Multiple Treatment Study Using Low Field Magnetic Stimulation for Bipolar Depression

NCT01929681 | Completed Results

• 1 other identifier: 2012P002380
• Study Type: interventional
• Target: 53
• Locations: 1 country
• Sites: 1

Brief 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.

Conditions

Bipolar Depression

Keywords

Low Field Magnetic Stimulation; bipolar; depression; alternative treatment

Outcome Measures

Primary Outcomes (2)

• Long Term Change: Montgomery-Åsberg Depression Rating Scale (MADRS)

  The Montgomery-Asberg Depression Rating scale assesses 10 symptom areas of depression during an interview. Each of the 10 items received a score ranging from 0 to 6. The scale has a range of 0-60 for the reported total. A higher score indicates increased depression for all items and for the total. This outcome measure is the change from pretreatment baseline acquired at the screening visit to a follow-up visit 7 days after the first treatment.

  Variable based on screening visit schedule, > 2 weeks.

• Change Over First Treatment: Positive and Negative Affect Schedule (PANAS) Positive Items Subscale

  PANAS consists of 10 positive and 10 negative valence word items. Items are rated by the participant to indicate their assessment of how they are feeling about this item "right now" on a scale of 1(slightly) or not at all through 5 (extremely). 10 of of the items form a positive affect subscale, in which a higher score indicates increased positive affect, with a subscale range of 10 to 50. 10 of the items form a negative affect subscale, in which a higher score indicates more negative affect, with a subscale range of 10 to 50. This outcome measure is change in the 10 item positive affect subscale. This outcome measure is the difference between the scale administered immediately (\<30min) prior to the first treatment and immediately after (\<30min) the first treatment.

  90 minutes; change immediately (<30min) prior to the first treatment and immediately after (<30min) the first treatment.

Secondary Outcomes (3)

• Rate of of Change in Daily Improvement Over 3 Treatments: Positive and Negative Affect Schedule (PANAS) Positive Items Subscale

  Over 3 days of treatment

• Rate of Change Over 3 Treatments: Montgomery-Asberg Depression Rating Scale (MADRS)

  Over 3 days of treatment

• Rate of Change Over 3 Treatments: Positive and Negative Affect Schedule (PANAS) Positive Items Subscale

  Over 3 days of treatment

Study Arms (2)

LFMS - active treatment

EXPERIMENTAL

Low Field Magnetic Stimulation (LFMS) active treatment Active low field magnetic stimulation treatment applied with the LFMS Device; the device is on and magnetic field stimulation is present.

Device: Low Field Magnetic Stimulation

LFMS - sham treatment

SHAM COMPARATOR

Low Field Magnetic Stimulation - sham treatment Inactive low field magnetic stimulation (no stimulation) treatment applied with the LFMS Device; the device is on, however no magnetic field stimulation is present.

Device: Low Field Magnetic Stimulation

Interventions

Low Field Magnetic Stimulation DEVICE

Low Field Magnetic Stimulation is an electromagnetic technique. It uses low strength electric fields operating at a high frequency.

Also known as: LFMS

LFMS - active treatment; LFMS - sham treatment

Eligibility Criteria

• Age: 21 Years - 65 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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.

You may not qualify if:

• 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.

Sponsors & Collaborators

• Mclean Hospital: lead
• The Depressive and Bipolar Disorder Alternative Treatment Foundation: collaborator

Study Sites (1)

McLean Hospital

Belmont, Massachusetts, 02478, United States

Location

MeSH Terms

Conditions

Bipolar Disorder; Depression

Condition Hierarchy (Ancestors)

Bipolar and Related Disorders; Mood Disorders; Mental Disorders; Behavioral Symptoms; Behavior

Limitations and Caveats

Study was designed for 72 subjects but only 50 subjects were completed due to lack of funds.

Results Point of Contact

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

mrohan@mclean.harvard.edu

617-855-3127

Study Officials

• Michael L Rohan, PhD

  Mclean Hospital

  PRINCIPAL INVESTIGATOR

Publication Agreements

• PI is Sponsor Employee: No
• Restrictive Agreement: No

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: TRIPLE
• Who Masked: PARTICIPANT, CARE PROVIDER, INVESTIGATOR
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Imaging Physicist

Study Record Dates

• First Submitted: July 23, 2013
• First Posted: August 28, 2013
• Study Start: July 1, 2013
• Primary Completion: April 1, 2016
• Study Completion: April 1, 2016
• Last Updated: September 26, 2017
• Results First Posted: June 27, 2017

Record last verified: 2017-08

Locations

US (1)