LFMS: Initial Trial in Geriatric Bipolar Depression
Stopped: Limited resources and funding resulted in a decision to prematurely halt study and redirect remaining funds to partner study Low Field Magnetic Stimulation: Imaging Biomarkers in Geriatric Bipolar Depression (Protocol #2017P002783).
United States16 participantsStarted 2016-09-07
Plain-language summary
The primary aim of this study is to assess the efficacy of Low Field Magnetic Stimulation (LFMS) in treating symptoms of depression and anxiety in older adults suffering from bipolar depression. The investigators also aim to assess any cognitive benefits from regular LFMS treatments in older adults suffering from bipolar depression.
Who can participate
Age range55 Years – 85 Years
SexALL
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Inclusion criteria
✓. Subjects will be men or women aged 55 years or older.
✓. Subjects will have a diagnosis of Bipolar Disorder Type I or II, current episode depressed as measure by a MADRS ≥ 20.
✓. Subjects must have failed at least one FDA approved treatment for bipolar depression before enrolling in this study. Failed treatment is defined as 8 weeks of treatment at standard dose (Selective Serotonin Reuptake Inhibitors (SSRI) , Selective Norepinephrine Reuptake Inhibitors (SNRI), mood stabilizer, or typical or atypical antipsychotic).
✓. Subjects must be maintained on a stable dose of all psychotropic medications for a period of at least two weeks prior to screening.
✓. Subjects must be capable of providing informed consent.
Exclusion criteria
✕. Subjects meeting Diagnostic Statistical Manual-IV-TR (DSM-IV-TR) criteria for any Axis I disorder other than Bipolar Disorder or an anxiety disorder (eg. Major Depressive Disorder, dementia).
✕. Subject has an Mini Mental State Exam (MMSE) score ≤ 24.
✕
What they're measuring
1
Change in Montgomery Asberg Depression Rating Scale (MADRS)
Timeframe: Phase 1 cross-over: scores at base visit 1 (week 0), visit 5 (week 2), and visit 9 (week 4). Differences are between visits 5-1 and 9-5. Phase 2 parallel: scores at base visit 1 (day 0) and visit 7 (day 10). Differences are between visits 7-1.
2
Change in Hamilton Anxiety Rating Scale (HARS)
Timeframe: Phase 1 cross-over: scores at base visit 1 (week 0), visit 5 (week 2), and visit 9 (week 4). Differences are between visits 5-1 and 9-5. Phase 2 parallel: scores at base visit 1 (day 0) and visit 7 (day 10). Differences are between visits 7-1.
3
Change in Positive and Negative Affect Schedule (PANAS), Positive Sub Scale
Timeframe: Phase 1 cross-over: scores at base visit 1 (week 0), visit 5 (week 2), and visit 9 (week 4). Differences are between visits 5-1 and 9-5. Phase 2 parallel: scores at base visit 1 (day 0) and visit 7 (day 10). Differences are between visits 7-1.
. Subject is pregnant or plans on becoming pregnant.
✕. Subject has recent history (within 7 days of screening) of ECT or TMS treatment.
✕. Subject has recent history of substance abuse (cannot meet DSM-IV-TR criteria for substance abuse, no significant drug abuse within last 3 months, no history of dependence in last year, no drug use within last month, other than marijuana use).
✕. Subject has any contraindication for Magnetic Resonance Imaging (MRI) (i.e. Presence of a pacemaker, neurostimulator, or metal in head or neck).