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Multiple Treatment Study Using Low Field Magnetic Stimulation for Bipolar Depression

NCT01929681 · Status: COMPLETED · Phase: NA · Type: INTERVENTIONAL · Enrollment: 53

Last updated 2017-09-26

Study results available
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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

Interventions

DEVICE

Low Field Magnetic Stimulation

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

Sponsors & Collaborators

  • The Depressive and Bipolar Disorder Alternative Treatment Foundation

    collaborator OTHER

  • Mclean Hospital

    lead OTHER

Principal Investigators

  • Michael L Rohan, PhD · Mclean Hospital

Study Design

Allocation
RANDOMIZED
Purpose
TREATMENT
Masking
TRIPLE
Model
PARALLEL

Eligibility

Min Age
21 Years
Max Age
65 Years
Sex
ALL
Healthy Volunteers
No

Timeline & Regulatory

Start
2013-07-31
Primary Completion
2016-04-30
Completion
2016-04-30

Countries

  • United States

Study Locations

More Related Trials

Entities

Diseases

Read the full study record

This page highlights key information. For complete eligibility criteria, study locations, investigator contacts, and the full protocol, visit the original record on ClinicalTrials.gov.

View NCT01929681 on ClinicalTrials.gov