Informed Consent
Item
1. written informed consent
boolean
C0021430 (UMLS CUI [1])
DEPRESSIVE DISORDER MAJOR WITH PSYCHOTIC FEATURE
Item
2. diagnosis of major depressive disorder with psychotic features by the dsm-iv
boolean
C0743080 (UMLS CUI [1])
Age
Item
3. females and males between the ages of 18-85 years.
boolean
C0001779 (UMLS CUI [1])
Childbearing Potential Contraceptive methods | Childbearing Potential Urine pregnancy test negative HCG
Item
4. female patients of childbearing potential must be using a reliable method of contraception and have a negative urine human chorionic gonadotropin (hcg) test at enrolment
boolean
C3831118 (UMLS CUI [1,1])
C0700589 (UMLS CUI [1,2])
C3831118 (UMLS CUI [2,1])
C0430057 (UMLS CUI [2,2])
C1141639 (UMLS CUI [2,3])
Protocol Compliance
Item
5. able to understand and comply with the requirements of the study
boolean
C0525058 (UMLS CUI [1])
Hamilton Depression Rating Scale 17 Item Clinical Classification Initial
Item
6. initial ham-d-17 score of > 16, both at the screen visit and at the baseline visit.
boolean
C3639712 (UMLS CUI [1,1])
C0205265 (UMLS CUI [1,2])
Brief Psychiatric Rating Scale Initial
Item
7. participants must have an initial bprs score of > 25 and at least one of the following: > 5 for item 1, > 5 for item 5, > 5 for item 8, > 4 for item 9, > 1 for item 10, > 1 for item 11; these bprs criteria msut be met both at the screen visit and at the baseline visit.
boolean
C0029941 (UMLS CUI [1,1])
C0205265 (UMLS CUI [1,2])
Clinical global impression scale Initial
Item
8. participants must have an initial cgi score of > 2, both at the screen visit and at the baseline visit.
boolean
C3639708 (UMLS CUI [1,1])
C0205265 (UMLS CUI [1,2])
Pregnancy | Breast Feeding
Item
1. pregnancy or lactation
boolean
C0032961 (UMLS CUI [1])
C0006147 (UMLS CUI [2])
Axis I diagnosis | Exception Inclusion criteria
Item
2. any dsm-iv axis i disorder not defined in the inclusion criteria
boolean
C0270287 (UMLS CUI [1])
C1705847 (UMLS CUI [2,1])
C1512693 (UMLS CUI [2,2])
At risk for suicide | DANGER OF HARM TO SELF | Risk of violence or harm to others
Item
3. patients who, in the opinion of the investigator, pose an imminent risk of suicide or a danger to self or others
boolean
C0563664 (UMLS CUI [1])
C0149660 (UMLS CUI [2])
C0549013 (UMLS CUI [3])
Intolerance to Quetiapine fumarate | Response Lacking Quetiapine fumarate
Item
4. known intolerance or lack of response to quetiapine fumarate, as judged by the investigator
boolean
C1744706 (UMLS CUI [1,1])
C0724680 (UMLS CUI [1,2])
C1704632 (UMLS CUI [2,1])
C0332268 (UMLS CUI [2,2])
C0724680 (UMLS CUI [2,3])
Cytochrome P-450 CYP3A4 Inhibitors | Ketoconazole | Itraconazole | Fluconazole | Erythromycin | Clarithromycin | Troleandomycin | Indinavir | Nelfinavir | Ritonavir | Fluvoxamine | Saquinavir
Item
5. use of any of the following cytochrome p450 3a4 inhibitors in the 14 days preceding enrolment including but not limited to: ketoconazole, itraconazole, fluconazole, erythromycin, clarithromycin, troleandomycin, indinavir, nelfinavir, ritonavir, fluvoxamine and saquinavir
boolean
C3850053 (UMLS CUI [1])
C0022625 (UMLS CUI [2])
C0064113 (UMLS CUI [3])
C0016277 (UMLS CUI [4])
C0014806 (UMLS CUI [5])
C0055856 (UMLS CUI [6])
C0041165 (UMLS CUI [7])
C0376637 (UMLS CUI [8])
C0525005 (UMLS CUI [9])
C0292818 (UMLS CUI [10])
C0085228 (UMLS CUI [11])
C0286738 (UMLS CUI [12])
Cytochrome P450 3A4 Inducer | Phenytoin | Carbamazepine | Barbiturates | Rifampin | Hypericum perforatum | Glucocorticoids
Item
6. use of any of the following cytochrome p450 inducers in the 14 days preceding enrollment including but not limited to: phenytoin, carbamazepine, barbiturates, rifampin, st. john's wort, and glucocorticoids
