ID

14357

Descrição

A Randomized, Active-controlled, Double-blind, Parallel-Goup Study of the Efficacy and Safety of Extended Release(ER) Paliperidone in the Treatment of Schizophrenia; ODM derived from: https://clinicaltrials.gov/show/NCT00350467

Link

https://clinicaltrials.gov/show/NCT00350467

Palavras-chave

  1. 12/04/2016 12/04/2016 -
Transferido a

12 de abril de 2016

DOI

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Licença

Creative Commons BY 4.0

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Eligibility Acute Schizophrenia NCT00350467

Eligibility Acute Schizophrenia NCT00350467

Inclusion Criteria
Descrição

Inclusion Criteria

Alias
UMLS CUI
C1512693
patients (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
Descrição

Informed Consent

Tipo de dados

boolean

Alias
UMLS CUI [1]
C0021430
dsm-iv diagnosis of schizophrenia (295.10, 295.20, 295.30, 295.60, 295.90) at entry
Descrição

Schizophrenia

Tipo de dados

boolean

Alias
UMLS CUI [1]
C0036341
total panss score at screening and baseline between 60 and 120, inclusive
Descrição

Positive and negative syndrome scale

Tipo de dados

boolean

Alias
UMLS CUI [1]
C0451383
female patients must be postmenopausal for at least 1 year, surgically sterile, or practicing an effective method of birth control (e.g., prescription oral contraceptives, contraceptive injections, intrauterine device, double-barrier method, contraceptive patch) before entry (and agree to continue that method throughout the study) - abstinence is not an acceptable method
Descrição

Contraceptive methods

Tipo de dados

boolean

Alias
UMLS CUI [1]
C0700589
UMLS CUI [2]
C0232970
have a negative urine b hcg pregnancy test at screening
Descrição

Urine pregnancy test negative

Tipo de dados

boolean

Alias
UMLS CUI [1]
C0430057
capable of self-administering study drug, or has consistent help and support available throughout the study to do this
Descrição

Standard Drug Stability Study

Tipo de dados

boolean

Alias
UMLS CUI [1]
C3272550
Exclusion Criteria
Descrição

Exclusion Criteria

Alias
UMLS CUI
C0680251
a dsm-iv (diagnostic and statistical manual of mental disorders) axis i diagnosis other than schizophrenia
Descrição

Axis I diagnosis

Tipo de dados

boolean

Alias
UMLS CUI [1]
C0270287
inability to swallow the study drug whole with the aid of water (participants may not chew, divide, dissolve, or crush the study drug, as this may affect the release profile)
Descrição

Ability to swallow

Tipo de dados

boolean

Alias
UMLS CUI [1]
C0566355
previous history of a lack of response to any antipsychotic (lack of response defined as subject having had least twice a documented medical history of no clinical response despite adequate doses and durations of treatment, or the inability to tolerate effective doses)
Descrição

Antipsychotic Agents

Tipo de dados

boolean

Alias
UMLS CUI [1]
C0040615
significant risk of suicidal or violent behavior
Descrição

At risk for suicide

Tipo de dados

boolean

Alias
UMLS CUI [1]
C0563664
injection of a depot antipsychotic within 120 days before screening, or use of paliperidone palmitate within 10 months before screening
Descrição

Injection of depot antipsychotic agent

Tipo de dados

boolean

Alias
UMLS CUI [1]
C2585377
use of monoamine oxidase inhibitors within 4 weeks before screening
Descrição

Monoamine Oxidase Inhibitors

Tipo de dados

boolean

Alias
UMLS CUI [1]
C0026457
use of antidepressants other than monoamine oxidase inhibitors or mood stabilizers (e.g., antiepileptics, lithium) within 2 weeks before screening
Descrição

Antidepressive Agents

Tipo de dados

boolean

Alias
UMLS CUI [1]
C0003289
received electroconvulsive therapy within 3 months before screening
Descrição

Electroconvulsive Therapy

Tipo de dados

boolean

Alias
UMLS CUI [1]
C0013806

Similar models

Eligibility Acute Schizophrenia NCT00350467

Name
Tipo
Description | Question | Decode (Coded Value)
Tipo de dados
Alias
Item Group
C1512693 (UMLS CUI)
Informed Consent
Item
patients (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])
Schizophrenia
Item
dsm-iv diagnosis of schizophrenia (295.10, 295.20, 295.30, 295.60, 295.90) at entry
boolean
C0036341 (UMLS CUI [1])
Positive and negative syndrome scale
Item
total panss score at screening and baseline between 60 and 120, inclusive
boolean
C0451383 (UMLS CUI [1])
Contraceptive methods
Item
female patients must be postmenopausal for at least 1 year, surgically sterile, or practicing an effective method of birth control (e.g., prescription oral contraceptives, contraceptive injections, intrauterine device, double-barrier method, contraceptive patch) before entry (and agree to continue that method throughout the study) - abstinence is not an acceptable method
boolean
C0700589 (UMLS CUI [1])
C0232970 (UMLS CUI [2])
Urine pregnancy test negative
Item
have a negative urine b hcg pregnancy test at screening
boolean
C0430057 (UMLS CUI [1])
Standard Drug Stability Study
Item
capable of self-administering study drug, or has consistent help and support available throughout the study to do this
boolean
C3272550 (UMLS CUI [1])
Item Group
C0680251 (UMLS CUI)
Axis I diagnosis
Item
a dsm-iv (diagnostic and statistical manual of mental disorders) axis i diagnosis other than schizophrenia
boolean
C0270287 (UMLS CUI [1])
Ability to swallow
Item
inability to swallow the study drug whole with the aid of water (participants may not chew, divide, dissolve, or crush the study drug, as this may affect the release profile)
boolean
C0566355 (UMLS CUI [1])
Antipsychotic Agents
Item
previous history of a lack of response to any antipsychotic (lack of response defined as subject having had least twice a documented medical history of no clinical response despite adequate doses and durations of treatment, or the inability to tolerate effective doses)
boolean
C0040615 (UMLS CUI [1])
At risk for suicide
Item
significant risk of suicidal or violent behavior
boolean
C0563664 (UMLS CUI [1])
Injection of depot antipsychotic agent
Item
injection of a depot antipsychotic within 120 days before screening, or use of paliperidone palmitate within 10 months before screening
boolean
C2585377 (UMLS CUI [1])
Monoamine Oxidase Inhibitors
Item
use of monoamine oxidase inhibitors within 4 weeks before screening
boolean
C0026457 (UMLS CUI [1])
Antidepressive Agents
Item
use of antidepressants other than monoamine oxidase inhibitors or mood stabilizers (e.g., antiepileptics, lithium) within 2 weeks before screening
boolean
C0003289 (UMLS CUI [1])
Electroconvulsive Therapy
Item
received electroconvulsive therapy within 3 months before screening
boolean
C0013806 (UMLS CUI [1])

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