ID

32110

Description

An Efficacy, Safety And Tolerability Study of Flexibly Dosed Paliperidone Extended-Release (ER) in Participants With Schizophrenia; ODM derived from: https://clinicaltrials.gov/show/NCT00757705

Lien

https://clinicaltrials.gov/show/NCT00757705

Mots-clés

Versions (2)
  1. 18/10/2018 18/10/2018 -
  2. 18/10/2018 18/10/2018 -
Détendeur de droits

See clinicaltrials.gov

Téléchargé le

18 octobre 2018

DOI

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Licence

Creative Commons BY 4.0
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Eligibility Schizophrenia NCT00757705

Anglais

Eligibility Schizophrenia NCT00757705

1 Formulaires  
Inclusion Criteria
Description

Inclusion Criteria

Alias
UMLS CUI
C1512693
participant meets the diagnostic and statistical manual of mental disorders, fourth edition (dsm-iv) criteria for schizophrenia
Description

Schizophrenia

Type de données

boolean

Alias
UMLS CUI [1]
C0036341
participant has been given an adequate dose of an appropriate oral atypical antipsychotic for an adequate period of time prior to enrollment, but previous treatment is considered unsuccessful due to one or more of the following reasons: lack of efficacy, lack of tolerability or safety, lack of compliance and/or other reasons to switch to another antipsychotic medication
Description

Atypical antipsychotic Oral Dose | Prior Therapy Unsuccessful | Etiology aspects | Lack of Efficacy | Intolerance to substance | Safety Lacking | Medication Compliance Lacking | Change Antipsychotic Agent Other

Type de données

boolean

Alias
UMLS CUI [1,1]
C1276996
UMLS CUI [1,2]
C1527415
UMLS CUI [1,3]
C0178602
UMLS CUI [2,1]
C1514463
UMLS CUI [2,2]
C1272705
UMLS CUI [3]
C0015127
UMLS CUI [4]
C0235828
UMLS CUI [5]
C1744706
UMLS CUI [6,1]
C0036043
UMLS CUI [6,2]
C0332268
UMLS CUI [7,1]
C3489773
UMLS CUI [7,2]
C0332268
UMLS CUI [8,1]
C0392747
UMLS CUI [8,2]
C0040615
UMLS CUI [8,3]
C0205394
participant or their legally acceptable representatives must have signed an informed consent document indicating that they understand the purpose of and procedures required for the study and are willing to participate in the study
Description

Informed Consent | Informed Consent Patient Representatives

Type de données

boolean

Alias
UMLS CUI [1]
C0021430
UMLS CUI [2,1]
C0021430
UMLS CUI [2,2]
C0030701
female participants must be postmenopausal for at least 1 year, surgically sterile, abstinent, or, if sexually active, agree to practice an effective method of birth control before entry and throughout the study and must also have a negative urine pregnancy test at screening
Description

Postmenopausal state | Female Sterilization | Gender Sexual Abstinence | Gender Sexually active Contraceptive methods | Gender Sexually active Urine pregnancy test negative

Type de données

boolean

Alias
UMLS CUI [1]
C0232970
UMLS CUI [2]
C0015787
UMLS CUI [3,1]
C0079399
UMLS CUI [3,2]
C0036899
UMLS CUI [4,1]
C0079399
UMLS CUI [4,2]
C0241028
UMLS CUI [4,3]
C0700589
UMLS CUI [5,1]
C0079399
UMLS CUI [5,2]
C0241028
UMLS CUI [5,3]
C0430057
male or female, aged greater than or equal to 18 years
Description

Age

Type de données

boolean

Alias
UMLS CUI [1]
C0001779
Exclusion Criteria
Description

Exclusion Criteria

Alias
UMLS CUI
C0680251
participants on clozapine, any conventional depot neuroleptic or risperdal consta during the last 3 months
Description

Clozapine | Injection of depot antipsychotic agent | Risperdal Consta Depot Preparation

