UMIN-CTR Clinical Trial

Unique ID issued by UMIN UMIN000042116
Receipt number R000048065
Scientific Title A study of taste and perceptual tendencies that predict asenapine dropout
Date of disclosure of the study information 2020/10/14
Last modified on 2020/10/14 14:47:02

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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 or person

Institute

The Jikei University School of Medicine

Institute

Department

Personal name



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

Value
https://center6.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000048065


Research Plan
Registered date File name

Research case data specifications
Registered date File name

Research case data
Registered date File name