in China.
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… Read more about this study
- Who is it for?
- Ages 12 to 45 years
- Conditions the study is for
- Bipolar Disorder, Suicidal Ideation, Suicide, Attempted
- What is being tested?
- Lithium Carbonate and Non-lithium medication
- How many people
- 600 participants
- Where
- 1 siteChina
- Study dates
- 18 Apr 2024to 31 Dec 2024
- Phase
- Observational
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 12 to 45 years
- All sexes
- No healthy volunteers
- Child, Adult
Study population: Individuals with bipolar disorder ranged in age from 12 to 45 years
Who may be able to join
- -
- 1 For Lithium group
- Aged 12-45 years (adolescents 12-17, young adults 18-45).
- 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.
- Adolescents diagnosed using the M.I.N.I. Kid version.
- Lithium medication adherence of at least 80% in the first six months over the past year.
Show all 17Show fewer
- Not in an acute phase of illness.
- Patient or guardian able to participate in assessment interviews.
- Informed consent signed by participants and guardians (for adolescents).
- 2 for Non-lithium group
- Aged 12-45 years (adolescents 12-17, young adults 18-45).
- Diagnosed with bipolar disorder using the Mini-International Neuropsychiatric Interview (M.I.N.I.; version 5.0) based on DSM-IV criteria.
- Adolescents diagnosed using the M.I.N.I. Kid version.
- No lithium use over the past year.
- Not in an acute phase of illness.
- Patient or guardian able to participate in assessment interviews.
- Informed consent signed by participants and guardians (for adolescents).
Who cannot join
- Severe physical illness or active substance abuse.
- Severe cognitive impairments, including developmental delays or dementia.
Trial locations and contacts
1 site in 1 country.
Ni Xu contact
China1 site, 1 recruiting
- Recruiting
Mental Health Institute of Peking University
Beijing, Beijing Municipality, 100191
Xin Yu, Professor, 86-10-82801999, yuxin@bjmu.edu.cn
About this study
Official title: 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.
- Being tested
- Lithium Carbonate, Non-lithium medication
- Keywords
- Lithium, Bipolar disorder, Suicide, Nonsuicidal Self Injury
- Medical subject headings
- Bipolar Disorder, Suicidal Ideation, Suicide, Attempted, Self-Injurious Behavior, Suicide
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Lithium CarbonateDrug
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 medicationDrug
No history of lithium use within the past year
| Study group | Role | What they receive |
|---|---|---|
| Lithium Group | Not described Receives: Drug: Lithium Carbonate | |
| Non-lithium Group | Not described Receives: Drug: Non-lithium medication |
What is being measured
The primary outcome is the main question the study is designed to answer.
Suicidal ideation
Measured using the Columbia Suicide Severity Rating Scale (C-SSRS)
Measured: over the past year
Secondary outcomes (3)
Suicidal attempt
measured using the Columbia Suicide Severity Rating Scale (C-SSRS)
Measured: over the past year
Non-suicidal self-injury
Measured: over the past year
Violent and aggressive behaviors
measured using the Chinese version of the Buss \& Perry Aggression Questionnaire
Measured: over the past year
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted22 May 2024
- Study start18 Apr 2024
- Primary completion31 Dec 2024 (estimated)
- Study completion31 Dec 2024 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Bipolar DisorderStudies of the same condition, open and under way.
- More trials run by Peking UniversityThe sponsor's other registered studies.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Observational
- Observational model
- Cohort
- Time perspective
- Retrospective
- Enrolment
- 600 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Peking University
- Sponsor type
- University, hospital or other
- Collaborators
- Jiangsu Nhwa Pharmaceutical Co., Ltd.
- Responsible party
- Sponsor
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT06424613
- Sponsor's protocol ID
- F2023-12-20-4-1
- Status last verified
- May 2024
- First submitted
- 16 May 2024
- Last updated
- 22 May 2024
- Results posted
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No
Study at a glance
From the registry record, last updated by the sponsor on 22 May 2024. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Investigating the Effects of Lithium Carbonate on Suicide and Self-harm in Adolescents and Young Adults With Bipolar Disorder in China
- ClinicalTrials.gov ID
- NCT06424613
- Acronym / sponsor ID
- F2023-12-20-4-1
- Keywords
- Lithium, Bipolar disorder, Suicide, Nonsuicidal Self Injury
- Study type
- Observational
- Recruitment status
- Unknown status
- Enrolment
- 600 participants (estimated)
- Lead sponsor
- Peking UniversityUniversity, hospital or other
- Collaborators
- Jiangsu Nhwa Pharmaceutical Co., Ltd.
- Study start
- 18 Apr 2024 (actual)
- Primary completion
- 31 Dec 2024 (estimated)
- Study completion
- 31 Dec 2024 (estimated)
- First posted
- 22 May 2024 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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 design
- Observational model
- Cohort
- Time perspective
- Retrospective
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Lithium Group | – | Drug: Lithium Carbonate |
| Non-lithium Group | – | Drug: Non-lithium medication |
Who may qualify
- Ages
- 12 to 45 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Child, Adult
- Study population
- Individuals with bipolar disorder ranged in age from 12 to 45 years
Key inclusion criteria (17 listed)
- -
- 1 For Lithium group
- Aged 12-45 years (adolescents 12-17, young adults 18-45).
- 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.
- Adolescents diagnosed using the M.I.N.I. Kid version.
Key exclusion criteria (2 listed)
- Severe physical illness or active substance abuse.
- Severe cognitive impairments, including developmental delays or dementia.
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Lithium CarbonateParticipants 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. | Drug | Lithium Group |
| Non-lithium medicationNo history of lithium use within the past year | Drug | Non-lithium Group |
Primary outcome
Suicidal ideation
Time frame: over the past year
Measured using the Columbia Suicide Severity Rating Scale (C-SSRS)
3 secondary outcomes
Suicidal attempt
Time frame: over the past year
Non-suicidal self-injury
Time frame: over the past year
Violent and aggressive behaviors
Time frame: over the past year
Results and safety
Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 22 May 2024.
- Individual participant dataSharing planned: No
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Ni Xu contact
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
An observational study of Bipolar Disorder and Suicidal Ideation, run by Peking University at 1 site in China.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 17 inclusion and 2 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: status not confirmed, as of the sponsor's last update on 22 May 2024. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in China. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
Results are not available in the source record.
How can a doctor refer a patient or contact the research team?
Contact Xin Yu (86-10-82801999, yuxin@bjmu.edu.cn), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Suicidal ideation (time frame: over the past year). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 22 May 2024.