ID

30471

Description

A Study Evaluating Duloxetine in Patients Hospitalized for Severe Depression; ODM derived from: https://clinicaltrials.gov/show/NCT00422162

Link

https://clinicaltrials.gov/show/NCT00422162

Keywords

Versions (1)
  1. 6/6/18 6/6/18 -
Copyright Holder

See clinicaltrials.gov

Uploaded on

June 6, 2018

DOI

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License

Creative Commons BY 4.0
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Eligibility Major Depressive Disorder NCT00422162

English

Eligibility Major Depressive Disorder NCT00422162

1 forms  
Inclusion Criteria
Description

Inclusion Criteria

Alias
UMLS CUI
C1512693
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]).
Description

Age | Severe Depressive disorder major without psychotic feature

Data type

boolean

Alias
UMLS CUI [1]
C0001779
UMLS CUI [2,1]
C0743081
UMLS CUI [2,2]
C0205082
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.
Description

Hamilton rating scale for depression | CGI - Severity of Illness

Data type

boolean

Alias
UMLS CUI [1]
C0451203
UMLS CUI [2]
C3639887
requirement of hospitalization (not for social or other non-medical reasons) at screening visit and at least up to visit 4.
Description

Hospitalization Required

Data type

boolean

Alias
UMLS CUI [1]
C1708385
patients willing and able to comply with the requirement for hospitalization and with all scheduled visits, tests and procedures required by the protocol.
Description

Protocol Compliance

Data type

boolean

Alias
UMLS CUI [1]
C0525058
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.
Description

Informed Consent

Data type

boolean

Alias
UMLS CUI [1]
C0021430
Exclusion Criteria
Description

Exclusion Criteria

Alias
UMLS CUI
C0680251
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.
Description

Major depressive episode Quantity | Antidepressive Agents Dosage | Therapeutic procedure Quantity Unresponsive to Treatment

Data type

boolean

Alias
UMLS CUI [1,1]
C0024517
UMLS CUI [1,2]
C1265611
UMLS CUI [2,1]
C0003289
UMLS CUI [2,2]
C0178602
UMLS CUI [3,1]
C0087111
UMLS CUI [3,2]
C1265611
UMLS CUI [3,3]
C0205269
lack of response to at least two antidepressant therapies given at adequate doses for at least 6 weeks for the current depressive episode.
Description

Depressive episode | Antidepressive Agents Dosage | Therapeutic procedure Quantity Unresponsive to Treatment

Data type

boolean

Alias
UMLS CUI [1]
C0349217
UMLS CUI [2,1]
C0003289
UMLS CUI [2,2]
C0178602
UMLS CUI [3,1]
C0087111
UMLS CUI [3,2]
C1265611
UMLS CUI [3,3]
C0205269
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.
Description

Symptoms Axis I diagnosis | Exception Anxiety Disorders | Exception Obsessive-Compulsive Disorder | Exception Major Depressive Disorder

Data type

boolean

Alias
UMLS CUI [1,1]
C1457887
UMLS CUI [1,2]
C0270287
UMLS CUI [2,1]
C1705847
UMLS CUI [2,2]
C0003469
UMLS CUI [3,1]
C1705847
UMLS CUI [3,2]
C0003469
UMLS CUI [4,1]
C1705847
UMLS CUI [4,2]
C0028768
UMLS CUI [5,1]
C1705847
UMLS CUI [5,2]
C1269683
any previous diagnosis of a bipolar disorder, schizophrenia or ocd.
Description

Bipolar Disorder | Schizophrenia | Obsessive-Compulsive Disorder

Data type

boolean

Alias
UMLS CUI [1]
C0005586
UMLS CUI [2]
C0036341
UMLS CUI [3]
C0028768
depression with catatonic features (according to dsm-iv), depression with post-partum onset, or organic mental disorders.
Description

Depressive disorder Feature Catatonic | Depression, Postpartum | Organic mental disorders

Data type

boolean

Alias
UMLS CUI [1,1]
C0011581
UMLS CUI [1,2]
C2348519
UMLS CUI [1,3]
C0007398
UMLS CUI [2]
C0221074
UMLS CUI [3]
C0029227
the presence of an axis ii disorder
Description

Axis II diagnosis

Data type

boolean

Alias
UMLS CUI [1]
C0270288
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Similar models

Eligibility Major Depressive Disorder NCT00422162

1 forms
Name
Type
Description | Question | Decode (Coded Value)
Data type
Alias
Item Group
C1512693 (UMLS CUI)
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])
Item Group
C0680251 (UMLS CUI)
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])
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