UMIN-CTR Clinical Trial
| Unique ID issued by UMIN | UMIN000005587 |
|---|---|
| Receipt number | R000006605 |
| Scientific Title | Evaluation of effectiveness in patients with schizophrenia who are switched from prior antipsychotics to aripiprazole |
| Date of disclosure of the study information | 2011/06/01 |
| Last modified on | 2014/10/10 14:54:35 |
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Basic information
Public title
Evaluation of effectiveness in patients with schizophrenia who are switched from prior antipsychotics to aripiprazole
Acronym
Evaluation of effectiveness in patients with schizophrenia who are switched from prior antipsychotics to aripiprazole
Scientific Title
Evaluation of effectiveness in patients with schizophrenia who are switched from prior antipsychotics to aripiprazole
Scientific Title:Acronym
Evaluation of effectiveness in patients with schizophrenia who are switched from prior antipsychotics to aripiprazole
Region
| Japan |
Condition
Condition
schizophrenia
Classification by specialty
| Psychiatry |
Classification by malignancy
Others
Genomic information
NO
Objectives
Narrative objectives1
Evaluation of efficacy, safety, Quality of Life (QOL), and tolerability in patients with schizophrenia who are switched from prior antipsychotics to aripiprazole
Basic objectives2
Safety,Efficacy
Basic objectives -Others
Trial characteristics_1
Confirmatory
Trial characteristics_2
Pragmatic
Developmental phase
Not applicable
Assessment
Primary outcomes
Brief Psychiatric Rating Scale: BPRS,
Clinical global impression : CGI-S and I,
Drug-Induced Extrapyramidal Symptoms Scale: DIEPSS
Japanese Version for the Schizophrenia Quality of Life Scale: JSQLS
Key secondary outcomes
Drug Attitude Inventory:DAI-10
Preference of medicine Questionnaire:POM
Body Weight,Body Mass Index,Blood Glucose,Prolactin
Base
Study type
Interventional
Study design
Basic design
Single arm
Randomization
Non-randomized
Randomization unit
Blinding
Open -no one is blinded
Control
Uncontrolled
Stratification
Dynamic allocation
Institution consideration
Blocking
Concealment
Intervention
No. of arms
1
Purpose of intervention
Treatment
Type of intervention
| Medicine |
Interventions/Control_1
Patients are switched from prior antipsychotics to aripiprazole
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
| Not applicable |
Age-upper limit
| 65 | years-old | > |
Gender
Male and Female
Key inclusion criteria
-participants who meet the criteria for schizophrenia according to the DSM ver.4
-participants who are ongoing treatment and are considered that they should change the medicine for clinical reasons
-Participants who are either inpatients or outpatients
Key exclusion criteria
-articipants under the comatose state
-participants under the strong influence of central nervous system depressant
-participants in administration of epinephrine
-participants who have a histry of allergy for aripiprazole
-participants who are contacting diabetes mellitus, or have a medical history of diabetes mellitus
-participants who are during pregnancy or possibility of pregnancy
-the attending doctor appraise participants for inadequate
Target sample size
20
Research contact person
Name of lead principal investigator
| 1st name | |
| Middle name | |
| Last name | Toshiya Murai |
Organization
Graduate School of Medicine, Kyoto University
Division name
Department of Psychiatry
Zip code
Address
54 Shogoin-Kawaharacho, Sakyo-ku, Kyoto 606-8507, JAPAN
TEL
Public contact
Name of contact person
| 1st name | |
| Middle name | |
| Last name |
Organization
Graduate School of Medicine, Kyoto University
Division name
Department of Psychiatry
Zip code
Address
TEL
Homepage URL
Sponsor or person
Institute
Department of Psychiatry, Graduate School of Medicine, Kyoto University
Institute
Department
Personal name
Funding Source
Organization
none
Organization
Division
Category of Funding Organization
Self funding
Nationality of Funding Organization
Other related organizations
Co-sponsor
Kitano Hospital:The Tazuke Kofukai medical Research Institute,Takashima General hospital,Ueno Clinic
Name of secondary funder(s)
none
IRB Contact (For public release)
Organization
Address
Tel
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
| 2011 | Year | 06 | Month | 01 | 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
Terminated
Date of protocol fixation
| 2011 | Year | 04 | Month | 28 | Day |
Date of IRB
Anticipated trial start date
| 2011 | Year | 06 | Month | 01 | Day |
Last follow-up date
| 2014 | Year | 09 | Month | 30 | Day |
Date of closure to data entry
Date trial data considered complete
Date analysis concluded
Other
Other related information
Management information
Registered date
| 2011 | Year | 05 | Month | 11 | Day |
Last modified on
| 2014 | Year | 10 | Month | 10 | Day |
Link to view the page
Value
https://center6.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000006605
| Research Plan | |
|---|---|
| Registered date | File name |
| Research case data specifications | |
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| Registered date | File name |
| Research case data | |
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| Registered date | File name |
