Unique ID issued by UMIN | UMIN000031579 |
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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 | 2018/03/05 12:24:49 |
Lacosamide for treatment-resistant bipolar disorder: a open-label study
Lacosamide for treatment-resistant bipolar disorder
Lacosamide for treatment-resistant bipolar disorder: a open-label study
Lacosamide for treatment-resistant bipolar disorder
Japan |
treatment-resistant bipolar disorder
Psychiatry |
Others
NO
Investigation whether lacosamide has therapeutic potential for treatment-resistant bipolar disorder.
Safety,Efficacy
Exploratory
Explanatory
Not applicable
Clinical Global Impression-Severity score from baseline to endpoint (12 weeks)
Young Mania Rating Scale, Hamilton Rating Scale for Depression, discontinuation rate, incidence of individual adverse events
Interventional
Single arm
Non-randomized
Open -no one is blinded
Uncontrolled
NO
NO
NO
No need to know
1
Treatment
Medicine |
lacosamide200mg/day
25 | years-old | <= |
75 | years-old | > |
Male and Female
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.
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
20
1st name | |
Middle name | |
Last name | Taro Kishi |
Fujita Health University School of Medicine
Psychiatry
1-98 Dengakugakubo, Kutsukake, Toyoake, Aichi Pref, Japan
0562-93-2111
tarok@fujita-hu.ac.jp
1st name | |
Middle name | |
Last name | Taro Kishi |
Fujita Health University School of Medicine
Psychiatry
1-98 Dengakugakubo, Kutsukake, Toyoake, Aichi Pref, Japan
0562-93-2111
tarok@fujita-hu.ac.jp
Fujita Health University School of Medicine
Fujita Health University School of Medicine research grant
Other
NO
藤田保健衛生大学
2018 | Year | 03 | Month | 05 | Day |
Unpublished
Open public recruiting
2018 | Year | 03 | Month | 05 | Day |
2018 | Year | 03 | Month | 05 | Day |
2018 | Year | 03 | Month | 05 | Day |
2018 | Year | 03 | Month | 05 | Day |
Value
https://center6.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000036057
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