UMIN-CTR Clinical Trial
| Unique ID issued by UMIN | UMIN000003094 |
|---|---|
| Receipt number | 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 16:51:43 |
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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
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
niitsu@chiba-u.jp
Sponsor or person
Institute
Department of Psychiatry, Chiba University Graduate School of Medicine
Institute
Department
Personal name
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
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
Value
https://center6.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 | |
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| Registered date | File name |
