ID

23089

Description

Best Event Schizophrenia Trial--A Randomized Double-Blind Trial of Aripiprazole and Risperidone in Schizophrenia; ODM derived from: https://clinicaltrials.gov/show/NCT00712270

Lien

https://clinicaltrials.gov/show/NCT00712270

Mots-clés

Versions (1)
  1. 23/06/2017 23/06/2017 -
Téléchargé le

23 juin 2017

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.

Retour au modèle Commentaires
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 NCT00712270

Anglais

Eligibility Schizophrenia NCT00712270

1 Formulaires  
Inclusion Criteria
Description

Inclusion Criteria

Alias
UMLS CUI
C1512693
1. subjects will meet dsm-iv diagnostic criteria for schizophreniform disorder, schizophrenia, schizoaffective disorder or (non-affective) psychotic disorder, nos. subjects with schizophreniform disorder or psychotic disorder, nos, will be diagnostically reevaluated (recontacted if no longer involved in the study) after a minimum of six months of psychotic symptoms in order to determine whether diagnostic criteria for schizophrenia or schizoaffective disorder have been met.
Description

Schizophreniform Disorders | Schizophrenia | Schizoaffective Disorder | Psychotic Disorders

Type de données

boolean

Alias
UMLS CUI [1]
C0036358
UMLS CUI [2]
C0036341
UMLS CUI [3]
C0036337
UMLS CUI [4]
C0033975
2. subjects will be between 18 and 55 years of age, inclusive.
Description

Age

Type de données

boolean

Alias
UMLS CUI [1]
C0001779
3. subjects will be able to fully participate in the informed consent process, or have a legal guardian able to participate in the informed consent process.
Description

Informed Consent | Informed Consent Legal Guardian

Type de données

boolean

Alias
UMLS CUI [1]
C0021430
UMLS CUI [2,1]
C0021430
UMLS CUI [2,2]
C0023226
4. present score on at least one panss psychosis items (p1, p2, p3, p5 or p6) > 4(moderately severe) and cgi severity score > 4 (moderate).
Description

Positive and negative syndrome scale | Psychotic Disorder Moderate | Psychotic Disorder Severe | Clinical Global Impression Questionnaire

Type de données

boolean

Alias
UMLS CUI [1]
C0451383
UMLS CUI [2,1]
C0033975
UMLS CUI [2,2]
C0205081
UMLS CUI [3,1]
C0033975
UMLS CUI [3,2]
C0205082
UMLS CUI [4]
C3639708
5. female patients of childbearing potential must be using a medically accepted means of contraception
Description

Childbearing Potential Contraceptive methods

Type de données

boolean

Alias
UMLS CUI [1,1]
C3831118
UMLS CUI [1,2]
C0700589
Exclusion Criteria
Description

Exclusion Criteria

Alias
UMLS CUI
C0680251
1. current active substance use disorder diagnosis or a history of cocaine abuse or dependence;
Description

Substance Use Disorders | Cocaine Abuse | Cocaine Dependence

Type de données

boolean

Alias
UMLS CUI [1]
C0038586
UMLS CUI [2]
C0009171
UMLS CUI [3]
C0600427
2. female patients who are either pregnant or nursing;
Description

Pregnancy | Breast Feeding

Type de données

boolean

Alias
UMLS CUI [1]
C0032961
UMLS CUI [2]
C0006147
3. known history of mental retardation, seizure disorder, or a clinically significant head injury (prolonged loss of consciousness, neurological sequelae, or demonstrated structural brain injury);
Description

Mental Retardation | Epilepsy | Craniocerebral Trauma | Prolonged loss of consciousness | neurologic sequelae | Brain Injury structural

Type de données

boolean

Alias
UMLS CUI [1]
C0025362
UMLS CUI [2]
C0014544
UMLS CUI [3]
C0018674
UMLS CUI [4]
C0234433
UMLS CUI [5]
C0746864
UMLS CUI [6,1]
C0270611
UMLS CUI [6,2]
C0678594
4. non-english speaking (mastery of english insufficient to participate in study evaluation procedures);
Description

