Unique ID issued by UMIN | UMIN000009463 |
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Receipt number | R000011102 |
Scientific Title | Open-label study on the efficacy of lamotrigine in patients with brain tumor, stroke or head injury, and comorbid depressive symptoms |
Date of disclosure of the study information | 2012/12/03 |
Last modified on | 2015/06/03 13:55:14 |
Open-label study on the efficacy of lamotrigine in patients with brain tumor, stroke or head injury, and comorbid depressive symptoms
Efficacy of lamotrigine in neurosurgical patients with depressive symptoms
Open-label study on the efficacy of lamotrigine in patients with brain tumor, stroke or head injury, and comorbid depressive symptoms
Efficacy of lamotrigine in neurosurgical patients with depressive symptoms
Japan |
Depressive symptoms in patients with brain tumor, stroke, or head injuries, and comorbid epilepsy
Neurosurgery |
Others
NO
This study evaluates the antidepressant qualities of lamotrigine in neurosurgical patients with epilepsy
Safety,Efficacy
Confirmatory
Pragmatic
Hospital Anxiety and Depression Scale (HADS)
50% responder rate
Interventional
Single arm
Non-randomized
Open -no one is blinded
Uncontrolled
1
Treatment
Medicine |
5 months treatment
Patients taking an enzyme-inhibiting antiepileptic drug (AED) receive lamotrigine (LTG) 100 mg per day, and those taking an enzyme-inducing AED receive LTG 200 mg per day.
20 | years-old | <= |
Not applicable |
Male and Female
Included in this study are men and women aged 20 years and older who suffered from brain tumor, stroke, or head injuries and comorbid epilepsy, and who exhibit low to moderate depressive symptoms and are treated with antiepileptic drug. Each patient completes Hospital Anxiety and Depression Scale to verify the presence of mild depressive symptoms.
1.abnormal liver function
2.history of allergy to other antiepileptic drugs
3.currently pregnant
4.within two weeks after the patients suffered from head injury or stroke
5.within two weeks after brain surgery
6.the life expectancy is less than six months
7.concent of patients can not be obtained because of disturbance of consciousness or cognitive dysfunction
8.patients demonstrate bad compliance
50
1st name | |
Middle name | |
Last name | Kazuhiko Nozaki |
Shiga University of Medical Science
Department of Neurosurgery
Seta-Tsukinowa-Cho, Otsu, Shiga 520-2192, Japan
0775482257
noz@belle.shiga-med.ac.jp
1st name | |
Middle name | |
Last name | Naoki Nitta |
Shiga University of Medical Science
Department of Neurosurgery
Seta-Tsukinowa-Cho, Otsu, Shiga 520-2192, Japan
0775482257
nnitta@belle.shiga-med.ac.jp
Department of Neurosurgery,
Shiga University of Medical Science
Department of Neurosurgery,
Shiga University of Medical Science
Self funding
NO
滋賀医科大学付属病院
2012 | Year | 12 | Month | 03 | Day |
Unpublished
Completed
2012 | Year | 08 | Month | 17 | Day |
2013 | Year | 01 | Month | 01 | Day |
2012 | Year | 12 | Month | 03 | Day |
2015 | Year | 06 | Month | 03 | Day |
Value
https://center6.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000011102
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