## Protocol Section
### Identification Module
**NCT ID:** NCT06424613

**Brief Title:** 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

#### Organization Study ID Info
**ID:** F2023-12-20-4-1
#### Organization
**Class:** OTHER
**Full Name:** Peking University
### Status Module
#### Completion Date
**Date:** 2024-12-31

**Type:** ESTIMATED

#### Expanded Access Info
#### Last Update Post Date
**Date:** 2024-05-22

**Type:** ACTUAL

**Last Update Submit Date:** 2024-05-16

**Overall Status:** RECRUITING

#### Primary Completion Date
**Date:** 2024-12-31

**Type:** ESTIMATED

#### Start Date
**Date:** 2024-04-18

**Type:** ACTUAL

**Status Verified Date:** 2024-05

#### Study First Post Date
**Date:** 2024-05-22
**Type:** ACTUAL
**Study First Submit Date:** 2024-05-16
**Study First Submit QC Date:** 2024-05-16
### Sponsor Collaborators Module

#### Collaborators

**Class:** INDUSTRY

**Name:** Jiangsu Nhwa Pharmaceutical Co., Ltd.

#### Lead Sponsor

**Class:** OTHER

**Name:** Peking University

#### Responsible Party

**Type:** SPONSOR

### Oversight Module

**Is FDA Regulated Device:** False

**Is FDA Regulated Drug:** False

### Description Module

**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.

### Conditions Module

**Conditions:**

- Bipolar Disorder

- Suicidal Ideation

- Suicide, Attempted

- Nonsuicidal Self Injury

**Keywords:**

- Lithium

- Bipolar disorder

- Suicide

- Nonsuicidal Self Injury

### Design Module

#### Design Info

**Observational Model:** COHORT

**Time Perspective:** RETROSPECTIVE

#### Enrollment Info

**Count:** 600

**Type:** ESTIMATED

**Study Type:** OBSERVATIONAL

### Arms Interventions Module

#### Arm Group 1

**Intervention Names:**

- Drug: Lithium Carbonate

**Label:** Lithium Group

#### Arm Group 2

**Intervention Names:**

- Drug: Non-lithium medication

**Label:** Non-lithium Group

### Interventions

#### Intervention 1

**Arm Group Labels:**

- Lithium Group

**Description:** 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.

**Name:** Lithium Carbonate

**Type:** DRUG

#### Intervention 2

**Arm Group Labels:**

- Non-lithium Group

**Description:** No history of lithium use within the past year

**Name:** Non-lithium medication

**Type:** DRUG

### Outcomes Module

#### Other Outcomes

**Description:** measured by Beck Depression Inventory

**Measure:** Depressive symptoms

**Time Frame:** over the past two weeks

**Description:** measured by Mood Disorder Questionnaire

**Measure:** Mood symptoms

**Time Frame:** over the past year

#### Primary Outcomes

**Description:** Measured using the Columbia Suicide Severity Rating Scale (C-SSRS)

**Measure:** Suicidal ideation

**Time Frame:** over the past year

#### Secondary Outcomes

**Description:** measured using the Columbia Suicide Severity Rating Scale (C-SSRS)

**Measure:** Suicidal attempt

**Time Frame:** over the past year

**Measure:** Non-suicidal self-injury

**Time Frame:** over the past year

**Description:** measured using the Chinese version of the Buss \& Perry Aggression Questionnaire

**Measure:** Violent and aggressive behaviors

**Time Frame:** over the past year

### Eligibility Module

**Eligibility Criteria:** 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.

**Maximum Age:** 45 Years

**Minimum Age:** 12 Years

**Sampling Method:** NON_PROBABILITY_SAMPLE

**Sex:** ALL

**Standard Ages:**

- CHILD

- ADULT

