UMIN-CTR Clinical Trial
| Unique ID issued by UMIN | UMIN000022148 |
|---|---|
| Receipt number | R000025518 |
| Scientific Title | Transcranial magnetic stimulation (TMS) in the treatment of refractory bipolar depression: a preliminary study |
| Date of disclosure of the study information | 2016/05/09 |
| Last modified on | 2018/10/03 13:48:05 |
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Basic information
Public title
Transcranial magnetic stimulation (TMS) in the treatment of refractory bipolar depression: a preliminary study
Acronym
Transcranial magnetic stimulation (TMS) in the treatment of refractory bipolar depression
Scientific Title
Transcranial magnetic stimulation (TMS) in the treatment of refractory bipolar depression: a preliminary study
Scientific Title:Acronym
Transcranial magnetic stimulation (TMS) in the treatment of refractory bipolar depression
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 tolerability of low-frequency right prefrontal transcranial magnetic stimulation in treatment-resistant bipolar depression and to identify a biological marker about its treatment response
Basic objectives2
Safety,Efficacy
Basic objectives -Others
Trial characteristics_1
Trial characteristics_2
Developmental phase
Assessment
Primary outcomes
Changes in the total score of Hamilton's Rating Scale for Depression (HAMD 17 items) at week 4
Key secondary outcomes
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
| Device,equipment |
Interventions/Control_1
Low-frequency right prefrontal transcranial magnetic stimulation for 4 weeks
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. DSM-5 diagnosis of bipolar disorder, major depressive disorder
2. HAMD 17 score >= 18
3. Current episode duration < 3 y
4. Patient does not respond to the medications described below for more than 8 weeks.
i. Lithium, 0.8mmol/L
ii. Quetiapine, 300mg/day
iii. Olanzapine, 5-20mg/day
iv. Lamotrigine, 200mg/day
Key exclusion criteria
1. Rapid cycler type
2. Patient has a history of psychotic episode, OCD, PTSD, and eating disorder.
3. Patient had a previous treatment with ECT, TMS, VNS, DBS, and tDCS within 6 months.
4. Patient did not respond to ECT and TMS previously.
5. Pregnancy
6. Patient has a history of epilepsy and convulsion. Personal or close family history of seizure disorder
7. Neurologic disorder, organic brain disease
8. Substance or alcohol dependence
9. Ferromagnetic material in body or close to head
10. Severe metabolic disease, endocrine disease
11. Active suicide idea
12. Taking medications known to lower seizure threshold
Target sample size
40
Research contact person
Name of lead principal investigator
| 1st name | |
| Middle name | |
| Last name | Shinsuke Kito |
Organization
National Center Hospital, National Center of Neurology and Psychiatry
Division name
Department of Psychiatry and Advanced Medical Technology
Zip code
Address
4-1-1 Ogawa-Higashi, Kodaira, Tokyo 187-8551, Japan
TEL
042-341-2711
kito@ncnp.go.jp
Public contact
Name of contact person
| 1st name | |
| Middle name | |
| Last name | Shinsuke Kito |
Organization
National Center of Neurology and Psychiatry
Division name
Department of Psychiatry and Advanced Medical Technology
Zip code
Address
4-1-1 Ogawa-Higashi, Kodaira, Tokyo 187-8551, Japan
TEL
042-341-2711
Homepage URL
kito@ncnp.go.jp
Sponsor or person
Institute
National Center Hospital, National Center of Neurology and Psychiatry
Institute
Department
Personal name
Funding Source
Organization
1. Fiduciary funding by Inter Reha Co.,Ltd
2. Self funding
Organization
Division
Category of Funding Organization
Other
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
Other administrative information
Date of disclosure of the study information
| 2016 | Year | 05 | Month | 09 | Day |
Related information
URL releasing protocol
Publication of results
Published
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
Completed
Date of protocol fixation
| 2016 | Year | 04 | Month | 20 | Day |
Date of IRB
Anticipated trial start date
| 2016 | Year | 05 | Month | 09 | 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
| 2016 | Year | 04 | Month | 30 | Day |
Last modified on
| 2018 | Year | 10 | Month | 03 | Day |
Link to view the page
Value
https://center6.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000025518
| 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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