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Name:
UMIN ID:

Recruitment status Completed
Unique ID issued by UMIN UMIN000022148
Receipt No. 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

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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
Email 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
Email kito@ncnp.go.jp

Sponsor
Institute National Center Hospital, National Center of Neurology and Psychiatry
Institute
Department

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
Email

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
URL(English) https://upload.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000025518

Research Plan
Registered date File name

Research case data specifications
Registered date File name

Research case data
Registered date File name


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