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Name:
UMIN ID:

Recruitment status Enrolling by invitation
Unique ID issued by UMIN UMIN000037437
Receipt No. 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 2019/07/21

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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
Institute Hokkaido Prefectural Midorigaoka Hospital
Institute
Department

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 Enrolling by invitation
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
2019 Year 07 Month 21 Day


Link to view the page
URL(English) https://upload.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


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