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

Conditions

Depression

Trial Phase

Phase II

Trial Purpose and Description

Trial Purpose

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


Participation Guidelines

Age:
18 Years - 65 Years
Gender:
Both

Eligibility Criteria

Inclusion Criteria:

1. Male or female, 18-65 years old

2. Diagnosed with Major Depressive Disorder (MDD) are currently experiencing a Major Depressive Episode (MDE) of at least eight weeks (Moderate to Severe)

3. A participant has TRD of the current MDE

4. Good general health

5. For female participants, status of non-childbearing potential or use of an acceptable form of birth control

6. Body mass index between 18-40 kg/m2

7. Concurrent psychotherapy will be allowed if the type and frequency of the therapy has been stable for at least three months prior to screening is expected to remain stable during participation in the study

8. 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

Exclusion Criteria

1. A woman of childbearing potential who is not willing to use one of the specified forms of birth control during the study

2. Pregnant or breastfeeding

3. A woman with a positive pregnancy test at screening or baseline

4. Participant has TRD of the current MDE with failure to achieve a satisfactory response) as perceived by the subject to>3 treatment courses of a therapeutic dose of an antidepressant therapy at least six week duration

5. 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

6. 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.

7. 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

8. Subject has a history of eating disorders within five years of screening

9. 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

10. The participant is considered at significant risk for suicide during the study

11. Subject has had electroconvulsive therapy in the current episode of depression

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

13. Subject has received Vagus Nerve Stimulation at any time

14. Dementia, delirium, amnestic, or other cognitive disorders

15. Clinically significant abnormality on the screening physical examination

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

17. Known history or current episode of: Uncontrolled hypertension, Recently 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

18. Chronic lung disease

19. Lifetime history of surgical procedures involving the brain or meninges encephalitis, meningitis, degenerative central nervous system disorder, epilepsy, mental retardation, any other disease/procedure/accident/intervention associated with significant injury to or malfuntion of the central nervous system, history of significant head trauma with in the past two years, or is currently receiving anticonvulsant therapy

20. Clinically significant lab abnormalities are present

21. History of hypothyroidism or hypothyroidism which was treated (medically or surgically) less than six months prior to screening (>6 months stable medication dosage required for eligibility)

22. 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

23. History of positive screening urine test for drugs of abuse

24. Patient with any non-removable stimulation device

25. Patients requiring treatment with excluded concomitant medications

26. Patients who have non-removable magnetic-sensitive metal present in their head or upper body(above the waist).

27. Patients who are able to lie on their back for 20 minutes or more

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

Sponsor:
National Institutes of Health
Dates:
12/18/2012
Last Updated:
Study HIC#:
1201009609