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UMIN-CTR Clinical Trial |
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Name: | UMIN ID: |
Recruitment status | Terminated |
Unique ID issued by UMIN | UMIN000004277 |
Receipt No. | R000004658 |
Scientific Title | Theta-burst transcranial magnetic stimulation in the treatment of depression: A double-blind, randomized, placebo-controlled crossover trial |
Date of disclosure of the study information | 2010/10/01 |
Last modified on | 2012/10/11 |
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 |
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Condition | ||
Condition | Major depressive disorder | |
Classification by specialty |
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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 |
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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) |
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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 |
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Age-upper limit |
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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 |
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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 |
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Target sample size | 18 |
Research contact person | |||||||
Name of lead principal investigator |
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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 | ||||||
Public contact | |||||||
Name of contact person |
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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 | |||||||
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 | |
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Name of secondary funder(s) |
IRB Contact (For public release) | |
Organization | |
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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 |
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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 |
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Anticipated trial start date |
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Date analysis concluded |
Other | |
Other related information |
Management information | |||||||
Registered date |
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Last modified on |
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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 |