臨床研究等提出・公開システム

Japanese

Date of registration	Jan. 29, 2019
Last modified on	Sept. 23, 2020
Trial ID	jRCTs041180033

Scientific Title	Lacosamide for treatment-resistant bipolar disorder: a open-label study (Lacosamide for bipolar disorder)
Public Title	Lacosamide for bipolar disorder (Lacosamide for bipolar disorder)

Completion date	Aug. 21, 2020
Result actual enrolment	20
Baseline Characteristics	Bipolar disorder
Participant flow	The study was completed because the target enrollment was reached.
Adverse events	1 patients who had severe adverse event (pseudo bartter syndrome). Other adverse events included at least one adverse event (40.0%), somnolence (15.0%), agitation (10.0%), dizziness (10.0%), constipation (10.0%), insomnia (5.0%), hypertension (5.0%) and nausea (5.0%).
Outcome measures	Lacosamide associated with a significant decrease in the CGI-S score at week 4, week 8 and week 12, and the HRSD21 score at weeks 4 and 12 but not at week 8. Lacosamide treatment reduced YMRS score at week 8 but not at weeks 4 and 12.
Brief summary	Lacosamide improve depressive symptoms in patients with bipolar disorder.
Date of posting of results summaries	Sept. 16, 2020

Plan to share IPD	No
Plan description	No
URL link to protocol file(s) with version and date	https://jrct.mhlw.go.jp/latest-detail/jRCTs041180033

Contact for Scientific Queries	Name	Kishi Taro
	Affiliation	Fujita Health University Hospital
	Address	1-98 Dengakugakubo, Kutsukake-cho, Toyoake, Aichi 470-1192, Japan
	Telephone	+81-562-93-9250
	E-mail	tarok@fujita-hu.ac.jp
Contact for Public Queries	Name	Kishi Taro
	Affiliation	Fujita Health University Hospital
	Address	1-98 Dengakugakubo, Kutsukake-cho, Toyoake, Aichi 470-1192, Japan
	Telephone	+81-562-93-9250
	E-mail	tarok@fujita-hu.ac.jp

Recruitment status	Complete

Anticipated date of first enrollment		Mar. 05, 2018
Actual date of first enrollment		April. 16, 2018
Target sample size		20
Study Type		Interventional
Study Design	allocation	single arm study
	masking	open(masking not used)
	control	uncontrolled control
	assignment	single assignment
	purpose	treatment purpose
Key inclusion & exclusion 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	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
	Age Minimum	20age old
	Age Maximum	74age old
	Gender	Both
Health Condition(s) or Problem(s) Studied		bipolar disorder
Intervention(s)		taking lacosamide
Health Condition(s) Keyword		bipolar disorder
Intervention(s) Keyword		lacosamide
Health Condition(s) Code		D001714
Intervention(s) Code		D000078334
Primary Outcome(s)		Clinical Global Impression-Severity
Secondary Outcome(s)		Young Mania Rating Scale, Hamilton Rating Scale for Depression, discontinuation rate, incidence of individual adverse events

Source of Monetary Support	Research grant of Fujita Health University Hospital
Secondary Sponsor	Not applicable

Name of Certified Review Board	Fujita Health University Certified Clinical Research Review Board
Address	1-98 Dengakugakubo, Kutsukake-cho, Toyoake, Aichi
Telephone	+81-562-93-2865
E-Mail	f-irb@fujita-hu.ac.jp
Approval Status	Approval
Date of approval	Dec. 27, 2018

Countries of Recruitment（Except Japan）	none

History of Changes

No	Publication date
2	Sept. 23, 2020	(this page)	Changes
1	Jan. 29, 2019	Detail

List of change history