Able to speak English Language Insufficient | Participation Evaluation procedure

Type de données

boolean

Alias
UMLS CUI [1,1]
C0564215
UMLS CUI [1,2]
C0376245
UMLS CUI [1,3]
C0231180
UMLS CUI [2,1]
C0679823
UMLS CUI [2,2]
C1261322
5. serious, unstable medical illness;
Description

Illness Serious Unstable

Type de données

boolean

Alias
UMLS CUI [1,1]
C0221423
UMLS CUI [1,2]
C0205404
UMLS CUI [1,3]
C0443343
6. known hypersensitivity to any study medication;
Description

Hypersensitivity Investigational New Drugs

Type de données

boolean

Alias
UMLS CUI [1,1]
C0020517
UMLS CUI [1,2]
C0013230
7. medical contraindication to any element of the study procedure;
Description

Medical contraindication Study Element

Type de données

boolean

Alias
UMLS CUI [1,1]
C1301624
UMLS CUI [1,2]
C3812827
8. current symptoms which present serious risk of danger to self or others;
Description

Symptoms DANGER OF HARM TO SELF Risk Serious | Symptoms High risk of harm to others

Type de données

boolean

Alias
UMLS CUI [1,1]
C1457887
UMLS CUI [1,2]
C0149660
UMLS CUI [1,3]
C0035647
UMLS CUI [1,4]
C0205404
UMLS CUI [2,1]
C1457887
UMLS CUI [2,2]
C1320315
9. participation in a clinical trial of an investigational drug within 30 days of study entry;
Description

Study Subject Participation Status | Investigational New Drugs

Type de données

boolean

Alias
UMLS CUI [1]
C2348568
UMLS CUI [2]
C0013230
10. current severity of psychiatric symptoms contraindicates a delay in initiation of antipsychotic medication treatment until functional imaging studies and neuropsychological testing have been completed;
Description

Psychiatric symptom Severity | Medical contraindication Delay Antipsychotic drug therapy | Functional Imaging | Neuropsychological Tests

Type de données

boolean

Alias
UMLS CUI [1,1]
C0233401
UMLS CUI [1,2]
C0392364
UMLS CUI [2,1]
C1301624
UMLS CUI [2,2]
C0205421
UMLS CUI [2,3]
C1319421
UMLS CUI [3]
C1517324
UMLS CUI [4]
C0027902
11. baseline qtc interval of > 450 msec.
Description

