The investigators have previously observed mood improvement in participants with bipolar depression in a population aged 21-60. Here the investigators hope to extend these results to a similar but new population, geriatric bipolar depression (GPD). In addition to the evaluation of the effect of multiple treatments, as well as observation of the duration of the effect after a delay of one week in this population, the investigators will assess whether this population presents any noticeable difference in tolerance or effect.
This study was completed in two phases; the design of the second phase was revised based on results from a related study (2012P002380). The first phase had a randomized, double-blind, sham-controlled crossover design. Subjects were distributed equally into two groups; one group received three active LFMS sessions during a first treatment week and three sham LFMS sessions during a second treatment week, while the second group received sham LFMS first and then active LFMS. Specifically, all subjects made a baseline visit during week 0 (visit 1, any day) where scales of depression (Montgomery-Asberg Rating Scale (MADRS)), anxiety (Hamilton Anxiety Rating Scale (HARS)), and positive affect (Positive and Negative Affect Schedule (PANAS)) were completed. Subjects returned during week 1 for three treatment visits (visits 2,3,4 any days) during which they received active or sham LFMS according to their order assignment. Subject returned for the same mood ratings during week 2 (visit 5, any day). Subjects returned during week 3 for three treatment visits and received the alternate treatment according to their order assignment (visits 6,7,8, any days). Finally, subjects returned week 4 for to receive the mood ratings (visit 9, any day). The MADRS, HARS, and PANAS scales completed during weeks 0, 2, and 4 were the outcome measures. Treatment order assignments were randomized and balanced within blocks of 10 via a random number generator.
Following review of data from a different Low Field Magnetic Stimulation study (2012P002380), the study design was revised, and a second phase of this protocol resulted. This is a randomized, double-blind, sham-controlled study with a parallel design (subjects will either receive active treatment or sham treatment for all treatment sessions). Specifically, the MADRS, HARS, and PANAS were completed on baseline visit 1 (day 0, Friday); 5 treatment visits were made on days 3,4,5,6,7 (visits 2-6); a mood rating visit 7 was made on day 10. The MADRS, HARS, and PANAS scales completed during days 0 and 10 were the outcome measures. Treatment order assignments were randomized and balanced within blocks of 10 via a random number generator.
The mechanisms of depression in a geriatric population may differ from those in a younger population. Brain structures and connectivity have changed, and there is the increased risk of comorbid diagnoses such as dementia that might confound treatment and assessment. In this study the investigators hope to extend the findings of LFMS in the general population to directly address the treatment of bipolar depression in a geriatric population.
