rTMS for Depression in Young Adults With Autism
Trial statusRecruiting
Trial phaseNot applicable
Trial typeInterventional
Biological sexAll
Age16-35
SponsorCentre for Addiction and Mental Health
About this trial
The current clinical trial is focused on evaluating the efficacy of rTMS for treatment of depression in youth and young adults (hereafter called transition aged youth, TAY) with autism spectrum disorder (ASD). The motivation to undertake the current efficacy study is driven by: (1) the substantial impact of depression on TAY with ASD (based on prevalence and contribution to disability/impairment); (2) lack of evidence-based treatments for depression in autism (there are no current trials rigorously evaluating any treatment for depression, i.e., psychotherapeutic, pharmacotherapeutic, brain stimulation); (3) rTMS has demonstrated efficacy in non-autistic individuals to improve symptoms of depression and may be better tolerated in youth than medication treatment; (4) a prior pilot rTMS study focused on treatment of executive function deficits in autism indicated that high frequency rTMS delivered using a rigorous randomized control trial (RCT) protocol can be feasibly implemented in TAY with autism, is well tolerated (mild to moderate adverse effects and low drop out), and has the potential to improve symptoms of depression.
Eligibility criteria
This trial does not accept healthy volunteersQualifiers
Fluent in English
ASD diagnosis confirmed by the clinician/clinical team, and IQ> or =70
Able to participate in the informed consent process, provide voluntary informed consent and provide a spontaneous narrative description of the key elements of the study
Clinical stability: determined by a physician, no switch of psychotropic medications or increase in dosage in the last 30 days; no change in other therapeutic interventions in last 30 days
Disqualifiers
A history of a DSM-5 substance use disorder (other than tobacco) within the past six months; or a positive baseline urine drug screen
Significantly debilitating medical or neurologic illness, or acute or unstable medical illnesses as determined by study physician
Metal implants or a pace-maker, claustrophobia that would preclude the MRI scan
Actively suicidal (i.e., suicidal ideation with plan and intent) or high risk for suicide as assessed by a study psychiatrist
Trial design
Design model
Parallel
Treatments tested in this trial
Active Bilateral Theta Burst Stimulation
DeviceA total of 30 active BL-TBS sessions. Stimulation will begin with right DLPFC (cTBS) followed by left DLPFC (iTBS)
Sham Bilateral Theta Burst Stimulation
DeviceA total of 30 sham BL-TBS sessions. Stimulation will begin with right DLPFC (cTBS) followed by left DLPFC (iTBS)
Treatment groups
80 Participants
are divided into 2 treatment groupsGroup A: Active bilateral theta burst stimulationActive comparator 1 intervention
Group B: Sham bilateral theta burst stimulationSham comparator 1 intervention
Trial outcomes
Primary outcomes
1
Change in scores on the 17-item Hamilton Rating Scale for Depression (HRSD-17)
The investigators will evaluate the changes in the severity of symptoms of depression before, during, and after rTMS treatment. HRSD-17 scores range from 0 to 52, with higher scores indicating greater severity of depressive symptoms (worse outcome).
Time frame
Baseline, end of weeks 1, 2, 3, 4, 5, and 6 of treatment, and at 1-week, 4-weeks and 12-weeks post-treatment.Secondary outcomes
1
Change in scores on the Beck Scale for Suicide Ideation (BSI)
The investigators will evaluate the changes in suicidal thinking scores before, during, and after rTMS treatment. BSI scores range from 0 to 38, with higher scores indicating greater suicidal ideation (worse outcome).
Time frame
Baseline, end of weeks 1, 2, 3, 4, 5, and 6 of treatment, and at 1-week, 4-weeks and 12-weeks post-treatment.Sponsors and contacts
Click on the lead sponsor to view all of their trials.
Source ClinicalTrials.gov