Lacosamide for bipolar disorder

JRCT ID: jRCTs041180033

Registered date:29/01/2019

Basic Information

• Recruitment status: Complete
• Health condition(s) or Problem(s) studied: bipolar disorder
• Date of first enrollment: 16/04/2018
• Target sample size: 20
• Study type: Interventional
• Intervention(s): taking lacosamide

Outcome(s)

• Primary Outcome: Clinical Global Impression-Severity
• Secondary Outcome: Young Mania Rating Scale, Hamilton Rating Scale for Depression, discontinuation rate, incidence of individual adverse events

Key inclusion & exclusion criteria

• Age minimum: 20age
• Age maximum: 74age
• Gender: Both

Include criteria

1. The clinical trial was described in detail to the subjects, and written informed consent was obtained from all participants and their guardians. 2. patients age: 20 > years olds and < 70 years old 3. Patients met at least 2 the following inclusion criteria -Patients did not improve their symptoms using at least one mood stabilizer with adequate dose for 4 weeks or more than 4 weeks.
-Patients did not improve their symptoms using at least one second generation antipsychotic with adequate dose for 4 weeks or more than 4 weeks.
-Patients did not improve their symptoms using combination therapy of mood stabilizer with second generation antipsychotic with adequate dose for 4 weeks or more than 4 weeks.

Exclude criteria

1. patients receiving electroconvulsive therapy within 6 months prior to the study enrollment.
2. no pregnancy, no lactation.
3. no severe physical illness.
4. no neurological disease.
5. patients have suicidal ideation.
6. patients judged that researchers are inappropriate to participate in the study

Related Information

• Primary Sponsor: Kishi Taro
• Source(s) of Monetary Support: Research grant of Fujita Health University Hospital