Pilot Study in Multi-Coil Repetitive Transcranial Magnetic Stimulation (rTMS) for Treatment Resistant Depression

Major Depressive Disorder Clinical Trial

Official title:

Determining Effectiveness of Multi-Coil rTMS for Patients With Major Depressive Disorder: A Pilot Study

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT01431001
• Other study ID #: NS-CPS-TRMD-1
• Status: Completed
• Phase: N/A
• First received: September 6, 2011
• Last updated: May 15, 2014
• Start date: October 2011
• Est. completion date: October 2013

Study information

• Verified date: May 2014
• Source: Cervel Neurotech, Inc.
• Contact: n/a
• Is FDA regulated: No
• Health authority: United States: Institutional Review BoardAustralia: Human Research Ethics Committee
• Study type: Interventional

Clinical Trial Summary

The purpose of this study is to assess the efficacy of a Deep Shaped-Field repetitive transcranial magnetic stimulation (DSF-rTMS) system in the treatment of depression.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 40
• Est. completion date: October 2013
• Est. primary completion date: October 2013
• Accepts healthy volunteers: No
• Gender: Both
• Age group: 18 Years to 70 Years

Eligibility

Inclusion Criteria:

• Major depressive disorder (MDD)

• Mild to moderate level of resistance or intolerance to antidepressant treatment in the current episode.

• Will not become pregnant during study.

Exclusion Criteria:

• Seizure disorder.

• History of brain injury or active CNS disease.

• Metal implants on or in brain, spinal cord, ear, eye or heart.

• Current use of proconvulsant medications (e.g., bupropion).

• Other significant psychiatric disorder.

• Substance use disorder (not including caffeine or nicotine).

• 7 or more failed treatment attempts for depression in one's lifetime.

• Have failed to clinically remit to an adequate trial of ECT or TMS.

Study Design

Allocation: Randomized, Endpoint Classification: Safety/Efficacy Study, Intervention Model: Parallel Assignment, Masking: Open Label, Primary Purpose: Treatment

Related Conditions & MeSH terms

• Depression
• Depressive Disorder
• Depressive Disorder, Major
• Depressive Disorder, Treatment-Resistant
• Major Depressive Disorder

Intervention

Device:
• Cervel Neurotech Deep Shaped-Field repetitive transcranial magnetic stimulator (DSF-rTMS)
The Cervel Neurotech Deep Shaped-Field repetitive transcranial magnetic stimulator is an investigational rTMS device

Locations

Country	Name	City	State
Australia	Monash Alfred Psychiatry Research Centre	Melbourne	Victoria
United States	Emory University	Atlanta	Georgia
United States	Medical University of South Carolina	Charleston	South Carolina
United States	Rush Medical College	Chicago	Illinois

Sponsors (1)

Lead Sponsor	Collaborator
Cervel Neurotech, Inc.

Countries where clinical trial is conducted

United States,  Australia, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Remission from depression	Changes in Hamilton Rating Scale from Depression (HRSD) measured after each block of 5 treatment sessions, 2 weeks post and 4 weeks post	baseline through 4 weeks post	No
Secondary	Safety and tolerability of rTMS	Determined by presence and absence of adverse events recorded daily	baseline through 4 weeks post	Yes