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
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
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
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
