Accelerated Theta Burst in Treatment-Resistant Depression (aTBS)
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|ClinicalTrials.gov Identifier: NCT03068715|
Recruitment Status : Recruiting
First Posted : March 3, 2017
Last Update Posted : August 9, 2018
|Condition or disease||Intervention/treatment||Phase|
|Treatment Resistant Depression||Device: Active TBS-DLPFC Device: Sham TBS-DLPFC Device: Open label TBS-DLPFC||Not Applicable|
|Study Type :||Interventional (Clinical Trial)|
|Estimated Enrollment :||60 participants|
|Intervention Model:||Parallel Assignment|
|Masking:||Triple (Participant, Care Provider, Investigator)|
|Official Title:||Accelerated Theta Burst in Treatment-Resistant Depression: A Dose Finding and Biomarker Study|
|Actual Study Start Date :||March 20, 2017|
|Estimated Primary Completion Date :||March 2021|
|Estimated Study Completion Date :||March 2021|
Experimental: Active TBS-DLPFC
The active group will receive theta-burst TMS stimulation.
Device: Active TBS-DLPFC
Participants in the active stimulation group will receive intermittent TBS to left DLPFC. The L-DLPFC will be targeted utilizing the Localite neuronavigation system. Stimulation intensity will be standardized at 80% of RMT and adjusted to the skull to cortical surface distance (see Nahas 2004).
Stimulation will be delivered to the L-DLPFC using a MagPro stimulator.
Sham Comparator: Sham TBS-DLPFC
The sham group will receive sham theta-burst TMS stimulation. Participants will have the option of open label TBS-DLPFC treatment following study completion.
Device: Sham TBS-DLPFC
The parameters in the active arms will be as above with the internal randomization of the device internally switching to sham in a blinded fashion.
Device: Open label TBS-DLPFC
Patients will have the option of receiving active, open label aTBS treatment following sham.
- Percentage change in Montgomery-Åsberg Depression Rating Scale (MADRS) [ Time Frame: Pretreatment, immediately posttreatment, 2 weeks posttreatment, 4 weeks posttreatment ]A ten item diagnostic questionnaire used to measure the severity of depressive episodes in patients with mood disorders.
- Hamilton Rating Scale for Depression (HAMD-17) [ Time Frame: 4 weeks posttreatment ]A provider administered questionnaire used to assess remission and recovery from depression.
- Columbia Suicide Severity Rating Scale (C-SSRS) [ Time Frame: Pretreatment, immediately posttreatment, 2 weeks posttreatment, 4 weeks posttreatment ]A suicidal ideation rating scale created by researchers at Columbia University.
- Hamilton Rating Scale for Depression (HAM-6) [ Time Frame: Follow-up every 2 weeks for 6 months by telephone ]A 6 item questionnaire used to score the severity of depression.
- Hamilton Rating Scale for Depression (HAMD-17) [ Time Frame: Pretreatment, immediately posttreatment, 2 weeks posttreatment ]A provider administered questionnaire used to assess remission and recovery from depression.
- Change from baseline functional connectivity immediately posttreatment [ Time Frame: Pretreatment, immediately posttreatment ]Functional connectivity of subcallosal cingulate to the default mode network and within the default mode network.
- Change from baseline functional connectivity at 4 weeks posttreatment [ Time Frame: Pretreatment, 4 weeks posttreatment ]We will assess functional connectivity as seen on resting state fMRI, between the subcallosal cingulate to the default mode network and within the default mode network.
- Change in heart rate variability [ Time Frame: Pretreatment, during treatment, immediately posttreatment, weekly posttreatment ]Heart rate variability measures will be compared pre-treatment and at several time points post-treatment.
To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.
Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT03068715
|United States, California|
|Department of Psychiatry and Behavioral Sciences, Stanford School of Medicine||Recruiting|
|Stanford, California, United States, 94305|
|Contact: Claudia K Tischler, BSc 650-498-8535 firstname.lastname@example.org|
|Principal Investigator: Nolan Williams, MD|