UMIN-CTR Clinical Trial

Basic information
Public title	Theta-burst transcranial magnetic stimulation in the treatment of depression: A double-blind, randomized, placebo-controlled crossover trial
Acronym	Theta-burst transcranial magnetic stimulation in the treatment of depression: A double-blind, randomized, placebo-controlled crossover trial
Scientific Title	Theta-burst transcranial magnetic stimulation in the treatment of depression: A double-blind, randomized, placebo-controlled crossover trial
Scientific Title:Acronym	Theta-burst transcranial magnetic stimulation in the treatment of depression: A double-blind, randomized, placebo-controlled crossover trial
Region	Japan

Condition
Condition	Major depressive disorder
Classification by specialty	Psychiatry
Classification by malignancy	Others
Genomic information	NO

Objectives
Narrative objectives1	To evaluate 1) the efficacy of intermittent theta-burst stimulation (iTBS) and continuous theta-burst stimulation (cTBS) over the prefrontal cortex in depression, 2) changes in biological markers associated with depression before and after theta-burst stimulation, and 3) changes in electroencephalography and polysomnography before and after theta-burst stimulation
Basic objectives2	Safety,Efficacy
Basic objectives -Others
Trial characteristics_1
Trial characteristics_2
Developmental phase

Assessment
Primary outcomes	HAMD, MADRS, and CGI at baseline, week 1, week 2, week 3, and week 4
Key secondary outcomes

Base
Study type	Interventional

Study design
Basic design	Cross-over
Randomization	Randomized
Randomization unit	Individual
Blinding	Double blind -all involved are blinded
Control	Placebo
Stratification
Dynamic allocation
Institution consideration
Blocking
Concealment	Numbered container method

Intervention
No. of arms	3
Purpose of intervention	Treatment
Type of intervention	Device,equipment
Interventions/Control_1	iTBS or cTBS will be applied in the left and right prefrontal cortex. Sham (1 week), Washout (3 weeks), Left TBS (1 week), Washout (3 weeks), Right TBS (1 week)
Interventions/Control_2	Left TBS (1 week), Washout (3 weeks), Right TBS (1 week), Washout (3 weeks), Sham (1 week)
Interventions/Control_3	Right TBS (1 week), Washout (3 weeks), Sham (1 week), Washout (3 weeks), Left TBS (1 week)
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)Patients with DSM-IV-TR of major depressive disorder 2)Patients scored greater than 18 on the HAMD 3)Patients have failed a minimum of 1 course of antidepressant medication in the current depressive episode
Key exclusion criteria	1)Severe suicidal idea 2)Neurological disorders/organic brain disorders 3)History of convulsive disorders 4)Drug or alcohol abuse/dependence 5)Implanted electronic devices/magnetic material 6)Severe physical diseases
Target sample size	18

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
Email

Public contact
Name of contact person	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
Homepage URL
Email	psychiat@ks.kyorin-u.ac.jp

Sponsor
Institute	Department of Neuropsychiatry, Kyorin University School of Medicine
Institute
Department

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
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	杏林大学付属病院（東京）

Other administrative information
Date of disclosure of the study information	2010 Year 10 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	2010 Year 07 Month 05 Day
Date of IRB
Anticipated trial start date	2010 Year 10 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	2010 Year 09 Month 28 Day
Last modified on	2012 Year 10 Month 11 Day

Link to view the page
URL(English)	https://upload.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000004658

Research Plan
Registered date	File name

Research case data specifications
Registered date	File name

Research case data
Registered date	File name

Contact us.