Informed Consent
Item
ability and willingness to provide written informed consent.
boolean
C0021430 (UMLS CUI [1])
Major Depressive Disorder Principal diagnosis | Initial insomnia
Item
primary diagnosis of mdd with initial insomnia.
boolean
C1269683 (UMLS CUI [1,1])
C0332137 (UMLS CUI [1,2])
C0393760 (UMLS CUI [2])
Age
Item
age 18-70.
boolean
C0001779 (UMLS CUI [1])
Hamilton Depression Rating Scale 17 Item Questionnaire | CGI - Severity of Illness
Item
screening hrsd17 score greater than or equal to 16 or cgi-s score of at least 4.
boolean
C3639712 (UMLS CUI [1])
C3639887 (UMLS CUI [2])
Initial insomnia Difficulty with | Questionnaire Symptoms Depressive disorder | Middle insomnia | Late insomnia
Item
subjective report of difficulties with initial insomnia with a score of 2 or greater on the ids-c30 item addressing this symptom (#1). middle and late insomnia may also be present so long as initial insomnia is present.
boolean
C0393760 (UMLS CUI [1,1])
C0332218 (UMLS CUI [1,2])
C0034394 (UMLS CUI [2,1])
C0683368 (UMLS CUI [2,2])
C0011581 (UMLS CUI [2,3])
C0393761 (UMLS CUI [3])
C0581874 (UMLS CUI [4])
Comorbidity | Sleep Apnea Severe | Epilepsy | Chronic Obstructive Airway Disease
Item
presence of significant comorbid medical condition based on laboratory test, physician information, or evidence at examination; this includes severe sleep apnea, seizure disorder, or chronic obstructive pulmonary disease (copd).
boolean
C0009488 (UMLS CUI [1])
C0037315 (UMLS CUI [2,1])
C0205082 (UMLS CUI [2,2])
C0014544 (UMLS CUI [3])
C0024117 (UMLS CUI [4])
Abnormality Physical Examination | Abnormality Laboratory Procedures | Sleep Apnea Severe | Epilepsy | Chronic Obstructive Airway Disease
Item
patient report or evidence (based on physical examination or laboratory tests) of significant medical abnormalities; this includes severe sleep apnea, seizure disorder, or copd.
boolean
C1704258 (UMLS CUI [1,1])
C0031809 (UMLS CUI [1,2])
C1704258 (UMLS CUI [2,1])
C0022885 (UMLS CUI [2,2])
C0037315 (UMLS CUI [3,1])
C0205082 (UMLS CUI [3,2])
C0014544 (UMLS CUI [4])
C0024117 (UMLS CUI [5])
Psychological disorders other | Depressive disorder Due to Comorbidity | At risk for suicide | High suicide risk | Psychotic Disorders | Bipolar I disorder | Bipolar II disorder | Bipolar Disorder | Schizophrenia | Schizoaffective Disorder | Anorexia | Bulimia | Obsessive-Compulsive Disorder | Substance Use Disorders | Mental disorders | Medical contraindication Escitalopram | Medical contraindication ramelteon
Item
presence of other psychological disorders, including depression due to other comorbid conditions, currently suicidal or high suicide risk, current or past psychotic disorders of any type, bipolar disorder (i, ii, or nos), schizophrenia, or schizoaffective disorder, anorexia, bulimia, obsessive compulsive disorder, alcohol or substance abuse within the last 6 months, or patients with comorbid psychiatric conditions that are relative or absolute contraindications to the use of escitalopram or ramelteon.
boolean
C0497334 (UMLS CUI [1])
C0011581 (UMLS CUI [2,1])
C0678226 (UMLS CUI [2,2])
C0009488 (UMLS CUI [2,3])
C0563664 (UMLS CUI [3])
C1271074 (UMLS CUI [4])
C0033975 (UMLS CUI [5])
C0853193 (UMLS CUI [6])
C0236788 (UMLS CUI [7])
C0005586 (UMLS CUI [8])
C0036341 (UMLS CUI [9])
C0036337 (UMLS CUI [10])
C0003123 (UMLS CUI [11])
C0006370 (UMLS CUI [12])
C0028768 (UMLS CUI [13])
C0038586 (UMLS CUI [14])
C0004936 (UMLS CUI [15])
C1301624 (UMLS CUI [16,1])
C1099456 (UMLS CUI [16,2])
C1301624 (UMLS CUI [17,1])
C1565316 (UMLS CUI [17,2])
Pharmacotherapy | Fluoxetine | Monoamine Oxidase Inhibitors | Psychotherapy | Anti-Anxiety Agents | Antipsychotic Agents | Mood Stabilizers | Aid to Sleep | Melatonin Over The Counter | Cognitive Therapy | Medical contraindication ramelteon | Medical contraindication Escitalopram
Item
concomitant (i.e. within 2 weeks; 4 weeks for fluoxetine or maois) pharmacological or psychotherapeutic treatment including but not limited to anxiolytics, neuroleptics, mood stabilizers, sleep aids including over the counter melatonin, and/or other agents without proven antidepressant efficacy, cognitive behavioral therapy; current use of other medications that would be contraindicated with ramelteon or escitalopram,, as determined by the study doctor.
boolean
C0013216 (UMLS CUI [1])
C0016365 (UMLS CUI [2])
C0026457 (UMLS CUI [3])
C0033968 (UMLS CUI [4])
C0040616 (UMLS CUI [5])
C0040615 (UMLS CUI [6])
C4020582 (UMLS CUI [7])
C0718303 (UMLS CUI [8])
C0025219 (UMLS CUI [9,1])
C2709201 (UMLS CUI [9,2])
C0009244 (UMLS CUI [10])
C1301624 (UMLS CUI [11,1])
C1565316 (UMLS CUI [11,2])
C1301624 (UMLS CUI [12,1])
C1099456 (UMLS CUI [12,2])
SSRI Antidepressive Agents | Course Quantity failed
Item
failure to respond to 2 adequate courses of ssri class antidepressant in the current episode (as measured by the antidepressant treatment history form).
boolean
C0360105 (UMLS CUI [1,1])
C0003289 (UMLS CUI [1,2])
C0750729 (UMLS CUI [2,1])
C1265611 (UMLS CUI [2,2])
C0231175 (UMLS CUI [2,3])
psychiatric hospitalization
Item
hospitalization for mental illness within the past year.
boolean
C0748061 (UMLS CUI [1])
Pregnancy | Pregnancy, Planned | Breast Feeding
Item
for women, currently pregnant, planning to become pregnant in the next year, or breastfeeding.
boolean
C0032961 (UMLS CUI [1])
C0032992 (UMLS CUI [2])
C0006147 (UMLS CUI [3])
Able to speak English Language Lacking
Item
patient does not speak english. (patient needs to be fluent in written and oral english because not all assessments are available and/or validated in languages other than english).
boolean
C0564215 (UMLS CUI [1,1])
C0376245 (UMLS CUI [1,2])
C0332268 (UMLS CUI [1,3])