Status:
COMPLETED
iTBS for Adolescent Depression: An Open Label Study Evaluating Safety and Efficacy of Treatment
Lead Sponsor:
University of North Carolina, Chapel Hill
Conditions:
Depression
Eligibility:
All Genders
13-17 years
Phase:
NA
Brief 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. Safet...
Detailed Description
This study will investigate the efficacy and durability of the effects of Intermittent Theta Burst Stimulation (iTBS) in adolescent depression by measuring changes in clinical ratings before, during, ...
Eligibility Criteria
Inclusion
- 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
- 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.
Key Trial Info
Start Date :
September 21 2020
Trial Type :
INTERVENTIONAL
Allocation :
ACTUAL
End Date :
July 29 2021
Estimated Enrollment :
5 Patients enrolled
Trial Details
Trial ID
NCT04485455
Start Date
September 21 2020
End Date
July 29 2021
Last Update
November 30 2021
Active Locations (1)
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1
University of North Carolina at Chapel Hill-Psychiatry Outpatient Clinic
Chapel Hill, North Carolina, United States, 27514