Information:
Error:
ID
14357
Description
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
Keywords
Versions (1)
- 4/12/16 4/12/16 -
Uploaded on
April 12, 2016
DOI
To request one please log in.
License
Creative Commons BY 4.0
Model comments :
You can comment on the data model here. Via the speech bubbles at the itemgroups and items you can add comments to those specificially.
Itemgroup comments for :
Item comments for :
In order to download data models you must be logged in. Please log in or register for free.
Eligibility Acute Schizophrenia NCT00350467
Eligibility Acute Schizophrenia NCT00350467
- StudyEvent: Eligibility
Similar models
Eligibility Acute Schizophrenia NCT00350467
- StudyEvent: Eligibility
Name
Type
Description | Question | Decode (Coded Value)
Data type
Alias
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])
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])
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])