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

Email

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


Email

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


Email



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


Research Plan
Registered date File name

Research case data specifications
Registered date File name

Research case data
Registered date File name