CI

At a glance

ClinicalIndex Comparison Record
Phase 3Completed· 190 enrolled
Drug / intervention
Antidepressant Regimen +2 moredrug
Likely dose
Prefrontal rTMS at 120% motor threshold, daily for 3 weeksAI-extracted
Key inclusion· 3
  • ✓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
Key exclusion· 4
  • ✕Current use of antidepressants
  • ✕Diagnosis of psychosis or anxiety disorder
  • ✕Current substance abuse
  • ✕Seizures or history of head trauma

Standardized by ClinicalIndex from the ClinicalTrials.gov record · verify against the source.

Search/NCT00149838
NCT00149838Phase 3Completed
CompareCT.gov

Optimization of Transcranial Magnetic Stimulation (TMS) for Depression

Medical University of South Carolina·interventional·Posted Sep 8, 2005·Updated Dec 28, 2018

In Brief

A Phase 3 clinical trial evaluating Prefrontal rTMS, Antidepressant Regimen, and 1 other intervention for Depression. Completed, enrolled 190 participants across 4 sites.

Detailed 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.

Study Details

Study Typeinterventional
Allocation--
Masking--
Primary Purpose--
ConditionsDepression
CountriesUnited States
CollaboratorsNational Institute of Mental Health (NIMH)

Timeline

Phase 3CompletedFinished
20052006200720082009201020112012201320142015201620172018201920202021202220232024202520262027
First PostedSep 8, 2005
Enrollment StartFeb 1, 2005
Primary CompletionApr 1, 2009
Study CompletionMay 1, 2009
TodayJul 2, 2026
Enrollment to primary: 4.2 yearsPosted 20.8 years ago

Interventions

Prefrontal rTMSprocedure

Participants receive 120% motor threshold (MT) over left and right prefrontal cortex. Treatments will be administered daily for 3 weeks. Participants who show signs of improvement may continue Phase I for up to 3 additional weeks.

Antidepressant Regimendrug

Particpants who acheive remission with rTMS may start antidepressant medication in phase III.

Sham Stimulationprocedure

The sham stimulation will mimic the sensation of rTMS but will not induce an intracerebral current. Treatments will be administered daily for 3 weeks.