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.

Syntocinon Spray 3-4 doses daily inpatient; 2 daily doses outpatient for 12 weeks intranasal oxytocin spray. Inpatient Withdrawal

Intranasal Oxytocin Spray (Syntocinon)

Placebo spray 3-4 doses daily inpatient; 2 daily doses outpatient for 12 weeks intranasal placebo spray. Inpatient Withdrawal

Intranasal Placebo Spray

2 daily doses intranasal oxytocin spray for 12 weeks

Outpatient Treatment Intranasal Oxytocin Spray (Syntocinon)

2 daily doses intranasal placebo spray for 12 weeks

Outpatient Treatment Placebo Spray

Total

Sex: Female, Male

Ethnicity (NIH/OMB)

Race (NIH/OMB)

Region of Enrollment

The Clinical Institute Withdrawal Assessment for Alcohol (CIWA) measure is a ten item measure of alcohol withdrawal symptoms. The CIWA total score is the summation of 10 questions, with a range from 0 (little to no withdrawal) to 67 (worse alcohol withdrawal).

Clinical Institute Withdrawal Assessment for Alcohol (CIWA)

Syntocinon Spray 3-4 doses daily inpatient
intranasal oxytocin spray: Administration of oxytocin in a nasal spray

Intranasal Oxytocin Spray (Syntocinon Spray)

Placebo spray 3-4 doses daily inpatient
intranasal oxytocin spray: Administration of oxytocin in a nasal spray
Intranasal Placebo Spray: Intranasal Placebo Spray

Change in Clinical Institute Withdrawal Assessment for Alcohol (CIWA) Score

Cumulative lorazepam received (2 mg doses)
After initiation of test treatments, CIWA scores and vital signs were obtained every 4 hours or whenever subjects or staff reported/observed significant increases in symptoms. Lorazepam (2 mg dose) was given if CIWA scores were >7, diastolic blood pressure rose to >120, or heart rate rose to >110. An additional 2 mg was given 1 hour after each lorazepam dose if CIWA scores and/or vital signs remained elevated.

Syntocinon Spray 3-4 doses daily inpatient

Total mg of Lorazepam for Detoxification

A heavy drinking day is defined by consumption of 5 or more standard drinks for men, 4 or more standard drinks for women. The outcome measure is the change in percentage of heavy drinking days as determine by the Timeline Followback interview between the baseline 90 day period and the first 4 weeks of intranasal test treatment in the outpatient setting.

Change in Percentage Heavy Drinking Days

Syntocinon Spray 3-4 doses daily inpatient; 2 daily doses outpatient for 12 weeks.
Inpatient Withdrawal

Active Comparator:Intranasal Oxytocin Spray (Syntocinon Spray)

Placebo spray 3-4 doses daily inpatient; 2 daily doses outpatient for 12 weeks Inpatient Withdrawal

Placebo Comparator: Intranasal Placebo Spray

Inpatient Withdrawal

Outpatient Drinking

Dr. Cort A. Pedersen

Syntocinon Spray 3-4 doses daily inpatient; 2 daily doses outpatient for 12 weeks
intranasal oxytocin spray: Administration of oxytocin in a nasal spray

Placebo spray 3-4 doses daily inpatient; 2 daily doses outpatient for 12 weeks
intranasal oxytocin spray: Administration of oxytocin in a nasal spray
Intranasal Placebo Spray: Intranasal Placebo Spray

Alcohol Withdrawal

Alcohol Dependence

Administration of oxytocin in a nasal spray

intranasal oxytocin spray

Oxytocin Treatment of Alcohol Dependence

Oxytocin Treatment of Alcohol Dependence: A Randomized, Placebo-Controlled Trial

Cort Pedersen, MD

Principal Investigator

University of North Carolina, Chapel Hill

Women in their first trimester of pregnancy who are not diagnosed with epilepsy

Women diagnosed with epilepsy and not currently pregnant.

Women in their first trimester of pregnancy and diagnosed with epilepsy

Epilepsy

Pregnancy

University of Alabama Birmingham Hospital- UAB

University of Arizona - University Medical Center

Keck Hospital of the University of Southern California

Stanford University

University of Miami Hospital - University of Miami School of Medicine

Emory University School of Medicine

Medical College of Georgia at Georgia Regents University

Northwestern Memorial Hospital-Northwestern University Feinberg School of Medicine

John Hopkins Bayview Medical Center

Brigham & Women's Hospital - Harvard

Henry Ford Hospital

Minnesota Epilepsy Group

North Shore Jewish Medical Center

New York University School of Medicine

Columbia University Medical Center/NY Presbyterian Hospital

Wake Forest Baptist Health-Wake Forest University School of Medicine

University of Cincinnati UC Health University Hospital

Geisinger Medical Center

University of Pittsburgh Medical Center

University of Washington Medical Center

Maternal and Neurodevelopmental Outcomes of in Utero Antiepileptic Drug (AED) Exposure

Maternal Outcomes and Neurodevelopmental Effects of Antiepileptic Drugs

Change in seizure frequency during pregnancy vs postpartum as measured by subject completed daily electronic seizure diaries

rate of C-sections in pregnant women without epilepsy vs pregnant women with epilepsy

Rate of depression during pregnancy in pregnant women with epilepsy vs pregnant women without epilepsy screened by the Beck Depression Inventory and confirmed by the Structured Clinical Interview for Diagnostic and Statistical Manual-IV.

Child verbal intellectual ability as measured by the Language Scale of the Bayley Scales of Infant Development -III at visit 9 (2Yo) and by the Differential Abilities Scale-II at visit 10 (3Yo)and 4.5YO and 6YO.

Rate of children considered small for gestational age (<10%tile)born to women with epilepsy vs women without epilepsy

Measuring difference in verbal intellectual ability in breastfed children vs non-breastfed children born to women on aeds via the Bayley Scales of Infant Development III Language scale at 2 years of age and Differential Abilities Scale III at 3, 4.5 and 6 Years of age.

folate/seizures

Clinical Utility of Pharmacogenomics of Psychotropic Medications

Oxytocin Treatment of Alcohol Dependence

Maternal and Neurodevelopmental Outcomes of in Utero Antiepileptic Drug (AED) Exposure

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