N/A N=5 Treatment

iTBS for Adolescent Depression: An Open Label Study Evaluating Safety and Efficacy of Treatment

Depression

Bottom Line

View on ClinicalTrials.gov: NCT04485455 ↗

Enrolled (actual)

Serious AEs

0.0%

Results posted

Nov 2021

Primary outcome: Primary: Change in HAM-D Score From Baseline to Week 1 — -7.6 score on a scale

Study Design & Population

Study type: Interventional
Phase: N/A
Interventions: iTBS Device/Motor Threshold Coil (Device); iTBS Device/Treatment Coil (Device)
Age: Pediatric · 13+ yrs
Sex: All
Sponsor: University of North Carolina, Chapel Hill
Primary completion: Apr 2021

Outcome Measures

Outcome	Result	p-value
PRIMARY Change in HAM-D Score From Baseline to Week 1	-7.6	—
PRIMARY Change in CDRS-R Score From Baseline to Week 1	-9.0	—
PRIMARY Change in HAM-D Score From Baseline to Week 2	-6.2	—
PRIMARY Change in CDRS-R Score From Baseline to Week 2	-16	—
PRIMARY Change in HAM-D Score From Baseline to Week 3	-9.2	—
PRIMARY Change in CDRS-R Score From Baseline to Week 3	-11	—
PRIMARY Change in HAM-D Score From Baseline to Week 4	-7.8	—
PRIMARY Change in CDRS-R Score From Baseline to Week 4	-14	—
SECONDARY Number of Occurrences of Passive Suicidal Ideation	2; 2; 1; 0; 2; 2	—
SECONDARY Number of Participants Who Completed the Study	5	—
SECONDARY Number of Participants Who Withdrew From the Study	—	—
SECONDARY Durability of Treatment Effect With HAM-D Scores	-8.8; -11; -9.4	—
SECONDARY Durability of Treatment Effect With CDRS-R Scores	-21; -19; -23	—
SECONDARY Number of Occurrences of Non-Suicidal Self Injurious Behavior Through SITBI	0; 0; 0; 0; 0; 0	—

Summary

This is an open label, pilot, feasibility study evaluating effects of Intermittent Theta Burst Transcranial Magnetic Stimulation (iTBS) on 5 eligible adolescents for the treatment of depression. Safety and tolerability will be evaluated with changes in depression scores, and suicidality and non-suicidal self injurious behavior will also be monitored for exploratory and safety measures.

Eligibility Criteria

Inclusion Criteria

A score of greater than 40 on the CDRS-R and 17 on HAM-D.
Documentation of DSM-V criteria for current MDD or TRD will be required for study entry.
Patients may be on antidepressant medication at a stable dose or receiving psychotherapy with a licensed provider during the active phase of TMS treatment for 4 weeks.
Ability to provide consent and take part in questionnaires and scales (i.e.: not currently intellectually disabled).
The presence of suicidality or NSSIB are not required to enter this study. Although our secondary end-points include suicidality, and the investigators are also exploring NSSIB, and thus this may not lead to many data, the investigators' plan is to use data from this study to justify a larger study where this can be more robustly investigated.

Exclusion Criteria

Past or current diagnosis of bipolar disorder, psychosis, seizures or traumatic brain injury.
Presence of intracranial metallic implants or fragments, which is a contraindication for TMS.
Lifetime history of (or currently present) epilepsy.
Current diagnosis of substance abuse, eating disorder, PTSD (Post Traumatic Stress Disorder), or intellectual disability.* Nicotine use disorder will not directly preclude a potential subject from this study. Although chronic nicotine use does effect central nervous system excitability, what would be more confounding to our study would be if there is a sudden change in nicotine use during the treatment phase, as this may affect the motor threshold. Inclusion will however be at the PI's discretion.
Current imminent suicide ideation or other clinical reasons for inpatient psychiatric hospitalization.
Currently pregnant. There is currently not adequate data from this population to ensure safety with the scope of this protocol.
Any reason the investigator determines may cause noncompliance with study rules or is unfit for receiving treatment.
Currently taking certain medications including antidepressants, stimulants, benzodiazepines, and antipsychotics, antiepileptic (per investigator discretion).
Any positive drug testing from a urine drug test unless medically indicated with a valid prescription.
Those with marijuana/cannabis positive results may retest later if at that time they do not meet criteria for substance abuse at screening and agree to refrain from use for the duration of study participation. Decision to be made by Investigator discretion.

View full record on ClinicalTrials.gov →

Data sourced from ClinicalTrials.gov (NCT04485455). 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.