UMIN-CTR Clinical Trial

Basic information
Official scientific title of the study	Transcranial magnetic stimulation (TMS) in the treatment of refractory bipolar depression: a preliminary study
Title of the study (Brief title)	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	Shinsuke Kito
Organization	National Center Hospital, National Center of Neurology and Psychiatry
Division name	Department of Psychiatry and Advanced Medical Technology
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	Shinsuke Kito
Organization	National Center of Neurology and Psychiatry
Division name	Department of Psychiatry and Advanced Medical Technology
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)

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

Progress
Recruitment status	Completed
Date of protocol fixation	2016 Year 04 Month 20 Day
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

Related information
URL releasing protocol
Publication of results	Published
URL releasing results
Results
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/icdr_e/ctr_view.cgi?recptno=R000025518