Clinical Trials Logo

Clinical Trial Details — Status: Recruiting

Administrative data

NCT number NCT06424613
Other study ID # F2023-12-20-4-1
Secondary ID
Status Recruiting
Phase
First received
Last updated
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
Health authority
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.

Study Design


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
See also
  Status Clinical Trial Phase
Completed NCT05111548 - Brain Stimulation and Cognitive Training - Efficacy N/A
Completed NCT02855762 - Targeting the Microbiome to Improve Clinical Outcomes in Bipolar Disorder N/A
Recruiting NCT05915013 - Alpha-Amino-3-Hydroxy-5-Methyl-4- Isoxazole Propionic Acid Receptor Components of the Anti-Depressant Ketamine Response Phase 1
Recruiting NCT05206747 - Ottawa Sunglasses at Night for Mania Study N/A
Completed NCT02513654 - Pharmacokinetics, Safety and Tolerability of Repeat Dosing Lamotrigine in Healthy Chinese Subjects Phase 1
Recruiting NCT06313918 - Exercise Therapy in Mental Disorders-study N/A
Completed NCT02304432 - Targeting a Genetic Mutation in Glycine Metabolism With D-cycloserine Early Phase 1
Recruiting NCT06197048 - Effect of Nutritional Counseling on Anthropometry and Biomarkers in Patients Diagnosed With Schizophrenia/Psychosis or Bipolar Affective Disorder N/A
Completed NCT03497663 - VIA Family - Family Based Early Intervention Versus Treatment as Usual N/A
Completed NCT04284813 - Families With Substance Use and Psychosis: A Pilot Study N/A
Completed NCT02212041 - Electronic Cigarettes in Smokers With Mental Illness N/A
Recruiting NCT05030272 - Comparing Two Behavioral Approaches to Quitting Smoking in Mental Health Settings N/A
Recruiting NCT04298450 - ED to EPI: Using SMS to Improve the Transition From the Emergency Department to Early Psychosis Intervention N/A
Active, not recruiting NCT03641300 - Efficacy of Convulsive Therapies for Bipolar Depression N/A
Not yet recruiting NCT04432116 - Time and Virtual Reality in Schizophrenia and Bipolar Disorder N/A
Terminated NCT02909504 - Gao NARASD Lithium Study Phase 4
Terminated NCT02893371 - Longitudinal Comparative Effectiveness of Bipolar Disorder Therapies
Completed NCT02970721 - Use of Psychotropic Medications Among Pregnant Women With Bipolar Disorder
Recruiting NCT03088657 - Design and Methods of the Mood Disorder Cohort Research Consortium (MDCRC) Study
Recruiting NCT02481245 - BezafibrateTreatment for Bipolar Depression: A Proof of Concept Study Phase 2