UMIN-CTR Clinical Trial
| Unique ID issued by UMIN | UMIN000058093 |
|---|---|
| Receipt number | R000066394 |
| Scientific Title | rTMS and CBT Combination Therapy for Difficult-to-Treat Depression: A Pilot Single-Arm Pre-Post Study |
| Date of disclosure of the study information | 2025/06/05 |
| Last modified on | 2025/06/05 16:33:57 |
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Basic information
Public title
rTMS and CBT Combination Therapy for Difficult-to-Treat Depression: A Pilot Single-Arm Pre-Post Study
Acronym
rTMS and CBT Combination Therapy for Difficult-to-Treat Depression: A Pilot Single-Arm Pre-Post Study
Scientific Title
rTMS and CBT Combination Therapy for Difficult-to-Treat Depression: A Pilot Single-Arm Pre-Post Study
Scientific Title:Acronym
rTMS and CBT Combination Therapy for Difficult-to-Treat Depression: A Pilot Single-Arm Pre-Post Study
Region
| Japan |
Condition
Condition
Major Depressive Disorder
Classification by specialty
| Psychiatry |
Classification by malignancy
Others
Genomic information
NO
Objectives
Narrative objectives1
To assess the therapeutic efficacy and feasibility of CBT with rTMS for treatment-resistant depression.
Basic objectives2
Safety,Efficacy
Basic objectives -Others
Trial characteristics_1
Trial characteristics_2
Developmental phase
Assessment
Primary outcomes
Improvement in GRID-Hamilton Depression Rating Scale (GRID-HAMD) after 5 months (20 weeks) of treatment
Key secondary outcomes
Base
Study type
Interventional
Study design
Basic design
Single arm
Randomization
Non-randomized
Randomization unit
Blinding
Open -no one is blinded
Control
Uncontrolled
Stratification
Dynamic allocation
Institution consideration
Blocking
Concealment
Intervention
No. of arms
1
Purpose of intervention
Treatment
Type of intervention
| Behavior,custom | Other |
Interventions/Control_1
Cognitive behavioural therapy combined with repetitive transcranial magnetic stimulation therapy
Interventions/Control_2
Interventions/Control_3
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
| 18 | years-old | <= |
Age-upper limit
| 70 | years-old | >= |
Gender
Male and Female
Key inclusion criteria
1) Post-consent, admitted diagnosis of DSM-IV Major Depressive Disorder Major Depressive Disorder at pre-enrolment screening.
2) HAMD >=14 at post-consent and pre-enrolment screening
3) After obtaining consent and at the time of pre-registration screenings, those who do not improve adequately with adequate treatment with one or more antidepressants with different mechanisms of action.
4) Persons aged between 18 and 70 years at the time of pre-enrolment screenings after consent has been obtained.
Key exclusion criteria
1) Patients with severe organic brain lesions (e.g. intracranial organic lesions of moderate or greater severity or neurodegenerative diseases) or cognitive impairment after obtaining consent and within one year from the time of pre-registration screening or assessment.
2) A history of convulsive seizures or epilepsy
3) Persons with comorbid alcohol or other substance use disorders within 12 months of obtaining consent and from the time of pre-registration screening
4) Cases with multiple coexisting psychiatric diagnoses that cannot be narrowed down to a single primary diagnosis
5) Patients with a history or presenting symptoms of hypomanic episodes, manic episodes or psychotic disorders after consent was obtained and at the time of pre-registration screening
6) Persons with other primary Axis I Disorders within 12 months of obtaining consent and at the time of pre-registration screening.
7) Who, after obtaining consent and at the time of pre-registration screening, have a clinical judgement of imminent suicidal ideation
8) Who have a clinical diagnosis of a life-threatening, serious or unstable physical condition at the time of obtaining consent and pre-registration screening
9) who have undergone ECT within the last 6 months
10) Who have undergone rTMS in the past
11) Who have received individual CBT (more than 8 sessions) in the past
12) Who have received other structured psychotherapy (excluding supportive care) during the intervention period
13) Pregnant, lactating or planning or expecting a pregnancy
14) Persons with contraindications to TMS or MRI procedures such as metal implants, pacemakers, claustrophobia, tattoos larger than 2 x 2 cm in a single point on the head and neck area, including tattoos and art make-up
15) If the size of the head, neck or body is not suitable for the MRI scanner.
16) Persons with obvious hearing impairment at the time of examination
17) Other subjects deemed unsuitable for the study by the principal investigator.
Target sample size
10
Research contact person
Name of lead principal investigator
| 1st name | Nariko |
| Middle name | |
| Last name | Katayama |
Organization
Keio University School of Medicine
Division name
Health Center
Zip code
160-8582
Address
35 Shinanomachi, Shinjuku-ku, Tokyo, Japan
TEL
03-5363-3971
narikoktym@keio.jp
Public contact
Name of contact person
| 1st name | Nariko |
| Middle name | |
| Last name | Katayama |
Organization
Keio University
Division name
Health Center
Zip code
160-8582
Address
35 Shinanomachi, Shinjuku-ku, Tokyo, Japan
TEL
03-5363-3971
Homepage URL
narikoktym@keio.jp
Sponsor or person
Institute
Keio University
Institute
Department
Personal name
Funding Source
Organization
Japan Agency for Medical Research and Development (AMED)
Organization
Division
Category of Funding Organization
Japanese Governmental office
Nationality of Funding Organization
Other related organizations
Co-sponsor
Name of secondary funder(s)
IRB Contact (For public release)
Organization
Keio University School of Medicine
Address
35 Shinanomachi, Shinjuku-ku, Tokyo, Japan
Tel
03-5363-3971
narikoktym@keio.jp
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
| 2025 | Year | 06 | Month | 05 | 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
Preinitiation
Date of protocol fixation
| 2025 | Year | 06 | Month | 05 | Day |
Date of IRB
Anticipated trial start date
| 2025 | Year | 06 | Month | 15 | Day |
Last follow-up date
| 2026 | Year | 03 | Month | 31 | Day |
Date of closure to data entry
Date trial data considered complete
Date analysis concluded
Other
Other related information
Management information
Registered date
| 2025 | Year | 06 | Month | 05 | Day |
Last modified on
| 2025 | Year | 06 | Month | 05 | Day |
Link to view the page
Value
https://center6.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000066394
