Trial Outcomes & Findings for iTBS for Adolescent Depression: An Open Label Study Evaluating Safety and Efficacy of Treatment (NCT NCT04485455)

NCT ID: NCT04485455

Last Updated: 2021-11-30

Results Overview

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.

• Recruitment status: COMPLETED
• Study phase: NA
• Target enrollment: 5 participants
• Primary outcome timeframe: Baseline, Week 1
• Results posted on: 2021-11-30

Participant Flow

Participant milestones

Measure	iTBS Open Label All subjects enrolled into this study were in the same group, with all receiving active Intermittent Theta Burst Stimulation (iTBS) treatment.
Overall Study STARTED	5
Overall Study COMPLETED	5
Overall Study NOT COMPLETED	0

Reasons for withdrawal

Withdrawal data not reported

Baseline Characteristics

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

Baseline characteristics by cohort

Measure	iTBS Open Label n=5 Participants All subjects enrolled into this study were in the same group, with all receiving active iTBS treatment.
Age, Continuous 13 to 17 year old	16.2 years n=93 Participants
Age, Customized Age 17	4 Participants n=93 Participants
Age, Customized Age 13	1 Participants n=93 Participants
Sex/Gender, Customized Female	2 Participants n=93 Participants
Sex/Gender, Customized Male	2 Participants n=93 Participants
Sex/Gender, Customized Non-Binary	1 Participants n=93 Participants
Ethnicity (NIH/OMB) Hispanic or Latino	2 Participants n=93 Participants
Ethnicity (NIH/OMB) Not Hispanic or Latino	1 Participants n=93 Participants
Ethnicity (NIH/OMB) Unknown or Not Reported	2 Participants n=93 Participants
Race (NIH/OMB) American Indian or Alaska Native	0 Participants n=93 Participants
Race (NIH/OMB) Asian	0 Participants n=93 Participants
Race (NIH/OMB) Native Hawaiian or Other Pacific Islander	0 Participants n=93 Participants
Race (NIH/OMB) Black or African American	0 Participants n=93 Participants
Race (NIH/OMB) White	4 Participants n=93 Participants
Race (NIH/OMB) More than one race	1 Participants n=93 Participants
Race (NIH/OMB) Unknown or Not Reported	0 Participants n=93 Participants
Region of Enrollment United States	5 Participants n=93 Participants
Mean Depression HAM-D Rating Score	16.8 Score on scale n=93 Participants
Mean Depression CDRS-R Rating Score	65.2 Score on an assessment n=93 Participants

PRIMARY outcome

Timeframe: Baseline, 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.

Outcome measures

Measure	iTBS Open Label n=5 Participants All subjects enrolled into this study were in the same group, with all receiving active iTBS treatment.
Change in HAM-D Score From Baseline to Week 1	-7.6 score on a scale Interval -15.0 to -0.42

PRIMARY outcome

Timeframe: Baseline, 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.

Outcome measures

Measure	iTBS Open Label n=5 Participants All subjects enrolled into this study were in the same group, with all receiving active iTBS treatment.
Change in CDRS-R Score From Baseline to Week 1	-9.0 score on a scale Interval -15.0 to -3.5

PRIMARY outcome

Timeframe: Baseline, 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.

Outcome measures

Measure	iTBS Open Label n=5 Participants All subjects enrolled into this study were in the same group, with all receiving active iTBS treatment.
Change in HAM-D Score From Baseline to Week 2	-6.2 score on a scale Interval -13.0 to 0.44

PRIMARY outcome

Timeframe: Baseline, 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.

Outcome measures

Measure	iTBS Open Label n=5 Participants All subjects enrolled into this study were in the same group, with all receiving active iTBS treatment.
Change in CDRS-R Score From Baseline to Week 2	-16 score on a scale Interval -24.0 to -7.5

PRIMARY outcome

Timeframe: Baseline, 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.

Outcome measures

Measure	iTBS Open Label n=5 Participants All subjects enrolled into this study were in the same group, with all receiving active iTBS treatment.
Change in HAM-D Score From Baseline to Week 3	-9.2 score on a scale Interval -15.0 to -3.5

PRIMARY outcome

Timeframe: Baseline, 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.

Outcome measures

Measure	iTBS Open Label n=5 Participants All subjects enrolled into this study were in the same group, with all receiving active iTBS treatment.
Change in CDRS-R Score From Baseline to Week 3	-11 score on a scale Interval -22.0 to -0.07

PRIMARY outcome

Timeframe: Baseline, 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.

Outcome measures

Measure	iTBS Open Label n=5 Participants All subjects enrolled into this study were in the same group, with all receiving active iTBS treatment.
Change in HAM-D Score From Baseline to Week 4	-7.8 score on a scale Interval -14.0 to -1.6

PRIMARY outcome

Timeframe: Baseline, 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.

