ID

19257

Description

Safety Study With Paliperidone ER Extended-Release (ER) Tablets in Geriatric Patients With Schizophrenia; ODM derived from: https://clinicaltrials.gov/show/NCT00085748

Lien

https://clinicaltrials.gov/show/NCT00085748

Mots-clés

  1. 15/12/2016 15/12/2016 -
Téléchargé le

15 décembre 2016

DOI

Pour une demande vous connecter.

Licence

Creative Commons BY 4.0

Modèle Commentaires :

Ici, vous pouvez faire des commentaires sur le modèle. À partir des bulles de texte, vous pouvez laisser des commentaires spécifiques sur les groupes Item et les Item.

Groupe Item commentaires pour :

Item commentaires pour :

Vous devez être connecté pour pouvoir télécharger des formulaires. Veuillez vous connecter ou s’inscrire gratuitement.

Eligibility Schizophrenia NCT00085748

Eligibility Schizophrenia NCT00085748

Inclusion Criteria
Description

Inclusion Criteria

Alias
UMLS CUI
C1512693
double-blind phase: 65 years of age or older
Description

Age

Type de données

boolean

Alias
UMLS CUI [1]
C0001779
dsm-iv diagnosis of schizophrenia for at least 1 year
Description

Schizophrenia disease length

Type de données

boolean

Alias
UMLS CUI [1,1]
C0036341
UMLS CUI [1,2]
C0872146
total panss score at screening and baseline between 70 and 120, inclusive
Description

Positive and negative syndrome scale

Type de données

boolean

Alias
UMLS CUI [1]
C0451383
agrees to hospitalization for a minimum of 14 days and for the duration of the study, if clinically indicated
Description

Hospitalization Duration Agreement | Indication Hospitalization Duration

Type de données

boolean

Alias
UMLS CUI [1,1]
C0019993
UMLS CUI [1,2]
C0449238
UMLS CUI [1,3]
C0680240
UMLS CUI [2,1]
C3146298
UMLS CUI [2,2]
C0019993
UMLS CUI [2,3]
C0449238
open-label treatment phase: completed 6 weeks of the double-blind treatment phase or finished at least 21 days of treatment and discontinued because of lack of efficacy.
Description

Therapeutic procedure Double-Blind Method Complete | Therapeutic procedure Discontinued Lack of Efficacy

Type de données

boolean

Alias
UMLS CUI [1,1]
C0087111
UMLS CUI [1,2]
C0013072
UMLS CUI [1,3]
C0205197
UMLS CUI [2,1]
C0087111
UMLS CUI [2,2]
C1444662
UMLS CUI [2,3]
C0235828
Exclusion Criteria
Description

Exclusion Criteria

Alias
UMLS CUI
C0680251
dsm-iv axis i diagnosis other than schizophrenia
Description

Axis I diagnosis | Schizophrenia

Type de données

boolean

Alias
UMLS CUI [1]
C0270287
UMLS CUI [2]
C0036341
dsm-iv diagnosis of substance dependence within the 6 months before screening (nicotine and caffeine dependence are not exclusionary)
Description

Substance Dependence | Nicotine Dependence | Caffeine dependence

Type de données

boolean

Alias
UMLS CUI [1]
C0038580
UMLS CUI [2]
C0028043
UMLS CUI [3]
C1386553
history of tardive dyskinesia or neuroleptic malignant syndrome (nms)
Description

Tardive Dyskinesia | Neuroleptic Malignant Syndrome

Type de données

boolean

Alias
UMLS CUI [1]
C0686347
UMLS CUI [2]
C0027849
history of any severe preexisting severe gastrointestinal narrowing (pathologic or iatrogenic)
Description

Gastrointestinal stenosis Pathologic Pre-existing Severe | Gastrointestinal stenosis Iatrogenic Pre-existing Severe

