UMIN-CTR Clinical Trial
| Unique ID issued by UMIN | UMIN000031579 |
|---|---|
| Receipt number | 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 | 2026/09/10 10:32:32 |
* 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 | Taro |
| Middle name | |
| Last name | Kishi |
Organization
Fujita Health University School of Medicine
Division name
Psychiatry
Zip code
470-1192
Address
1-98 Dengakugakubo, Kutsukake, Toyoake, Aichi Pref, Japan
TEL
0562-93-2111
tarok@fujita-hu.ac.jp
Public contact
Name of contact person
| 1st name | Taro |
| Middle name | |
| Last name | Kishi |
Organization
Fujita Health University School of Medicine
Division name
Psychiatry
Zip code
470-1192
Address
1-98 Dengakugakubo, Kutsukake, Toyoake, Aichi Pref, Japan
TEL
0562-93-2111
Homepage URL
tarok@fujita-hu.ac.jp
Sponsor or person
Institute
Fujita Health University School of Medicine
Institute
Department
Personal name
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
Fujita Health University Ethics Committee
Address
1-98 Dengakugakubo, Kutsukake-cho, Toyoake, Aichi
Tel
0562-93-2865
f-irb@fujita-hu.ac.jp
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
| 2018 | Year | 03 | Month | 30 | Day |
Anticipated trial start date
| 2018 | Year | 03 | Month | 05 | Day |
Last follow-up date
| 2020 | Year | 03 | Month | 31 | Day |
Date of closure to data entry
| 2020 | Year | 03 | Month | 31 | Day |
Date trial data considered complete
| 2020 | Year | 03 | Month | 31 | Day |
Date analysis concluded
| 2020 | Year | 03 | Month | 31 | Day |
Other
Other related information
Management information
Registered date
| 2018 | Year | 03 | Month | 05 | Day |
Last modified on
| 2026 | Year | 09 | Month | 10 | Day |
Link to view the page
Value
https://center6.umin.ac.jp/cgi-open-bin/icdr_e/ctr_view.cgi?recptno=R000036057
