Clinical trial NCT03601117: Accelerated Intermittent Theta Burst Stimulation for Depressive Symptoms
Official title: Accelerated Intermittent Theta Burst Stimulation for Depressive Symptoms
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: NA
Conditions: Depression and Suicide
Lead sponsor: Stanford University
Sponsor class: OTHER
First posted: 2018-07-26
Enrollment: 23
Sex: ALL
Minimum age (years): 18
Maximum age (years): 85
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: NON_RANDOMIZED
Intervention model: PARALLEL
Intervention model description: A small pilot study (n=22) will be an open-label study in which all participants receive stimulation to the L-DLPFC to demonstrate feasibility of delivering this accelerated protocol on an inpatient unit.

For participants who do not respond to L-DLPFC stimulation, we will offer an alternative site, the ACC.

If patients are enrolled that have a psychiatric diagnosis other than MDD, scales measuring symptoms related to their other diagnosis/(es) will also be collected in addition to measuring change in depressive symptoms (see 'other pre-specified outcome measures' for a list of measures used to measure symptoms related to psychiatric diagnoses other than depression).
Primary purpose: TREATMENT

Brief 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).

Detailed description: This study intends to investigate whether modifying stimulation parameters enables typical 6-8 week long rTMS protocols to be compressed to only five days. The influence of this accelerated protocol on the length of patient stay in the hospital will be investigated.

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.

