UMIN-CTR Clinical Trial
| Unique ID issued by UMIN | UMIN000007612 |
|---|---|
| Receipt number | R000008790 |
| Scientific Title | Transcranial magnetic stimulation (TMS) for the treatment of lithium-resistant bipolar depression and exploring the optimal technical parameters of TMS |
| Date of disclosure of the study information | 2012/04/01 |
| Last modified on | 2015/03/30 17:06:54 |
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Basic information
Public title
Transcranial magnetic stimulation (TMS) for the treatment of lithium-resistant bipolar depression and exploring the optimal technical parameters of TMS
Acronym
Transcranial magnetic stimulation (TMS) for the treatment of lithium-resistant bipolar depression and exploring the optimal technical parameters of TMS
Scientific Title
Transcranial magnetic stimulation (TMS) for the treatment of lithium-resistant bipolar depression and exploring the optimal technical parameters of TMS
Scientific Title:Acronym
Transcranial magnetic stimulation (TMS) for the treatment of lithium-resistant bipolar depression and exploring the optimal technical parameters of TMS
Region
| Japan |
Condition
Condition
Bipolar depression
Classification by specialty
| Psychiatry |
Classification by malignancy
Others
Genomic information
NO
Objectives
Narrative objectives1
To examine the efficacy and safety of high-frequency left prefrontal transcranial magnetic stimulation in lithium-resistant bipolar depression
Basic objectives2
Safety,Efficacy
Basic objectives -Others
Trial characteristics_1
Confirmatory
Trial characteristics_2
Pragmatic
Developmental phase
Not applicable
Assessment
Primary outcomes
HAMD 17, HAMD 24, MADRS
Severity of depression is rated with these scales every 2 weeks.
Key secondary outcomes
CGI, YMRS
Base
Study type
Interventional
Study design
Basic design
Parallel
Randomization
Randomized
Randomization unit
Individual
Blinding
Double blind -all involved are blinded
Control
Placebo
Stratification
Dynamic allocation
Institution consideration
Blocking
Concealment
Intervention
No. of arms
2
Purpose of intervention
Treatment
Type of intervention
| Medicine | Device,equipment |
Interventions/Control_1
Lithium (0.8 mEq/L, 8 weeks), active TMS (double-blind trial, 6 weeks), active TMS (non-blind trial, 2-6 weeks)
Interventions/Control_2
Lithium (0.8 mEq/L, 8 weeks), sham TMS (double-blind trial, 6 weeks), active TMS (non-blind trial, 2-6 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
| 70 | years-old | >= |
Gender
Male and Female
Key inclusion criteria
1. DSM-IV-TR diagnosis of bipolar disorder, major depressive disorder
2. Aged 20-70 y/o
3. HAMD 17 score ≥ 18
4. Current episode duration ≤ 3 y
Key exclusion criteria
1. Rapid cycler type
2. Psychotic episode, OCD, PTSD, eating disorder
3. Previous treatment with ECT, TMS, VNS, DBS, tDCS
4. Pregnancy
5. Personal or close family history of seizure disorder
6. Neurologic disorder, organic brain disease
7. Substance or alcohol dependence
8. Ferromagnetic material in body or close to head
9. Severe metabolic disease, endocrine disease
10. Active suicide idea
11. Taking medications known to lower seizure threshold
Target sample size
50
Research contact person
Name of lead principal investigator
| 1st name | |
| Middle name | |
| Last name | Shinsuke Kito |
Organization
Kyorin University School of Medicine
Division name
Department of Neuropsychiatry
Zip code
Address
6-20-2 Shinkawa, Mitaka, Tokyo 181-8611, Japan
TEL
0422-47-5511
Public contact
Name of contact person
| 1st name | |
| Middle name | |
| Last name |
Organization
Kyorin University School of Medicine
Division name
Department of Neuropsychiatry
Zip code
Address
TEL
0422-47-5511
Homepage URL
psychiat@ks.kyorin-u.ac.jp
Sponsor or person
Institute
Department of Neuropsychiatry, Kyorin University School of Medicine
Institute
Department
Personal name
Funding Source
Organization
None
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
杏林大学病院（東京）
Other administrative information
Date of disclosure of the study information
| 2012 | Year | 04 | Month | 01 | 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
Terminated
Date of protocol fixation
| 2012 | Year | 03 | Month | 26 | Day |
Date of IRB
Anticipated trial start date
| 2012 | Year | 04 | 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
Management information
Registered date
| 2012 | Year | 03 | Month | 30 | Day |
Last modified on
| 2015 | Year | 03 | Month | 30 | Day |
Link to view the page
Value
https://center6.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000008790
| 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 |
