ID

37173

Description

Pharmacokinetics and Tolerability Study of Risperidone ISM® in Schizophrenia; ODM derived from: https://clinicaltrials.gov/show/NCT02086786

Lien

https://clinicaltrials.gov/show/NCT02086786

Mots-clés

  1. 06/07/2019 06/07/2019 -
Détendeur de droits

See clinicaltrials.gov

Téléchargé le

6 juillet 2019

DOI

Pour une demande vous connecter.

Licence

Creative Commons BY 4.0

Modèle Commentaires :

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Eligibility Schizophrenia NCT02086786

Eligibility Schizophrenia NCT02086786

Inclusion Criteria
Description

Inclusion Criteria

Alias
UMLS CUI
C1512693
1. capable of providing informed consent.
Description

Informed Consent

Type de données

boolean

Alias
UMLS CUI [1]
C0021430
2. male or female aged ≥18 years to ≤65 years.
Description

Age

Type de données

boolean

Alias
UMLS CUI [1]
C0001779
3. current diagnosis of schizophrenia, according to diagnostic and statistical manual
Description

Schizophrenia

Type de données

boolean

Alias
UMLS CUI [1]
C0036341
4. body mass index (bmi) ≥17 kg/m2 but ≤35 kg/m2.
Description

Body mass index

Type de données

boolean

Alias
UMLS CUI [1]
C1305855
5. medically stable over the last month, and psychiatrically stable
Description

Stable status Medical | Stable status Psychiatric

Type de données

boolean

Alias
UMLS CUI [1,1]
C0205360
UMLS CUI [1,2]
C0205476
UMLS CUI [2,1]
C0205360
UMLS CUI [2,2]
C0205487
6. on oral stable dosage of risperidone ≥4 mg daily as maintenance therapy.
Description

Risperidone Dose Stable U/day | Maintenance therapy

Type de données

boolean

Alias
UMLS CUI [1,1]
C0073393
UMLS CUI [1,2]
C0178602
UMLS CUI [1,3]
C0205360
UMLS CUI [1,4]
C0456683
UMLS CUI [2]
C0677908
7. total score ≤70 on the positive and negative syndrome scale.
Description

PANSS Clinical Classification

Type de données

boolean

Alias
UMLS CUI [1]
C4086747
8. using a medically accepted contraceptive method
Description

Use of Contraceptive method

Type de données

boolean

Alias
UMLS CUI [1,1]
C1524063
UMLS CUI [1,2]
C0700589
9. agrees to washout all prohibited medications prior to baseline (day -1)
Description

Washout Illicit medication

Type de données

boolean

Alias
UMLS CUI [1,1]
C1710661
UMLS CUI [1,2]
C0281875
Exclusion Criteria
Description

Exclusion Criteria

Alias
UMLS CUI
C0680251
1. informed consent obtained from a third party.
Description

Informed Consent Third Party

Type de données

boolean

Alias
UMLS CUI [1,1]
C0021430
UMLS CUI [1,2]
C1698594
2. prisoners or patients who are compulsorily detained.
Description

Prisoners

Type de données

boolean

Alias
UMLS CUI [1]
C0033167
3. females who are breast-feeding and/or who have a positive pregnancy test.
Description

Breast Feeding | Pregnancy test positive

Type de données

boolean

Alias
UMLS CUI [1]
C0006147
UMLS CUI [2]
C0240802
4. presence of an uncontrolled, unstable clinically significant medical condition.
Description

Medical condition Unstable Uncontrolled

Type de données

boolean

Alias
UMLS CUI [1,1]
C3843040
UMLS CUI [1,2]
C0443343
UMLS CUI [1,3]
C0205318
5. positive serology for hepatitis b, hepatitis c or anti-hiv 1 and 2 at screening.
Description

Serology positive Hepatitis B | Serology positive Hepatitis C | Serology positive HIV-1 antibody | Serology positive HIV-2 antibody

Type de données

boolean

Alias
UMLS CUI [1,1]
C0242089
UMLS CUI [1,2]
C0019163
UMLS CUI [2,1]
C0242089
UMLS CUI [2,2]
C0019196
UMLS CUI [3,1]
C0242089
UMLS CUI [3,2]
C0369497
UMLS CUI [4,1]
C0242089
UMLS CUI [4,2]
C0369500
6. history of neuroleptic malignant syndrome.
Description

