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acosamide for bipolar disorder

Phase 2
Conditions
bipolar disorder
D001714
Registration Number
JPRN-jRCTs041180033
Lead Sponsor
Kishi Taro
Brief Summary

acosamide improve depressive symptoms in patients with bipolar disorder.

Detailed Description

Not available

Recruitment & Eligibility

Status
Complete
Sex
All
Target Recruitment
20
Inclusion 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.

Exclusion 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

Study & Design

Study Type
Interventional
Study Design
Not specified
Primary Outcome Measures
NameTimeMethod
Secondary Outcome Measures
NameTimeMethod
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