Primary outcomes:
measure: Change in Montgomery Asberg Depression Rating Scale (MADRS) Score
timeFrame: After all stimulation sessions have been completed (approximately 48 hours after the final session)
Secondary outcomes:
measure: Change in Scale of Suicidal Ideation (SSI) Score
timeFrame: After all stimulation sessions have been completed (approximately 48 hours after the final session)
measure: Change in Hamilton Rating Scale for Depression Six Item (HAMD-6) Score
timeFrame: After all stimulation sessions have been completed (approximately 48 hours after the final session)
measure: Change in Young Mania Rating Scale (YMRS)
timeFrame: After all stimulation sessions have been completed (approximately 48 hours after the final session)
measure: Change in Beck Depression Inventory II (BDI-II)
timeFrame: After all stimulation sessions have been completed (approximately 48 hours after the final session)
measure: Change in Quick Inventory Depressive Scale-Self Reported (QIDS) Score
timeFrame: After all stimulation sessions have been completed (approximately 48 hours after the final session)
measure: Change in Pittsburgh Insomnia Rating Scale-20 Item Version (PIRS-20) Score
timeFrame: After all stimulation sessions have been completed (approximately 48 hours after the final session)
measure: Change in Resting-state Recordings and TMS-evoked Potentials in EEG Data.
timeFrame: After all stimulation sessions have been completed (approximately 48 hours after the final session)
measure: Biomarker Analysis in Patient Blood (Plasma) Samples
timeFrame: After all stimulation sessions have been completed (approximately 48 hours after the final session)
measure: Biomarker Analysis in Patient Stool Samples
timeFrame: After all stimulation sessions have been completed (approximately 48 hours after the final session)
measure: Biomarker Analysis in Patient Saliva Samples
timeFrame: After all stimulation sessions have been completed (approximately 48 hours after the final session)
measure: Change in th Quality of Life Enjoyment and Satisfaction Questionnaire-short Form Score
timeFrame: After all stimulation sessions have been completed (approximately 48 hours after the final session)
measure: Change in Performance on the NIH Toolbox
timeFrame: After all stimulation sessions have been completed (approximately 48 hours after the final session)
measure: Change in Immediate Mood Scaler (Ims-12) Depression Subscale Score
timeFrame: After all stimulation sessions have been completed (approximately 48 hours after the final session)
measure: Change in Heart Rate Variability
timeFrame: After all stimulation sessions have been completed (approximately 48 hours after the final session)
Other outcomes:
measure: Change in Alcohol Craving Questionnaire Score (Adapted for All Drug Use)
timeFrame: After all stimulation sessions have been completed (approximately 48 hours after the final session)
measure: Change in Borderline Evaluation Of Severity Over Time (BEST) Score
timeFrame: After all stimulation sessions have been completed (approximately 48 hours after the final session)
measure: Change in Obsessive Compulsive Drinking Scale Score (Adapted for Use of Any Drug)
timeFrame: After all stimulation sessions have been completed (approximately 48 hours after the final session)
measure: Change in Average Weekly Substance Use
timeFrame: After all stimulation sessions have been completed (approximately 48 hours after the final session)
measure: Change in Eating Disorder Examination Questionnaire (EDE-Q) Score
timeFrame: After all stimulation sessions have been completed (approximately 48 hours after the final session)
measure: Change in Generalized Anxiety Disorder 7-item (GAD-7) Score
timeFrame: After all stimulation sessions have been completed (approximately 48 hours after the final session)
measure: Change in Yale Brown Cornell Eating Disorder Scale (YBC-EDS) Score
timeFrame: After all stimulation sessions have been completed (approximately 48 hours after the final session)
measure: Change in Massachusetts General Hospital (MGH) Hairpulling Scale Score (Edited so Can be Used With Any Impulse Disorder)
timeFrame: After all stimulation sessions have been completed (approximately 48 hours after the final session)
measure: Change in Obsessive Compulsive Inventory (OCI) Score
timeFrame: After all stimulation sessions have been completed (approximately 48 hours after the final session)
measure: Change in Yalebrown Obsessive Compulsive Scale (YBOCS) Score
timeFrame: After all stimulation sessions have been completed (approximately 48 hours after the final session)
measure: Change in Numeric Rating Scale For Pain Score
timeFrame: After all stimulation sessions have been completed (approximately 48 hours after the final session)
measure: Change in Panic Disorder Severity Scale (PDSS) Score
timeFrame: Pre-treatment, after each day of stimulation and immediate post-treatmentAfter all stimulation sessions have been completed (approximately 48 hours after the final session)
measure: PTSD Checklist Civilian Version (PCL-C)
timeFrame: After all stimulation sessions have been completed (approximately 48 hours after the final session)
measure: Change in Calgary Depression Scale For Schizophrenia (CDSS) Score
timeFrame: After all stimulation sessions have been completed (approximately 48 hours after the final session)
measure: Change in the Positive And Negative Syndrome Scale (PANSS) Score
timeFrame: After all stimulation sessions have been completed (approximately 48 hours after the final session)
Locations:
city: Palo Alto
country: United States
facility: Stanford Hospital
state: California
Study officials:
affiliation: Stanford University
name: Nolan Williams, MD
role: PRINCIPAL_INVESTIGATOR
References:
citation: George MS, Lisanby SH, Avery D, McDonald WM, Durkalski V, Pavlicova M, Anderson B, Nahas Z, Bulow P, Zarkowski P, Holtzheimer PE 3rd, Schwartz T, Sackeim HA. Daily left prefrontal transcranial magnetic stimulation therapy for major depressive disorder: a sham-controlled randomized trial. Arch Gen Psychiatry. 2010 May;67(5):507-16. doi: 10.1001/archgenpsychiatry.2010.46.
citation: George MS, Wassermann EM, Williams WA, Callahan A, Ketter TA, Basser P, Hallett M, Post RM. Daily repetitive transcranial magnetic stimulation (rTMS) improves mood in depression. Neuroreport. 1995 Oct 2;6(14):1853-6. doi: 10.1097/00001756-199510020-00008.
citation: Pascual-Leone A, Rubio B, Pallardo F, Catala MD. Rapid-rate transcranial magnetic stimulation of left dorsolateral prefrontal cortex in drug-resistant depression. Lancet. 1996 Jul 27;348(9022):233-7. doi: 10.1016/s0140-6736(96)01219-6.