**Study Population:** Individuals with bipolar disorder ranged in age from 12 to 45 years

### Contacts Locations Module

#### Central Contacts

**Contact 1:**

**Email:** yuxin@bjmu.edu.cn

**Name:** Xin Yu

**Phone:** 86-10-82801999

**Role:** CONTACT

**Contact 2:**

**Email:** nixu@bjmu.edu.cn

**Name:** Ni Xu

**Role:** CONTACT

#### Locations

**Location 1:**

**City:** Beijing

**Contacts:**

***Contact 1:***

- **Email:** yuxin@bjmu.edu.cn

- **Name:** Xin Yu, Professor

- **Phone:** 86-10-82801999

- **Role:** CONTACT

**Country:** China

**Facility:** Mental Health Institute of Peking University

**State:** Beijing

**Status:** RECRUITING

**Zip:** 100191

### IPD Sharing Statement Module

**IPD Sharing:** NO

## Derived Section

### Condition Browse Module - Ancestors

- ID: D000068105

- Term: Bipolar and Related Disorders

- ID: D000019964

- Term: Mood Disorders

- ID: D000001523

- Term: Mental Disorders

- ID: D000001526

- Term: Behavioral Symptoms

### Condition Browse Module - Browse Branches

- Abbrev: BXM

- Name: Behaviors and Mental Disorders

- Abbrev: All

- Name: All Conditions

### Condition Browse Module - Browse Leaves

- ID: M4996

- Name: Bipolar Disorder

- Relevance: HIGH

- As Found: Bipolar Disorder

- ID: M29364

- Name: Suicidal Ideation

- Relevance: HIGH

- As Found: Suicidal Ideation

- ID: M16191

- Name: Suicide

- Relevance: HIGH

- As Found: Suicide

- ID: M16192

- Name: Suicide, Attempted

- Relevance: HIGH

- As Found: Suicide, Attempted

- ID: M19089

- Name: Self-Injurious Behavior

- Relevance: HIGH

- As Found: Nonsuicidal Self-injury

- ID: M2958

- Name: Suicide Prevention

- Relevance: LOW

- As Found: Unknown

- ID: M226

- Name: Bipolar and Related Disorders

- Relevance: LOW

- As Found: Unknown

- ID: M21835

- Name: Mood Disorders

- Relevance: LOW

- As Found: Unknown

- ID: M4815

- Name: Mental Disorders

- Relevance: LOW

- As Found: Unknown

- ID: M14473

- Name: Psychotic Disorders

- Relevance: LOW

- As Found: Unknown

- ID: M4818

- Name: Behavioral Symptoms

- Relevance: LOW

- As Found: Unknown

### Condition Browse Module - Meshes

- ID: D000001714

- Term: Bipolar Disorder

- ID: D000013405

- Term: Suicide

- ID: D000059020

- Term: Suicidal Ideation

- ID: D000013406

- Term: Suicide, Attempted

- ID: D000016728

- Term: Self-Injurious Behavior

### Intervention Browse Module - Ancestors

- ID: D000000928

- Term: Antidepressive Agents

- ID: D000011619

- Term: Psychotropic Drugs

- ID: D000004791

- Term: Enzyme Inhibitors

- ID: D000045504

- Term: Molecular Mechanisms of Pharmacological Action

- ID: D000018692

- Term: Antimanic Agents

- ID: D000014149

- Term: Tranquilizing Agents

- ID: D000002492

- Term: Central Nervous System Depressants

- ID: D000045505

- Term: Physiological Effects of Drugs

### Intervention Browse Module - Browse Branches

- Abbrev: CNSDep

- Name: Central Nervous System Depressants

- Abbrev: PsychDr

- Name: Psychotropic Drugs

- Abbrev: All

- Name: All Drugs and Chemicals

### Intervention Browse Module - Browse Leaves

- ID: M19022

- Name: Lithium Carbonate

- Relevance: HIGH

- As Found: Labeling

- ID: M4247

- Name: Antidepressive Agents

- Relevance: LOW

- As Found: Unknown

- ID: M14474

- Name: Psychotropic Drugs

- Relevance: LOW

- As Found: Unknown

- ID: M7951

- Name: Enzyme Inhibitors

- Relevance: LOW

- As Found: Unknown

### Intervention Browse Module - Meshes

- ID: D000016651

- Term: Lithium Carbonate

### Misc Info Module

- Version Holder: 2024-05-31
