Double-Blind, Proof-of-Concept (POC) Trial of Low Field Magnetic Stimulation (LFMS) Augmentation of Antidepressant Therapy in Treatment-Resistant Depression

Massachusetts General Hospital6 sites in 1 country84 target enrollmentApril 2013

ConditionsTreatment Resistant Depression

Overview

Phase: Not Applicable
Intervention: Not specified
Conditions: Treatment Resistant Depression
Sponsor: Massachusetts General Hospital
Enrollment: 84
Locations: 6
Primary Endpoint: Hamilton Rating Scale for Depression - 6 Items
Status: Completed
Last Updated: 8 years ago

Overview Investigators Eligibility Criteria Outcomes Sites Similar Trials

Overview

Brief Summary

This study is looking at the safety and efficacy of low field magnetic stimulation (LFMS) for treating patients with treatment resistant depression who are taking an antidepressant that is not working for them.

Registry

clinicaltrials.gov

Start Date

April 2013

End Date

September 2016

Last Updated

8 years ago

Study Type

Interventional

Study Design

Parallel

Sex

All

Investigators

Sponsor

Massachusetts General Hospital

Responsible Party

Principal Investigator

Maurizio Fava, MD

Overall Principal Investigator

Massachusetts General Hospital

Eligibility Criteria

Inclusion Criteria

•Male or female, 18-65 years old
•Diagnosed with Major Depressive Disorder (MDD) and currently experiencing a Major Depressive Episode (MDE) of at least eight weeks
•A participant has Treatment Resistant Depression (TRD) of the current MDE
•Good general health
•For female participants, status of non-childbearing potential or use of an acceptable form of birth control
•Body mass index between 18-40 kg/m2
•Concurrent psychotherapy will be allowed if the type and frequency of the therapy has been stable for at least three months prior to screening and is expected to remain stable during participation in the study
•Concurrent hypnotic therapy will be allowed if the therapy has been stable for at least 4 weeks prior to screening and is expected to remain stable during the subject's participation in the study
•Participant must be able to lie flat for 20 minutes

Exclusion Criteria

•A woman of childbearing potential who is not willing to use one of the specified forms of birth control during the study
•Pregnant or breastfeeding
•A woman with a positive pregnancy test at screening or baseline
•Participant has TRD of the current MDE with failure to achieve a satisfactory response, as perceived by the subject, to more than 3 treatment courses of a therapeutic dose of an antidepressant therapy of at least eight weeks duration
•Participant has a current diagnosis of a Substance Use Disorder with the exception of nicotine dependence, at screening or within six months prior to screening
•Current diagnosis of Axis I disorders other than Generalized Anxiety Disorder, Social Anxiety Disorder, Panic Disorder, Specific Phobia, Post Traumatic Stress Disorder or Complicated Grief (unless one of these is comorbid and clinically unstable, and/or the focus of the participant's treatment for the past six months or more).
•Subject has a history of schizophrenia or schizoaffective disorders, any history of psychotic symptoms or is on antipsychotic medication for the treatment of psychotic symptoms
•Subject has a history of eating disorders within five years of screening
•Subject has any Axis I or Axis II Disorder, which at screening is clinically predominant to their MDD or has been predominant at any time within six months prior to screening
•The participant is considered at significant risk for suicide during the study

Outcomes

Primary Outcomes

Hamilton Rating Scale for Depression - 6 Items

Time Frame: Baseline and 48 hours after initiating treatment

The total HAM-D-6 score is reported. The range of possible scores on the HAM-D-6 is from 0 to 22. Higher values indicate increased depression severity, and worse outcomes. This instrument is completed with a structured interview guide by the clinician based on his/her assessment of the patient's symptoms. This structured interview has been validated for use with time frames shorter than one week.The time frame for this scale is the past 24 hours.