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
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
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
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
