UMIN-CTR Clinical Trial
| Unique ID issued by UMIN | UMIN000001297 |
|---|---|
| Receipt number | 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 16:26:17 |
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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
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
Sponsor or person
Institute
Department of Neuropsychiatry, The University of Tokyo Hospital
Institute
Department
Personal name
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
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
Value
https://center6.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000001571
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