Major Depressive Disorder Clinical Trial
— PORTOfficial title:
Patient-oriented Randomized Pragmatic Feasibility Trial With rTMS in Depression and Anxiety
NCT number | NCT05028738 |
Other study ID # | H17-00161 |
Secondary ID | |
Status | Recruiting |
Phase | N/A |
First received | |
Last updated | |
Start date | October 11, 2021 |
Est. completion date | August 2022 |
This trial compares intermittent theta-burst stimulation (iTBS) to low frequency repetitive transcranial magnetic stimulation (LFR) in regards to depression and anxiety outcomes in 100 patients with treatment resistant depression (TRD).
Status | Recruiting |
Enrollment | 100 |
Est. completion date | August 2022 |
Est. primary completion date | July 2022 |
Accepts healthy volunteers | No |
Gender | All |
Age group | 18 Years and older |
Eligibility | Inclusion Criteria: 1. are outpatients; 2. are voluntary and competent to consent to treatment; 3. are = 18 years; 4. have a score = 26 on the IDS-30-SR; 5. have had no increase or initiation of any psychotropic medication in the 4 weeks prior to screening; 6. able to adhere to the treatment schedule; 7. pass the TMS adult safety screening (TASS) questionnaire Exclusion Criteria: 1. have active suicidal intent; 2. are pregnant; 3. have a lifetime diagnosis of schizophrenia, bipolar disorder type I, schizophreniform, schizoaffective disorder or presence of psychotic symptoms within last 3 months; 4. have a concomitant major unstable medical illness; 5. have any significant form of dementia or any history of epilepsy; 6. have any intracranial implant (e.g., aneurysm clips, shunts, stimulators, cochlear implants, or electrodes) or any other metal object within or near the head, excluding the mouth, that cannot be safely removed; 7. If participating in psychotherapy, must have been in stable treatment for at least 3 months prior to entry into the study, with no anticipation of change in the frequency of therapeutic sessions, or the therapeutic focus over the duration of the study; 8. If they are taking psychotropic medication, be on a stable dose for 4 weeks before starting treatment, and no initiation of new regular psychotropic medication; 9. have a clinically significant laboratory abnormality, in the opinion of the one of the principal investigators; 10. have a non-correctable clinically significant sensory impairment (i.e., cannot hear well enough to cooperate with interview). |
Country | Name | City | State |
---|---|---|---|
Canada | Non-Invasive Neurostimulation Therapies (NINET) Laboratory, UBC Department of Psychiatry | Vancouver | British Columbia |
Lead Sponsor | Collaborator |
---|---|
University of British Columbia |
Canada,
Type | Measure | Description | Time frame | Safety issue |
---|---|---|---|---|
Primary | Depression severity | Inventory of Depressive Symptoms (IDS-30-SR); Minimum value per question: 0; Maximum value per question: 3; Total minimum value: 0; Total maximum value: 84; Higher score means worse outcome. | one week post treatment | |
Secondary | Suicidal ideation | Columbia-Suicide Severity Rating Scale (C-SSRS); This questionnaire has binary responses (Yes/No). More responses with "Yes" mean worse outcome. | one week post treatment | |
Secondary | Anxiety severity | Brief Symptom Inventory anxiety subscale (BSI-Anxiety); Minimum value per question: 0 (Not at all); Maximum value per question: 4 (Extremely); Total minimum value: 0; Total maximum value: 24; Higher score means worse outcome. | one week post treatment |
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