N/A
N=53
Multiple Treatment Study Using Low Field Magnetic Stimulation for Bipolar Depression
Bipolar Depression
Bottom Line
View on ClinicalTrials.gov: NCT01929681 ↗Enrolled (actual)
53
Serious AEs
0.0%
Results posted
Jun 2017
Primary outcome: Primary: Long Term Change: Montgomery-Åsberg Depression Rating Scale (MADRS) — -14.03; -9.75 units on a scale — p=<0.049
Study Design & Population
- Study type
- Interventional
- Phase
- N/A
- Interventions
- Low Field Magnetic Stimulation (Device)
- Age
- Adult, Older Adult · 21+ yrs
- Sex
- All
- Sponsor
- Mclean Hospital
- Primary completion
- Apr 2016
Outcome Measures
| Outcome | Result | p-value |
|---|---|---|
| PRIMARY Long Term Change: Montgomery-Åsberg Depression Rating Scale (MADRS) |
-14.03; -9.75 | <0.049 sig |
| PRIMARY Change Over First Treatment: Positive and Negative Affect Schedule (PANAS) Positive Items Subscale |
0.5; 1.4 | <0.182 |
| SECONDARY Rate of of Change in Daily Improvement Over 3 Treatments: Positive and Negative Affect Schedule (PANAS) Positive Items Subscale |
-0.471; -0.375; 0.50; 1.40; -0.63; 0.21 | <0.449 |
| SECONDARY Rate of Change Over 3 Treatments: Montgomery-Asberg Depression Rating Scale (MADRS) |
-5.42; -5.60; 26.15; 26.13; 16.81; 17.83 | <0.444 |
| SECONDARY Rate of Change Over 3 Treatments: Positive and Negative Affect Schedule (PANAS) Positive Items Subscale |
1.70; 0.80; 21.00; 22.25; 24.04; 23.54 | <0.182 |
Summary
Objectives:
To demonstrate the duration of the antidepressant effect of Low Field Magnetic Stimulation (LFMS)in subjects with bipolar depression.
Hypotheses:
Investigators expect subjects who receive LFMS to show significant mood improvement one week after the start of a three day course of daily stimulation as compared to subjects who receive sham LFMS.
Investigators expect subjects who receive LFMS to show immediate mood improvement over the first treatment as measured by the difference in pre and post-treatment PANAS+ ratings.
Investigators expect to show that LFMS will be well tolerated in a three-treatment protocol.
Eligibility Criteria
Inclusion Criteria
- Subjects will be men or women between the ages of 21-65.
- Subjects must not have serious physical illnesses, neurological diseases or dementias.
- 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).
- Subject must have a MADRS >= 20, Young Mania Rating Score (YMRS score) < 7.
- Subjects must be capable of providing informed consent.
- Subjects must have an established residence and phone.
- Subjects may be medicated or unmedicated.
Exclusion Criteria
- 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).
- Mania, hypomania or mixed mood state.
- Significant medical or neurological illness that might pose a risk to study enrollment or interfere with interpretation of study data.
- Changes in psychiatric medication (e.g. dose or drug) within 6 weeks prior to enrollment.
- History of schizophrenia, schizoaffective, obsessive-compulsive or post-traumatic stress disorders.
- 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).)
- Contraindications for Magnetic Resonance Imaging (MRI): Presence of a pacemaker, neurostimulator, or metal in head or neck.
Data sourced from ClinicalTrials.gov (NCT01929681). 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.