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Recruitment status Open public recruiting
Unique ID issued by UMIN UMIN000011856
Receipt No. R000013859
Scientific Title Therapeutic Effects of Theta-Burst Stimulation on severity of depression and cognitive functions in major depression
Date of disclosure of the study information 2013/09/25
Last modified on 2017/01/15

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Basic information
Public title Therapeutic Effects of Theta-Burst Stimulation on severity of depression and cognitive functions in major depression
Acronym Antidepressant efficacy of TBS
Scientific Title Therapeutic Effects of Theta-Burst Stimulation on severity of depression and cognitive functions in major depression
Scientific Title:Acronym 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

In outcomes field, the entry of just a few words such as "safety" or "efficiency" will not be accepted. Specify the name of outcome measures, including the time when you plan to measure. Usually, only one primary outcome is accepted. Write the other outcomes in "secondary outcomes" field.

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

In interventions field, include the details of interventions, such as duration, amount, and frequency. If the intervention includes prescription or use of medical devices, duration is required.

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
1st name
Middle name
Last name Cheng-Ta Li
Organization Taipei Veterans General Hospital, Taiwan
Division name Psychiatry
Zip code
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
1st name
Middle name
Last name Cheng-Ta Li
Organization Taipei Veterans General Hospital, Taiwan
Division name Psychiatry
Zip code
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

Sponsor means an organization that is responsible for plan, deployment and
report of the research including funding management. It doesn't mean
funding agency". Therefore, all clinical trial should have the one.

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)

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
2013 Year 09 Month 25 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 Open public recruiting
Date of protocol fixation
2011 Year 08 Month 01 Day
Date of IRB
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

Other
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


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