Type de données

boolean

Alias
UMLS CUI [1]
C0009079
UMLS CUI [2]
C2585377
UMLS CUI [3,1]
C1320098
UMLS CUI [3,2]
C0086129
participants with serious unstable medical condition, including known clinically relevant laboratory abnormalities
Description

Medical condition Serious Unstable | Laboratory test result abnormal

Type de données

boolean

Alias
UMLS CUI [1,1]
C3843040
UMLS CUI [1,2]
C0205404
UMLS CUI [1,3]
C0443343
UMLS CUI [2]
C0438215
participants with history or current symptoms of tardive dyskinesia (twitching or jerking movements that you cannot control in your face, tongue, or other parts of your body)
Description

Tardive Dyskinesia | Symptoms Tardive Dyskinesia | Twitching | Jerking movements

Type de données

boolean

Alias
UMLS CUI [1]
C0686347
UMLS CUI [2,1]
C1457887
UMLS CUI [2,2]
C0686347
UMLS CUI [3]
C0231530
UMLS CUI [4]
C2674421
participants with history of neuroleptic malignant syndrome (high fever, rigid muscles, shaking, confusion, sweating more than usual, increased heart rate or blood pressure, or muscle pain or weakness)
Description

Neuroleptic Malignant Syndrome | FEVER HIGH | Muscle Rigidity | Tremor | Confusion | Increased sweating | Tachycardia | Increase in blood pressure | Myalgia | Weakness

Type de données

boolean

Alias
UMLS CUI [1]
C0027849
UMLS CUI [2]
C0743973
UMLS CUI [3]
C0026837
UMLS CUI [4]
C0040822
UMLS CUI [5]
C0009676
UMLS CUI [6]
C0700590
UMLS CUI [7]
C0039231
UMLS CUI [8]
C0497247
UMLS CUI [9]
C0231528
UMLS CUI [10]
C3714552
participants with a current use or known history (over the past 6 months) of substance dependence except for nicotine, caffeine, and betal nut according to dsm-iv criteria
Description

Substance Dependence | Exception Nicotine Dependence | Exception Caffeine dependence | Exception Betel Nut dependence

Type de données

boolean

Alias
UMLS CUI [1]
C0038580
UMLS CUI [2,1]
C1705847
UMLS CUI [2,2]
C0028043
UMLS CUI [3,1]
C1705847
UMLS CUI [3,2]
C1386553
UMLS CUI [4,1]
C1705847
UMLS CUI [4,2]
C0684282
UMLS CUI [4,3]
C0085281
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Similar models

