UMIN-CTR Clinical Trial

Basic information
Official scientific title of the study	Effect of aripiprazole on swallowing function
Title of the study (Brief title)	Aripiprazole and swallowing function
Region	Japan

Condition
Condition	Schizophrenia
Classification by specialty	Geriatrics Psychiatry
Classification by malignancy	Others
Genomic information	NO

Objectives
Narrative objectives1	Aspiration is a major risk factor for pneumonia. We have previously reported that a use of neuroleptics depresses swallowing function and might be a risk for aspiration pneumonia. Aripiprazole is a partial agonist of dopamine D2 receptor and might not be a risk for aspiration pneumonia. We therefore examine the effect of apripiprazloe on the swallowing function in patients with schizophrenia.
Basic objectives2	Others
Basic objectives -Others	We study the other symptoms than swallowing function.
Trial characteristics_1	Confirmatory
Trial characteristics_2	Explanatory
Developmental phase

Assessment
Primary outcomes	We perform swallowing tests and measure swallowing latency in selected patients before and after administration of aripiprazole.
Key secondary outcomes

Base
Study type	Interventional

Study design
Basic design	Single arm
Randomization	Non-randomized
Randomization unit
Blinding	Open -no one is blinded
Control	No treatment
Stratification
Dynamic allocation
Institution consideration
Blocking
Concealment

Intervention
No. of arms	1
Purpose of intervention	Treatment
Type of intervention	Medicine
Interventions/Control_1	We perform swallowing tests and record the swallowing latency before and after administration of aripiprazole in schizophrenia patients with symptoms or signs of aspiration.
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	30 years-old <=
Age-upper limit	Not applicable
Gender	Male and Female
Key inclusion criteria	Eligible are schizophrenia patients older than 30 years having symptoms or signs of aspiration.
Key exclusion criteria	We exclude patients with delirium and infections.
Target sample size	50

Research contact person
Name of lead principal investigator	Takashi Ohrui
Organization	Institute of Development, Aging and Cancer, Tohoku University
Division name	Division of Geriatric Pharmacotherapy
Address	Seiryo-machi 4-1, Aoba-ku, Sendai, Japan
TEL	022-717-8480
Email	ohruit@idac.tohoku.ac.jp

Public contact
Name of contact person	Takashi Ohrui
Organization	Institute of Development, Aging and Cancer, Tohoku University
Division name	Division of Geriatric Pharmacotherapy
Address	Seiryo-machi 4-1, Aoba-ku, Sendai, Japan
TEL	022-717-8480
Homepage URL
Email	ohruit@idac.tohoku.ac.jp

Sponsor
Institute	Institute of Development, Aging and Cancer, Tohoku University
Institute
Department

Funding Source
Organization	Institute of Development, Aging and Cancer, Tohoku University
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	東北大学病院（Tohoku University Hospital）

Other administrative information
Date of disclosure of the study information	2012 Year 04 Month 30 Day

Progress
Recruitment status	Terminated
Date of protocol fixation	2012 Year 04 Month 30 Day
Anticipated trial start date	2012 Year 05 Month 01 Day
Last follow-up date	2014 Year 07 Month 08 Day
Date of closure to data entry	2014 Year 07 Month 08 Day
Date trial data considered complete	2014 Year 07 Month 08 Day
Date analysis concluded	2014 Year 07 Month 08 Day

Related information
URL releasing protocol
Publication of results	Unpublished
URL releasing results
Results
Other related information

Management information
Registered date	2012 Year 03 Month 30 Day
Last modified on	2016 Year 10 Month 03 Day

Link to view the page
URL(English)	https://upload.umin.ac.jp/cgi-open-bin/icdr_e/ctr_view.cgi?recptno=R000008993