boolean
C3830625 (UMLS CUI [1])
C0031507 (UMLS CUI [2])
C0006949 (UMLS CUI [3])
C0004745 (UMLS CUI [4])
C0035608 (UMLS CUI [5])
C0936242 (UMLS CUI [6])
C0017710 (UMLS CUI [7])
Injection of depot antipsychotic agent
Item
7. administration of a depot antipsychotic injection within one dosing interval (for the depot) before randomization
boolean
C2585377 (UMLS CUI [1])
Substance Dependence | Exception Dependence Remission | Exception Caffeine dependence | Exception Nicotine Dependence
Item
8. substance or alcohol dependence within the past three months (except dependence in full remission, and except for caffeine or nicotine dependence), as defined by dsm-iv criteria
boolean
C0038580 (UMLS CUI [1])
C1705847 (UMLS CUI [2,1])
C0038580 (UMLS CUI [2,2])
C0544452 (UMLS CUI [2,3])
C1705847 (UMLS CUI [3,1])
C1386553 (UMLS CUI [3,2])
C1705847 (UMLS CUI [4,1])
C0028043 (UMLS CUI [4,2])
Opioid abuse | Amphetamine Abuse | Barbiturate abuse | Cocaine Abuse | Cannabis Abuse | Hallucinogen abuse
Item
9. opiates, amphetamine, barbiturate, cocaine, cannabis, or hallucinogen abuse by dsm-iv criteria within 4 weeks prior to enrolment
boolean
C0029095 (UMLS CUI [1])
C0236807 (UMLS CUI [2])
C0338700 (UMLS CUI [3])
C0009171 (UMLS CUI [4])
C0006868 (UMLS CUI [5])
C0018526 (UMLS CUI [6])
Medical condition Affecting Absorption Investigational New Drugs | Medical condition Affecting Distribution Investigational New Drugs | Medical condition Affecting Metabolism Investigational New Drugs | Medical condition Affecting Excretion Investigational New Drugs
Item
10. medical conditions that would affect absorption, distribution, metabolism, or excretion of study treatment
boolean
C3843040 (UMLS CUI [1,1])
C0392760 (UMLS CUI [1,2])
C0237442 (UMLS CUI [1,3])
C0013230 (UMLS CUI [1,4])
C3843040 (UMLS CUI [2,1])
C0392760 (UMLS CUI [2,2])
C1378698 (UMLS CUI [2,3])
C0013230 (UMLS CUI [2,4])
C3843040 (UMLS CUI [3,1])
C0392760 (UMLS CUI [3,2])
C0025520 (UMLS CUI [3,3])
C0013230 (UMLS CUI [3,4])
C3843040 (UMLS CUI [4,1])
C0392760 (UMLS CUI [4,2])
C0683141 (UMLS CUI [4,3])
C0013230 (UMLS CUI [4,4])
Illness Unstable | Illness Treated Inadequate | Diabetes Mellitus | Angina Pectoris | Hypertensive disease
Item
11. unstable or inadequately treated medical illness (e.g. diabetes, angina pectoris, hypertension) as judged by the investigator
boolean
C0221423 (UMLS CUI [1,1])
C0443343 (UMLS CUI [1,2])
C0221423 (UMLS CUI [2,1])
C1522326 (UMLS CUI [2,2])
C0205412 (UMLS CUI [2,3])
C0011849 (UMLS CUI [3])
C0002962 (UMLS CUI [4])
C0020538 (UMLS CUI [5])
Involvement Clinical Trial Planning | Involvement Completion of clinical trial
Item
12. involvement in the planning and conduct of the study
boolean
C1314939 (UMLS CUI [1,1])
C0008976 (UMLS CUI [1,2])
C1301732 (UMLS CUI [1,3])
C1314939 (UMLS CUI [2,1])
C2732579 (UMLS CUI [2,2])
Study Subject Participation Status | Randomization Therapeutic procedure
Item
13. previous enrolment or randomization of treatment in the present study.
boolean
C2348568 (UMLS CUI [1])
C0034656 (UMLS CUI [2,1])
C0087111 (UMLS CUI [2,2])
Study Subject Participation Status
Item
14. participation in another drug trial within 4 weeks prior enrollment into this study or longer in accordance with local requirements
boolean
C2348568 (UMLS CUI [1])
Diabetes Mellitus | Criteria Fulfill
Item
15. a patient with diabetes mellitus (dm) fulfilling one of the following criteria:
boolean
C0011849 (UMLS CUI [1])
C0243161 (UMLS CUI [2,1])
C1550543 (UMLS CUI [2,2])
Diabetes Mellitus Unstable | Hemoglobin A1c measurement
Item
unstable dm defined as enrollment glycosylated hemoglobin (hba1c) > 8.5%.
