UMIN-CTR Clinical Trial
| Unique ID issued by UMIN | UMIN000003516 |
|---|---|
| Receipt number | R000004262 |
| Scientific Title | A study of the efficacy of milnacipran in patients with major depressive disorder (MDD) after SSRI treatment failure, and biological research for MDD using peripheral blood. |
| Date of disclosure of the study information | 2010/04/21 |
| Last modified on | 2016/04/26 16:57:23 |
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Basic information
Public title
A study of the efficacy of milnacipran in patients with major depressive disorder (MDD) after SSRI treatment failure, and biological research for MDD using peripheral blood.
Acronym
A study of the efficacy of milnacipran in patients with major depressive disorder (MDD) after SSRI treatment failure, and biological research for MDD using peripheral blood.
Scientific Title
A study of the efficacy of milnacipran in patients with major depressive disorder (MDD) after SSRI treatment failure, and biological research for MDD using peripheral blood.
Scientific Title:Acronym
A study of the efficacy of milnacipran in patients with major depressive disorder (MDD) after SSRI treatment failure, and biological research for MDD using peripheral blood.
Region
| Japan |
Condition
Condition
Major depressive disorder
Classification by specialty
| Psychiatry |
Classification by malignancy
Others
Genomic information
NO
Objectives
Narrative objectives1
To examine the efficacy and safety of milnacipran in the patients with SSRI-resistant major depresive disorder, and short- and long-term effects of switching to milnacipran on the relationship between clinical outcomes and blood molecules levels.
Basic objectives2
Safety,Efficacy
Basic objectives -Others
Trial characteristics_1
Exploratory
Trial characteristics_2
Pragmatic
Developmental phase
Not applicable
Assessment
Primary outcomes
Exploratory examination of short- and long-term effects of switching to milnacipran on the relationship between clinical outcomes and blood molecules levels.
Key secondary outcomes
1) The rate of Response by Hamilton Depression
Rating Scale (HDRS-17)
2) The rate of Remission by Hamilton Depression Rating Scale (HDRS-17)
3) The rate continuation of treatment
4) Remission and response rate by QIDS-SR
5) Social Adaptation Self-evaluation Scale (SASS).
6) Clinical Global Inpression (CGI).
7) Montogomery-Asberg Depression rating Scale (MADRS).
8) Safety
9) Neurotransmitters, Neuropeptide, and others in peripheral blood.
Base
Study type
Interventional
Study design
Basic design
Single arm
Randomization
Non-randomized
Randomization unit
Blinding
Open -no one is blinded
Control
Uncontrolled
Stratification
Dynamic allocation
Institution consideration
Blocking
Concealment
Intervention
No. of arms
1
Purpose of intervention
Treatment
Type of intervention
| Medicine |
Interventions/Control_1
Switching from prior SSRI (fluvoxamine, paroxetine, sertraline, or escitalopram) to milnacipran. This is a 24-week trial.
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
Eligibility
Age-lower limit
| 20 | years-old | <= |
Age-upper limit
| 75 | years-old | > |
Gender
Male and Female
Key inclusion criteria
1) Subjects with current DSM-IV Major Depressive Disorder
2) Written informed consent by patients
and more than 19 years old, less than 75 years old
3) unremitted patients by a SSRI(paroxetine, fluvoxamine, sertraline or escitalopram) for six more weeks
4) The score of 17-item Hamilton Depression Rating Scale (HDRS) is 14 or more.
Key exclusion criteria
1) treating with selegiline hydrochloride
2) Allergy against milnacipran
3) patients with urinary retension
4) pregnant or breast-feeding women or women, who may be pregnant
5) significant risk of suicide
6) patients with dementia, bipolar or psychotic disorders, those with a primary diagnosis of obsessive-compulsive disorder or an eating disorder.
7) Patient whom examination doctor judge improper as a trial subject
Target sample size
40
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
+81-43-226-2148
iyom@faculty.chiba-u.jp
Public contact
Name of contact person
| 1st name | |
| Middle name | |
| Last name | Tasuku Hashimoto |
Organization
Chiba University Graduate School of Medicine
Division name
Department of Psychiatry
Zip code
Address
1-8-1 Inohana, Chuo-ku, Chiba, Japan
TEL
+81-43-226-2148
Homepage URL
t-hashimoto@faculty.chiba-u.jp
Sponsor or person
Institute
Department of Psychiatry, Chiba University Graduate School of Medicine, Division of Psychiatry, Chiba University Hospital
Institute
Department
Personal name
Funding Source
Organization
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
YES
Study ID_1
G21054
Org. issuing International ID_1
IRB committee in Chiba University Hospital
Study ID_2
Org. issuing International ID_2
IND to MHLW
Institutions
Institutions
千葉大学医学部附属病院 Chiba University Hospital（千葉県, Chiba Pref）、袖ヶ浦さつき台病院 Sodegaura Satsukidai Hospital（千葉県, Chiba Pref）、茂原神経科病院 Mobarashinkeika Hospital（千葉県, Chiba Pref）、銚子こころクリニック Choshikokoro Clinic（千葉県, Chiba Pref）
Other administrative information
Date of disclosure of the study information
| 2010 | Year | 04 | Month | 21 | Day |
Related information
URL releasing protocol
Publication of results
Published
Result
URL related to results and publications
https://www.dovepress.com/milnacipran-treatment-and-potential-biomarkers-in-depressed-patients-f-pee
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
Main results already published
Date of protocol fixation
| 2010 | Year | 02 | Month | 15 | Day |
Date of IRB
Anticipated trial start date
| 2010 | Year | 04 | Month | 01 | Day |
Last follow-up date
| 2012 | Year | 12 | Month | 25 | Day |
Date of closure to data entry
| 2014 | Year | 09 | Month | 01 | Day |
Date trial data considered complete
| 2014 | Year | 10 | Month | 31 | Day |
Date analysis concluded
| 2014 | Year | 11 | Month | 21 | Day |
Other
Other related information
Management information
Registered date
| 2010 | Year | 04 | Month | 21 | Day |
Last modified on
| 2016 | Year | 04 | Month | 26 | Day |
Link to view the page
Value
https://center6.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000004262
