N/A Completed N=107 Randomized Quadruple-blind Treatment

Low Field Magnetic Stimulation in Mood Disorders Using the LFMS Device

Depression · Major Depressive Disorder

Source: ClinicalTrials.gov NCT00578383 ↗

Enrolled (actual)

107

Serious AEs

0.0%

Results posted

Apr 2014

Primary outcomePrimary: Mean Change in Hamilton Depression Rating Scale (HAM-D) (17 Item) in Subjects With Bipolar Depression — -8.3; -5.79 units on a scale — p=0.09

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.

Outcome Measures

Outcome	Result	p-value
PRIMARY Mean Change in Hamilton Depression Rating Scale (HAM-D) (17 Item) in Subjects With Bipolar Depression	-8.3; -5.79	0.09
PRIMARY Mean Change in Hamilton Depression Depression Rating Scale (HAM-D) (17 Item) in Subjects With Major Depressive Disorder	-7.19; -4.02	0.19
PRIMARY Visual Analog Scale (VAS) in Subjects With Bipolar Depression	-1.18; -1.05	0.15
PRIMARY Visual Analog Scale (VAS) in Subjects With Major Depressive Disorder	-1.33; 0.25	0.04 sig
SECONDARY Mean Change in Hamilton Depression Rating Scale (HAM-D) (17 Item): Combined Diagnostic Groups.	-8.13; -5.02	0.009 sig
SECONDARY Visual Analog Scale (VAS): Combined Diagnostic Groups.	-1.66; -0.60	0.006 sig
SECONDARY Positive and Negative Affect Schedule (PANAS) Positive Score: Combined Diagnostic Group.	3.16; -0.94	0.001 sig
SECONDARY Positive and Negative Affect Schedule (PANAS) Negative Score: Combined Diagnostic Group.	-7.00; -5.00	0.15
SECONDARY Positive and Negative Affect Schedule (PANAS) Positive Score in Subjects With Bipolar Depression.	4.18; -0.79	0.004 sig
SECONDARY Positive and Negative Affect Schedule (PANAS) Positive Score in Subjects With Major Depressive Disorder	1.05; -0.63	0.30
SECONDARY Positive and Negative Affect Schedule (PANAS) Negative Score in Subjects With Bipolar Depression	-7.66; -6.31	0.52
SECONDARY Positive and Negative Affect Schedule (PANAS) Negative Score in Subjects With Major Depressive Disorder	-5.28; -3.04	0.10

Eligibility Criteria

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

View full record on ClinicalTrials.gov →

Data sourced from ClinicalTrials.gov (NCT00578383). Outcome figures and adverse-event rates are extracted automatically from the registry's posted results and are provided for clinician reference, not as a substitute for the primary publication. Informational only — not medical advice.