UMIN-CTR Clinical Trial

Basic information
Official scientific title of the study	Does Quetiapine improve mood symptoms in schizophrenia patients?
Title of the study (Brief title)	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

In outcomes field, the entry of just a few words such as "safety" or "efficiency" will not be accepted. Specify the name of outcome measures, including the time when you plan to measure. Usually, only one primary outcome is accepted. Write the other outcomes in "secondary outcomes" field.

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

In interventions field, include the details of interventions, such as duration, amount, and frequency. If the intervention includes prescription or use of medical devices, duration is required.

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	Setsuko Yasugawa
Organization	Yatsushiro Kosei Hospital
Division name	Departmennt of psychiatry
Address	Furushiromachi1705 Yatsushiro-shi Kumamoto
TEL	0965-33-4025
Email	yasugawa@orange.ocn.ne.jp

Public contact
Name of contact person	Setsuko Yasugawa
Organization	Yatsushiro Kosei Hospital
Division name	Departmennt of psychiatry
Address	Furushiromachi1705 Yatsushiro-shi Kumamoto
TEL	0965-33-4025
Homepage URL
Email	yasugawa@orange.ocn.ne.jp

Sponsor
Institute	Yatsushiro Kosei Hospital
Institute
Department

Sponsor means an organization that is responsible for plan, deployment and report of the research including funding management. It doesn't mean funding agency". Therefore, all clinical trial should have the one.

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)

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

Progress
Recruitment status	Completed
Date of protocol fixation	2014 Year 02 Month 01 Day
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

Related information
URL releasing protocol
Publication of results	Unpublished
URL releasing results
Results
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
URL(English)	https://upload.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000015774