UMIN-CTR Clinical Trial

BACK TOP
UMIN-CTR English Home Glossary (Simple) FAQ Search clinical trials

Name:
UMIN ID:

Recruitment status Open public recruiting
Unique ID issued by UMIN UMIN000031579
Receipt No. R000036057
Scientific Title Lacosamide for treatment-resistant bipolar disorder: a open-label study
Date of disclosure of the study information 2018/03/05
Last modified on 2018/03/05

* This page includes information on clinical trials registered in UMIN clinical trial registed system.
* We don't aim to advertise certain products or treatments


Basic information
Public title Lacosamide for treatment-resistant bipolar disorder: a open-label study
Acronym Lacosamide for treatment-resistant bipolar disorder
Scientific Title Lacosamide for treatment-resistant bipolar disorder: a open-label study
Scientific Title:Acronym Lacosamide for treatment-resistant bipolar disorder
Region
Japan

Condition
Condition treatment-resistant bipolar disorder
Classification by specialty
Psychiatry
Classification by malignancy Others
Genomic information NO

Objectives
Narrative objectives1 Investigation whether lacosamide has therapeutic potential for treatment-resistant bipolar disorder.
Basic objectives2 Safety,Efficacy
Basic objectives -Others
Trial characteristics_1 Exploratory
Trial characteristics_2 Explanatory
Developmental phase Not applicable

Assessment
Primary outcomes Clinical Global Impression-Severity score from baseline to endpoint (12 weeks)
Key secondary outcomes Young Mania Rating Scale, Hamilton Rating Scale for Depression, discontinuation rate, incidence of individual adverse events

Base
Study type Interventional

Study design
Basic design Single arm
Randomization Non-randomized
Randomization unit
Blinding Open -no one is blinded
Control Uncontrolled
Stratification NO
Dynamic allocation NO
Institution consideration
Blocking NO
Concealment No need to know

Intervention
No. of arms 1
Purpose of intervention Treatment
Type of intervention
Medicine
Interventions/Control_1 lacosamide200mg/day
Interventions/Control_2
Interventions/Control_3
Interventions/Control_4
Interventions/Control_5
Interventions/Control_6
Interventions/Control_7
Interventions/Control_8
Interventions/Control_9
Interventions/Control_10

Eligibility
Age-lower limit
25 years-old <=
Age-upper limit
75 years-old >
Gender Male and Female
Key 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.
Key exclusion criteria no neurological or systemic diseases, including disturbance of hematopoiesis
no history of electroconvulsive therapy within 6 months prior to study enrollment
absence of pregnancy
no dependence on any addictive substances other than nicotine in the past 5 years before enrollment
no suicidal ideation and suicidal attempt
Target sample size 20

Research contact person
Name of lead principal investigator
1st name
Middle name
Last name Taro Kishi
Organization Fujita Health University School of Medicine
Division name Psychiatry
Zip code
Address 1-98 Dengakugakubo, Kutsukake, Toyoake, Aichi Pref, Japan
TEL 0562-93-2111
Email tarok@fujita-hu.ac.jp

Public contact
Name of contact person
1st name
Middle name
Last name Taro Kishi
Organization Fujita Health University School of Medicine
Division name Psychiatry
Zip code
Address 1-98 Dengakugakubo, Kutsukake, Toyoake, Aichi Pref, Japan
TEL 0562-93-2111
Homepage URL
Email tarok@fujita-hu.ac.jp

Sponsor
Institute Fujita Health University School of Medicine
Institute
Department

Funding Source
Organization Fujita Health University School of Medicine research grant
Organization
Division
Category of Funding Organization Other
Nationality of Funding Organization

Other related organizations
Co-sponsor
Name of secondary funder(s)

IRB Contact (For public release)
Organization
Address
Tel
Email

Secondary IDs
Secondary IDs NO
Study ID_1
Org. issuing International ID_1
Study ID_2
Org. issuing International ID_2
IND to MHLW

Institutions
Institutions 藤田保健衛生大学

Other administrative information
Date of disclosure of the study information
2018 Year 03 Month 05 Day

Related information
URL releasing protocol
Publication of results Unpublished

Result
URL related to results and publications
Number of participants that the trial has enrolled
Results
Results date posted
Results Delayed
Results Delay Reason
Date of the first journal publication of results
Baseline Characteristics
Participant flow
Adverse events
Outcome measures
Plan to share IPD
IPD sharing Plan description

Progress
Recruitment status Open public recruiting
Date of protocol fixation
2018 Year 03 Month 05 Day
Date of IRB
Anticipated trial start date
2018 Year 03 Month 05 Day
Last follow-up date
Date of closure to data entry
Date trial data considered complete
Date analysis concluded

Other
Other related information

Management information
Registered date
2018 Year 03 Month 05 Day
Last modified on
2018 Year 03 Month 05 Day


Link to view the page
URL(English) https://upload.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000036057

Research Plan
Registered date File name

Research case data specifications
Registered date File name

Research case data
Registered date File name


Contact us.