Lithium carbonate and lamotrigine monotherapy or combination therapy as maintenance treatment for childbearing women with bipolar disorder in remission: a randomized controlled study.

Status

Recruiting

Phases

Phase 4

Study type

Interventional

Source

ChiCTR

Registry ID

ChiCTR2000038166

Enrollment

Unknown

Registered

2020-09-11

Start date

2020-09-10

Completion date

Unknown

Last updated

2020-11-30

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

Bipolar disorder

Interventions

Group1:Lithium carbonate combined with Lamotrigine

Group 2:Lamotrigine

Eligibility

Sex/Gender

Female

Age

14 Years to 45 Years

Inclusion criteria

Inclusion criteria: 1. Women of childbearing age (aged 14-45 years); 2. Patients who met dsm-5 bipolar disorder diagnostic criteria (Mini 7.0.2); 3. The patients who received lithium carbonate combined with lamotrigine (lithium carbonate concentration of 0.4-1.0mmol/l, lamotrigine concentration of 3-14 ug/ml) for more than three months had good therapeutic effect, reaching the dsm-5 clinical remission or partial remission standard definition, clinical evaluation Global Impression scale cgi-bp-s <=3 points, MADRS <=12 points, YMRS <=8 points; 4. Patients who have received education for 5 years or more; 5. Patients who voluntarily participate in the study and sign informed consent.

Exclusion criteria

Exclusion criteria: 1. Patients who are considered unsuitable for the study by the researchers; 2. Patients who refuse to participate in this study can not sign informed consent or withdraw informed consent; 3. Patients with severe physical diseases, pregnancy or lactation patients; 4. Serious physical diseases such as heart, liver and kidney damage, severe hypothyroidism; 5. Lamotrigine has been used to treat patients with severe allergy; 6. Patients with mental retardation, dyslexia and unable to read normally; 7. The main diagnosis except attention deficit disorder, anxiety disorder, conduct disorder, oppositional defiant disorder.

Design outcomes

Primary

Measure	Time frame
recurrence rate;Time to recurrence;	—

Secondary

Measure	Time frame
Hamilton Depression Rating Scale for Depression- 17-item, HAMD17;Clinical Global Impression, CGI;Young Manic Rating Scale, YMRS;Montgomery Asberg Depression Rating Scale, MADRS;Globle Assessment Scale, GAS;Columbia-Suicide Severity Rating Scale, C-SSRS;	—

Countries

China

Contacts

Public ContactJiong Luo

Beijing Anding Hospital Affiliated to Capital Medical University

13716036201@163.com+86 13716036201

Outcome results

None listed

Source: ChiCTR (via WHO ICTRP) · Data processed: Feb 4, 2026