A Randomized Controlled Trial of Sequential Bilateral Accelerated Theta Burst Stimulation in Adolescents With Suicidal Ideation Associated With Major Depressive Disorder
Overview
- Phase
- Not Applicable
- Intervention
- Not specified
- Conditions
- Suicidal Ideation
- Sponsor
- Mayo Clinic
- Enrollment
- 80
- Locations
- 1
- Primary Endpoint
- Hospitalizations
- Status
- Recruiting
- Last Updated
- 11 months ago
Overview
Brief Summary
The purpose of this study is to gather information regarding the use of a new type of transcranial magnetic stimulation (TMS) called theta burst stimulation (TBS) for suicidal ideation in adolescents with Major Depressive Disorder (MDD). The investigators hope to learn if this TMS treatment improves suicidal ideation over 10 days and clinical outcomes over 1 year of follow-up.
Detailed Description
The proposed study will examine sequential bilateral accelerated theta burst stimulation (aTBS). Three sessions are administered daily for 10 days (5 days per week). During each session continuous theta burst stimulation (cTBS) in which 1800 pulses are delivered continuously over 120 seconds to the right dorsolateral prefrontal cortex (RDPFC) is administered first, followed by iTBS in which 1800 pulses are delivered in 2 second bursts, repeated every 10 seconds for 570 seconds (1800 pulses) to the left dorsolateral prefrontal cortex (LDPFC). The theta burst stimulation (TBS) parameters were adopted from prior work, with 3-pulse 50 Hz bursts given every 200 ms (at 5 Hz) with an intensity of 80% of active motor threshold. The comparison group will receive 3 daily sessions of bilateral sham TBS treatment for 10 days. Subjects in both groups will take part in a daily psychotherapeutic treatment program. The proposed study will examine sequential bilateral accelerated theta burst stimulation (aTBS). Three sessions are administered daily for 10 days (5 days per week). During each session continuous theta burst stimulation (cTBS) in which 1800 pulses are delivered continuously over 120 seconds to the right dorsolateral prefrontal cortex (RDPFC) is administered first, followed by iTBS in which 1800 pulses are delivered in 2 second bursts, repeated every 10 seconds for 570 seconds (1800 pulses) to the left dorsolateral prefrontal cortex (LDPFC). The theta burst stimulation (TBS) parameters were adopted from prior work, with 3-pulse 50 Hz bursts given every 200 ms (at 5 Hz) with an intensity of 80% of active motor threshold. The comparison group will receive 3 daily sessions of bilateral sham TBS treatment for 10 days. Subjects in both groups will take part in a daily psychotherapeutic treatment program. The study will enroll outpatient and inpatient adolescents (aged 12-18 years) with Major Depressive Disorder (MDD) of at least moderate severity defined as a Children's Depression Rating Scale Revised (CDRS-R) Score of 40 or greater and suicidal ideation defined as a score of 3 or greater on item 13 (Suicidal Ideation) of the CDRS-R.
Investigators
Paul E. Croarkin
Principal Investigator
Mayo Clinic
Eligibility Criteria
Inclusion Criteria
- •Inpatients or outpatients
- •Voluntary clinical patient with the capacity to assent to treatment and a parent or legal guardian with the capacity to consent
- •Female or male
- •12-18 years of age
- •Diagnosed with MDD based on Diagnostic and Statistical Manual for Mental Disorders, 5th edition (DSM-5) criteria122 with the Mini-International Neuropsychiatric Interview for Children and Adolescents (MINI Kid) in subjects 12-17 years of age;118 The Mini-International Neuropsychiatric Interview will be used for subjects who are 18 years of age117
- •In a current episode of MDD with duration of at least 4 weeks but less than 3 years
- •Depressive symptom severity as demonstrated by CDRS-R total composite score of 40 or greater and a suicidal ideation score of 3 or more on item 13 of the CDRS-R109
- •Demonstrating that depressive symptom severity as evaluated at the screening visit does not improve between screening and baseline by 25% or more
- •Eligible for transcranial magnetic stimulation (TMS) based on safety criteria104
- •On a medically acceptable form of birth control if female
Exclusion Criteria
- •Diagnosis of a psychotic disorder, bipolar disorder, anorexia nervosa, bulimia nervosa, substance use disorders within the past year (with the exception of caffeine and tobacco).
- •Intelligent quotient less than 70 (if there is a clinical concern, subjects will be psychometrically assessed with the Slosson Intelligence Test, Revised).123
- •Positive urine drug screen at baseline
- •Seizure history
- •Any family history of epilepsy
- •History of any treatment with electroconvulsive therapy or TMS
- •Use of any investigational drug within 4 weeks of baseline
- •Prior brain surgery
- •Risk for increased intracranial pressure such as a brain tumor
- •Head trauma with loss of consciousness
Outcomes
Primary Outcomes
Hospitalizations
Time Frame: up to 12 months
The total number of hospitalizations related to suicide idealization
Suicidal Ideation
Time Frame: up to 12 months
Suicidal Ideation as measured by the Columbia-Suicide Severity Rating Scale (C-SSRS). This is a validated, clinician-rated tool collected to assess lifetime and ongoing suicidal ideation and behavior. The severity of ideation subscale is a 5-point ordinal scale 1-5 . 1 = Wish to be dead - 5 = Active Suicidal Ideation with Specific Plan and Intent. Assessed at baseline, 10 days and 12 months.
Secondary Outcomes
- Cortical inhibition(baseline, 10 days)