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 2018/03/05 12:24:49

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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 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


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

Value
https://center6.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