UMIN-CTR Clinical Trial

BACK TOP
UMIN-CTR English Home Glossary (Simple) FAQ Search clinical trials

Name:
UMIN ID:

Recruitment status Preinitiation
Unique ID issued by UMIN UMIN000045703
Receipt No. R000052153
Scientific Title Survey on medication status and needs of formulation in patients with bipolar disorder
Date of disclosure of the study information 2021/10/11
Last modified on 2021/10/08

* This page includes information on clinical trials registered in UMIN clinical trial registed system.
* We don't aim to advertise certain products or treatments


Basic information
Public title Survey on medication status and needs of formulation in patients with bipolar disorder
Acronym Survey on medication status and needs of formulation in patients with bipolar disorder
Scientific Title Survey on medication status and needs of formulation in patients with bipolar disorder
Scientific Title:Acronym Survey on medication status and needs of formulation in patients with bipolar disorder
Region
Japan

Condition
Condition Bipolar disorder
Classification by specialty
Psychiatry
Classification by malignancy Others
Genomic information NO

Objectives
Narrative objectives1 To investigate medication status and needs of formulation in patients with bipolar disorder, and determine the current status and reasons for adherence and patients' preferences of dosage forms in bipolar disorder.
To investigate whether patients' preferences are being confirmed when particularly prescribing LAI, and to explore the causes of low rates of prescription in patients with bipolar disorder
Basic objectives2 Others
Basic objectives -Others others
Trial characteristics_1 Others
Trial characteristics_2
Developmental phase Not applicable

Assessment
Primary outcomes Questionnaire items
Screening items: Diagnosis of bipolar disorder, presence or absence of therapeutic drug use
patient background: gender, age, occupation, home, educational background, hospitalization history, impact on illness life, etc.
Items related to drugs / dosage forms: satisfaction, adherence, dosage forms.
Key secondary outcomes

Base
Study type Observational

Study design
Basic design
Randomization
Randomization unit
Blinding
Control
Stratification
Dynamic allocation
Institution consideration
Blocking
Concealment

Intervention
No. of arms
Purpose of intervention
Type of intervention
Interventions/Control_1
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 1. Patients who answered "yes" to all the screening items in the questionnaire survey
2. Patients aged 20 years or older
Key exclusion criteria None
Target sample size 500

Research contact person
Name of lead principal investigator
1st name Ryo
Middle name
Last name Inuyama
Organization Otsuka Pharmaceutical Co., Ltd.
Division name Department of Medical Affairs
Zip code 108-8242
Address Shinagawa Grand Central Tower 2-16-4 Konan, Minato-ku, Tokyo 108-8242, Japan
TEL 03-6717-1400
Email Inuyama.Lyo@otsuka.jp

Public contact
Name of contact person
1st name Yuki
Middle name
Last name Shiomi
Organization Otsuka Pharmaceutical Co., Ltd.
Division name Department of Medical Affairs
Zip code 108-8242
Address Shinagawa Grand Central Tower 2-16-4 Konan, Minato-ku, Tokyo 108-8242, Japan
TEL 03-6717-1400
Homepage URL
Email shiomiy@otsuka.jp

Sponsor
Institute Otsuka Pharmaceutical Co., Ltd.
Department of Medical Affairs
Institute
Department

Funding Source
Organization Otsuka Pharmaceutical Co., Ltd.
Department of Medical Affairs
Organization
Division
Category of Funding Organization Profit organization
Nationality of Funding Organization Japan

Other related organizations
Co-sponsor
Name of secondary funder(s)

IRB Contact (For public release)
Organization The research ethics committee of Otsuka Pharmaceutical Co., Ltd
Address 463-10 Kagasuno,Kawauchi-cho,Tokushima-city,Tokushima
Tel 088-665-2126
Email Imaizumi.Takashi@otsuka.jp

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
2021 Year 10 Month 11 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 Preinitiation
Date of protocol fixation
2021 Year 09 Month 29 Day
Date of IRB
2021 Year 09 Month 29 Day
Anticipated trial start date
2021 Year 10 Month 11 Day
Last follow-up date
2021 Year 10 Month 29 Day
Date of closure to data entry
Date trial data considered complete
Date analysis concluded

Other
Other related information To investigate medication status and needs of formulation in patients with bipolar disorder, and determine the current status and reasons for adherence and patients' preferences of dosage forms in bipolar disorder.

Management information
Registered date
2021 Year 10 Month 08 Day
Last modified on
2021 Year 10 Month 08 Day


Link to view the page
URL(English) https://upload.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000052153

Research Plan
Registered date File name

Research case data specifications
Registered date File name

Research case data
Registered date File name


Contact us.