Age | Severe Depressive disorder major without psychotic feature
Item
male or female patients of ≥ 18 years of age that meet criteria for severe major depressive disorder, without psychotic features (according to diagnostic and statistical manual of mental disorders fourth edition, [dsm-iv] and confirmed by mini international neuropsychiatric interview [mini]).
boolean
C0001779 (UMLS CUI [1])
C0743081 (UMLS CUI [2,1])
C0205082 (UMLS CUI [2,2])
Hamilton rating scale for depression | CGI - Severity of Illness
Item
with a total score montgomery-asberg depression rating scale (madrs) ≥ 30 and 6-item hamilton depression rating scale (hamd-6) ≥ 12 and clinical global impression of severity (cgi-severity) ≥ 4 at both screening and baseline.
boolean
C0451203 (UMLS CUI [1])
C3639887 (UMLS CUI [2])
Hospitalization Required
Item
requirement of hospitalization (not for social or other non-medical reasons) at screening visit and at least up to visit 4.
boolean
C1708385 (UMLS CUI [1])
Protocol Compliance
Item
patients willing and able to comply with the requirement for hospitalization and with all scheduled visits, tests and procedures required by the protocol.
boolean
C0525058 (UMLS CUI [1])
Informed Consent
Item
informed consent document must be signed at screening visit, in accordance with good clinical practice (gcp) and local regulatory requirements, prior to any study procedure.
boolean
C0021430 (UMLS CUI [1])
Major depressive episode Quantity | Antidepressive Agents Dosage | Therapeutic procedure Quantity Unresponsive to Treatment
Item
more than two previous episodes of major depression that did not respond (according to investigator's opinion) to adequate doses and duration of two different antidepressant therapies.
boolean
C0024517 (UMLS CUI [1,1])
C1265611 (UMLS CUI [1,2])
C0003289 (UMLS CUI [2,1])
C0178602 (UMLS CUI [2,2])
C0087111 (UMLS CUI [3,1])
C1265611 (UMLS CUI [3,2])
C0205269 (UMLS CUI [3,3])
Depressive episode | Antidepressive Agents Dosage | Therapeutic procedure Quantity Unresponsive to Treatment
Item
lack of response to at least two antidepressant therapies given at adequate doses for at least 6 weeks for the current depressive episode.
boolean
C0349217 (UMLS CUI [1])
C0003289 (UMLS CUI [2,1])
C0178602 (UMLS CUI [2,2])
C0087111 (UMLS CUI [3,1])
C1265611 (UMLS CUI [3,2])
C0205269 (UMLS CUI [3,3])
Symptoms Axis I diagnosis | Exception Anxiety Disorders | Exception Obsessive-Compulsive Disorder | Exception Major Depressive Disorder
Item
concurrent presence of symptoms fulfilling criteria for any axis i disorder other than anxiety disorders (with exception of the obsessive-compulsive disorder (ocd)) or major depressive disorder, in the investigator's judgment.
boolean
C1457887 (UMLS CUI [1,1])
C0270287 (UMLS CUI [1,2])
C1705847 (UMLS CUI [2,1])
C0003469 (UMLS CUI [2,2])
C1705847 (UMLS CUI [3,1])
C0003469 (UMLS CUI [3,2])
C1705847 (UMLS CUI [4,1])
C0028768 (UMLS CUI [4,2])
C1705847 (UMLS CUI [5,1])
C1269683 (UMLS CUI [5,2])
Bipolar Disorder | Schizophrenia | Obsessive-Compulsive Disorder
Item
any previous diagnosis of a bipolar disorder, schizophrenia or ocd.
boolean
C0005586 (UMLS CUI [1])
C0036341 (UMLS CUI [2])
C0028768 (UMLS CUI [3])
Depressive disorder Feature Catatonic | Depression, Postpartum | Organic mental disorders
Item
depression with catatonic features (according to dsm-iv), depression with post-partum onset, or organic mental disorders.
boolean
C0011581 (UMLS CUI [1,1])
C2348519 (UMLS CUI [1,2])
C0007398 (UMLS CUI [1,3])
C0221074 (UMLS CUI [2])
C0029227 (UMLS CUI [3])
Axis II diagnosis
Item
the presence of an axis ii disorder
boolean
C0270288 (UMLS CUI [1])