In-patient SCC TMS
ConditionMajor Depressive Disorder
Trial statusRecruiting
Trial phaseNot applicable
Trial typeInterventional
Biological sexAll
Age18-65
SponsorUniversity of California, Los Angeles
About this trial
The investigators are studying the feasibility, safety, and tolerability of administering accelerated repetitive Transcranial magnetic stimulation(a-rTMS) at frequencies other than standard 10 Hz for in-patient Subjects diagnosed with Major Depressive Disorder. Participants will be recruited from the Resnick Neuropsychiatric Hospital. This study will enroll 30 participants who will undergo up to three brain activity recordings, one MRI scan, one TMS procedure to determine the appropriate frequency and intensity for treatment, daily symptom assessments, and 25 TMS treatments. Participants will be asked to participate for up to 2 weeks.
Eligibility criteria
This trial does not accept healthy volunteersQualifiers
All subjects must be between 18-65 years of age.
Must have confirmed diagnosis of moderate to severe Major Depressive Disorder (single or recurrent episode) as defined by a HAM-D score of 17 or higher.
Failure to respond to a minimum of 2 trials of antidepressant medication
Failure to respond from at least two different agent classes
Disqualifiers
Are mentally or legally incapacitated, unable to give informed consent
Have an infection or poor skin condition over the scalp where the device will be positioned
Have increased risk of seizure because of family history, stroke, or currently use medications that lead to increased risk for seizure
Diagnosis of acute or chronic psychotic symptoms or disorders (such as schizophrenia, schizophreniform or schizoaffective disorder) in the current depressive episode.
Trial design
Design model
Single group
Treatments tested in this trial
Open-label TMS
DeviceCustomized, Open-Label Transcranial Magnetic Stimulation
Treatment groups
30 Participants
are divided into 1 treatment groupGroup A: Open-label TMSExperimental treatment 1 intervention
Trial outcomes
Primary outcomes
1
Treatment Efficacy as Measured by Change in Inventory of Depressive Symptoms (Self-Report) at Baseline and Final Visit
Treatment efficacy as measured by change in Inventory of Depressive Symptoms (Self-Report) at Baseline and Week 8 visit. This is a 30-item questionnaire with minimum and maximum score values ranging from 0 to 84. Higher scores indicate a worse outcome and lower scores indicate better outcome.
Time frame
2 Weeks (Baseline and Final Visit)Secondary outcomes
1
Treatment Efficacy as Measured by Change in Patient Health Questionnaire-9 (PHQ-9) at Baseline and Final Visit.
Treatment efficacy as measured by change in Patient Health Questionnaire-9 (PHQ-9) at Baseline and Final Visit. This is a 9-item questionnaire with minimum and maximum score values ranging from 0 to 27. Higher scores indicate a worse outcome and lower scores indicate better outcome.
Time frame
2 Weeks (Baseline and Final Visit)Sponsors and contacts
Click on the lead sponsor to view all of their trials.
Source ClinicalTrials.gov