Neuroleptic Malignant Syndrome

Type de données

boolean

Alias
UMLS CUI [1]
C0027849
7. current or past history of tardive dyskinesia.
Description

Tardive Dyskinesia

Type de données

boolean

Alias
UMLS CUI [1]
C0686347
8. positive urine drug or alcohol screen finding.
Description

Urine drug screen positive | Alcohol Screen Positive

Type de données

boolean

Alias
UMLS CUI [1]
C0743300
UMLS CUI [2,1]
C0001962
UMLS CUI [2,2]
C0220908
UMLS CUI [2,3]
C1514241
9. risk of committing self-harm or harm based on columbia suicidal rating scale.
Description

At risk for deliberate self harm Columbia suicide severity rating scale

Type de données

boolean

Alias
UMLS CUI [1,1]
C1276053
UMLS CUI [1,2]
C3888485
10. taking more than one antidepressant.
Description

Antidepressive Agents Quantity

Type de données

boolean

Alias
UMLS CUI [1,1]
C0003289
UMLS CUI [1,2]
C1265611
11. use of depot antipsychotics within the last three months.
Description

Depot Antipsychotic Agents

Type de données

boolean

Alias
UMLS CUI [1,1]
C0086129
UMLS CUI [1,2]
C0040615
12. use of strong or moderate cytochrome p450 isoenzyme 3a4inducers
Description

CYP3A4 Inducers Strong | CYP3A4 Inducers Moderate

Type de données

boolean

Alias
UMLS CUI [1,1]
C3850041
UMLS CUI [1,2]
C0442821
UMLS CUI [2,1]
C3850041
UMLS CUI [2,2]
C0205081
13. use of electroconvulsive therapy (ect) within the last three months.
Description

Electroconvulsive Therapy

Type de données

boolean

Alias
UMLS CUI [1]
C0013806
14. receipt of any investigational drugs within the last three months.
Description

Investigational New Drugs

Type de données

boolean

Alias
UMLS CUI [1]
C0013230
15. known or suspected allergy or hypersensitivity to risperidone
Description

Risperidone allergy | Risperidone allergy Suspected

Type de données

boolean

Alias
UMLS CUI [1]
C0570837
UMLS CUI [2,1]
C0570837
UMLS CUI [2,2]
C0750491
16. previous non-responder to risperidone treatment.
Description

