UMIN-CTR Clinical Trial
| Unique ID issued by UMIN | UMIN000008421 |
|---|---|
| Receipt number | R000009908 |
| Scientific Title | Antidepressant efficacy and mechanism of add-on cognitive activation to repetitive transcranial magnetic stimulation in depression |
| Date of disclosure of the study information | 2012/07/12 |
| Last modified on | 2014/05/03 21:23:30 |
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Basic information
Public title
Antidepressant efficacy and mechanism of add-on cognitive activation to repetitive transcranial magnetic stimulation in depression
Acronym
Cognition-engineered anhancement of rACC activity in boostering antidepressant efficacy
Scientific Title
Antidepressant efficacy and mechanism of add-on cognitive activation to repetitive transcranial magnetic stimulation in depression
Scientific Title:Acronym
Cognition-engineered anhancement of rACC activity in boostering antidepressant efficacy
Region
| Asia(except Japan) |
Condition
Condition
A randomized sham-controlled study
Classification by specialty
| Medicine in general | Psychiatry |
Classification by malignancy
Others
Genomic information
NO
Objectives
Narrative objectives1
We assumed that if ACC could be activated before each rTMS session, maybe the general rTMS antidepressant efficacy would be enhanced.
Basic objectives2
Efficacy
Basic objectives -Others
Trial characteristics_1
Exploratory
Trial characteristics_2
Pragmatic
Developmental phase
Not applicable
Assessment
Primary outcomes
EEG-theta (esp. frontal regions)
PET-glucose metabolism: ACC and PFC
Antidepressant efficacy (HAMD-17 scores)
Key secondary outcomes
Base
Study type
Interventional
Study design
Basic design
Parallel
Randomization
Randomized
Randomization unit
Blinding
Double blind -all involved are blinded
Control
Placebo
Stratification
Dynamic allocation
Institution consideration
Blocking
Concealment
Intervention
No. of arms
3
Purpose of intervention
Treatment
Type of intervention
| Device,equipment | Other |
Interventions/Control_1
Cognition demanding tests for 10 minutes before active rTMS treatment
Interventions/Control_2
Non-cognition demanding tests for 10 mins
before active rTMS treatment
Interventions/Control_3
Cognition demanding tests for 10 minutes before sham rTMS treatment
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
| 21 | years-old | <= |
Age-upper limit
| 65 | years-old | >= |
Gender
Male and Female
Key inclusion criteria
DSM-IV Major depressive disorders, recurrent
Refractory to at least 2 adequate trials of antidepressant treatments (including one SSRI)
Key exclusion criteria
Major systemic, neurological illness
Substance abuse
Personality disorders
OCD
PTSD
Major psychotic disorders(e.g., Schizophrenia)
Target sample size
36
Research contact person
Name of lead principal investigator
| 1st name | |
| Middle name | |
| Last name | Cheng-Ta Li |
Organization
Taipei Veterans General Hospital
Division name
Psychiatry
Zip code
Address
No.201, Sec.2, Shih-Pai Rd, Beitou district, Taipei, Taiwan
TEL
+81-1886228757027
on5083@msn.com
Public contact
Name of contact person
| 1st name | |
| Middle name | |
| Last name | Cheng-Ta Li |
Organization
Taipei Veterans General Hospital
Division name
Psychiatry
Zip code
Address
No.201, Sec.2, Shih-Pai Road, Beitou district
TEL
+81-1886228757027
Homepage URL
on5083@msn.com
Sponsor or person
Institute
Taipei Veterans General Hospital
Institute
Department
Personal name
Funding Source
Organization
Yen Tjing Ling Medical Foundation (CI-100-6)
Organization
Division
Category of Funding Organization
Non profit foundation
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
Taipei Veterans General Hospital(Taiwan)
Other administrative information
Date of disclosure of the study information
| 2012 | Year | 07 | Month | 12 | 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
No longer recruiting
Date of protocol fixation
| 2011 | Year | 08 | Month | 01 | Day |
Date of IRB
Anticipated trial start date
| 2011 | Year | 08 | Month | 01 | Day |
Last follow-up date
Date of closure to data entry
Date trial data considered complete
| 2013 | Year | 12 | Month | 31 | Day |
Date analysis concluded
| 2014 | Year | 03 | Month | 29 | Day |
Other
Other related information
Management information
Registered date
| 2012 | Year | 07 | Month | 12 | Day |
Last modified on
| 2014 | Year | 05 | Month | 03 | Day |
Link to view the page
Value
https://center6.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000009908
| Research Plan | |
|---|---|
| Registered date | File name |
| Research case data specifications | |
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| Registered date | File name |
| Research case data | |
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| Registered date | File name |
