NCT01842542

Efficacy and Safety Study of NeuroStar TMS Therapy in Patients With Major Depressive Disorder With Postpartum Onset

An Open-Label Study to Evaluate the Efficacy and Safety of the Neuronetics NeuroStar TMS Therapy System in Patients With Major Depressive Disorder (MDD) With Postpartum Onset.

• Status: Terminated
• Phase: N/A
• Study type: Interventional
• Enrollment: 25 (actual)
• Sponsor: Neuronetics · Academic / Other
• Sex: Female
• Age: 18 Years – 50 Years
• Healthy volunteers: Not accepted

Summary

The purpose of this study is to evaluate the safety and effectiveness of acute NeuroStar TMS therapy in women who have postpartum depression.

Detailed description

Evaluate the antidepressant effectiveness of acute treatment with NeuroStar TMS Therapy in patients with MDD with postpartum onset. Determine the safety of NeuroStar TMS Therapy by assessment of any medically significant, device-related adverse events during acute treatment. Determine the Safety of NeuroStar TMS Therapy by assessment of maternal and infant interactions on standardized bonding questionnaires.

Conditions

• Depression, Postpartum

Interventions

Type	Name	Description
DEVICE	NeuroStar Transcranial Magnetic Stimulation (TMS)	Acute phase: 120% of observed MT, 10 pulses per second, 4 second on-time, 26 second off-time, 75 trains, 3,000 total pulses/session, five times weekly for up to 8 weeks. 3 week taper phase: 120% of observed MT, 10 pulses per second, 4 second on-time, 26 second off-time, 75 trains, 3,000 total pulses/session, 3 times during the first week, 2 times during the second week and one time during the third week. In addition to treatments, patients may receive treatment as usual at the direction of their treating physician.

Timeline

• Start date: 2013-12-01
• Primary completion: 2015-07-01
• Completion: 2015-08-01
• First posted: 2013-04-29
• Last updated: 2025-02-10
• Results posted: 2025-02-10

Locations

8 sites across 1 country: United States

Regulatory

• FDA-regulated device study