Number of Subjects Author/Publication Publication Title Type of Study Enrolled/ Qualified Evaluable/ Analyzable Patient Population Primary Endpoint

Responders PEER Control Summary/Results Evidence Level

PEER Online (rEEG) Controlled Clinical Trials

The use of Referenced-EEG (rEEG) in DeBattista, C, et al., Journal assisting medication selection for the of Psychiatric Research, 2010 treatment of depression Treatment Resistant Depression
rEEG-guided pharmacotherapy was more effective in subjects with depression than employing a treatment algorithm derived from the most effective medications in the STAR*D study. rEEG may represent an easy, inexpensive, predictive, objective office procedure that builds on clinical judgment to guide antidepressant choice. rEEG group had better outcomes than those medicated per TMAP standard, regardless of sub-grouping by equivalency. Depression scores (QIDS) and quality of life scores (Q-LES-Q) were significantly improved vs. TMAP. Results consistent with prior trials investigating the use of rEEG efficacy in guiding Treatment Resistant patients. Prospective, randomized, blinded, controlled study comparing outcomes in refractory major depressive disorder (MDD) guided by electroencephalography-based medication outcome prediction. There were statistically significant differences between the two groups in pretreatment vs. treatment HAM-D and Beck Depression Inventory scores (P<.009) and CGI scores (P = .02). In this open label controlled study, 81 subjects were treated following rEEG guidance and 25 subjects followed treatment as usual from DSM categories. Of the 81 subjects, 67 (83%) were rated as 'much or very much' improved at the 9 month follow up period. Of the control group, 13 patients dropped from the study and of the remaining 10 patients, none were rated as 'ver. much improved'. An unblinded prospective analysis of 100 patients, 46 with attentional disorders and 54 with depressive (unipolar or bipolar) disorders. Demonstrated clear correlations between rEEG subtypes, response to medications, and clinical outcome--independent of DSM diagnoses.

SB-RCT

114

89

QIDS-SR16; Q-LES-Q-SF

65%

39%

1b

DeBattista, C, et al., NCDEU Poster, 2009

Review of current results in the use of Referenced-EEG in the guidance of psychotropic medication selection for treatment-resistant depressed patients A QEEG Database Method for Predicting Pharmacotherapeutic Outcome in Refractory major Depressive Disorders

SB-RCT

18

18

Treatment Resistant Depression

QIDS and Q-LES-Q scores

58%

0%

2b

Suffin, S, et al., Journal of American Physicians & Surgeons, 2007

DB-RCT

13

13

Treatment Resistant Depression

Ham-D, BDI scores & CGI scale

85%

17%

2b

Schiller, M, et al., NIMH's 44th NCDEU Poster, 2004

Referenced-EEG in the treatment of eating disorders

nRCT

119

91

Eating disorders

CGI Scale

83%

0%

Neurometric subgroups in Suffin, S, et al., Journal of Attentional and Affective Disorders Clinical and their association with Electroencephalography, 1995 pharmacotherapeutic outcome

nRCT

103

100

Attention deficit disorders and affective disorders

CGI Scale

68%

22%

2b

PEER Online (rEEG) Retrospective Clinical Studies

The results suggest that non-psychotic psychiatric patients in an outpatient setting, most of whom were treatment resistant, demonstrated significant improvement on a global clinical scale and quality of life questionnaire, reached MMI quickly and with fewer incidents of suicidality. In addition, 59% of previous medications causing a severe adverse event would have raised as a caution had the PEER Online outcome report Patients whose EEG data was used for clinical treatment reported significant decreases in associated depressive symptoms (HDRS scores), overall severity of illness (Clinical Global Impression-Severity), and overall clinical global improvement (Clinical Global ImpressionImprovement). This cohort also reported fewer inpatient, residential, and partial hospitalization program days following referenced-EEG compared with rEEG guided medication predictions resulting in improvements with depression and eating disorder symptoms in treatment refractory patients that had required either partial, residential, or inpatient level of care. At 6 months, all patients were rated as 'much improved' or 'very much improved' on the CGI scale. Seventy-seven (77) dualy diagnosed subjects were treated pharmacologically based upon rEEG guidance in a variety of residential and outpatient settings as per standard clinical care at these sites. Overall, 79% of patients were rated as 'much improved' to 'very much improved'. Of the 4 subjects, one subject with a diagnosis of bipolar and MDD had an exceptional response to the medication suggested by rEEG. The other 3 subjects dramatically improved during the medication washout required for their rEEG and elected to remain off medication with their positive responses maintained for 6 months to 1 Fifty-eight (58) dually diagnosed patients in a residentail substance abuse treatment program were treated following rEEG guidance. Overall, 54 of the 58 patients (92%) were rated as 'much improved' to 'very much improved'. From 5 clinical sites, 247 subjects were treated following rEEG guidance and 182 (74%) of the treated subjects were rated as being 'much improved' or 'very much improved'.

Hoffman D, DeBattista C, Valuck R, Iosifescu D, Neuropsychiatric Disease and Treatment, 2012

Measuring severe adverse events and medication selection using a "PEER Retrospective Report" for nonpsychotic patients: a Chart Review retrospective chart review

435

230

Nonpsychotic behavioral disorders

CGI scale, Q-LES-Q scores, & Suicidality

87%

Retrospective chart review of a Greenblatt, J, et al., referenced EEG database in assisting Retrospective Neuropsychiatric Disease and medication selection for treatment Chart Review Treatment. 2011 of depression in patients with eating disorders

33

22

TRD & bipolar HDRS scores patients with and CGI eating scale disorders

91%

PEER Online (rEEG) Open Label Case Series

EEG Guided medication predictions in treatment refractory eating Greenblatt, J, American disorder patients with comorbid Psychiatric Association annual depression: Opportunities for meeting, Poster, 2008 personalized medicine in managed healthcare Schiller, M., College on Referenced-EEG -Guided Problems of Drug Dependence pharmacotherapy of dual diagnosis Annual Meeting, Poster. 2008 patients Eating disorder patients c/ comorbid depression Dually diagnosed substance abuse patients

Open Label Case Series

16

13

HDRS and CGI Scale

100%

Open Label Case Series

77

77

CGI Scale

79%

Hoffman, D. Case study; Journal of Neurotherapy, 2006

First, do no harm - A Basic Tenet in Jeopardy?

Open Label Case Series

Treatment Resistant nonpsychotic CGI Scale behavioral disorders Nonpsychotic DSM IV diagnosis Nonpsychotic DSM IV diagnosis

100%

Shaffer, J., et al., American Psychiatric Association meeting. Poster, 2005

rEEG-Guided pharmacotherapy for severely ill, dually diagnosed patients

Open Label Case Series

58

58

CGI Scale

92%

Schiller, M, et al., American Psychiatric Association meeting, Poster, 2005

EEG guidance of psychopharmacologic treatment: muliti-site experience

Open Label Case Series

247

247

CGI Scale

74%

DB-RCT = double blind, randomized contolled trial SB-RCT = single blind, randomized controlled trial nRCT = non-randomized, controlled trial