Low Field Magnetic Stimulation in Mood Disorders Using the LFMS Device

Not Applicable

Completed

Conditions: Major Depressive Disorder
Depression
Bipolar Depression

Interventions: Device: Low Field Magnetic Stimulation Device

Registration Number: NCT00578383

Lead Sponsor: Mclean Hospital

Brief Summary: This study is designed to test whether low-field magnetic stimulation (LFMS) can relieve some of the symptoms of depression in bipolar disorder or major depression.

Detailed Description: This study involves a screening visit with the study physician and a treatment visit. Participants will be asked to complete several questionnaires about their mood during both visits. The treatment visit will involve use of the LFMS device. Participants will place the top of their head inside the device for approximately 20 minutes. Participants will receive either the actual treatment or a sham treatment and will not know which they receive. This device produces weak electromagnetic fields. There is no discomfort or even sensation caused by the device. The device has been declared to be a "non-significant risk device" by the FDA, and there are no known risks associated with its use.

Recruitment & Eligibility

Status: COMPLETED

Sex: All

Target Recruitment: 107

Inclusion Criteria

Diagnosis of Major Depressive Disorder or Bipolar Disorder; must be currently depressed
May be medicated or unmedicated

Exclusion Criteria

Contraindication for MRI due to metal in eyes/head
Claustrophobia.
Inability to lie flat.
History of brain injury.
Pregnant
Current drug use/abuse/dependence
History of polysubstance use

Study & Design

Study Type: INTERVENTIONAL

Study Design: PARALLEL

Arm && Interventions

Group	Intervention	Description
Sham (inactive) Treatment BPD	Low Field Magnetic Stimulation Device	20 minutes of sham treatment with the Low Field Magnetic Stimulation Device (LFMS)in bipolar depressed subjects
Active LFMS treatment in BPD	Low Field Magnetic Stimulation Device	20 minutes of active treatment with the Low Field Magnetic Stimulation Device (LFMS)in bipolar depressed subjects
Sham LFMS Comparator: in MD	Low Field Magnetic Stimulation Device	20 minutes of sham treatment with the Low Field Magnetic Stimulation Device (LFMS) in major depressed subjects
Experimental LFMS: in MD	Low Field Magnetic Stimulation Device	20 minutes of active treatment with the Low Field Magnetic Stimulation Device (LFMS) in major depressed subjects

Primary Outcome Measures

Name	Time	Method
Mean Change in Hamilton Depression Rating Scale (HAM-D) (17 Item) in Subjects With Bipolar Depression	Once just before and once just after treatment	A multiple choice questionnaire used to rate depression severity. Mean change from pretreatment score. 17 items reflecting depression symptoms are scored on scale of severity; 9 items are scored 0 = Absent 1 = Trivial 2 = Mild 3 = Moderate 4 = Severe 8 items are scored 0 = Absent 1 = Mild 2 = Severe. Items are summed; minimum score is 0, maximum score is 52. Higher scores represent more severe depression.
Mean Change in Hamilton Depression Depression Rating Scale (HAM-D) (17 Item) in Subjects With Major Depressive Disorder	Once just before and once just after treatment	A multiple choice questionnaire used to rate depression severity. Mean change from pretreatment score. 17 items reflecting depression symptoms are scored on scale of severity; 9 items are scored 0 = Absent 1 = Trivial 2 = Mild 3 = Moderate 4 = Severe 8 items are scored 0 = Absent 1 = Mild 2 = Severe. Items are summed; minimum score is 0, maximum score is 52. Higher scores represent more severe depression.
Visual Analog Scale (VAS) in Subjects With Bipolar Depression	Once just before and once just after treatment	Eleven point Likert scales indicating immediate depression state. Mean change from pretreatment score. Participant marks an 'X' on a numbered line anchored by 0 = no depression and 10 = most depressed ever been.
Visual Analog Scale (VAS) in Subjects With Major Depressive Disorder	Once just before and once just after treatment	Eleven point Likert scales indicating immediate depression state. Mean change from pretreatment score. Participant marks an 'X' on a numbered line anchored by 0 = no depression and 10 = most depressed ever been.

