Low Field Magnetic Stimulation (LFMS) in Mood Disorders: 6 Treatments

Paused · Phase 1 · Has a placebo group

Conditions studied: Bipolar Depression, Unipolar Depression

In brief

To demonstrate the efficacy of multiple applications of Low Field Magnetic Stimulation (LFMS) as an antidepressant treatment in subjects with mood disorders.

Key facts

Study ID

NCT01557192

Run by

Mclean Hospital

People needed

200

Starts

2010-05-01

Expected to finish

2020-05-01

Last updated by the study team

2016-04-13

Who can join

Age: 21 and older, up to 55. Sex: any. Healthy volunteers: not accepted.

You may qualify if…

• Subjects MUST be significantly depressed, currently.
• Subjects must not have serious physical illnesses, neurological diseases or dementias.
• 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.
• Subject must have a Ham-D score > 17, YMRS score < 7 (bipolar subjects only), and a MADRS score > 18.
• Subjects must be capable of providing informed consent.
• Subjects must have an established residence and phone.
• Subjects may be medicated or unmedicated.

You may not qualify if…

• Dangerous or active suicidal ideation.
• Pregnant or planning on becoming pregnant.
• 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).
• Mixed mood state or rapid cycling.
• Presence of a pacemaker, neurostimulator, or metal in head or neck.

Where it is running

• McLean Hospital — Belmont, Massachusetts, United States

Full record on ClinicalTrials.gov

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