Phase 3 N=190 Randomized Quadruple-blind Treatment

Magnetic Brain Stimulation for the Treatment of Adult Depression

Depression

Bottom Line

View on ClinicalTrials.gov: NCT00149838 ↗

Enrolled (actual)

190

Serious AEs

0.0%

Results posted

Dec 2018

Primary outcome: Primary: Depression Remission, as Measured by the Hamilton Rating Scale for Depression — 13; 5; 43; 12 number of remitted patients

Study Design & Population

Study type: Interventional
Phase: Phase 3
Interventions: Prefrontal rTMS (Procedure); Antidepressant Regimen (Drug); Sham Stimulation (Procedure)
Age: Adult, Older Adult · 21+ yrs
Sex: All
Sponsor: Medical University of South Carolina
Primary completion: Apr 2009

Outcome Measures

Outcome	Result	p-value
PRIMARY Depression Remission, as Measured by the Hamilton Rating Scale for Depression	13; 5; 43; 12	—

Summary

This study will evaluate the safety and effectiveness of magnetic brain stimulation for the treatment of major depression in depressed adults with moderate treatment resistance.

Eligibility Criteria

Inclusion Criteria

Diagnosis of major depression with a current episode
Hamilton Rating Scale for Depression score higher than 20
No response or intolerance to antidepressant medication in the current depressive episode

Exclusion Criteria

Current use of antidepressants
Diagnosis of psychosis or anxiety disorder
Current substance abuse
Seizures or history of head trauma

View full record on ClinicalTrials.gov →

Data sourced from ClinicalTrials.gov (NCT00149838). 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.