Major Depressive Disorder
Conditions
Interventions
Cognitive behavioural therapy combined with repetitive transcranial magnetic stimulation therapy
Sponsors
Keio University
Eligibility
Sex/Gender
All
Inclusion criteria
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.
Exclusion criteria
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.
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| Improvement in GRID-Hamilton Depression Rating Scale (GRID-HAMD) after 5 months (20 weeks) of treatment | — |
Countries
Japan
Contacts
Public ContactNariko Katayama
Keio University Health Center
Outcome results
None listed