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

NCT04485455 | Completed Results FDA Device

• 1 other identifier: 19-1100
• Study Type: interventional
• Target: 5
• Locations: 1 country
• Sites: 1

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. 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.

Conditions

Depression

Keywords

Adolescent Depression; Teen Depression

Outcome Measures

Primary Outcomes (8)

• Change in HAM-D Score From Baseline to Week 1

  The Hamilton Rating Scale for Depression (HAM-D) total score comprises a sum of the 17 individual item scores which ranges from 0 to 52. Higher scores indicate a greater degree of depression.

  Baseline, Week 1

• Change in CDRS-R Score From Baseline to Week 1

  The Children's Depression Rating Scale-Revised (CDRS-R) total score ranges from 17 (minimal or no symptoms of depression) to 113 (indicative of depression) is a semi-structured, clinician-rated instrument designed for use with children and adolescents between the ages of 6 to 17 years of age and their caregivers. The CDRS-R evaluates the presence and severity of symptoms commonly associated with depression in childhood.

  Baseline, Week 1

• Change in HAM-D Score From Baseline to Week 2

  The Hamilton Rating Scale for Depression (HAM-D) total score comprises a sum of the 17 individual item scores which ranges from 0 to 52. Higher scores indicate a greater degree of depression.

  Baseline, Week 2

• Change in CDRS-R Score From Baseline to Week 2

  The Children's Depression Rating Scale-Revised (CDRS-R) total score ranges from 17 (minimal or no symptoms of depression) to 113 (indicative of depression) is a semi-structured, clinician-rated instrument designed for use with children and adolescents between the ages of 6 to 17 years of age and their caregivers. The CDRS-R evaluates the presence and severity of symptoms commonly associated with depression in childhood.

  Baseline, Week 2

• Change in HAM-D Score From Baseline to Week 3

  The Hamilton Rating Scale for Depression (HAM-D) total score comprises a sum of the 17 individual item scores which ranges from 0 to 52. Higher scores indicate a greater degree of depression.

  Baseline, Week 3

• Change in CDRS-R Score From Baseline to Week 3

  The Children's Depression Rating Scale-Revised (CDRS-R) total score ranges from 17 (minimal or no symptoms of depression) to 113 (indicative of depression) is a semi-structured, clinician-rated instrument designed for use with children and adolescents between the ages of 6 to 17 years of age and their caregivers. The CDRS-R evaluates the presence and severity of symptoms commonly associated with depression in childhood.

  Baseline, Week 3

• Change in HAM-D Score From Baseline to Week 4

  The Hamilton Rating Scale for Depression (HAM-D) total score comprises a sum of the 17 individual item scores which ranges from 0 to 52. Higher scores indicate a greater degree of depression.

  Baseline, Week 4

• Change in CDRS-R Score From Baseline to Week 4

  The Children's Depression Rating Scale-Revised (CDRS-R) total score ranges from 17 (minimal or no symptoms of depression) to 113 (indicative of depression) is a semi-structured, clinician-rated instrument designed for use with children and adolescents between the ages of 6 to 17 years of age and their caregivers. The CDRS-R evaluates the presence and severity of symptoms commonly associated with depression in childhood.

  Baseline, Week 4

Secondary Outcomes (6)

• Number of Occurrences of Passive Suicidal Ideation

  Up to 12 Weeks Post-Treatment Completion, a total of up to 16 weeks

• Number of Participants Who Completed the Study

  Up to Week 5

• Number of Participants Who Withdrew From the Study

  Up to Week 5

• Durability of Treatment Effect With HAM-D Scores

  From Baseline up to 12 Weeks Post-Treatment Completion, a total of up to 16 weeks

• Durability of Treatment Effect With CDRS-R Scores

  Up to 12 Weeks Post-Treatment Completion, a total of up to 16 weeks

Study Arms (1)

iTBS Therapy

EXPERIMENTAL

Teenage participants with depression will receive iTBS therapy using a Transcranial Magnetic Stimulation (TMS) protocol delivering electro-magnetic stimulation

Device: iTBS Device/Motor Threshold Coil; Device: iTBS Device/Treatment Coil

Interventions

iTBS Device/Motor Threshold Coil DEVICE

Motor Threshold determination, done prior to starting treatments, determines the location and the intensity for the iTBS treatments. A magnetic field is applied with increasing intensity stimulating the motor region of the brain until there is thumb movement; this indicates the intensity of the treatments; the location for treatment is in the sensory area parallel to this location.

Also known as: MagProX100 with MagOption Stimulator and Magpro Coil C-B60 or C-B70

iTBS Therapy

iTBS Device/Treatment Coil DEVICE

iTBS is a particular TMS protocol which delivers the magnetic field in triplet bursts (three stimulations very close together at a frequency of 50 Hz very quickly). The triplet bursts are repeated at a rate of 5 Hz for 2 seconds (30 pulses), followed by 8 seconds rest, repeated 20 times for a total of 600 pulses. Each treatments lasts approximately 3 minutes, and sessions are provided 20 times (Monday-Friday for 4 consecutive weeks).

Also known as: MagPro, Models R30 with MagOption, X100 WITH MagOption, Coil Cool-B65

iTBS Therapy

Eligibility Criteria

• Age: 13 Years - 17 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Child (0-17)

You may qualify if:

• 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.

You may not qualify if:

• 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 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.

Sponsors & Collaborators

• University of North Carolina, Chapel Hill: lead

Study Sites (1)

University of North Carolina at Chapel Hill-Psychiatry Outpatient Clinic

Chapel Hill, North Carolina, 27514, United States

Location

MeSH Terms

Conditions

Depression

Condition Hierarchy (Ancestors)

Behavioral Symptoms; Behavior

Results Point of Contact

• Title: Shahzad Ali, MD
• Organization: University of North Carolina at Chapel Hill

shali@med.unc.edu

984-974-0033

Study Officials

• Shahzad Ali, MD

  University of North Carolina, Chapel Hill

  PRINCIPAL INVESTIGATOR

Publication Agreements

• PI is Sponsor Employee: Yes
• Restrictive Agreement: No

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: NA
• Masking: NONE
• Purpose: TREATMENT
• Intervention Model: SINGLE GROUP
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: July 21, 2020
• First Posted: July 24, 2020
• Study Start: September 21, 2020
• Primary Completion: April 30, 2021
• Study Completion: July 29, 2021
• Last Updated: November 30, 2021
• Results First Posted: November 30, 2021

Record last verified: 2021-11

Data Sharing

• IPD Sharing: Will share
• Shared Documents: STUDY PROTOCOL, ICF
• Time Frame: 9 to 36 months following publication
• Access Criteria: Approval from an IRB, IEC, or REB and an executed data use/sharing agreement with UNC.

Locations

US (1)