N/A
N=52
Feasibility Study to Test Clinical Efficacy of Low Energy AC Magnetic Field to Treat Major Depression
Major Depressive Disorder (MDD)
Bottom Line
View on ClinicalTrials.gov: NCT01683019 ↗Enrolled (actual)
52
Serious AEs
0.0%
Results posted
May 2014
Primary outcome: Primary: Percent Change in Hamilton Depression Rating Scale (HAMD-17) at Baseline and the End of Week 4 of Treatment. — -53.8; -53.1; -24.2 % change in HAM-D score
Study Design & Population
- Study type
- Interventional
- Phase
- N/A
- Interventions
- NeoSync EEG Synchronization Therapy (Device); Sham NeoSync EEG Synchronization Therapy (Device)
- Age
- Adult, Older Adult · 18+ yrs
- Sex
- All
- Sponsor
- Wave Neuroscience
- Primary completion
- Nov 2008
Outcome Measures
| Outcome | Result | p-value |
|---|---|---|
| PRIMARY Percent Change in Hamilton Depression Rating Scale (HAMD-17) at Baseline and the End of Week 4 of Treatment. |
-53.8; -53.1; -24.2 | — |
Summary
This feasibility study investigates effects of EEG-based low frequency, low emission magnetic cortical stimulation in comparison to a sham treatment in subjects with moderate to severe depressive disorder.
Eligibility Criteria
Inclusion Criteria
- 18 years of age or older
- Diagnosis of MDD with HAMD-17 greater than or equal to 17
- On a stable dose of existing medication or no medication for 1 month or longer prior to the study
Exclusion Criteria
- Diagnosed with another primary Axis I illness
- Recent history of or current substance abuse
- Clinically significant medical illness, including any thyroid disorders
- Known pregnancy and/or lactation, or intent to become pregnant during the study
Data sourced from ClinicalTrials.gov (NCT01683019). Outcome figures and adverse-event rates are extracted automatically from the registry's posted results and are provided for clinician reference, not as a substitute for the primary publication.