Trial of Low Field Magnetic Stimulation Augmentation of Antidepressant Therapy in Treatment-Resistant Depression

Treatment Resistant Depression Clinical Trial

— RAPID  

Official title:

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

Clinical Trial Details — Status: Active, not recruiting

Administrative data

• NCT number: NCT01654796
• Other study ID #: 2012P001233
• Status: Active, not recruiting
• Phase: N/A
• First received: July 30, 2012
• Last updated: April 25, 2016
• Start date: April 2013
• Est. completion date: May 2016

Study information

• Verified date: April 2016
• Source: Massachusetts General Hospital
• Contact: n/a
• Is FDA regulated: No
• Health authority: United States: Food and Drug AdministrationUnited States: Institutional Review BoardUnited States: Data and Safety Monitoring Board
• Study type: Interventional

Clinical Trial 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.

Recruitment information / eligibility

• Status: Active, not recruiting
• Enrollment: 90
• Est. completion date: May 2016
• Est. primary completion date: May 2016
• Accepts healthy volunteers: No
• Gender: Both
• Age group: 18 Years to 65 Years

Eligibility

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

• Subject has had electroconvulsive therapy in the current episode of depression

• Subject has had Transcranial Magnetic Stimulation or has received treatment with other experimental devices for the treatment of the current episode of depression

• Subject has received Vagus Nerve Stimulation at any time

• Dementia, delirium, amnestic, or other cognitive disorders

• There is a clinically significant abnormality on the screening physical examination

• Participation in any clinical trial with an investigational drug or device within the past month or concurrent to study participation

• Known history or current episode of:

--Uncontrolled hypertension, Recent myocardial infarction (within one year) or a history of more than one myocardial infarction, Syncopal event within the past year, Congestive heart failure, Angina pectoris

• Lifetime history of surgical procedures involving the brain or meninges, encephalitis, meningitis, degenerative central nervous system disorder (e.g., Alzheimer's or Parkinson's Disease), epilepsy, mental retardation, any other disease/procedure/accident/intervention associated with significant injury to or malfunction of the central nervous system, or a history of significant head trauma within the past two years.

• Lab abnormalities are present

• History of hypothyroidism and has been on a stable dosage of thyroid replacement medication for less than six months prior to screening

• Hisotry of hyperthyroidism which was treated (medically or sugically) less than six months prior to screening

• Any current or past history of any physical condition which in the investigator's opinion might put the subject at risk or interfere with the interpretation of study results

• History of positive screening urine test for drugs of abuse

• Patient with any non-removable stimulation device such as neurostimulators, pacemakers and cochlear implants

• Patients requiring treatment with excluded concomitant medications

• Patients who cannot be in a MRI

• Patients who are currently using a metal intrauterine device (IUD)

Study Design

Allocation: Randomized, Endpoint Classification: Safety/Efficacy Study, Intervention Model: Parallel Assignment, Masking: Double Blind (Subject, Caregiver, Investigator, Outcomes Assessor), Primary Purpose: Treatment

Related Conditions & MeSH terms

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

Intervention

Device:
• Low Field Magnetic Stimulation (LFMS)
The LFMS devices produces a unique magnetic field that may help alleviate symptoms of depression.
• Sham LFMS
SHam LFMS looks and sounds like the active treatment but does not produce any magnetic stimulation.

Locations

Country	Name	City	State
United States	Emory University	Atlanta	Georgia
United States	University of Alabama at Birmingham	Birmingham	Alabama
United States	Massachusetts General Hospital	Boston	Massachusetts
United States	University of Texas Southwestern	Dallas	Texas
United States	Yale University	New Haven	Connecticut
United States	Mount Sinai School of Medecine	New York	New York

Sponsors (7)

Lead Sponsor	Collaborator
Massachusetts General Hospital	Emory University, Icahn School of Medicine at Mount Sinai, National Institute of Mental Health (NIMH), University of Alabama at Birmingham, University of Texas Southwestern Medical Center, Yale University

Country where clinical trial is conducted

United States, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Hamilton Rating Scale for Depression - 6 items	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.	past 24 hours	No