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Name:
UMIN ID:

Recruitment status Completed
Unique ID issued by UMIN UMIN000003094
Receipt No. R000003756
Scientific Title Double-blind study of the effect of selective serotonin reuptake inhabitor fluvoxamine on cognitive deficits in schizophrenia
Date of disclosure of the study information 2010/01/26
Last modified on 2019/02/28

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Basic information
Public title Double-blind study of the effect of selective serotonin reuptake inhabitor fluvoxamine on cognitive deficits in schizophrenia
Acronym Double-blind study of the effect of fluvoxamine on cognitive deficits in schizophrenia
Scientific Title Double-blind study of the effect of selective serotonin reuptake inhabitor fluvoxamine on cognitive deficits in schizophrenia
Scientific Title:Acronym Double-blind study of the effect of fluvoxamine on cognitive deficits in schizophrenia
Region
Japan

Condition
Condition Schizophrenia
Classification by specialty
Psychiatry
Classification by malignancy Others
Genomic information NO

Objectives
Narrative objectives1 We will study the effects of fluvoxamine on the cognitive deficits of schizophrenic patients.
Basic objectives2 Efficacy
Basic objectives -Others
Trial characteristics_1
Trial characteristics_2
Developmental phase

Assessment
Primary outcomes cognitive function of the patient at 4, and 8 weeks after starting
Key secondary outcomes

Base
Study type Interventional

Study design
Basic design Parallel
Randomization Randomized
Randomization unit Individual
Blinding Double blind -all involved are blinded
Control Placebo
Stratification NO
Dynamic allocation YES
Institution consideration Institution is not considered as adjustment factor.
Blocking NO
Concealment Central registration

Intervention
No. of arms 2
Purpose of intervention Treatment
Type of intervention
Medicine
Interventions/Control_1 50mg of fluvoxamine daily during the first 4 weeks, next 100mg during 2 weeks, 150mg during the last 2 weeks.
Interventions/Control_2 placebo during 8 weeks.
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
60 years-old >
Gender Male and Female
Key inclusion criteria outpatient of Chiba University Hospital with schizophrenia meeting the DSM-IV-TR criteria taking the second generation antipsychotic monotherapy for at least 8 weeks
Key exclusion criteria history of the manic state, other neurologic illness, pregnant or suckling are excluded
Target sample size 48

Research contact person
Name of lead principal investigator
1st name
Middle name
Last name Masaomi Iyo
Organization Chiba University Graduate School of Medicine
Division name Department of Psychiatry
Zip code
Address 1-8-1 Inohana, Chuo-ku Chiba, Japan
TEL 043-226-2148
Email iyom@faculty.chiba-u.jp

Public contact
Name of contact person
1st name
Middle name
Last name Tomihisa Niitsu
Organization Chiba University Hospital
Division name Department of Psychiatry
Zip code
Address 1-8-1 Inohana, Chuo-ku, Chiba, Japan
TEL 043-222-7171
Homepage URL
Email niitsu@chiba-u.jp

Sponsor
Institute Department of Psychiatry, Chiba University Graduate School of Medicine
Institute
Department

Funding Source
Organization Department of Psychiatry, Chiba University Graduate School of Medicine
Organization
Division
Category of Funding Organization Self funding
Nationality of Funding Organization

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

Other administrative information
Date of disclosure of the study information
2010 Year 01 Month 26 Day

Related information
URL releasing protocol
Publication of results Published

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
2007 Year 02 Month 04 Day
Date of IRB
Anticipated trial start date
2007 Year 08 Month 01 Day
Last follow-up date
Date of closure to data entry
Date trial data considered complete
Date analysis concluded

Other
Other related information A randomized, double-blind, placebo-controlled trial of fluvoxamine in patients with schizophrenia: a preliminary study.

Niitsu T, Fujisaki M, Shiina A, Yoshida T, Hasegawa T, Kanahara N, Hashimoto T, Shiraishi T, Fukami G, Nakazato M, Shirayama Y, Hashimoto K, Iyo M.

J Clin Psychopharmacol. 2012 Oct;32(5):593-601. doi: 10.1097/JCP.0b013e3182664cfc.

PMID: 22926591

Management information
Registered date
2010 Year 01 Month 26 Day
Last modified on
2019 Year 02 Month 28 Day


Link to view the page
URL(English) https://upload.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000003756

Research Plan
Registered date File name

Research case data specifications
Registered date File name

Research case data
Registered date File name


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