ID

32043

Description

Quetiapine Extended Release Depression Symptoms; ODM derived from: https://clinicaltrials.gov/show/NCT00640562

Lien

https://clinicaltrials.gov/show/NCT00640562

Mots-clés

Versions (1)
  1. 15/10/2018 15/10/2018 -
Détendeur de droits

See clinicaltrials.gov

Téléchargé le

15 octobre 2018

DOI

Pour une demande vous connecter.

Licence

Creative Commons BY 4.0
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Eligibility Schizophrenia NCT00640562

Anglais

Eligibility Schizophrenia NCT00640562

1 Formulaires  
Inclusion Criteria
Description

Inclusion Criteria

Alias
UMLS CUI
C1512693
provision of written informed consent
Description

Informed Consent

Type de données

boolean

Alias
UMLS CUI [1]
C0021430
patients who satisfy the criteria for diagnosis of schizophrenia or schizoaffective disorder according to dsm-ivtr
Description

Schizophrenia | Schizoaffective Disorder

Type de données

boolean

Alias
UMLS CUI [1]
C0036341
UMLS CUI [2]
C0036337
baseline depressive symptoms, assessed by means of ham-d (21-item) score ≥20, and ham-d item 1 score ≥2
Description

Depressive Symptoms Hamilton Depression Rating Scale 21-Item Clinical Classification | Depressive Symptoms Hamilton rating scale for depression

Type de données

boolean

Alias
UMLS CUI [1,1]
C0086132
UMLS CUI [1,2]
C3640518
UMLS CUI [2,1]
C0086132
UMLS CUI [2,2]
C0451203
Exclusion Criteria
Description

Exclusion Criteria

Alias
UMLS CUI
C0680251
any dsm-iv axis i disorder other than schizophrenia and schizoaffective disorder
Description

Axis I diagnosis | Exception Schizophrenia | Exception Schizoaffective Disorder

Type de données

boolean

Alias
UMLS CUI [1]
C0270287
UMLS CUI [2,1]
C1705847
UMLS CUI [2,2]
C0036341
UMLS CUI [3,1]
C1705847
UMLS CUI [3,2]
C0036337
patients treated with depot antipsychotic medications within 1 dosing interval before day 0; patients treated with other ap oral medications during the trial except for the switch period
Description

Injection of depot antipsychotic agent | Antipsychotic Agents Oral | Exception Drug Switching

Type de données

boolean

Alias
UMLS CUI [1]
C2585377
UMLS CUI [2,1]
C0040615
UMLS CUI [2,2]
C1527415
UMLS CUI [3,1]
C1705847
UMLS CUI [3,2]
C2936279
use of clozapine within 28 days prior to enrollment or clozapine non responders
Description

Clozapine | Clozapine non-responder

Type de données

boolean

Alias
UMLS CUI [1]
C0009079
UMLS CUI [2,1]
C0009079
UMLS CUI [2,2]
C0919875
any significant clinical disorder that, in the opinion of the investigator, made the subject unsuitable to be given treatment with an investigational drug
Description

Disease Clinical Significance | Patient Inappropriate Investigational New Drugs

Type de données

boolean

Alias
UMLS CUI [1,1]
C0012634
UMLS CUI [1,2]
C2826293
UMLS CUI [2,1]
C0030705
UMLS CUI [2,2]
C1548788
UMLS CUI [2,3]
C0013230
an absolute neutrophil count (anc) of ≤1.5 x 109 per liter
Description

Absolute neutrophil count

Type de données

boolean

Alias
UMLS CUI [1]
C0948762
patients who, in the opinion of the investigator, pose an imminent risk of suicide or a danger to self or others.
Description

At risk for suicide | At risk for deliberate self harm | At risk of harming others

Type de données

boolean

Alias
UMLS CUI [1]
C0563664
UMLS CUI [2]
C1276053
UMLS CUI [3]
C1271966
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Similar models

Eligibility Schizophrenia NCT00640562

1 Formulaires
Name
Type
Description | Question | Decode (Coded Value)
Type de données
Alias
Item Group
C1512693 (UMLS CUI)
Informed Consent
Item
provision of written informed consent
boolean
C0021430 (UMLS CUI [1])
Schizophrenia | Schizoaffective Disorder
Item
patients who satisfy the criteria for diagnosis of schizophrenia or schizoaffective disorder according to dsm-ivtr
boolean
C0036341 (UMLS CUI [1])
C0036337 (UMLS CUI [2])
Depressive Symptoms Hamilton Depression Rating Scale 21-Item Clinical Classification | Depressive Symptoms Hamilton rating scale for depression
Item
baseline depressive symptoms, assessed by means of ham-d (21-item) score ≥20, and ham-d item 1 score ≥2
boolean
C0086132 (UMLS CUI [1,1])
C3640518 (UMLS CUI [1,2])
C0086132 (UMLS CUI [2,1])
C0451203 (UMLS CUI [2,2])
Item Group
C0680251 (UMLS CUI)
Axis I diagnosis | Exception Schizophrenia | Exception Schizoaffective Disorder
Item
any dsm-iv axis i disorder other than schizophrenia and schizoaffective disorder
boolean
C0270287 (UMLS CUI [1])
C1705847 (UMLS CUI [2,1])
C0036341 (UMLS CUI [2,2])
C1705847 (UMLS CUI [3,1])
C0036337 (UMLS CUI [3,2])
Injection of depot antipsychotic agent | Antipsychotic Agents Oral | Exception Drug Switching
Item
patients treated with depot antipsychotic medications within 1 dosing interval before day 0; patients treated with other ap oral medications during the trial except for the switch period
boolean
C2585377 (UMLS CUI [1])
C0040615 (UMLS CUI [2,1])
C1527415 (UMLS CUI [2,2])
C1705847 (UMLS CUI [3,1])
C2936279 (UMLS CUI [3,2])
Clozapine | Clozapine non-responder
Item
use of clozapine within 28 days prior to enrollment or clozapine non responders
boolean
C0009079 (UMLS CUI [1])
C0009079 (UMLS CUI [2,1])
C0919875 (UMLS CUI [2,2])
Disease Clinical Significance | Patient Inappropriate Investigational New Drugs
Item
any significant clinical disorder that, in the opinion of the investigator, made the subject unsuitable to be given treatment with an investigational drug
boolean
C0012634 (UMLS CUI [1,1])
C2826293 (UMLS CUI [1,2])
C0030705 (UMLS CUI [2,1])
C1548788 (UMLS CUI [2,2])
C0013230 (UMLS CUI [2,3])
Absolute neutrophil count
Item
an absolute neutrophil count (anc) of ≤1.5 x 109 per liter
boolean
C0948762 (UMLS CUI [1])
At risk for suicide | At risk for deliberate self harm | At risk of harming others
Item
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])
C1276053 (UMLS CUI [2])
C1271966 (UMLS CUI [3])
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