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Name:
UMIN ID:

Recruitment status Enrolling by invitation
Unique ID issued by UMIN UMIN000004450
Receipt No. R000005326
Scientific Title Prevalence of bipolarity in hospitalized elderly patients in depressive or depressive mixed state and efficacy of mood stabilizer
Date of disclosure of the study information 2010/11/11
Last modified on 2013/03/09

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Basic information
Public title Prevalence of bipolarity in hospitalized elderly patients in depressive or depressive mixed state and efficacy of mood stabilizer
Acronym Bipolarity in elderly patients in depressive or depressive mixed state
Scientific Title Prevalence of bipolarity in hospitalized elderly patients in depressive or depressive mixed state and efficacy of mood stabilizer
Scientific Title:Acronym Bipolarity in elderly patients in depressive or depressive mixed state
Region
Japan

Condition
Condition depressive or depressive mixed state in elderly
Classification by specialty
Psychiatry
Classification by malignancy Others
Genomic information NO

Objectives
Narrative objectives1 Elderly patients with dementia visiting psychiatry hospital are often in depressive or depressive mixed state. Our previous study revealed presence of soft form of bipolar disorder in elderly population. Evaluation of bipolarity proposed by Akiskal and his colleagues may help diagnosis of soft bipolar.
The study aims to clarify prevalence of bipolarity and efficacy of mood stabilizer in this population.
Basic objectives2 Safety,Efficacy
Basic objectives -Others
Trial characteristics_1
Trial characteristics_2
Developmental phase

Assessment
Primary outcomes Prevalence of bipolarity
Key secondary outcomes Remission rate of depression with mood stabilizer

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
65 years-old <=
Age-upper limit

Not applicable
Gender Male and Female
Key inclusion criteria Elderly patients in depressive or depressive mixed state
Patients can be followed or observed according to the study protocol
Patients or their caregivers can provide necessary information for the stud
Key exclusion criteria patients with severe or unstable physical disease
Target sample size 100

Research contact person
Name of lead principal investigator
1st name
Middle name
Last name Shoryoku Hino
Organization Ishikawa Prefectural Takamatsu Hospital
Division name Department of Psychiatry
Zip code
Address Ya-36,Uchi-Takamatsu, Kahoku City 929-1293,Japan
TEL
Email

Public contact
Name of contact person
1st name
Middle name
Last name
Organization Ishikawa Prefectural Takamatsu Hospital
Division name Department of Psychiatry
Zip code
Address
TEL
Homepage URL
Email shoryok@ninus.ocn.ne.jp

Sponsor
Institute Ishikawa Prefectural Takamatsu Hospital
Institute
Department

Funding Source
Organization None
Organization
Division
Category of Funding Organization Self funding
Nationality of Funding Organization None

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

Other administrative information
Date of disclosure of the study information
2010 Year 11 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 Enrolling by invitation
Date of protocol fixation
2010 Year 11 Month 01 Day
Date of IRB
Anticipated trial start date
2010 Year 11 Month 01 Day
Last follow-up date
Date of closure to data entry
Date trial data considered complete
Date analysis concluded

Other
Other related information Bipolarity is evaluated in the elderly patients in depressive or depressive mixed state at their first visit. They are treated with mood stabilizer and responce rate and factors affecting efficacy of the treatments are evaluated.

Management information
Registered date
2010 Year 10 Month 26 Day
Last modified on
2013 Year 03 Month 09 Day


Link to view the page
URL(English) https://upload.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000005326

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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