The active arm - where patients will receive genetically-guided treatment

TAU is the control arm - where patients will continue to receive their usual treatment as before.

Psychiatric Disorders

Pain

Psychiatric patients in this experimental arm will receive genetically-guided treatment with psychotropic medications

Genetically-guided treatment with FDA-approved psychotropic drugs

All subjects assigned to TAU group, which is the control arm, will continue to receive FDA-approved psychotropic medications for psychiatric indications investigated in this study

Treatment as usual (TAU)

Mujeeb Uddin Shad

Clinical Utility of Pharmacogenomics of Psychotropic Medications

PANSS is one of the most widely clinical scales to monitor positive and negative symptoms of schizophrenia. The scores range from 30 to 210. A score of 58 is considered mildly ill; 75 is moderately ill and 95 is markedly ill; and 116 is severely ill. This study will only use the scores from positive subscale (range 7 to 49) and the eligibility criteria will require a moderate score on 4 positive sub-scale items, including hallucinations, delusions, suspiciousness and conceptual disorganization to qualify for the study.

This scale assesses level of pain-related disability, psychological distress, and pain intensity. 0 - 3 = minimal levels of average pain intensity; 4 - 6 = moderate levels of average pain intensity; 7 - 10 = severe levels of average pain intensity.

This is a scale to assess severity of anxiety symptoms. Total score=21; 5-9 = Mild; 10-14 = Moderate; >15 = Severe
*For Panic Disorder, Social Phobia, & PTSD, cutoff score of 8 may be used for optimal sensitivity/specificity (see Evidence section).
Critical Actions
This tool should be used for screening and monitoring symptom severity and cannot replace a clinical assessment and diagnosis.
Do not forget to rule out medical causes of anxiety before diagnosing an anxiety disorder (for example, EKG for arrhythmias, TSH for thyroid disease).

This is a commonly used scale in clinical practice to assess depressive symptoms. The total score is 36. Score of 0-4 = Minimal or no depressive symptoms; 5-9 = Mild symptoms; 10-14 = moderate symptoms; 15-19 = Moderately severe symptoms; 20-27 = severe symptoms.

CGI-S will be used to assess severity o illness at baseline. The total score ranges from 0 to 7, where 0 is not assessed; 3 is mildly ill; 5 is markedly ill; and 7 is most extensively ill. While CGI-I is is scored from 0 to 7, where 0 is not assessed; 1 is very much improved; 3 is minimally improved; 5 is minimally worse and 7 is very much worse.

This is a 30-item questionnaire, comprising three scales ('psychosocial', 'motivation and energy', and 'symptoms and side-effects') addressing different SQLS dimensions. Each quality of life item is scored from 0 to 4, where 0 is not assessed, 1 is rare; 2 is sometimes, 3 is often and 4 is frequently. The score can range from 0 to 120, where higher scores reflect lower quality of life.

SOFAS focuses exclusively on the individual's level of social and occupational functioning and is not directly influenced by the overall severity of the individual's psychological symptoms. It is scored from 0 to 100, where 100 = Superior functioning in a wide range of activities; 80 = No more than a slight impairment in social, occupational, or school functioning (e.g., infrequent interpersonal conflict, temporarily falling behind in schoolwork); 60 is Moderate difficulty in social, occupational, or school functioning (e.g., few friends, conflicts with peers or co-workers); 40 = Major impairment in several areas, such as work or school, family relations; and 20 = Occasionally fails to maintain minimal personal hygiene; unable to function independently.

The AIMS is a 12-item clinician-rated scale to assess severity of EPS, especially dyskinesias in patients taking neuroleptic medications. It also assesses overall severity, incapacitation, and the patient's level of awareness of the movements, and distress associated with them. Items are scored on a 0 (none) to 4 (severe) basis; the scale provides a total score (items 1 through 7) or item 8 can be used in isolation as an indication of overall severity of symptoms.

USERS is a comprehensive scale to assess side effects from medications. It is composed of several sub-scales but in this study we will only use the sub-scales that are frequently associated with neuroleptic medications i.e., psychic (10 items), neurologic (8 items) and autonomic (11 items). Each item is scores as 9, 0, 1, 2 and 3, the higher number represents a subjectively reported increase in frequency of respective side effect.

Mujeeb U Shad, MD, MSCS

Associate Professor of Psychiatry

Oregon Health and Science University

This is a randomized prospective cohort study which will compare the utility of an interpretive report based on pharmacogenomic testing between study subjects receiving psychotropic medication with guidance from an interpretive report (i.e., Genetically-Guided Group) and those receiving psychotropic medications without the implementation of the interpretive report (Genetically-Unguided Group).

The study raters will be kept blinded to the two arms of the study to avoid assessment bias.

Movement Disorders

The imaging study will use a block design to (i) optimize amygdala activation to emotionally balanced images, (ii) to optimize analysis of PPI and (iii) to optimize the go/notask design. G. T2- sensitive functional images will be obtained on a MRI system with a 1.5 Tesla superconducting magnet and a standard head coil. An echo planar image sequence (TR=2500msec, TE=33 msec, 90 flip angle) with 30 contiguous 2mm thick coronal oblique slices with 1 mm interslice gap centered over the amygdala, tilted 30 to the anterior, to improve susceptibility artifact. Three dimensional anatomical images will be taken for the co-registration of the functional images.

National Institutes of Health Clinical Center, 9000 Rockville Pike

Rhode Island Hospital

Neurobiology of Functional Movement Disorder and Non-Epileptic Seizures

Neurobiological Studies of Functional Movement Disorders and Non-Epileptic Seizures

fMRI BOLD signal change focusing on regions of interest during emotional valence task

The S/S genotype of the 5HTTLPR polymorphism

catechol/seizures

Clinical Utility of Pharmacogenomics of Psychotropic Medications

Neurobiology of Functional Movement Disorder and Non-Epileptic Seizures

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