Multiple Treatment Study Using Low Field Magnetic Stimulation for Bipolar Depression

Low Field Magnetic Stimulation is an electromagnetic intervention being investigated at
McLean Hospital because of its effect on symptoms of depression. It consists of pulsed
electric fields that are induced remotely in the head by a portable coil. It has been
observed to have mood elevating effects in depressed patients with Bipolar Disorder (BPD).
These effects are immediate, occurring upon completion of a 20 minute treatment.

LFMS is unique because of its low electric field strength, and because of its high frequency
operation, compared to other electromagnetic treatments. While other treatments such as
Electroconvulsive Therapy (ECT) use electric fields equivalent to > 100-200 Volts/meter to
affect the brain, LFMS uses <1 V/m. Such a low electric field strength indicates that another
mechanism is activated by LFMS, and this provides a possibility for a new treatment. It may
also give insight into causes of depression.

LFMS is also unique because it has an immediate effect. This immediate effect may have
implications for emergency treatment.

The purpose of this study is to observe the response to LFMS in depressed BPD subjects with
the aim of assessing the effects of multiple treatments, and of observing the duration of the
mood improvement.To do so, the investigators propose to study 72 subjects in a protocol of
three treatments in three days. Subjects will be rated before and after each treatment, and
will return for mood ratings at one week after treatment. Investigators hope that this
characterization of LFMS will allow clinical research groups to perform large trials and to
evaluate its clinical effectiveness in patient populations.

Inclusion Criteria:

1. Subjects will be men or women between the ages of 21-65.

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 and meet criteria
for current depression (DSM-IV major depressive episode, current).

4. Subject must have a MADRS >= 20, Young Mania Rating Score (YMRS score) < 7.

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. Mania, hypomania or mixed mood state.

5. Significant medical or neurological illness that might pose a risk to study enrollment
or interfere with interpretation of study data.

6. Changes in psychiatric medication (e.g. dose or drug) within 6 weeks prior to
enrollment.

7. History of schizophrenia, schizoaffective, obsessive-compulsive or post-traumatic
stress disorders.

8. Treatment resistant depression (as determined by the study psychiatrist; consistently
and substantially symptomatic over several years despite electroconvulsive therapy, 2
or more adequate trials of a primary mood stabilizer with antidepressant effects
(e.g., lithium, valproate or lamotrigine) or antidepressant medications (e.g.,
bupropion, Selective Serotonin Reuptake Inhibitors (SSRI) or Serotonin Norepinephrine
Reuptake Inhibitor (SNRI).)

9. Contraindications for Magnetic Resonance Imaging (MRI): Presence of a pacemaker,
neurostimulator, or metal in head or neck.