ID

32188

Beskrivning

A Study to Evaluate Participants Satisfaction, Quality of Life and Effectiveness of Flexible-Dose of Paliperidone Extended Release (ER) in Participants With Schizophrenia, Previously Treated With Risperidone; ODM derived from: https://clinicaltrials.gov/show/NCT01010776

Länk

https://clinicaltrials.gov/show/NCT01010776

Nyckelord

Versioner (1)
  1. 2018-10-23 2018-10-23 -
Rättsinnehavare

See clinicaltrials.gov

Uppladdad den

23 oktober 2018

DOI

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Licens

Creative Commons BY 4.0
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Eligibility Schizophrenia NCT01010776

Engelsk

Eligibility Schizophrenia NCT01010776

1 Formulär  
Inclusion Criteria
Beskrivning

Inclusion Criteria

Alias
UMLS CUI
C1512693
female participants must be postmenopausal (after the time in life when a woman stops having a menstrual period) or surgically sterile or if sexually active, practicing an effective method of birth control (e.g., oral contraceptive, intrauterine device [iud- an intrauterine device made of plastic and/or copper that is inserted into the womb [uterus] by way of the vaginal canal to used to prevent pregnancy], diaphragm with spermicide [agent that kills spermatozoa] or condom [cover worn over the penis during sexual intercourse to prevent infection or pregnancy] with spermicide) throughout the study and have a negative serum beta - human chorionic gonadotropin (hcg) pregnancy test at screening
Beskrivning

Postmenopausal state | Female Sterilization | Gender Sexually active Contraceptive methods | Contraceptives, Oral | Intrauterine Devices | Vaginal contraceptive diaphragm | Vaginal Spermicides | Condom | Gender Serum pregnancy test (B-HCG) Negative

Datatyp

boolean

Alias
UMLS CUI [1]
C0232970
UMLS CUI [2]
C0015787
UMLS CUI [3,1]
C0079399
UMLS CUI [3,2]
C0241028
UMLS CUI [3,3]
C0700589
UMLS CUI [4]
C0009905
UMLS CUI [5]
C0021900
UMLS CUI [6]
C0042241
UMLS CUI [7]
C0087145
UMLS CUI [8]
C0677582
UMLS CUI [9,1]
C0079399
UMLS CUI [9,2]
C0430060
UMLS CUI [9,3]
C1513916
participants on oral monotherapy (treatment with a single drug) with risperidone in a regimen within the daily dosage recommended by the package insert and adhering to the prescribed risperidone regimen for at least 30 days before entering the study
Beskrivning

Risperidone Oral Daily Dose

Datatyp

boolean

Alias
UMLS CUI [1,1]
C0073393
UMLS CUI [1,2]
C1527415
UMLS CUI [1,3]
C2348070
participants with partial response to the current risperidone regimen (persistent symptoms or unstable clinical condition) or presence of unbearable side effects
Beskrivning

Risperidone | Partial therapeutic response | Symptoms Persistent | Clinical status Unstable | Side effects Severe

Datatyp

boolean

Alias
UMLS CUI [1]
C0073393
UMLS CUI [2]
C1275833
UMLS CUI [3,1]
C1457887
UMLS CUI [3,2]
C0205322
UMLS CUI [4,1]
C0449440
UMLS CUI [4,2]
C0443343
UMLS CUI [5,1]
C0879626
UMLS CUI [5,2]
C0205082
potential participants switching to another atypical antipsychotic due to their clinical response and/or side effects profile.
Beskrivning

Change Atypical antipsychotic Other | Etiology Clinical Response | Etiology Side effects

Datatyp

boolean

Alias
UMLS CUI [1,1]
C0392747
UMLS CUI [1,2]
C1276996
UMLS CUI [1,3]
C0205394
UMLS CUI [2,1]
C0015127
UMLS CUI [2,2]
C4055223
UMLS CUI [3,1]
C0015127
UMLS CUI [3,2]
C0879626
Exclusion Criteria
Beskrivning

Exclusion Criteria

Alias
UMLS CUI
C0680251
participants with past or current history of psychiatric disease other than schizophrenia according to diagnostic and statistical manual of mental disorders (dsm)-iv
Beskrivning

Mental disorders | Exception Schizophrenia

Datatyp

boolean

Alias
UMLS CUI [1]
C0004936
UMLS CUI [2,1]
C1705847
UMLS CUI [2,2]
C0036341
participants with concomitant (given at the same time) severe (very serious, life threatening) medical or neurological disorder or risk of suicide
Beskrivning

Comorbidity Severe | Comorbidity Life Threatening | Nervous system disorder Severe | Nervous system disorder Life Threatening | At risk for suicide

Datatyp

boolean

Alias
UMLS CUI [1,1]
C0009488
UMLS CUI [1,2]
C0205082
UMLS CUI [2,1]
C0009488
UMLS CUI [2,2]
C2826244
UMLS CUI [3,1]
C0027765
UMLS CUI [3,2]
C0205082
UMLS CUI [4,1]
C0027765
UMLS CUI [4,2]
C2826244
UMLS CUI [5]
C0563664
participants previously using clozapine
Beskrivning

Clozapine

Datatyp

boolean

Alias
UMLS CUI [1]
C0009079
participants with a history of previous non-responsiveness to oral antipsychotic treatment
Beskrivning

