UMIN-CTR Clinical Trial

Basic information
Official scientific title of the study	Analysis of genome and blood components for elucidation and treatment on dementia
Title of the study (Brief title)	Analysis of genome and blood components for elucidation and treatment on dementia
Region	Japan

Condition
Condition	dementia
Classification by specialty	Psychiatry Adult
Classification by malignancy	Others
Genomic information	YES

Objectives
Narrative objectives1	For dementia, we investigate that determine neurotransmitter, neurotrophin and their genome. Thereby, we clarify its mechanism and treatment protocol.
Basic objectives2	Safety,Efficacy
Basic objectives -Others
Trial characteristics_1	Confirmatory
Trial characteristics_2	Explanatory
Developmental phase	Not applicable

Assessment
Primary outcomes	Neuropsychiatric Inventory (NPI)
Key secondary outcomes	Mini Mental State Examination (MMSE)

In outcomes field, the entry of just a few words such as "safety" or "efficiency" will not be accepted. Specify the name of outcome measures, including the time when you plan to measure. Usually, only one primary outcome is accepted. Write the other outcomes in "secondary outcomes" field.

Base
Study type	Interventional

Study design
Basic design	Parallel
Randomization	Randomized
Randomization unit	Cluster
Blinding	Double blind -all involved are blinded
Control	Uncontrolled
Stratification	YES
Dynamic allocation	YES
Institution consideration	Institution is considered as a block.
Blocking	YES
Concealment	Central registration

Intervention
No. of arms	3
Purpose of intervention	Treatment
Type of intervention	Medicine
Interventions/Control_1	Antipsychotic agents
Interventions/Control_2	Antidepressants
Interventions/Control_3	Chinese herb
Interventions/Control_4
Interventions/Control_5
Interventions/Control_6
Interventions/Control_7
Interventions/Control_8
Interventions/Control_9
Interventions/Control_10

In interventions field, include the details of interventions, such as duration, amount, and frequency. If the intervention includes prescription or use of medical devices, duration is required.

Eligibility
Age-lower limit	Not applicable
Age-upper limit	Not applicable
Gender	Male and Female
Key inclusion criteria	dementia
Key exclusion criteria	severe physical illness
Target sample size	200

Research contact person
Name of lead principal investigator	Masatake Kurita
Organization	Social medical corporation Koutokukai Sato Hospital
Division name	Department of education and research
Address	Kunugiduka 948-1, Nanyo City, Yamagata
TEL	0238-40-3170
Email	kurita@koutoku.or.jp

Public contact
Name of contact person	Masatake Kurita
Organization	Social medical corporation Koutokukai Sato Hospital
Division name	Department of education and research
Address	Kunugiduka 948-1, Nanyo City, Yamagata
TEL	0238-40-3170
Homepage URL
Email	kurita@koutoku.or.jp

Sponsor
Institute	Social medical corporation Koutokukai Sato Hospital
Institute
Department

Sponsor means an organization that is responsible for plan, deployment and report of the research including funding management. It doesn't mean funding agency". Therefore, all clinical trial should have the one.

Funding Source
Organization	Social medical corporation Koutokukai Sato Hospital
Organization
Division
Category of Funding Organization	Self funding
Nationality of Funding Organization

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

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	社会医療法人　公徳会　佐藤病院（山形県）

Other administrative information
Date of disclosure of the study information	2011 Year 08 Month 11 Day

Progress
Recruitment status	Enrolling by invitation
Date of protocol fixation	2008 Year 04 Month 01 Day
Anticipated trial start date	2009 Year 01 Month 01 Day
Last follow-up date
Date of closure to data entry
Date trial data considered complete
Date analysis concluded

Related information
URL releasing protocol
Publication of results	Unpublished
URL releasing results
Results	J Clin Psychopharmacol. 2013 Oct;33(5):600-7. doi: 10.1097/JCP.0b013e31829798d5. Efficacy and tolerability of risperidone, yokukansan, and fluvoxamine for the treatment of behavioral and psychological symptoms of dementia: a blinded, randomized trial. Teranishi M1, Kurita M, Nishino S, Takeyoshi K, Numata Y, Sato T, Tateno A, Okubo Y.
Other related information

Management information
Registered date	2011 Year 08 Month 11 Day
Last modified on	2016 Year 04 Month 04 Day

Link to view the page
URL(English)	https://upload.umin.ac.jp/cgi-bin/ctr_e/ctr_view.cgi?recptno=R000007269