Evaluation of NeoSync EEG Synchronized TMS For the Treatment of Major Depressive Episode in Bipolar Disorder and Associated Neural Response: An Open Label Trial

Butler Hospital1 site in 1 country6 target enrollmentMay 2016

ConditionsMajor Depressive Episode Bipolar Depression Bipolar Disorder Mood Disorders

Overview

Phase: Phase 2
Intervention: Not specified
Conditions: Major Depressive Episode
Sponsor: Butler Hospital
Enrollment: 6
Locations: 1
Primary Endpoint: Mean MADRS Total Score Change (Last Observation Carried Forward)
Status: Terminated
Last Updated: 6 years ago

Overview Investigators Eligibility Criteria Outcomes Sites Similar Trials

Overview

Brief Summary

This study is designed to evaluate the safety and preliminary efficacy of synchronized transcranial magnetic stimulation (sTMS) using the NeoSync EEG Synchronized TMS device (NEST) in subjects with Bipolar Disorder type I in a Major Depressive Episode. This is an open label study in which subjects will receive treatment 5 days per week for 6 weeks.

Registry

clinicaltrials.gov

Start Date

May 2016

End Date

November 19, 2018

Last Updated

6 years ago

Study Type

Interventional

Study Design

Single Group

Sex

All

Investigators

Sponsor

Butler Hospital

Responsible Party

Principal Investigator

Linda L Carpenter MD

Chief, Mood Disorder Research Program

Butler Hospital

Eligibility Criteria

Inclusion Criteria

•Subjects must meet all of the following inclusion criteria to qualify for enrollment into the study:
•18 - 70 years of age;
•DSM-5 primary diagnosis of Bipolar Disorder type 1 (with a documented past manic episode), currently in a Major Depressive Episode by diagnostic criteria elicited by structured clinical interview (SCID-5-RV);
•MADRS score ≥ 20;
•Duration of current episode \>4 weeks
•YMRS score ≤ 12;
•baseline EEG of sufficient quality for quantitative analysis processing;
•willing and able to adhere to the intensive treatment schedule and all required study visits;
•currently on adequate dose of mood stabilizer with significant evidence base or FDA approval as antimanic or for maintenance therapy of bipolar disorder (e.g, valproic acid/divalproex, carbamazepine, lithium, aripiprazole, ziprasidone, risperidone, quetiapine, olanzapine, asenapine, haloperidol, chlorpromazine, paliperidone, cariprazine).

Exclusion Criteria

•Subjects will be excluded from study participation if one of the following exclusion criteria applies:
•unable or unwilling to give informed consent;
•diagnosed with current primary psychotic disorder (rather than BD);
•diagnosed with current mania or hypomanic mood episode;
•history of moderate to severe substance use disorder within the past 6 months (except nicotine and caffeine);
•currently being treated with a stimulant;
•clinically defined major neurological disorder; including, but not limited to, seizure disorder and history of loss of consciousness due to head injury for greater than 10 minutes, or with documented evidence of brain injury;
•increased risk of seizure for any reason, including diagnosis of increased intracranial pressure, comorbid neurological disorder, use of certain medications, highly unstable use of alcohol or benzodiazepines;
•initiation of new antidepressant treatments (new medication, new device-based stimulation, or new psychotherapy) within 6 weeks prior to study baseline;
•active suicidal intent or plan as detected on screening assessments, or in the Investigator's opinion, is likely to attempt suicide within the next six months;

Outcomes

Primary Outcomes

Mean MADRS Total Score Change (Last Observation Carried Forward)

Time Frame: Baseline to week 6 reported

The Montgomery-Asberg Depression Rating Scale (MADRS) will be performed as a baseline and endpoint assessments and efficacy measure. It's considered the gold standard for rating depression severity and used frequently in clinical trials. The MADRS score ranges from 0 to 60; a score of 0-6 is generally accepted to be within the normal range (or in clinical remission), while a score of 20 or higher indicates at least moderate severity.

Secondary Outcomes

Mean HDRS-17 Total Score Change (Last Observation Carried Forward)(Baseline and week 6)
Mean IDS-SR Score Change (Last Observation Carried Forward)(Baseline through week 6)