Clinical trial NCT01557192: Low Field Magnetic Stimulation (LFMS) in Mood Disorders: 6 Treatments
Official title: Low Field Magnetic Stimulation in Mood Disorders in Six Visits
Study type: INTERVENTIONAL
Overall status: SUSPENDED
Phase: PHASE1
Conditions: Bipolar Depression
Unipolar Depression
Keywords: Depression
Bipolar Depression
LFMS
Electromagnetic Stimulation
Lead sponsor: Mclean Hospital
Sponsor class: OTHER
First posted: 2012-03-19
Enrollment: 200
Sex: ALL
Minimum age (years): 21
Maximum age (years): 55
Standard ages: ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: TREATMENT

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.

Eligibility criteria: 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.

Primary outcomes:
measure: Change in Montgomery-Asberg Depression Rating Scale (MADRS)score
timeFrame: at baseline and at week 3
measure: Change in Positive-Negative Affect Scale (PANAS)score
timeFrame: at baseline and at one and at week 3
Secondary outcomes:
measure: Immediate mood improvement as measured by the difference in post and pre treatment PANAS ratings
timeFrame: at baseline and immediately before and after each treatment, 6 treatments across 2 weeks
measure: Change in Montgomery-Asberg Depression Rating Scale (MADRS)score
timeFrame: at baseline and at week 4
measure: Change in Positive-Negative Affect Scale (PANAS)score.
timeFrame: at baseline and at one and at week 4
Other outcomes:
Locations:
city: Belmont
country: United States
facility: McLean Hospital
state: Massachusetts
Study officials:
affiliation: Mclean Hospital
name: Michael L. Rohan, Ph.D.
role: PRINCIPAL_INVESTIGATOR
References:
citation: Rohan M, Parow A, Stoll AL, Demopulos C, Friedman S, Dager S, Hennen J, Cohen BM, Renshaw PF. Low-field magnetic stimulation in bipolar depression using an MRI-based stimulator. Am J Psychiatry. 2004 Jan;161(1):93-8. doi: 10.1176/appi.ajp.161.1.93.
citation: Carlezon WA Jr, Rohan ML, Mague SD, Meloni EG, Parsegian A, Cayetano K, Tomasiewicz HC, Rouse ED, Cohen BM, Renshaw PF. Antidepressant-like effects of cranial stimulation within a low-energy magnetic field in rats. Biol Psychiatry. 2005 Mar 15;57(6):571-6. doi: 10.1016/j.biopsych.2004.12.011.