N/A
Completed N=22
Accelerated Intermittent Theta Burst Stimulation for Depressive Symptoms
Depression and Suicide
Source: ClinicalTrials.gov NCT03601117 ↗
Enrolled (actual)
22
Serious AEs
4.6%
Results posted
Aug 2021
Primary outcomePrimary: Change in Montgomery Asberg Depression Rating Scale (MADRS) Score — 26.59; 16 score on a scale — p=<.001
Summary
This study evaluates an accelerated schedule of theta-burst stimulation for depressive symptoms in psychiatric inpatients.
A small pilot study (n=22) will be carried out to demonstrate feasibility, using the FDA-approved stimulation site for depression treatment (L-DLPFC). Participants will be offered stimulation at the anterior cingulate cortex (ACC).
Outcome Measures
| Outcome | Result | p-value |
|---|---|---|
| PRIMARY Change in Montgomery Asberg Depression Rating Scale (MADRS) Score |
26.59; 16 | <.001 sig |
| SECONDARY Change in Scale of Suicidal Ideation (SSI) Score |
9.82; 0 | — |
| SECONDARY Change in Hamilton Rating Scale for Depression Six Item (HAMD-6) Score |
10; 1 | — |
| SECONDARY Change in Young Mania Rating Scale (YMRS) |
.06; 0 | — |
| SECONDARY Change in Beck Depression Inventory II (BDI-II) |
18.88; 6 | — |
| SECONDARY Change in Quick Inventory Depressive Scale-Self Reported (QIDS) Score |
11.29; 6 | — |
| SECONDARY Change in Pittsburgh Insomnia Rating Scale-20 Item Version (PIRS-20) Score |
16.23; 24 | — |
| SECONDARY Change in Resting-state Recordings and TMS-evoked Potentials in EEG Data. |
— | — |
| SECONDARY Biomarker Analysis in Patient Blood (Plasma) Samples |
— | — |
| SECONDARY Biomarker Analysis in Patient Stool Samples |
— | — |
| SECONDARY Biomarker Analysis in Patient Saliva Samples |
— | — |
| SECONDARY Change in th Quality of Life Enjoyment and Satisfaction Questionnaire-short Form Score |
12.36; 5 | — |
| SECONDARY Change in Performance on the NIH Toolbox |
— | — |
| SECONDARY Change in Immediate Mood Scaler (Ims-12) Depression Subscale Score |
11; -6 | — |
| SECONDARY Change in Heart Rate Variability |
-1.88 | — |
Eligibility Criteria
Inclusion Criteria
- Over 18 years old
- Able to read, understand, and provide written, dated informed consent prior to screening. Participants will be deemed likely to comply with study protocol and communicate with study personnel about adverse events and other clinically important information.
- Currently diagnosed with Major Depressive Disorder (MDD) and/or in a current major depressive episode, according to the criteria defined in the Diagnosis and Statistical Manual of Mental Disorders, Fourth Edition, Text Revision (DSM-IV-TR)
- Currently an inpatient at Stanford Hospital
- Meet the threshold on the total HAMD17 score of >/=20 at screening/baseline.
- Qualifies and has access to outpatient rTMS treatment
Exclusion Criteria
- Any structural lesion e.g. structural neurological condition, more subcortical lesions than would be expected for age, stroke effecting stimulated area or connected areas or any other clinically significant abnormality that might affect safety, study participation, or confound interpretation of study results.
- Metal implant in brain (e.g. deep brain stimulation), cardiac pacemaker, or cochlear
- History of epilepsy/ seizures (including history of withdrawal/ provoked seizures)
- Shrapnel or any ferromagnetic item in the head
- Pregnancy
- Autism Spectrum disorder
- Active substance use (<1 week) or intoxication verified by toxicology screen--of cocaine, amphetamines, benzodiazepines
- Any current or past history of any physical condition which in the investigator's opinion might put the subject at risk or interfere with study results interpretation
- Cognitive impairment (including dementia)
- Current severe insomnia (must sleep a minimum of 4 hours the night before stimulation)
- Current mania
- Current unmanageable psychosis
- IQ <70
- Showing symptoms of withdrawal from alcohol or benzodiazepines
- Parkinsonism or other movement d/o determined by PI to interfere with treatment
- More subcortical lesions than would be expected for age or a stroke effecting stimulated area or connected areas.
- Any other indication the PI feels would comprise data.
Data sourced from ClinicalTrials.gov (NCT03601117). Outcome figures and adverse-event rates are extracted automatically from the registry's posted results and are provided for clinician reference, not as a substitute for the primary publication. Informational only — not medical advice.