Secondary Outcome Measures

Name	Time	Method
Mean Change in Hamilton Depression Rating Scale (HAM-D) (17 Item): Combined Diagnostic Groups.	Once just before and once just after treatment	A multiple choice questionnaire used to rate depression severity. Mean change from pretreatment score. 17 items reflecting depression symptoms are scored on scale of severity; 9 items are scored 0 = Absent 1 = Trivial 2 = Mild 3 = Moderate 4 = Severe 8 items are scored 0 = Absent 1 = Mild 2 = Severe. Items are summed; minimum score is 0, maximum score is 52. Higher scores represent more severe depression.
Visual Analog Scale (VAS): Combined Diagnostic Groups.	Once just before and once just after treatment	Eleven point Likert scales indicating immediate depression state. Mean change from pretreatment score. Participant marks an 'X' on a numbered line anchored by 0 = no depression and 10 = most depressed ever been.
Positive and Negative Affect Schedule (PANAS) Negative Score: Combined Diagnostic Group.	once pre and once post LFMS treatment	20 item list of words that describe different feelings and emotions with positive and negative valences (10 each), which the subject scores on a 1-5 scale: 1 = very slightly or not at all 2 = a little 3 = moderate 4 = quite a bit 5 = extremely. Positive and Negative scores are calculated and reported separately and range from 10-50. Higher positive score reflects stronger positive affect and higher negative score reflects stronger negative affect.
Positive and Negative Affect Schedule (PANAS) Negative Score in Subjects With Bipolar Depression	once pre and once post LFMS treatment	20 item list of words that describe different feelings and emotions with positive and negative valences (10 each), which the subject scores on a 1-5 scale: 1 = very slightly or not at all 2 = a little 3 = moderate 4 = quite a bit 5 = extremely. Positive and Negative scores are calculated and reported separately and range from 10-50. Higher positive score reflects stronger positive affect and higher negative score reflects stronger negative affect.
Positive and Negative Affect Schedule (PANAS) Positive Score: Combined Diagnostic Group.	Once just before and once just after treatment	20 item list of words that describe different feelings and emotions with positive and negative valences (10 each), which the subject scores on a 1-5 scale: 1 = very slightly or not at all 2 = a little 3 = moderate 4 = quite a bit 5 = extremely. Positive and Negative scores are calculated and reported separately and range from 10-50. Higher positive score reflects stronger positive affect and higher negative score reflects stronger negative affect.
Positive and Negative Affect Schedule (PANAS) Positive Score in Subjects With Bipolar Depression.	Once just before and once just after treatment	20 item list of words that describe different feelings and emotions with positive and negative valences (10 each), which the subject scores on a 1-5 scale: 1 = very slightly or not at all 2 = a little 3 = moderate 4 = quite a bit 5 = extremely. Positive and Negative scores are calculated and reported separately and range from 10-50. Higher positive score reflects stronger positive affect and higher negative score reflects stronger negative affect.
Positive and Negative Affect Schedule (PANAS) Positive Score in Subjects With Major Depressive Disorder	Once just before and once just after treatment	20 item list of words that describe different feelings and emotions with positive and negative valences (10 each), which the subject scores on a 1-5 scale: 1 = very slightly or not at all 2 = a little 3 = moderate 4 = quite a bit 5 = extremely. Positive and Negative scores are calculated and reported separately and range from 10-50. Higher positive score reflects stronger positive affect and higher negative score reflects stronger negative affect.
Positive and Negative Affect Schedule (PANAS) Negative Score in Subjects With Major Depressive Disorder	once pre and once post LFMS treatment	20 item list of words that describe different feelings and emotions with positive and negative valences (10 each), which the subject scores on a 1-5 scale: 1 = very slightly or not at all 2 = a little 3 = moderate 4 = quite a bit 5 = extremely. Positive and Negative scores are calculated and reported separately and range from 10-50. Higher positive score reflects stronger positive affect and higher negative score reflects stronger negative affect.