Clinical trial NCT02707276: LFMS: Initial Trial in Geriatric Bipolar Depression
Official title: Low Field Magnetic Stimulation: Initial Trial in Geriatric Bipolar Depression
Study type: INTERVENTIONAL
Overall status: TERMINATED
Phase: NA
Conditions: Bipolar Depression Depressed Phase
Keywords: Bipolar Depression
Geriatric
Low Field Magnetic Stimulation
Lead sponsor: Mclean Hospital
Sponsor class: OTHER
First posted: 2016-03-14
Enrollment: 16
Sex: ALL
Minimum age (years): 55
Maximum age (years): 85
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Intervention model description: There are two phases. The first, pilot phase was a randomized, double-blinded crossover design. Following review of data from a different Low Field Magnetic Stimulation study (2012P002380) that showed a large order effect from the crossover design, revision of study design was prompted. The study design for this second phase was a randomized, double-blinded sham-controlled parallel design.
Primary purpose: TREATMENT

Brief 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.

Detailed description: 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.

Eligibility criteria: Inclusion criteria:

1. Subjects will be men or women aged 55 years or older.
2. Subjects will have a diagnosis of Bipolar Disorder Type I or II, current episode depressed as measure by a MADRS ≥ 20.
3. 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).
4. Subjects must be maintained on a stable dose of all psychotropic medications for a period of at least two weeks prior to screening.
5. Subjects must be capable of providing informed consent.

Exclusion criteria:

1. 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).
2. Subject has an Mini Mental State Exam (MMSE) score ≤ 24.
3. Subject is pregnant or plans on becoming pregnant.
4. Subject has recent history (within 7 days of screening) of ECT or TMS treatment.
5. 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).
6. Subject has any contraindication for Magnetic Resonance Imaging (MRI) (i.e. Presence of a pacemaker, neurostimulator, or metal in head or neck).

Primary outcomes:
measure: 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.
measure: 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.
measure: 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.
Secondary outcomes:
Other outcomes:
Locations:
city: Belmont
country: United States
facility: McLean Hospital
state: Massachusetts
Study officials:
affiliation: Mclean Hospital
name: Brent Forester, M.D. MSc.
role: PRINCIPAL_INVESTIGATOR
References: