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N/A N=25 Randomized Double-blind Basic Science

Theta Burst Stimulation in Young Adults With Depression

Depression

Bottom Line

View on ClinicalTrials.gov: NCT03737032 ↗
Enrolled (actual)
25
Serious AEs
0.0%
Results posted
Mar 2024
Primary outcome: Primary: Dorsomedial Prefrontal Cortex Activation — 0.16; 1.35; 0.36 score in arbitrary units — p=0.80

Study Design & Population

Study type
Interventional
Phase
N/A
Interventions
Intermittent Theta Burst Stimulation (Device); Continuous Theta Burst Stimulation (Device); Sham Theta Burst Stimulation (Device)
Age
Adult · 18+ yrs
Sex
All
Sponsor
Erika Forbes
Primary completion
Jul 2022

Outcome Measures

OutcomeResultp-value
PRIMARY
Dorsomedial Prefrontal Cortex Activation		 0.16; 1.35; 0.36 0.80
SECONDARY
Positive Affect		 20.70; 20.05; 20.45; 20.45; 19.80; 22.10 0.23
SECONDARY
VS-dmPFC Functional Connectivity		 2.28; 4.10; 1.16 0.84

Summary

For the proposed 2-year study, the investigators will conduct a within-subject, counterbalanced investigation using functional magnetic resonance imaging (fMRI) and transcranial magnetic stimulation (TMS) to examine the acute effects of theta-burst stimulation (TBS) on function in dorsomedial prefrontal cortex (dmPFC) in 35 young adults with depression (18-25 years, 50% female).

Eligibility Criteria

Inclusion Criteria

  • DSM-5 Diagnosis of Major Depressive Disorder, Persistent Depressive Disorder (Dysthymia), Other Specified Depressive Disorder, or Other Unspecified Depressive Disorder

Exclusion Criteria

  • Bipolar disorder, substance dependence, or lifetime history of psychosis
  • Neurological disorder (e.g., seizure disorder)
  • Pregnant
  • MRI contradictions: claustrophobia, permanent orthodontic devices, metal implants or other forms of metal in the body that cannot be removed
View full record on ClinicalTrials.gov →

Data sourced from ClinicalTrials.gov (NCT03737032). Outcome figures and adverse-event rates are extracted automatically from the registry's posted results and are provided for clinician reference, not as a substitute for the primary publication.

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