Eligibility Schizophrenia NCT00757705

1 Formulaires
Name
Type
Description | Question | Decode (Coded Value)
Type de données
Alias
Item Group
C1512693 (UMLS CUI)
Schizophrenia
Item
participant meets the diagnostic and statistical manual of mental disorders, fourth edition (dsm-iv) criteria for schizophrenia
boolean
C0036341 (UMLS CUI [1])
Atypical antipsychotic Oral Dose | Prior Therapy Unsuccessful | Etiology aspects | Lack of Efficacy | Intolerance to substance | Safety Lacking | Medication Compliance Lacking | Change Antipsychotic Agent Other
Item
participant has been given an adequate dose of an appropriate oral atypical antipsychotic for an adequate period of time prior to enrollment, but previous treatment is considered unsuccessful due to one or more of the following reasons: lack of efficacy, lack of tolerability or safety, lack of compliance and/or other reasons to switch to another antipsychotic medication
boolean
C1276996 (UMLS CUI [1,1])
C1527415 (UMLS CUI [1,2])
C0178602 (UMLS CUI [1,3])
C1514463 (UMLS CUI [2,1])
C1272705 (UMLS CUI [2,2])
C0015127 (UMLS CUI [3])
C0235828 (UMLS CUI [4])
C1744706 (UMLS CUI [5])
C0036043 (UMLS CUI [6,1])
C0332268 (UMLS CUI [6,2])
C3489773 (UMLS CUI [7,1])
C0332268 (UMLS CUI [7,2])
C0392747 (UMLS CUI [8,1])
C0040615 (UMLS CUI [8,2])
C0205394 (UMLS CUI [8,3])
Informed Consent | Informed Consent Patient Representatives
Item
participant or their legally acceptable representatives must have signed an informed consent document indicating that they understand the purpose of and procedures required for the study and are willing to participate in the study
boolean
C0021430 (UMLS CUI [1])
C0021430 (UMLS CUI [2,1])
C0030701 (UMLS CUI [2,2])
Postmenopausal state | Female Sterilization | Gender Sexual Abstinence | Gender Sexually active Contraceptive methods | Gender Sexually active Urine pregnancy test negative
Item
female participants must be postmenopausal for at least 1 year, surgically sterile, abstinent, or, if sexually active, agree to practice an effective method of birth control before entry and throughout the study and must also have a negative urine pregnancy test at screening
boolean
C0232970 (UMLS CUI [1])
C0015787 (UMLS CUI [2])
C0079399 (UMLS CUI [3,1])
C0036899 (UMLS CUI [3,2])
C0079399 (UMLS CUI [4,1])
C0241028 (UMLS CUI [4,2])
C0700589 (UMLS CUI [4,3])
C0079399 (UMLS CUI [5,1])
C0241028 (UMLS CUI [5,2])
C0430057 (UMLS CUI [5,3])
Age
Item
male or female, aged greater than or equal to 18 years
boolean
C0001779 (UMLS CUI [1])
Item Group
C0680251 (UMLS CUI)
Clozapine | Injection of depot antipsychotic agent | Risperdal Consta Depot Preparation
Item
participants on clozapine, any conventional depot neuroleptic or risperdal consta during the last 3 months
boolean
C0009079 (UMLS CUI [1])
C2585377 (UMLS CUI [2])
C1320098 (UMLS CUI [3,1])
C0086129 (UMLS CUI [3,2])
Medical condition Serious Unstable | Laboratory test result abnormal
Item
participants with serious unstable medical condition, including known clinically relevant laboratory abnormalities
boolean
C3843040 (UMLS CUI [1,1])
C0205404 (UMLS CUI [1,2])
C0443343 (UMLS CUI [1,3])
C0438215 (UMLS CUI [2])
Tardive Dyskinesia | Symptoms Tardive Dyskinesia | Twitching | Jerking movements
Item
participants with history or current symptoms of tardive dyskinesia (twitching or jerking movements that you cannot control in your face, tongue, or other parts of your body)
boolean
C0686347 (UMLS CUI [1])
C1457887 (UMLS CUI [2,1])
C0686347 (UMLS CUI [2,2])
C0231530 (UMLS CUI [3])
C2674421 (UMLS CUI [4])
Neuroleptic Malignant Syndrome | FEVER HIGH | Muscle Rigidity | Tremor | Confusion | Increased sweating | Tachycardia | Increase in blood pressure | Myalgia | Weakness
Item
participants with history of neuroleptic malignant syndrome (high fever, rigid muscles, shaking, confusion, sweating more than usual, increased heart rate or blood pressure, or muscle pain or weakness)
boolean
C0027849 (UMLS CUI [1])
C0743973 (UMLS CUI [2])
C0026837 (UMLS CUI [3])
C0040822 (UMLS CUI [4])
C0009676 (UMLS CUI [5])
C0700590 (UMLS CUI [6])
C0039231 (UMLS CUI [7])
C0497247 (UMLS CUI [8])
C0231528 (UMLS CUI [9])
C3714552 (UMLS CUI [10])
Substance Dependence | Exception Nicotine Dependence | Exception Caffeine dependence | Exception Betel Nut dependence
Item
participants with a current use or known history (over the past 6 months) of substance dependence except for nicotine, caffeine, and betal nut according to dsm-iv criteria
boolean
C0038580 (UMLS CUI [1])
C1705847 (UMLS CUI [2,1])
C0028043 (UMLS CUI [2,2])
C1705847 (UMLS CUI [3,1])
C1386553 (UMLS CUI [3,2])
C1705847 (UMLS CUI [4,1])
C0684282 (UMLS CUI [4,2])
C0085281 (UMLS CUI [4,3])
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