Bipolar Depression, Unipolar Depression
Conditions
Keywords
Depression, Bipolar Depression, LFMS, Electromagnetic Stimulation
Brief summary
To demonstrate the efficacy of multiple applications of Low Field Magnetic Stimulation (LFMS) as an antidepressant treatment in subjects with mood disorders.
Detailed description
The Low Field Magnetic Stimulation (LFMS) procedure is an application of a series of electromagnetic pulses to the brain lasting twenty minutes. The field and timing parameters of the LFMS pulses, such as pulse timing, duration, frequency, and electric and magnetic field distribution and direction are different from other neurostimulation methods. The mechanism of action for the antidepressant effects of LFMS is hypothesized to be an effect on dendritic or synaptic activity in the cortex, brought about by low level electrical stimulation applied with particular timing. This is analogous to the synaptic effects of pharmaceutical antidepressants in providing a boost to synapses in certain brain regions. Previous investigations of LFMS included depressed subjects with bipolar disorder. This study will evaluate the antidepressant effects of multiple LFMS treatments in bipolar disorder and major depressive disorder.
Interventions
The Low Field Magnetic Stimulation (LFMS) procedure is an application of a series of electromagnetic pulses to the brain lasting twenty minutes. Subjects will be given one 20 minute exposure to either the LFMS or sham electromagnetic field treatment.
Sponsors
Mclean Hospital
Study design
Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
TREATMENT
Masking
TRIPLE (Subject, Investigator, Outcomes Assessor)
Eligibility
Sex/Gender
ALL
Age
21 Years to 55 Years
Healthy volunteers
No
Inclusion criteria
1. Subjects MUST be significantly depressed, currently. 2. Subjects must not have serious physical illnesses, neurological diseases or dementias. 3. Subjects will meet DSM-IV criteria for Bipolar Disorder Type I or II, Major Depressive Disorder, Post Traumatic Stress Disorder, or Obsessive Compulsive Disorder, and be currently depressed. 4. Subject must have a Ham-D score \> 17, YMRS score \< 7 (bipolar subjects only), and a MADRS score \> 18. 5. Subjects must be capable of providing informed consent. 6. Subjects must have an established residence and phone. 7. Subjects may be medicated or unmedicated.
Exclusion criteria
1. Dangerous or active suicidal ideation. 2. Pregnant or planning on becoming pregnant. 3. Substance abuse (cannot meet DSM criteria for substance abuse, no significant drug abuse within last 3 months, no major polysubstance abuse history, no history of dependence in last year, no drug use within last month). 4. Mixed mood state or rapid cycling. 5. Presence of a pacemaker, neurostimulator, or metal in head or neck.
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| Change in Montgomery-Asberg Depression Rating Scale (MADRS)score | at baseline and at week 3 | MADRS scores will be compared between the baseline and week 3, one week after the final treatment. |
| Change in Positive-Negative Affect Scale (PANAS)score | at baseline and at one and at week 3 | PANAS scores will be compared between the baseline and week 3, one week after the final treatment. |
Secondary
| Measure | Time frame | Description |
|---|---|---|
| Immediate mood improvement as measured by the difference in post and pre treatment PANAS ratings | at baseline and immediately before and after each treatment, 6 treatments across 2 weeks | PANAS scores will be assessed at baseline and before and after each treatment. There are six treatments (Monday, Wednesday and Friday for two weeks). |
| Change in Montgomery-Asberg Depression Rating Scale (MADRS)score | at baseline and at week 4 | MADRS scores will be compared between the baseline and week 4, two weeks after the final treatment. |
| Change in Positive-Negative Affect Scale (PANAS)score. | at baseline and at one and at week 4 | PANAS scores will be compared between the baseline and week 4, two weeks after the final treatment. |
Countries
United States
Outcome results
None listed