Risperidone Therapy non-responder Previous

Type de données

boolean

Alias
UMLS CUI [1,1]
C0073393
UMLS CUI [1,2]
C0919875
UMLS CUI [1,3]
C0205156

Similar models

Eligibility Schizophrenia NCT02086786

Name
Type
Description | Question | Decode (Coded Value)
Type de données
Alias
Item Group
C1512693 (UMLS CUI)
Informed Consent
Item
1. capable of providing informed consent.
boolean
C0021430 (UMLS CUI [1])
Age
Item
2. male or female aged ≥18 years to ≤65 years.
boolean
C0001779 (UMLS CUI [1])
Schizophrenia
Item
3. current diagnosis of schizophrenia, according to diagnostic and statistical manual
boolean
C0036341 (UMLS CUI [1])
Body mass index
Item
4. body mass index (bmi) ≥17 kg/m2 but ≤35 kg/m2.
boolean
C1305855 (UMLS CUI [1])
Stable status Medical | Stable status Psychiatric
Item
5. medically stable over the last month, and psychiatrically stable
boolean
C0205360 (UMLS CUI [1,1])
C0205476 (UMLS CUI [1,2])
C0205360 (UMLS CUI [2,1])
C0205487 (UMLS CUI [2,2])
Risperidone Dose Stable U/day | Maintenance therapy
Item
6. on oral stable dosage of risperidone ≥4 mg daily as maintenance therapy.
boolean
C0073393 (UMLS CUI [1,1])
C0178602 (UMLS CUI [1,2])
C0205360 (UMLS CUI [1,3])
C0456683 (UMLS CUI [1,4])
C0677908 (UMLS CUI [2])
PANSS Clinical Classification
Item
7. total score ≤70 on the positive and negative syndrome scale.
boolean
C4086747 (UMLS CUI [1])
Use of Contraceptive method
Item
8. using a medically accepted contraceptive method
boolean
C1524063 (UMLS CUI [1,1])
C0700589 (UMLS CUI [1,2])
Washout Illicit medication
Item
9. agrees to washout all prohibited medications prior to baseline (day -1)
boolean
C1710661 (UMLS CUI [1,1])
C0281875 (UMLS CUI [1,2])
Item Group
C0680251 (UMLS CUI)
Informed Consent Third Party
Item
1. informed consent obtained from a third party.
boolean
C0021430 (UMLS CUI [1,1])
C1698594 (UMLS CUI [1,2])
Prisoners
Item
2. prisoners or patients who are compulsorily detained.
boolean
C0033167 (UMLS CUI [1])
Breast Feeding | Pregnancy test positive
Item
3. females who are breast-feeding and/or who have a positive pregnancy test.
boolean
C0006147 (UMLS CUI [1])
C0240802 (UMLS CUI [2])
Medical condition Unstable Uncontrolled
Item
4. presence of an uncontrolled, unstable clinically significant medical condition.
boolean
C3843040 (UMLS CUI [1,1])
C0443343 (UMLS CUI [1,2])
C0205318 (UMLS CUI [1,3])
Serology positive Hepatitis B | Serology positive Hepatitis C | Serology positive HIV-1 antibody | Serology positive HIV-2 antibody
Item
5. positive serology for hepatitis b, hepatitis c or anti-hiv 1 and 2 at screening.
boolean
C0242089 (UMLS CUI [1,1])
C0019163 (UMLS CUI [1,2])
C0242089 (UMLS CUI [2,1])
C0019196 (UMLS CUI [2,2])
C0242089 (UMLS CUI [3,1])
C0369497 (UMLS CUI [3,2])
C0242089 (UMLS CUI [4,1])
C0369500 (UMLS CUI [4,2])
Neuroleptic Malignant Syndrome
Item
6. history of neuroleptic malignant syndrome.
boolean
C0027849 (UMLS CUI [1])
Tardive Dyskinesia
Item
7. current or past history of tardive dyskinesia.
boolean
C0686347 (UMLS CUI [1])
Urine drug screen positive | Alcohol Screen Positive
Item
8. positive urine drug or alcohol screen finding.
boolean
C0743300 (UMLS CUI [1])
C0001962 (UMLS CUI [2,1])
C0220908 (UMLS CUI [2,2])
C1514241 (UMLS CUI [2,3])
At risk for deliberate self harm Columbia suicide severity rating scale
Item
9. risk of committing self-harm or harm based on columbia suicidal rating scale.
boolean
C1276053 (UMLS CUI [1,1])
C3888485 (UMLS CUI [1,2])
Antidepressive Agents Quantity
Item
10. taking more than one antidepressant.
boolean
C0003289 (UMLS CUI [1,1])
C1265611 (UMLS CUI [1,2])
Depot Antipsychotic Agents
Item
11. use of depot antipsychotics within the last three months.
boolean
C0086129 (UMLS CUI [1,1])
C0040615 (UMLS CUI [1,2])
CYP3A4 Inducers Strong | CYP3A4 Inducers Moderate
Item
12. use of strong or moderate cytochrome p450 isoenzyme 3a4inducers
boolean
C3850041 (UMLS CUI [1,1])
C0442821 (UMLS CUI [1,2])
C3850041 (UMLS CUI [2,1])
C0205081 (UMLS CUI [2,2])
Electroconvulsive Therapy
Item
13. use of electroconvulsive therapy (ect) within the last three months.
boolean
C0013806 (UMLS CUI [1])
Investigational New Drugs
Item
14. receipt of any investigational drugs within the last three months.
boolean
C0013230 (UMLS CUI [1])
Risperidone allergy | Risperidone allergy Suspected
Item
15. known or suspected allergy or hypersensitivity to risperidone
boolean
C0570837 (UMLS CUI [1])
C0570837 (UMLS CUI [2,1])
C0750491 (UMLS CUI [2,2])
Risperidone Therapy non-responder Previous
Item
16. previous non-responder to risperidone treatment.
boolean
C0073393 (UMLS CUI [1,1])
C0919875 (UMLS CUI [1,2])
C0205156 (UMLS CUI [1,3])

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