Last updated: April 1, 2024
Sponsor: Massachusetts General Hospital
Overall Status: Active - Recruiting
Phase
N/A
Condition
Obsessive-compulsive Disorder
Panic Disorders
Anxiety Disorders
Treatment
Transcranial Direct Current Stimulation
Clinical Study ID
NCT04548609
2020P000847
Ages 10-17 All Genders
Study Summary
Eligibility Criteria
Inclusion
Inclusion Criteria:
- Outpatient youth between the ages 10-17 years
- Children's Yale-Brown Obsessive-Compulsive Scale (CY-BOCS) ≥16 (moderately severe).OCD must be determined to be the primary or co-primary diagnosis using the TheSchedule for Affective Disorders and Schizophrenia for School-Age Children- Computeradministered version (KSADS-COMP) based on all available information.
- Child has a full-scale IQ≥85 as assessed on the Wechsler Abbreviated Scale ofIntelligence® Second Edition (WASI®-II) (within 90% CI). To decrease participantburden, the WASI®-II will only be conducted in cases of suspected intellectualdisability after meeting with the PI.
- English speaking.
Exclusion
Exclusion Criteria:
- Receiving concurrent psychotherapy for subject's OCD (except maintenance).Subjectsreceiving pre- established concurrent psychotherapy for at least 8 weeks regardingother psychological issues are eligible for enrollment.
- New Treatments: Initiation of an antidepressant within 12 weeks before studyenrollment or an antipsychotic 6 weeks before study enrollment. No new alternativemedications, nutritional or therapeutic diets within 6 weeks of study enrolment.
- Established Treatment changes: Any change in established psychotropic medication (e.g., antidepressants, anxiolytics, stimulant, alpha agonist) within 8 weeks beforestudy enrollment (6 weeks for antipsychotic). Alternative medications must be stablefor 6 weeks prior to baseline. Any medications must remain stable during treatment;consistent with the National Institute of Health (NIH)-funded Child Anxiety MultimodalStudy (CAMS) trial, downward adjustments due to side effects may be acceptable andwill be discussed with the study child and adolescent psychiatrist and the communitypsychiatrist.
- Current clinically significant suicidality or individuals who have engaged in suicidalbehaviors within 6 months will be excluded and referred for appropriate clinical care.
- Meets Diagnostic and Statistical Manual of Mental Disorders, Fifth Edition (DSM-V)criteria for conduct disorder, autism, bipolar, attention deficit hyperactivitydisorder (ADHD), Tourette's syndrome, schizophrenia or schizoaffective disorders
- Youth with hoarding symptoms as they may be conceptually and genetically differentfrom other OCD subtypes.
- BMI less than 18.5.
- Contraindication to tDCS: history or epilepsy, metallic implants in the head and neck,brain stimulators, vagus nerve stimulators, ventriculoperitoneal (VP) shunt,pacemakers.
- Active substance dependence (except for tobacco).
- Pregnant or nursing females as the effects of tDCS on pregnancy are unknown.
- Presence of a significant and/or unstable medical illness that might lead tohospitalization during the study.
Study Design
Total Participants: 36
Treatment Group(s): 1
Primary Treatment: Transcranial Direct Current Stimulation
Phase:
Study Start date:
January 25, 2021
Estimated Completion Date:
March 31, 2025
Study Description
Connect with a study center
Massachusetts General Hospital
Boston, Massachusetts 02114
United StatesActive - Recruiting
Not the study for you?
Let us help you find the best match. Sign up as a volunteer and receive email notifications when clinical trials are posted in the medical category of interest to you.