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Name:
UMIN ID:

Recruitment status
Unique ID issued by UMIN UMIN000001297
Receipt No. R000001571
Scientific Title An exploratory study for development of neurophysiological indicators for prediction and evaluation of effectiveness of serotonin reuptake inhibitor fluvoxamine in patients with major depressive disorder
Date of disclosure of the study information 2008/08/04
Last modified on 2008/08/03

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Basic information
Public title An exploratory study for development of neurophysiological indicators for prediction and evaluation of effectiveness of serotonin reuptake inhibitor fluvoxamine in patients with major depressive disorder
Acronym An exploratory study for development of neurophysiological indicators for effectiveness of fluvoxamine in major depression
Scientific Title An exploratory study for development of neurophysiological indicators for prediction and evaluation of effectiveness of serotonin reuptake inhibitor fluvoxamine in patients with major depressive disorder
Scientific Title:Acronym An exploratory study for development of neurophysiological indicators for effectiveness of fluvoxamine in major depression
Region
Japan

Condition
Condition Major depressive disorder
Classification by specialty
Psychiatry
Classification by malignancy Others
Genomic information YES

Objectives
Narrative objectives1 The objective of this prospective study is to evaluate the relationship between the symptom improvement and neurophysiological indicators in advance of and during treatment
Basic objectives2 Efficacy
Basic objectives -Others
Trial characteristics_1 Exploratory
Trial characteristics_2 Pragmatic
Developmental phase

Assessment
Primary outcomes Relationship between changes of neurophysiological indicators (Near-infrared spectroscopy) and clinical indicator (HAM-D).
Key secondary outcomes 1.Numbers that satisfies HAM-D response criteria.
2.Numbers that satisfies HAM-D remission criteria.
3.Numbers that satisfies HAM-D recovery criteria.
4.CES-D, GAF, SASS, QOL-26, CGI
5. gene polymorphisms of sigma-1 receptor
6. BDNF blood concentration

Base
Study type Interventional

Study design
Basic design expanded access
Randomization Non-randomized
Randomization unit
Blinding Open -no one is blinded
Control Uncontrolled
Stratification
Dynamic allocation
Institution consideration
Blocking
Concealment

Intervention
No. of arms 2
Purpose of intervention Treatment
Type of intervention
Medicine Gene Device,equipment
Interventions/Control_1 12-week fluvoxiamine therapy
Interventions/Control_2 Continuation of 36-week fluvoxamine therapy in the patient group that satisfies HAM-D response criteria by 12-week fluvoxamine therapy
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
25 years-old <=
Age-upper limit
75 years-old >=
Gender Male and Female
Key inclusion criteria 1) Subjects with current DSM-IV Major Depressive Disorder single episode or recurrent.
2) Patients who understand the study contents and give informed consents by themselves
Key exclusion criteria 1) No major cognitive deficits
2) Subjects taking fluvoxamine therapy
3) Subjects who cannot discontinue therapies listed below from 7 days prior to the trial start to the end point.
1. Thioridazine Hydrochloride, pimozide
2. Tizanidine hydrochloride
3. MAO inhibitors, Selegiline hydrochloride ( 14 days before starting the trial)
4. Cisapride
5. Any drugs under development
6. Any anticonvulsants
7. Any antipsychotic drugs
8. Antidepressants excluding Fluvoxamine
9. Lithium Carbonate
10. Chinese medicine effective on psychotic symptoms
11. Electroconvulsive therapy
12. Other physical treatments
4) Subjects with current DSM-IV personality disorder or mental retardation
5) Pregnant or lactating women
6) Subjects with severe hepatic dysfunction (AST>100 or ALT>100)
7) Subjects with severe renal dysfunction (BUN>25 or Cre>2.0)
8) Subjects with current or past history of convulsion
9) Subjects with current or past history of serious suicidal ideation or attempt (HAM-D item No.11 score > 3)
10) Subjects with past history of manic state or bipolar disorder
11) Subjects with brain organic disease, including current or past history of cerebrovascular disease and other related disorders
12) Past history of electric convulsive therapy
13) Subjects with cardiac failure which requires clinical treatment
14) Subjects with hemophilic disease or hemophilic factor which requires clinical treatment
15) Subjects with thyroidal dysfunction which requires clinical treatment
16) Ungiven notification of the disease name
17) Patient whom examination doctor judged improper as a trial subject
Target sample size 20

Research contact person
Name of lead principal investigator
1st name
Middle name
Last name Kiyoto Kasai
Organization The University of Tokyo Hospital
Division name Department of Neuropsychiatry
Zip code
Address 7-3-1, Hongo, Bunkyo-Ku, Tokyo.
TEL 03-3815-5411
Email

Public contact
Name of contact person
1st name
Middle name
Last name
Organization The University of Tokyo Hospital
Division name Department of Neuropsychiatry
Zip code
Address 7-3-1, Hongo, Bunkyo-Ku, Tokyo.
TEL
Homepage URL
Email

Sponsor
Institute Department of Neuropsychiatry, The University of Tokyo Hospital
Institute
Department

Funding Source
Organization Health, Labour and Welfare Ministry
Organization
Division
Category of Funding 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

Other administrative information
Date of disclosure of the study information
2008 Year 08 Month 04 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
Date of protocol fixation
2008 Year 06 Month 26 Day
Date of IRB
Anticipated trial start date
2008 Year 08 Month 01 Day
Last follow-up date
2010 Year 08 Month 01 Day
Date of closure to data entry
Date trial data considered complete
Date analysis concluded

Other
Other related information

Management information
Registered date
2008 Year 08 Month 04 Day
Last modified on
2008 Year 08 Month 03 Day


Link to view the page
URL(English) https://upload.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000001571

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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