UMIN-CTR Clinical Trial

Unique ID issued by UMIN UMIN000009463
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

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Basic information

Public title

Open-label study on the efficacy of lamotrigine in patients with brain tumor, stroke or head injury, and comorbid depressive symptoms

Acronym

Efficacy of lamotrigine in neurosurgical patients with depressive symptoms

Scientific Title

Open-label study on the efficacy of lamotrigine in patients with brain tumor, stroke or head injury, and comorbid depressive symptoms

Scientific Title:Acronym

Efficacy of lamotrigine in neurosurgical patients with depressive symptoms

Region

Japan


Condition

Condition

Depressive symptoms in patients with brain tumor, stroke, or head injuries, and comorbid epilepsy

Classification by specialty

Neurosurgery

Classification by malignancy

Others

Genomic information

NO


Objectives

Narrative objectives1

This study evaluates the antidepressant qualities of lamotrigine in neurosurgical patients with epilepsy

Basic objectives2

Safety,Efficacy

Basic objectives -Others


Trial characteristics_1

Confirmatory

Trial characteristics_2

Pragmatic

Developmental phase



Assessment

Primary outcomes

Hospital Anxiety and Depression Scale (HADS)

Key secondary outcomes

50% responder rate


Base

Study type

Interventional


Study design

Basic design

Single arm

Randomization

Non-randomized

Randomization unit


Blinding

Open -no one is blinded

Control

Uncontrolled

Stratification


Dynamic allocation


Institution consideration


Blocking


Concealment



Intervention

No. of arms

1

Purpose of intervention

Treatment

Type of intervention

Medicine

Interventions/Control_1

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.

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

20 years-old <=

Age-upper limit


Not applicable

Gender

Male and Female

Key inclusion criteria

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.

Key exclusion criteria

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

Target sample size

50


Research contact person

Name of lead principal investigator

1st name
Middle name
Last name Kazuhiko Nozaki

Organization

Shiga University of Medical Science

Division name

Department of Neurosurgery

Zip code


Address

Seta-Tsukinowa-Cho, Otsu, Shiga 520-2192, Japan

TEL

0775482257

Email

noz@belle.shiga-med.ac.jp


Public contact

Name of contact person

1st name
Middle name
Last name Naoki Nitta

Organization

Shiga University of Medical Science

Division name

Department of Neurosurgery

Zip code


Address

Seta-Tsukinowa-Cho, Otsu, Shiga 520-2192, Japan

TEL

0775482257

Homepage URL


Email

nnitta@belle.shiga-med.ac.jp


Sponsor or person

Institute

Department of Neurosurgery,
Shiga University of Medical Science

Institute

Department

Personal name



Funding Source

Organization

Department of Neurosurgery,
Shiga University of Medical Science

Organization

Division

Category of Funding Organization

Self funding

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

滋賀医科大学付属病院


Other administrative information

Date of disclosure of the study information

2012 Year 12 Month 03 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

Completed

Date of protocol fixation

2012 Year 08 Month 17 Day

Date of IRB


Anticipated trial start date

2013 Year 01 Month 01 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

2012 Year 12 Month 03 Day

Last modified on

2015 Year 06 Month 03 Day



Link to view the page

Value
https://center6.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000011102


Research Plan
Registered date File name

Research case data specifications
Registered date File name

Research case data
Registered date File name