Table 2: Characteristics and Evidence Levels for PEER (referenced-EEG)

Author/Publication

Publication Title

Type of Study

Number of Subjects Evaluable/ Enrolled/ Patient Analyzabl Qualified Population e

Responders Primary Endpoint PEER Control Summary/Results Evidence Level

PEER Online (rEEG) Controlled Clinical Trials

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 electroencephalographybased 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.

DeBattista, C, et al., Journal The use of Referenced-EEG (rEEG) of Psychiatric Research, in assisting medication selection 2010 for the treatment of depression

SB-RCT

114

89

Treatment QIDS-SR16; Resistant Q-LES-Q-SF Depression

65%

39%

1b

Review of current results in the use of Referenced-EEG in the DeBattista, C, et al., NCDEU guidance of psychotropic Poster, 2009 medication selection for treatmentresistant depressed patients

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

A QEEG Database Method for Predicting Pharmacotherapeutic Outcome in Refractory major Depressive Disorders

DB-RCT

13

13

Treatment Ham-D, BDI Resistant scores & Depression 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%

Suffin, S, et al., Journal of Clinical Electroencephalography, 1995

Neurometric subgroups in Attentional and Affective Disorders and their association with 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 been available at the time the drug was prescribed. 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 the two-year period prior to treatment.

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

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

Retrospective Chart Review

435

230

Nonpsychotic behavioral disorders

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

87%

Greenblatt, J, et al., Neuropsychiatric Disease and Treatment. 2011

Retrospective chart review of a referenced EEG database in assisting medication selection for treatment of depression in patients with eating disorders

Retrospective Chart Review

33

22

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

91%

PEER Online (rEEG) Open Label Case Series

Greenblatt, J, American Psychiatric Association annual meeting, Poster, 2008 EEG Guided medication predictions in treatment refractory eating disorder patients with Open Label comorbid depression: Case Series Opportunities for personalized medicine in managed healthcare Referenced-EEG -Guided pharmacotherapy of dual diagnosis patients Eating disorder patients c/ comorbid depression Dually diagnosed substance abuse patients Treatment Resistant nonpsychotic behavioral disorders Nonpsychotic DSM IV diagnosis
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 year. 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'.

16

13

HDRS and CGI Scale

100%

Schiller, M., College on Problems of Drug Dependence Annual Meeting, Poster. 2008

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

CGI Scale

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 EEG guidance of Psychiatric Association psychopharmacologic treatment: meeting, Poster, 2005 muliti-site experience

Open Label Case Series

247

247

Nonpsychotic DSM IV diagnosis

CGI Scale

74%

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'.

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

Updated: 17-July 2012