Antipsychotic Agents Oral Unresponsive to Treatment

Datatyp

boolean

Alias
UMLS CUI [1,1]
C0040615
UMLS CUI [1,2]
C1527415
UMLS CUI [1,3]
C0205269
pregnant or breast-feeding female participants
Beskrivning

Pregnancy | Breast Feeding

Datatyp

boolean

Alias
UMLS CUI [1]
C0032961
UMLS CUI [2]
C0006147
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Similar models

Eligibility Schizophrenia NCT01010776

1 Formulär
Name
Typ
Description | Question | Decode (Coded Value)
Datatyp
Alias
Item Group
C1512693 (UMLS CUI)
Postmenopausal state | Female Sterilization | Gender Sexually active Contraceptive methods | Contraceptives, Oral | Intrauterine Devices | Vaginal contraceptive diaphragm | Vaginal Spermicides | Condom | Gender Serum pregnancy test (B-HCG) Negative
Item
female participants must be postmenopausal (after the time in life when a woman stops having a menstrual period) or surgically sterile or if sexually active, practicing an effective method of birth control (e.g., oral contraceptive, intrauterine device [iud- an intrauterine device made of plastic and/or copper that is inserted into the womb [uterus] by way of the vaginal canal to used to prevent pregnancy], diaphragm with spermicide [agent that kills spermatozoa] or condom [cover worn over the penis during sexual intercourse to prevent infection or pregnancy] with spermicide) throughout the study and have a negative serum beta - human chorionic gonadotropin (hcg) pregnancy test at screening
boolean
C0232970 (UMLS CUI [1])
C0015787 (UMLS CUI [2])
C0079399 (UMLS CUI [3,1])
C0241028 (UMLS CUI [3,2])
C0700589 (UMLS CUI [3,3])
C0009905 (UMLS CUI [4])
C0021900 (UMLS CUI [5])
C0042241 (UMLS CUI [6])
C0087145 (UMLS CUI [7])
C0677582 (UMLS CUI [8])
C0079399 (UMLS CUI [9,1])
C0430060 (UMLS CUI [9,2])
C1513916 (UMLS CUI [9,3])
Risperidone Oral Daily Dose
Item
participants on oral monotherapy (treatment with a single drug) with risperidone in a regimen within the daily dosage recommended by the package insert and adhering to the prescribed risperidone regimen for at least 30 days before entering the study
boolean
C0073393 (UMLS CUI [1,1])
C1527415 (UMLS CUI [1,2])
C2348070 (UMLS CUI [1,3])
Risperidone | Partial therapeutic response | Symptoms Persistent | Clinical status Unstable | Side effects Severe
Item
participants with partial response to the current risperidone regimen (persistent symptoms or unstable clinical condition) or presence of unbearable side effects
boolean
C0073393 (UMLS CUI [1])
C1275833 (UMLS CUI [2])
C1457887 (UMLS CUI [3,1])
C0205322 (UMLS CUI [3,2])
C0449440 (UMLS CUI [4,1])
C0443343 (UMLS CUI [4,2])
C0879626 (UMLS CUI [5,1])
C0205082 (UMLS CUI [5,2])
Change Atypical antipsychotic Other | Etiology Clinical Response | Etiology Side effects
Item
potential participants switching to another atypical antipsychotic due to their clinical response and/or side effects profile.
boolean
C0392747 (UMLS CUI [1,1])
C1276996 (UMLS CUI [1,2])
C0205394 (UMLS CUI [1,3])
C0015127 (UMLS CUI [2,1])
C4055223 (UMLS CUI [2,2])
C0015127 (UMLS CUI [3,1])
C0879626 (UMLS CUI [3,2])
Item Group
C0680251 (UMLS CUI)
Mental disorders | Exception Schizophrenia
Item
participants with past or current history of psychiatric disease other than schizophrenia according to diagnostic and statistical manual of mental disorders (dsm)-iv
boolean
C0004936 (UMLS CUI [1])
C1705847 (UMLS CUI [2,1])
C0036341 (UMLS CUI [2,2])
Comorbidity Severe | Comorbidity Life Threatening | Nervous system disorder Severe | Nervous system disorder Life Threatening | At risk for suicide
Item
participants with concomitant (given at the same time) severe (very serious, life threatening) medical or neurological disorder or risk of suicide
boolean
C0009488 (UMLS CUI [1,1])
C0205082 (UMLS CUI [1,2])
C0009488 (UMLS CUI [2,1])
C2826244 (UMLS CUI [2,2])
C0027765 (UMLS CUI [3,1])
C0205082 (UMLS CUI [3,2])
C0027765 (UMLS CUI [4,1])
C2826244 (UMLS CUI [4,2])
C0563664 (UMLS CUI [5])
Clozapine
Item
participants previously using clozapine
boolean
C0009079 (UMLS CUI [1])
Antipsychotic Agents Oral Unresponsive to Treatment
Item
participants with a history of previous non-responsiveness to oral antipsychotic treatment
boolean
C0040615 (UMLS CUI [1,1])
C1527415 (UMLS CUI [1,2])
C0205269 (UMLS CUI [1,3])
Pregnancy | Breast Feeding
Item
pregnant or breast-feeding female participants
boolean
C0032961 (UMLS CUI [1])
C0006147 (UMLS CUI [2])
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