Type de données

boolean

Alias
UMLS CUI [1,1]
C0521587
UMLS CUI [1,2]
C1521733
UMLS CUI [1,3]
C2347662
UMLS CUI [1,4]
C0205082
UMLS CUI [2,1]
C0521587
UMLS CUI [2,2]
C0439669
UMLS CUI [2,3]
C2347662
UMLS CUI [2,4]
C0205082
previous history of a lack of response (2 adequate trials) to any antipsychotic
Description

Antipsychotic Agents Quantity | Poor response to treatment

Type de données

boolean

Alias
UMLS CUI [1,1]
C0040615
UMLS CUI [1,2]
C1265611
UMLS CUI [2]
C1320680

Similar models

Eligibility Schizophrenia NCT00085748

Name
Type
Description | Question | Decode (Coded Value)
Type de données
Alias
Item Group
C1512693 (UMLS CUI)
Age
Item
double-blind phase: 65 years of age or older
boolean
C0001779 (UMLS CUI [1])
Schizophrenia disease length
Item
dsm-iv diagnosis of schizophrenia for at least 1 year
boolean
C0036341 (UMLS CUI [1,1])
C0872146 (UMLS CUI [1,2])
Positive and negative syndrome scale
Item
total panss score at screening and baseline between 70 and 120, inclusive
boolean
C0451383 (UMLS CUI [1])
Hospitalization Duration Agreement | Indication Hospitalization Duration
Item
agrees to hospitalization for a minimum of 14 days and for the duration of the study, if clinically indicated
boolean
C0019993 (UMLS CUI [1,1])
C0449238 (UMLS CUI [1,2])
C0680240 (UMLS CUI [1,3])
C3146298 (UMLS CUI [2,1])
C0019993 (UMLS CUI [2,2])
C0449238 (UMLS CUI [2,3])
Therapeutic procedure Double-Blind Method Complete | Therapeutic procedure Discontinued Lack of Efficacy
Item
open-label treatment phase: completed 6 weeks of the double-blind treatment phase or finished at least 21 days of treatment and discontinued because of lack of efficacy.
boolean
C0087111 (UMLS CUI [1,1])
C0013072 (UMLS CUI [1,2])
C0205197 (UMLS CUI [1,3])
C0087111 (UMLS CUI [2,1])
C1444662 (UMLS CUI [2,2])
C0235828 (UMLS CUI [2,3])
Item Group
C0680251 (UMLS CUI)
Axis I diagnosis | Schizophrenia
Item
dsm-iv axis i diagnosis other than schizophrenia
boolean
C0270287 (UMLS CUI [1])
C0036341 (UMLS CUI [2])
Substance Dependence | Nicotine Dependence | Caffeine dependence
Item
dsm-iv diagnosis of substance dependence within the 6 months before screening (nicotine and caffeine dependence are not exclusionary)
boolean
C0038580 (UMLS CUI [1])
C0028043 (UMLS CUI [2])
C1386553 (UMLS CUI [3])
Tardive Dyskinesia | Neuroleptic Malignant Syndrome
Item
history of tardive dyskinesia or neuroleptic malignant syndrome (nms)
boolean
C0686347 (UMLS CUI [1])
C0027849 (UMLS CUI [2])
Gastrointestinal stenosis Pathologic Pre-existing Severe | Gastrointestinal stenosis Iatrogenic Pre-existing Severe
Item
history of any severe preexisting severe gastrointestinal narrowing (pathologic or iatrogenic)
boolean
C0521587 (UMLS CUI [1,1])
C1521733 (UMLS CUI [1,2])
C2347662 (UMLS CUI [1,3])
C0205082 (UMLS CUI [1,4])
C0521587 (UMLS CUI [2,1])
C0439669 (UMLS CUI [2,2])
C2347662 (UMLS CUI [2,3])
C0205082 (UMLS CUI [2,4])
Antipsychotic Agents Quantity | Poor response to treatment
Item
previous history of a lack of response (2 adequate trials) to any antipsychotic
boolean
C0040615 (UMLS CUI [1,1])
C1265611 (UMLS CUI [1,2])
C1320680 (UMLS CUI [2])

Utilisez ce formulaire pour les retours, les questions et les améliorations suggérées.

Les champs marqués d’un * sont obligatoires.

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