QTc interval

Type de données

boolean

Alias
UMLS CUI [1]
C2216079
Retour au début de la page

Similar models

Eligibility Schizophrenia NCT00712270

1 Formulaires
Name
Type
Description | Question | Decode (Coded Value)
Type de données
Alias
Item Group
C1512693 (UMLS CUI)
Schizophreniform Disorders | Schizophrenia | Schizoaffective Disorder | Psychotic Disorders
Item
1. subjects will meet dsm-iv diagnostic criteria for schizophreniform disorder, schizophrenia, schizoaffective disorder or (non-affective) psychotic disorder, nos. subjects with schizophreniform disorder or psychotic disorder, nos, will be diagnostically reevaluated (recontacted if no longer involved in the study) after a minimum of six months of psychotic symptoms in order to determine whether diagnostic criteria for schizophrenia or schizoaffective disorder have been met.
boolean
C0036358 (UMLS CUI [1])
C0036341 (UMLS CUI [2])
C0036337 (UMLS CUI [3])
C0033975 (UMLS CUI [4])
Age
Item
2. subjects will be between 18 and 55 years of age, inclusive.
boolean
C0001779 (UMLS CUI [1])
Informed Consent | Informed Consent Legal Guardian
Item
3. subjects will be able to fully participate in the informed consent process, or have a legal guardian able to participate in the informed consent process.
boolean
C0021430 (UMLS CUI [1])
C0021430 (UMLS CUI [2,1])
C0023226 (UMLS CUI [2,2])
Positive and negative syndrome scale | Psychotic Disorder Moderate | Psychotic Disorder Severe | Clinical Global Impression Questionnaire
Item
4. present score on at least one panss psychosis items (p1, p2, p3, p5 or p6) > 4(moderately severe) and cgi severity score > 4 (moderate).
boolean
C0451383 (UMLS CUI [1])
C0033975 (UMLS CUI [2,1])
C0205081 (UMLS CUI [2,2])
C0033975 (UMLS CUI [3,1])
C0205082 (UMLS CUI [3,2])
C3639708 (UMLS CUI [4])
Childbearing Potential Contraceptive methods
Item
5. female patients of childbearing potential must be using a medically accepted means of contraception
boolean
C3831118 (UMLS CUI [1,1])
C0700589 (UMLS CUI [1,2])
Item Group
C0680251 (UMLS CUI)
Substance Use Disorders | Cocaine Abuse | Cocaine Dependence
Item
1. current active substance use disorder diagnosis or a history of cocaine abuse or dependence;
boolean
C0038586 (UMLS CUI [1])
C0009171 (UMLS CUI [2])
C0600427 (UMLS CUI [3])
Pregnancy | Breast Feeding
Item
2. female patients who are either pregnant or nursing;
boolean
C0032961 (UMLS CUI [1])
C0006147 (UMLS CUI [2])
Mental Retardation | Epilepsy | Craniocerebral Trauma | Prolonged loss of consciousness | neurologic sequelae | Brain Injury structural
Item
3. known history of mental retardation, seizure disorder, or a clinically significant head injury (prolonged loss of consciousness, neurological sequelae, or demonstrated structural brain injury);
boolean
C0025362 (UMLS CUI [1])
C0014544 (UMLS CUI [2])
C0018674 (UMLS CUI [3])
C0234433 (UMLS CUI [4])
C0746864 (UMLS CUI [5])
C0270611 (UMLS CUI [6,1])
C0678594 (UMLS CUI [6,2])
Able to speak English Language Insufficient | Participation Evaluation procedure
Item
4. non-english speaking (mastery of english insufficient to participate in study evaluation procedures);
boolean
C0564215 (UMLS CUI [1,1])
C0376245 (UMLS CUI [1,2])
C0231180 (UMLS CUI [1,3])
C0679823 (UMLS CUI [2,1])
C1261322 (UMLS CUI [2,2])
Illness Serious Unstable
Item
5. serious, unstable medical illness;
boolean
C0221423 (UMLS CUI [1,1])
C0205404 (UMLS CUI [1,2])
C0443343 (UMLS CUI [1,3])
Hypersensitivity Investigational New Drugs
Item
6. known hypersensitivity to any study medication;
boolean
C0020517 (UMLS CUI [1,1])
C0013230 (UMLS CUI [1,2])
Medical contraindication Study Element
Item
7. medical contraindication to any element of the study procedure;
boolean
C1301624 (UMLS CUI [1,1])
C3812827 (UMLS CUI [1,2])
Symptoms DANGER OF HARM TO SELF Risk Serious | Symptoms High risk of harm to others
Item
8. current symptoms which present serious risk of danger to self or others;
boolean
C1457887 (UMLS CUI [1,1])
C0149660 (UMLS CUI [1,2])
C0035647 (UMLS CUI [1,3])
C0205404 (UMLS CUI [1,4])
C1457887 (UMLS CUI [2,1])
C1320315 (UMLS CUI [2,2])
Study Subject Participation Status | Investigational New Drugs
Item
9. participation in a clinical trial of an investigational drug within 30 days of study entry;
boolean
C2348568 (UMLS CUI [1])
C0013230 (UMLS CUI [2])
Psychiatric symptom Severity | Medical contraindication Delay Antipsychotic drug therapy | Functional Imaging | Neuropsychological Tests
Item
10. current severity of psychiatric symptoms contraindicates a delay in initiation of antipsychotic medication treatment until functional imaging studies and neuropsychological testing have been completed;
boolean
C0233401 (UMLS CUI [1,1])
C0392364 (UMLS CUI [1,2])
C1301624 (UMLS CUI [2,1])
C0205421 (UMLS CUI [2,2])
C1319421 (UMLS CUI [2,3])
C1517324 (UMLS CUI [3])
C0027902 (UMLS CUI [4])
QTc interval
Item
11. baseline qtc interval of > 450 msec.
boolean
C2216079 (UMLS CUI [1])
Retour au début de la page 

Contact

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

Les champs marqués d’un * sont obligatoires.

Aide

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