RECRUITING

Theta Burst Stimulation for Refractory Depression in Autism Spectrum Disorder

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Conditions

ASDAutism Spectrum DisorderAutismDepression - Major Depressive DisorderMDDDepressionTMSTBSTranscranial Magnetic StimulationTheta Burst StimulationMajor Depressive Disorder

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Study Overview

This clinical trial focuses on testing the efficacy of different digital interventions to promote re-engagement in cancer-related long-term follow-up care for adolescent and young adult (AYA) survivors of childhood cancer.

Description

Evaluate the efficacy of accelerated theta burst stimulation (aTBS) in reducing depressive symptoms in autism spectrum disorder (ASD)

Official Title

Sham-Controlled RTMS for Refractory Depression in Autism Spectrum Disorder

Quick Facts

Study Start:2024-09-16
Study Completion:2026-01-31
Study Type:Not specified
Phase:Not Applicable
Enrollment:Not specified
Status:RECRUITING

Study ID

NCT06670040

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Ages Eligible for Study:13 Years to 26 Years
Sexes Eligible for Study:ALL
Accepts Healthy Volunteers:No
Standard Ages:CHILD, ADULT
Inclusion CriteriaExclusion Criteria
  1. 1. Fluent in English and able to volunteer in the informed consent process and provide spontaneous narrative description of key elements, risks, and benefits of the study.
  2. 2. Aged 13-26, inclusive.
  3. 3. Full-scale intelligence quotient ≥ 70.
  4. 4. Diagnosis of ASD using criteria from Diagnostic and Statistical Manual of Mental Disorders, 5th Edition (DSM-5). Diagnosis will be confirmed by study psychologist/social worker and supported by scoring in the ASD on the Autism Diagnostic Observation Schedule (ADOS-2).
  5. 5. Diagnosis of MDD based on psychologist diagnosis and DSM-5-based structural diagnostic interview determine via KSADS
  6. 6. Exhibiting treatment resistance to at least one antidepressant drug treatment of adequate dose and duration.
  7. 7. Symptoms of moderate to severe depression according to Hamilton Depression Rating Scale ≥ 20 which must be maintained through lead-in period.
  8. 8. Participants are not required to discontinue current interventions but must agree to attempt to keep medications and other interventions stable during the study.
  1. 1. Participation in an investigational drug trial within the past three months.
  2. 2. Active substance use disorder (excluding tobacco use) within the past 6 months.
  3. 3. Contraindications to Transcranial Magnetic Stimulation including, but not limited to, a history of epilepsy, the presence of metallic foreign bodies, or implanted medical devices (e.g. pacemaker, medical pump).
  4. 4. Actively suicidal (i.e., suicidal ideation with plan and intent) or deemed at high risk for suicide.
  5. 5. Current use of anticonvulsant, barbiturate, lithium, or benzodiazepine medications.
  6. 6. Prior rTMS treatment.
  7. 7. For female subjects of childbearing potential, a positive urine pregnancy test.

Contacts and Locations

Study Contact

Mohana Priya Santhan Ramesh Kumar Padma, Masters
CONTACT
5136364433
priya.ramesh@cchmc.org
Jennifer Combs, Masters
CONTACT
5138030007
jennifer.combs@cchmc.org

Principal Investigator

Rana Elmaghraby, MD
PRINCIPAL_INVESTIGATOR
Cincinnati Childrens Hospital Medical Center

Study Locations (Sites)

Cincinnati Childrens Hospital Medical Center
Cincinnati, Ohio, 45224
United States

Collaborators and Investigators

Sponsor: Children's Hospital Medical Center, Cincinnati

  • Rana Elmaghraby, MD, PRINCIPAL_INVESTIGATOR, Cincinnati Childrens Hospital Medical Center

Study Record Dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Registration Dates

Study Start Date2024-09-16
Study Completion Date2026-01-31

Study Record Updates

Study Start Date2024-09-16
Study Completion Date2026-01-31

Terms related to this study

Keywords Provided by Researchers

  • ASD
  • Autism
  • Autism Spectrum Disorder
  • MDD
  • Depression
  • TMS
  • TBS
  • Transcranial Magnetic Stimulation
  • Theta Burst Stimulation
  • Major Depressive Disorder

Additional Relevant MeSH Terms

  • ASD
  • Autism Spectrum Disorder
  • Autism
  • Depression - Major Depressive Disorder
  • MDD