UMIN-CTR Clinical Trial

Basic information
Public title	A study of taste and perceptual tendencies that predict asenapine dropout
Acronym	Taste and Perceptual Tendency to Predict Asenapine Dropout
Scientific Title	A study of taste and perceptual tendencies that predict asenapine dropout
Scientific Title:Acronym	Taste and Perceptual Tendency to Predict Asenapine Dropout
Region	Japan

Condition
Condition	schizophrenia
Classification by specialty	Psychiatry
Classification by malignancy	Others
Genomic information	NO

Objectives
Narrative objectives1	The purpose of this study was to explore the perceptual and gustatory tendencies that predict dropout of asenapine (SYCREST) sublingual tablets, an antipsychotic drug known to be difficult to take due to numbness and bitterness, using a secretive survey.
Basic objectives2	Others
Basic objectives -Others	N/A
Trial characteristics_1
Trial characteristics_2
Developmental phase

Assessment
Primary outcomes	Differences in taste tendencies between those who continued to take asenapine and those who dropped out. Identification of taste trends that predict asenapine dropout.
Key secondary outcomes	Differences in preference for additional flavors between those who continue to take asenapine and those who drop out

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	80 years-old >=
Gender	Male and Female
Key inclusion criteria	1) Patients between the ages of 20 and 80 2)Patients receiving treatment at the outpatient department of neuropsychiatry, The Jikei University School of Medicine, Tokyo, Japan, or the Katsushika Medical Center, Tokyo Jikei University School of Medicine 3) Patients diagnosed with schizophrenia on the DSM-IV-TR 4) Patients taking the antipsychotic drug asenapine (SYCREST) 5) Patients who can read and understand the Notice of Consent Explanation.
Key exclusion criteria	1) Patients with schizophrenia who have significant hallucinatory delusions and significant behavioralization. 2) Patients with poor judgment due to psychiatric symptoms such as depressed mood, anxiety, agitation, elated mood, and aggression, who have difficulty participating in the study voluntarily. 3) Patients who are deemed inappropriate by the attending physician or physician in charge.
Target sample size	70

Research contact person
Name of lead principal investigator	1st name Fumitoshi Middle name Last name Kodaka
Organization	The Jikei University School of Medicine
Division name	Department of Psychiatry
Zip code	105-8471
Address	3-25-8 Nishi-shinbashi, Minato-ku, Tokyo 105-8471, Japan
TEL	03-3433-1111
Email	kodaka@jikei.ac.jp

Public contact
Name of contact person	1st name Fumitoshi Middle name Last name Kodaka
Organization	The Jikei University School of Medicine
Division name	Department of Psychiatry
Zip code	105-8471
Address	3-25-8 Nishi-shinbashi, Minato-ku, Tokyo 105-8471, Japan
TEL	03-3433-1111
Homepage URL
Email	kodaka@jikei.ac.jp

Sponsor
Institute	The Jikei University School of Medicine
Institute
Department

Funding Source
Organization	The Jikei University School of Medicine
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	The Jikei University School of Medicine
Address	3-25-8 Nishi-shinbashi, Minato-ku, Tokyo 105-8471, Japan
Tel	03-3433-1111
Email	kodaka@jikei.ac.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	2020 Year 10 Month 14 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	2019 Year 11 Month 09 Day
Date of IRB	2020 Year 02 Month 12 Day
Anticipated trial start date	2020 Year 04 Month 01 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	N/A

Management information
Registered date	2020 Year 10 Month 14 Day
Last modified on	2020 Year 10 Month 14 Day

Link to view the page
URL(English)	https://upload.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000048065