ID

32043

Beskrivning

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

Länk

https://clinicaltrials.gov/show/NCT00640562

Nyckelord

Versioner (1)
  1. 2018-10-15 2018-10-15 -
Rättsinnehavare

See clinicaltrials.gov

Uppladdad den

15 oktober 2018

DOI

För en begäran logga in.

Licens

Creative Commons BY 4.0
Modellkommentarer :

Här kan du kommentera modellen. Med hjälp av pratbubblor i Item-grupperna och Item kan du lägga in specifika kommentarer.

Tillbaka till modellkommentarer
Itemgroup-kommentar för :

Item-kommentar för :

  • Senaste
  • Äldsta
  • Önskad
  • Senaste
    • Senaste
    • Äldsta
    • Önskad

Inga kommentarer

Du måste vara inloggad för att kunna ladda ner formulär. Var vänlig logga in eller registrera dig utan kostnad.

Eligibility Schizophrenia NCT00640562

Engelsk

Eligibility Schizophrenia NCT00640562

1 Formulär  
Inclusion Criteria
Beskrivning

Inclusion Criteria

Alias
UMLS CUI
C1512693
provision of written informed consent
Beskrivning

Informed Consent

Datatyp

boolean

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

Schizophrenia | Schizoaffective Disorder

Datatyp

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
Beskrivning

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

Datatyp

boolean

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

Exclusion Criteria

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

Axis I diagnosis | Exception Schizophrenia | Exception Schizoaffective Disorder

Datatyp

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
Beskrivning

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

Datatyp

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
Beskrivning

Clozapine | Clozapine non-responder

Datatyp

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
Beskrivning

Disease Clinical Significance | Patient Inappropriate Investigational New Drugs

Datatyp

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
Beskrivning

Absolute neutrophil count

Datatyp

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.
Beskrivning

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

Datatyp

boolean

Alias
UMLS CUI [1]
C0563664
UMLS CUI [2]
C1276053
UMLS CUI [3]
C1271966
Tillbaka till toppen

Similar models

Eligibility Schizophrenia NCT00640562

1 Formulär
Name
Typ
Description | Question | Decode (Coded Value)
Datatyp
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])
Tillbaka till toppen 

Hjälp

Do you need help on how to use the search function? Please watch the corresponding tutorial video for more details and learn how to use the search function most efficiently.

Watch Tutorial