UMIN-CTR Clinical Trial
| Unique ID issued by UMIN | UMIN000013542 |
|---|---|
| Receipt number | R000015774 |
| Scientific Title | Does Quetiapine improve mood symptoms in schizophrenia patients? |
| Date of disclosure of the study information | 2014/03/28 |
| Last modified on | 2016/06/19 22:40:33 |
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Basic information
Public title
Does Quetiapine improve mood symptoms in schizophrenia patients?
Acronym
Does Quetiapine improve mood symptoms in schizophrenia patients?
Scientific Title
Does Quetiapine improve mood symptoms in schizophrenia patients?
Scientific Title:Acronym
Does Quetiapine improve mood symptoms in schizophrenia patients?
Region
| Japan |
Condition
Condition
Schizophrenia
Classification by specialty
| Psychiatry |
Classification by malignancy
Others
Genomic information
NO
Objectives
Narrative objectives1
To evaluate the effectiveness of quetiapine on schizophrenia patients with depressive symptoms
Basic objectives2
Efficacy
Basic objectives -Others
Trial characteristics_1
Confirmatory
Trial characteristics_2
Pragmatic
Developmental phase
Not applicable
Assessment
Primary outcomes
HAM-D17
Key secondary outcomes
BPRS
DIEPSS
Blood test
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
| 18 | years-old | <= |
Age-upper limit
| Not applicable |
Gender
Male and Female
Key inclusion criteria
1.Chronic schizophrenia patients with depressive symptoms who have started the treatment with quetiapine
2.Patients whose positive symptoms are stable enough to keep a long term treatment with quetiapine
3.Patients who do not receive antidepressants
4.Age 18 and over
Key exclusion criteria
Cases judged inadequate by medical doctor
Target sample size
30
Research contact person
Name of lead principal investigator
| 1st name | |
| Middle name | |
| Last name | Setsuko Yasugawa |
Organization
Yatsushiro Kosei Hospital
Division name
Departmennt of psychiatry
Zip code
Address
Furushiromachi1705 Yatsushiro-shi Kumamoto
TEL
0965-33-4025
yasugawa@orange.ocn.ne.jp
Public contact
Name of contact person
| 1st name | |
| Middle name | |
| Last name | Setsuko Yasugawa |
Organization
Yatsushiro Kosei Hospital
Division name
Departmennt of psychiatry
Zip code
Address
Furushiromachi1705 Yatsushiro-shi Kumamoto
TEL
0965-33-4025
Homepage URL
yasugawa@orange.ocn.ne.jp
Sponsor or person
Institute
Yatsushiro Kosei Hospital
Institute
Department
Personal name
Funding Source
Organization
Astellas Pharma Inc.
Organization
Division
Category of Funding Organization
Profit organization
Nationality of Funding Organization
Japan
Other related organizations
Co-sponsor
Name of secondary funder(s)
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
八代更生病院（熊本県）
Other administrative information
Date of disclosure of the study information
| 2014 | Year | 03 | Month | 28 | 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
Completed
Date of protocol fixation
| 2014 | Year | 02 | Month | 01 | Day |
Date of IRB
Anticipated trial start date
| 2014 | Year | 04 | Month | 01 | Day |
Last follow-up date
| 2016 | Year | 03 | Month | 31 | Day |
Date of closure to data entry
| 2016 | Year | 04 | Month | 01 | Day |
Date trial data considered complete
| 2016 | Year | 04 | Month | 01 | Day |
Date analysis concluded
| 2016 | Year | 06 | Month | 30 | Day |
Other
Other related information
Depressive symptoms in schizophrenia patients wil be described.
Management information
Registered date
| 2014 | Year | 03 | Month | 27 | Day |
Last modified on
| 2016 | Year | 06 | Month | 19 | Day |
Link to view the page
Value
https://center6.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000015774
