LFMS: Initial Trial in Geriatric Bipolar Depression

NCT02707276 | Terminated Results

• 1 other identifier: 2015P001851
• Study Type: interventional
• Target: 16
• Locations: 1 country
• Sites: 1

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.

Conditions

Bipolar Depression Depressed Phase

Keywords

Bipolar Depression; Geriatric; Low Field Magnetic Stimulation

Outcome Measures

Primary Outcomes (3)

• Change in Montgomery Asberg Depression Rating Scale (MADRS)

  The Montgomery-Asberg Depression Rating Scale (MADRS) is a diagnostic assessment measuring the severity of depressive symptoms. It is a 10-item scale assessing all core symptoms of repression. Each item is scored on a 7-point scale, ranging from 0 (symptom not present) to 6 (symptom severely present). Thus, the total score range is 0-60, with higher scores indicating more depressive symptom endorsement.

  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.

• Change in Hamilton Anxiety Rating Scale (HARS)

  The Hamilton Anxiety Rating Scale (HARS) assesses the severity of anxiety symptoms. It is a 14-item scale covering psychic and somatic anxiety. Each item is scored on a 5-point scale, ranging from 0 (not present) to 4 (severe). Thus, the total score range is 0-56, wither higher scores indicating higher anxiety severity.

  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.

• Change in Positive and Negative Affect Schedule (PANAS), Positive Sub Scale

  The Positive and Negative Affect Schedule (PANAS) assesses the presence and severity of two factors: positive affect (PA), which indicates the extent that a person is experiencing high energy, enthusiastic, mood state, and negative affect (NA), which indicates the extent a person is experiencing an aversive mood state. The PANAS is a 20-item scale, with 10 items measured PA and 10 items measuring NA. Each item is scored on a 5-point scale ranging from 1 (very slightly or not at all) to 5 (extremely). Thus, the score range for PA is 10-50, and the score range for NA is 10-50, with higher scores indicated more endorsement of PA (more energy, concentration, and pleasure) or NA (more anger, disgust, contempt). This study reports data on the score ranges for the PA sub-scale.

  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.

Study Arms (4)

Phase 1: Cross-Over, Active LFMS first

EXPERIMENTAL

Phase 1 crossover: three 20 minute treatments of active low field magnetic stimulation, once per day for three consecutive days during week 1. Then repeat with three 20 minute treatments of sham LFMS, once per day for three consecutive days during week 3.

Device: Active Low Field Magnetic Stimulation

Phase 1: Cross-Over, Sham LFMS first

SHAM COMPARATOR

Phase 1 crossover: three 20 minute treatments of sham low field magnetic stimulation, once per day for three consecutive days during week 1. Then repeat with three 20 minute treatments of active LFMS, once per day for three consecutive days during week 3.

Device: Sham Low Field Magnetic Stimulation

Phase 2: Parallel, Active LFMS

EXPERIMENTAL

Phase 2 parallel: five 20-minute active low field magnetic stimulation treatments, once per day for five consecutive days during week 1.

Device: Active Low Field Magnetic Stimulation

Phase 2: Parallel, Sham LFMS

SHAM COMPARATOR

Phase 2 parallel: five 20-minute sham low field magnetic stimulation treatments, once per day for five consecutive days during week 1.

Device: Sham Low Field Magnetic Stimulation

Interventions

Active Low Field Magnetic Stimulation DEVICE

Low Field Magnetic Stimulation is an electromagnetic treatment being investigated for its effects on mood. It uses magnetic fields that are a fraction of the strength but at a higher frequency than the electromagnetic fields used in transcranial magnetic stimulation (TMS) and electroconvulsive therapy (ECT)

Also known as: Active LFMS

Phase 1: Cross-Over, Active LFMS first; Phase 2: Parallel, Active LFMS

Sham Low Field Magnetic Stimulation DEVICE

The sham treatment does not provide any electromagnetic stimulation. However, it is designed so that it cannot be differentiated from the active treatment by producing mimicking sounds.

Also known as: Sham LFMS

Phase 1: Cross-Over, Sham LFMS first; Phase 2: Parallel, Sham LFMS

Eligibility Criteria

• Age: 55 Years - 85 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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.

You may not qualify if:

• 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.
• 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).

Sponsors & Collaborators

• Mclean Hospital: lead

Study Sites (1)

McLean Hospital

Belmont, Massachusetts, 02478, United States

Location

MeSH Terms

Conditions

Bipolar Disorder

Condition Hierarchy (Ancestors)

Bipolar and Related Disorders; Mood Disorders; Mental Disorders

Results Point of Contact

• Title: Dr. Michael Rohan
• Organization: McLean Hospital

mrohan@mclean.harvard.edu

617-855-3127

Study Officials

• Brent Forester, M.D. MSc.

  Mclean Hospital

  PRINCIPAL INVESTIGATOR

Publication Agreements

• PI is Sponsor Employee: Yes

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: DOUBLE
• Who Masked: PARTICIPANT, INVESTIGATOR
• Masking Details: The system can operate in sham mode, with identical sounds to active mode. The system can be programmed to randomize subjects automatically without the knowledge of study staff.
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Clinical Director

Model Details: 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.

Study Record Dates

• First Submitted: March 4, 2016
• First Posted: March 14, 2016
• Study Start: September 7, 2016
• Primary Completion: June 1, 2019
• Study Completion: June 1, 2019
• Last Updated: March 2, 2022
• Results First Posted: March 2, 2022

Record last verified: 2022-01

Data Sharing

• IPD Sharing: Will not share

Locations

US (1)