Outcome measures

Measure	iTBS Open Label n=5 Participants All subjects enrolled into this study were in the same group, with all receiving active iTBS treatment.
Change in CDRS-R Score From Baseline to Week 4	-14 score on a scale Interval -23.0 to -4.3

SECONDARY outcome

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

Columbia Suicide Severity Rating Scale (C-SSRS) is a semi-structured interview that has "yes or no" answers to assess the likelihood of a subject harming themselves, including "yes/no" to passive suicidal ideation. Participants indicating a "yes" response to any of these questions were reported as having passive suicidal ideation. Each participant was assessed at 8 timepoints during the study.

Outcome measures

Measure	iTBS Open Label n=5 Participants All subjects enrolled into this study were in the same group, with all receiving active iTBS treatment.
Number of Occurrences of Passive Suicidal Ideation Baseline	2 Occurrences passive suicidal ideation
Number of Occurrences of Passive Suicidal Ideation Treatment Week 1	2 Occurrences passive suicidal ideation
Number of Occurrences of Passive Suicidal Ideation Treatment Week 2	1 Occurrences passive suicidal ideation
Number of Occurrences of Passive Suicidal Ideation Treatment Week 3	0 Occurrences passive suicidal ideation
Number of Occurrences of Passive Suicidal Ideation Treatment Week 4	2 Occurrences passive suicidal ideation
Number of Occurrences of Passive Suicidal Ideation Follow Up Week 1	2 Occurrences passive suicidal ideation
Number of Occurrences of Passive Suicidal Ideation Follow Up Week 4	0 Occurrences passive suicidal ideation
Number of Occurrences of Passive Suicidal Ideation Follow Up Week 12	1 Occurrences passive suicidal ideation

SECONDARY outcome

Timeframe: Up to Week 5

Feasibility for this protocol is partially determined by completion rate. Treatment completion is defined in this protocol by 75% of treatments completed (15/20) per subject. This will be measured through completion of Week 4 of treatment (Week 5 of protocol when including screening phase).

Outcome measures

Measure	iTBS Open Label n=5 Participants All subjects enrolled into this study were in the same group, with all receiving active iTBS treatment.
Number of Participants Who Completed the Study	5 Participants

SECONDARY outcome

Timeframe: Up to Week 5

Feasibility for this protocol is partially determined by withdrawal rate. Withdrawal is defined as no more than 1 out of 5 subjects (20% of participants) withdrawing due to intolerable side effects caused by treatment or persistent depressive symptoms. This will be measured through completion of Week 4 of treatment (Week 5 of protocol when including screening phase).

Outcome measures

Measure	iTBS Open Label n=5 Participants All subjects enrolled into this study were in the same group, with all receiving active iTBS treatment.
Number of Participants Who Withdrew From the Study	0 Participants

SECONDARY outcome

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

Change in scores of Hamilton Depression Rating Scale (HAM-D) will be evaluated comparing Baseline to each follow-up phase at 1 week, 4 weeks, and 12 weeks post-treatment. The (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.

Outcome measures

Measure	iTBS Open Label n=5 Participants All subjects enrolled into this study were in the same group, with all receiving active iTBS treatment.
Durability of Treatment Effect With HAM-D Scores Follow Up Week 1	-8.8 score on a scale Interval -14.0 to -3.2
Durability of Treatment Effect With HAM-D Scores Follow Up Week 4	-11 score on a scale Interval -17.0 to -3.8
Durability of Treatment Effect With HAM-D Scores Follow Up Week 12	-9.4 score on a scale Interval -15.0 to -4.2

SECONDARY outcome

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

Change in scores of Children Depression Rating Scale Revised (CDRS-R) during follow-up phase at 1 week, 4 weeks, and 12 weeks post-treatment. 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.

Outcome measures

Measure	iTBS Open Label n=5 Participants All subjects enrolled into this study were in the same group, with all receiving active iTBS treatment.
Durability of Treatment Effect With CDRS-R Scores Follow Up Week 1	-21 score on a scale Interval -33.0 to -7.9
Durability of Treatment Effect With CDRS-R Scores Follow Up Week 4	-19 score on a scale Interval -32.0 to -6.2
Durability of Treatment Effect With CDRS-R Scores Follow Up Week 12	-23 score on a scale Interval -34.0 to -12.0

SECONDARY outcome

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

Self Injurious Thoughts and Behavior Interview (SITBI) is a semi-structured interview commonly used and administered by a clinician to determine if self-harm behavior has been present since the last visit. This will be evaluated at baseline (screening), once per week during the treatment phase, and at each follow up visit.

Outcome measures

Measure	iTBS Open Label n=5 Participants All subjects enrolled into this study were in the same group, with all receiving active iTBS treatment.
Number of Occurrences of Non-Suicidal Self Injurious Behavior Through SITBI Baseline	0 Occurrences self-harm behavior
Number of Occurrences of Non-Suicidal Self Injurious Behavior Through SITBI Treatment Week 1	0 Occurrences self-harm behavior
Number of Occurrences of Non-Suicidal Self Injurious Behavior Through SITBI Treatment Week 2	0 Occurrences self-harm behavior
Number of Occurrences of Non-Suicidal Self Injurious Behavior Through SITBI Treatment Week 3	0 Occurrences self-harm behavior
Number of Occurrences of Non-Suicidal Self Injurious Behavior Through SITBI Treatment Week 4	0 Occurrences self-harm behavior
Number of Occurrences of Non-Suicidal Self Injurious Behavior Through SITBI Follow Up Week 1	0 Occurrences self-harm behavior
Number of Occurrences of Non-Suicidal Self Injurious Behavior Through SITBI Follow Up Week 4	0 Occurrences self-harm behavior
Number of Occurrences of Non-Suicidal Self Injurious Behavior Through SITBI Follow Up Week 12	0 Occurrences self-harm behavior

Adverse Events

iTBS Open Label

Serious events: 0 serious events

Other events: 5 other events

Deaths: 0 deaths

Serious adverse events

Adverse event data not reported

Other adverse events

Measure	iTBS Open Label n=5 participants at risk All subjects enrolled into this study were in the same group, with all receiving active iTBS treatment.
Musculoskeletal and connective tissue disorders Scalp Pain - mild	60.0% 3/5 • Number of events 8 • From date of informed consent to completion of study, which is the last follow-up visit, an approximate total of 16 weeks.
Musculoskeletal and connective tissue disorders Scalp Pain - moderate	60.0% 3/5 • Number of events 3 • From date of informed consent to completion of study, which is the last follow-up visit, an approximate total of 16 weeks.
Musculoskeletal and connective tissue disorders Ear Pain - mild	20.0% 1/5 • Number of events 1 • From date of informed consent to completion of study, which is the last follow-up visit, an approximate total of 16 weeks.
Musculoskeletal and connective tissue disorders Jaw Twitching - mild	100.0% 5/5 • Number of events 12 • From date of informed consent to completion of study, which is the last follow-up visit, an approximate total of 16 weeks.
Musculoskeletal and connective tissue disorders Jaw Twitching - moderate	40.0% 2/5 • Number of events 2 • From date of informed consent to completion of study, which is the last follow-up visit, an approximate total of 16 weeks.
Musculoskeletal and connective tissue disorders Tingling	20.0% 1/5 • Number of events 1 • From date of informed consent to completion of study, which is the last follow-up visit, an approximate total of 16 weeks.
Musculoskeletal and connective tissue disorders Right arm twitch - moderate	20.0% 1/5 • Number of events 1 • From date of informed consent to completion of study, which is the last follow-up visit, an approximate total of 16 weeks.
Musculoskeletal and connective tissue disorders Right arm twitch - mild	40.0% 2/5 • Number of events 3 • From date of informed consent to completion of study, which is the last follow-up visit, an approximate total of 16 weeks.
Skin and subcutaneous tissue disorders Burn on shoulder - moderate	20.0% 1/5 • Number of events 1 • From date of informed consent to completion of study, which is the last follow-up visit, an approximate total of 16 weeks.
Immune system disorders Fever - mild	20.0% 1/5 • Number of events 1 • From date of informed consent to completion of study, which is the last follow-up visit, an approximate total of 16 weeks.
Psychiatric disorders Anxiety in social setting - mild	20.0% 1/5 • Number of events 1 • From date of informed consent to completion of study, which is the last follow-up visit, an approximate total of 16 weeks.
Musculoskeletal and connective tissue disorders Eyebrow twitching - mild	60.0% 3/5 • Number of events 9 • From date of informed consent to completion of study, which is the last follow-up visit, an approximate total of 16 weeks.
Musculoskeletal and connective tissue disorders Eye twitching - moderate	20.0% 1/5 • Number of events 3 • From date of informed consent to completion of study, which is the last follow-up visit, an approximate total of 16 weeks.
Nervous system disorders Migraine - severe	20.0% 1/5 • Number of events 1 • From date of informed consent to completion of study, which is the last follow-up visit, an approximate total of 16 weeks.
Nervous system disorders Headache - mild	20.0% 1/5 • Number of events 2 • From date of informed consent to completion of study, which is the last follow-up visit, an approximate total of 16 weeks.
Nervous system disorders Headache- moderate	20.0% 1/5 • Number of events 2 • From date of informed consent to completion of study, which is the last follow-up visit, an approximate total of 16 weeks.
Musculoskeletal and connective tissue disorders Arm soreness - moderate	20.0% 1/5 • Number of events 2 • From date of informed consent to completion of study, which is the last follow-up visit, an approximate total of 16 weeks.
Musculoskeletal and connective tissue disorders Arm soreness - mild	20.0% 1/5 • Number of events 1 • From date of informed consent to completion of study, which is the last follow-up visit, an approximate total of 16 weeks.

Additional Information

Shahzad Ali, MD

University of North Carolina at Chapel Hill

Phone: 984-974-0033

Email: shali@med.unc.edu

Results disclosure agreements

• Principal investigator is a sponsor employee
• Publication restrictions are in place