UMIN-CTR Clinical Trial
| Unique ID issued by UMIN | UMIN000011856 |
|---|---|
| Receipt number | 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 15:25:00 |
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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
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
| 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
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
on5083@msn.com
Sponsor or person
Institute
Taipei Veterans General Hospital, Taiwan
Institute
Department
Personal name
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
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
Value
https://center6.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000013859
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