UMIN-CTR Clinical Trial

Basic information
Official scientific title of the study	Therapeutic Effects of Theta-Burst Stimulation on severity of depression and cognitive functions in major depression
Title of the study (Brief title)	Antidepressant efficacy of TBS
Region	Asia(except Japan)

Condition
Condition	A treatment option for refracfory depression
Classification by specialty	Psychiatry
Classification by malignancy	Others
Genomic information	NO

Objectives
Narrative objectives1	In this randomized sham-controlled study, antidepressant effects of TBS (cTBS, iTBS and bilateral TBS) will be compared with that of sham-controlled stimulation in patients with major depression. Besides, since previous study showed dose effects of TBS, we will enhance the stimulation parameters to 1800 pulses for 10 sessions (total number: 18000 pulses) and follow up the effects of TBS 3 months after the 2-week TBS treatment to see if any antidepressant effects persist one month after the end of TBS treatment. We will compare antidepressant effects among cTBS (1800, right DLPFC), iTBS (1800, left DLPFC), cTBS(1800, right)/iTBS(1800, left) and sham-controlled group in medication-resistant depressives.
Basic objectives2	Others
Basic objectives -Others	It is still not clear whether TBS could have an effect on reversing cognitive problems in these medication-resistant depressives.
Trial characteristics_1	Exploratory
Trial characteristics_2	Pragmatic
Developmental phase	Phase III

Assessment
Primary outcomes	Maudsley staging scoring questionnaires (baseline); Depressive symptoms: Hamilton Depression Rating Scale-17 (HDRS-17), Depression Subscales for Somatic Symptoms (DSSS), Short-form McHill Pain Questionnaire(MPQ) and Visual Analogue Scores (VAS) Manic symptoms: Young Mania Rating Scales (YMRS) Quality of life: MOS SF-12 quality of life rating scales
Key secondary outcomes	Nerocognitive testings will be also performed twice, baseline and 2 weeks post-treatment, to check their attention (Test for Attentional Performance) and executive function (Wisconsin Card Sorting Tests). 3T MRI and 18F-FDG PET

Base
Study type	Interventional

Study design
Basic design	Parallel
Randomization	Randomized
Randomization unit	Cluster
Blinding	Double blind -all involved are blinded
Control	Placebo
Stratification	NO
Dynamic allocation	NO
Institution consideration	Institution is not considered as adjustment factor.
Blocking	YES
Concealment	Numbered container method

Intervention
No. of arms	4
Purpose of intervention	Treatment
Type of intervention	Device,equipment
Interventions/Control_1	cTBS (1800): right DLPFC, 1800 pulses/session, 10 sessions/ 2 weeks
Interventions/Control_2	iTBS (1800): left DLPFC, 1800 pulses/session, 10 sessions/ 2 weeks
Interventions/Control_3	cTBS (1800) + iTBS (1800): cTBS over right DLPFC and iTBS over left DLPFC; randomized sequences in determining which side to be started with
Interventions/Control_4	Sham controlled group: figure-of-eight coil targeted at either side of DLPFC (randomized) with 90 degree against skull
Interventions/Control_5
Interventions/Control_6
Interventions/Control_7
Interventions/Control_8
Interventions/Control_9
Interventions/Control_10

Eligibility
Age-lower limit	21 years-old <=
Age-upper limit	70 years-old >=
Gender	Male and Female
Key inclusion criteria	Major Depressive Disorder(MDD), no substance abuse and personality disorders (based on DSM-IV) Meet medication-resistant depression: fail to respond to at least 2 trials of adequate antidepressant treatments (dosage and duration) At least moderate depression before TBS: Clinical Global Index of severity >=4 and 17-item Hamilton Depression Rating Scale (HDRS-17)>= 18
Key exclusion criteria	No major systemic illness(e.g.,severe arrhythmia);no neurological disorders(e.g., neuro-stimulators, stroke, seizure, traumatic brain injury); Not in pregnant; No brain implants; No pacemakers; No brain surgery past history
Target sample size	120

Research contact person
Name of lead principal investigator	Cheng-Ta Li
Organization	Taipei Veterans General Hospital, Taiwan
Division name	Psychiatry
Address	No.201, Sec.2, Shih-Pai Rd, Beitou district, Taipei, Taiwan
TEL	+81-188628757027
Email	on5083@msn.com

Public contact
Name of contact person	Cheng-Ta Li
Organization	Taipei Veterans General Hospital, Taiwan
Division name	Psychiatry
Address	No.201, Sec. 2, Shih-Pai Road, Beitou district, Taipei, Taiwan
TEL	+81-188628757027
Homepage URL
Email	on5083@msn.com

Sponsor
Institute	Taipei Veterans General Hospital, Taiwan
Institute
Department

Funding Source
Organization	Taipei Veterans General Hospital, Taiwan
Organization
Division
Category of Funding Organization	Outside Japan
Nationality of Funding Organization	Taiwan, ROC

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	2013 Year 09 Month 25 Day

Progress
Recruitment status	Open public recruiting
Date of protocol fixation	2011 Year 08 Month 01 Day
Anticipated trial start date	2012 Year 04 Month 01 Day
Last follow-up date	2016 Year 12 Month 31 Day
Date of closure to data entry	2016 Year 12 Month 31 Day
Date trial data considered complete
Date analysis concluded

Related information
URL releasing protocol
Publication of results	Unpublished
URL releasing results
Results
Other related information

Management information
Registered date	2013 Year 09 Month 25 Day
Last modified on	2017 Year 01 Month 15 Day

Link to view the page
URL(English)	https://upload.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000013859