UMIN-CTR Clinical Trial

Unique ID issued by UMIN UMIN000037437
Receipt number R000042673
Scientific Title Effect of zonisamide on psychotropic drug induced weight gain
Date of disclosure of the study information 2019/08/01
Last modified on 2024/01/24 19:12:09

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Basic information

Public title

Effect of zonisamide on psychotropic drug induced weight gain

Acronym

Effect of zonisamide on psychotropic drug induced weight gain

Scientific Title

Effect of zonisamide on psychotropic drug induced weight gain

Scientific Title:Acronym

Effect of zonisamide on psychotropic drug induced weight gain

Region

Japan


Condition

Condition

Psychotropic drug induced weight gain

Classification by specialty

Psychiatry

Classification by malignancy

Others

Genomic information

NO


Objectives

Narrative objectives1

To estimate the effect of zonisamide on psychotropic drug induced weight gain.

Basic objectives2

Efficacy

Basic objectives -Others


Trial characteristics_1

Exploratory

Trial characteristics_2

Pragmatic

Developmental phase

Not applicable


Assessment

Primary outcomes

Body weight after 2 months.

Key secondary outcomes

Waist circumference, BMI, etc.


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

Administer zonisamide 400-600mg/day to whom topiramate was not effective. When zonisamide alone is not effective, combine zonisamide with topiramate.

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


Not applicable

Age-upper limit


Not applicable

Gender

Male and Female

Key inclusion criteria

Topiramate was not effective to psychotropic drug induced weight gain.

Key exclusion criteria

Not applicable.

Target sample size

10


Research contact person

Name of lead principal investigator

1st name Masatoshi
Middle name
Last name Eda

Organization

Hokkaido Prefectural Midorigaoka Hospital

Division name

Psychiatry

Zip code

080-0334

Address

Hokkaido Kato-gun Otofuke-cho Midorigaoka 1

TEL

0155-42-3377

Email

masazo2008@gmail.com


Public contact

Name of contact person

1st name Masatoshi
Middle name
Last name Eda

Organization

Hokkaido Prefectural Midorigaoka Hospital

Division name

Psychiatry

Zip code

080-0334

Address

Hokkaido Kato-gun Otofuke-cho Midorigaoka 1

TEL

0155-42-3377

Homepage URL


Email

masazo2008@gmail.com


Sponsor or person

Institute

Hokkaido Prefectural Midorigaoka Hospital

Institute

Department

Personal name



Funding Source

Organization

None.

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

Hokkaido Prefectural Midorigaoka Hospital

Address

Hokkaido Kato-gun Otofuke-cho Midorigaoka 1

Tel

0155-42-3377

Email

masazo2008@gmail.com


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



Other administrative information

Date of disclosure of the study information

2019 Year 08 Month 01 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

Terminated

Date of protocol fixation

2019 Year 06 Month 12 Day

Date of IRB

2019 Year 06 Month 12 Day

Anticipated trial start date

2019 Year 06 Month 12 Day

Last follow-up date

2021 Year 12 Month 31 Day

Date of closure to data entry


Date trial data considered complete


Date analysis concluded



Other

Other related information



Management information

Registered date

2019 Year 07 Month 21 Day

Last modified on

2024 Year 01 Month 24 Day



Link to view the page

Value
https://center6.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000042673


Research Plan
Registered date File name

Research case data specifications
Registered date File name

Research case data
Registered date File name