boolean
C0011849 (UMLS CUI [1,1])
C0443343 (UMLS CUI [1,2])
C0474680 (UMLS CUI [2])
Hospital admission | Therapeutic procedure Diabetes Mellitus | Therapeutic procedure Illness Relationship Diabetes Mellitus
Item
admitted to hospital for treatment of dm or dm related illness in past 12 weeks.
boolean
C0184666 (UMLS CUI [1])
C0087111 (UMLS CUI [2,1])
C0011849 (UMLS CUI [2,2])
C0087111 (UMLS CUI [3,1])
C0221423 (UMLS CUI [3,2])
C0439849 (UMLS CUI [3,3])
C0011849 (UMLS CUI [3,4])
Under care of doctor Diabetes Mellitus
Item
not under physician care for dm.
boolean
C0583348 (UMLS CUI [1,1])
C0011849 (UMLS CUI [1,2])
Diabetic - poor control
Item
physician responsible for patient's dm care has not indicated that patient's dm is controlled.
boolean
C0421258 (UMLS CUI [1])
Study Subject Participation Status Approval Lacking
Item
physician responsible for patient's dm care has not approved patient's participation in the study
boolean
C2348568 (UMLS CUI [1,1])
C0205540 (UMLS CUI [1,2])
C0332268 (UMLS CUI [1,3])
Oral hypoglycemic Dose Changed | Diet Dose Changed | Thiazolidinediones
Item
has not been on the same dose of oral hypoglycaemic drug(s) and/or diet for the 4 weeks prior to randomization. for thiazolidinediones (glitazones) this period should not be less than 8 weeks.
boolean
C0359086 (UMLS CUI [1,1])
C0178602 (UMLS CUI [1,2])
C0392747 (UMLS CUI [1,3])
C0012159 (UMLS CUI [2,1])
C0178602 (UMLS CUI [2,2])
C0392747 (UMLS CUI [2,3])
C1257987 (UMLS CUI [3])
Insulin Dose Abnormal Quantity
Item
taking insulin whose daily dose on one occasion in the past 4 weeks has been more than 10% above or below their mean dose in the preceding 4 weeks
boolean
C0021641 (UMLS CUI [1,1])
C0178602 (UMLS CUI [1,2])
C0205161 (UMLS CUI [1,3])
C1265611 (UMLS CUI [1,4])
Absolute neutrophil count
Item
16. an absolute neutrophil count (anc) of 1.5 x 10^9 per liter
boolean
C0948762 (UMLS CUI [1])
Epilepsy | Physical illness Unstable | Cardiovascular Diseases | Liver diseases | Kidney Diseases | Respiration Disorders | Endocrine System Diseases | Nervous system disorder | Hematological Disease | Physical illness Affecting Central nervous system function
Item
17. patients with a history seizure disorder; unstable physical disorders (cardiovascular, hepatic, renal, respiratory, endocrine, neurologic, or hematologic); or any physical disorder judged to significantly affect central nervous system function.
boolean
C0014544 (UMLS CUI [1])
C0683323 (UMLS CUI [2,1])
C0443343 (UMLS CUI [2,2])
C0007222 (UMLS CUI [3])
C0023895 (UMLS CUI [4])
C0022658 (UMLS CUI [5])
C0035204 (UMLS CUI [6])
C0014130 (UMLS CUI [7])
C0027765 (UMLS CUI [8])
C0018939 (UMLS CUI [9])
C0683323 (UMLS CUI [10,1])
C0392760 (UMLS CUI [10,2])
C0683212 (UMLS CUI [10,3])
Antidepressive Agents | Exception Selective Serotonin Reuptake Inhibitors | Mood Stabilizer | Antipsychotic Agents | Exception Quetiapine
Item
18. patients who are currently treated with antidepressants other than the selective serotonin reuptake inhibitors, with mood stabilizing or antipsychotic drugs other than quetiapine.
boolean
C0003289 (UMLS CUI [1])
C1705847 (UMLS CUI [2,1])
C0360105 (UMLS CUI [2,2])
C2917435 (UMLS CUI [3])
C0040615 (UMLS CUI [4])
C1705847 (UMLS CUI [5,1])
C0123091 (UMLS CUI [5,2])
Cardiac Arrhythmia | Cardiac Arrhythmia Screening ECG
Item
19. patients with known arrhythmias or arrhythmias noted on screening ekg.
boolean
C0003811 (UMLS CUI [1])
C0003811 (UMLS CUI [2,1])
C0220908 (UMLS CUI [2,2])
C0013798 (UMLS CUI [2,3])
Outpatients | Clinical global impression scale
Item
20. outpatients with a cgi score of 7.
boolean
C0029921 (UMLS CUI [1])
C3639708 (UMLS CUI [2])