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Lacosamide for bipolar disorder

Lacosamide for treatment-resistant bipolar disorder: a open-label study - Lacosamide for bipolar disorder

Status
Active, not recruiting
Phases
Phase 2
Study type
Interventional
Source
JPRN
Registry ID
JPRN-jRCTs041180033
Enrollment
20
Registered
2019-01-29
Start date
2018-04-16
Completion date
Unknown
Last updated
2026-06-29

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

Conditions

bipolar disorder bipolar disorder

Interventions

taking lacosamide
D000078334
lacosamide

Sponsors

Kishi Taro
Lead Sponsor

Eligibility

Sex/Gender
All

Inclusion criteria

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

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

Design outcomes

Primary

MeasureTime frame
Clinical Global Impression-Severity

Secondary

MeasureTime frame
Young Mania Rating Scale, Hamilton Rating Scale for Depression, discontinuation rate, incidence of individual adverse events

Contacts

Public ContactTaro Kishi

Fujita Health University Hospital

tarok@fujita-hu.ac.jp+81-562-93-9250

Outcome results

None listed

Source: JPRN (via WHO ICTRP) · Data processed: Jul 3, 2026