ID

37173

Description

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

Link

https://clinicaltrials.gov/show/NCT02086786

Keywords

Versions (1)
  1. 7/6/19 7/6/19 -
Copyright Holder

See clinicaltrials.gov

Uploaded on

July 6, 2019

DOI

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License

Creative Commons BY 4.0
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Eligibility Schizophrenia NCT02086786

English

Eligibility Schizophrenia NCT02086786

1 forms  
Inclusion Criteria
Description

Inclusion Criteria

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

Informed Consent

Data type

boolean

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

Age

Data type

boolean

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

Schizophrenia

Data type

boolean

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

Body mass index

Data type

boolean

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

Stable status Medical | Stable status Psychiatric

Data type

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

Data type

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

Data type

boolean

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

Use of Contraceptive method

Data type

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

Data type

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

Data type

boolean

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

Prisoners

Data type

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

Data type

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

Data type

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

Data type

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

Data type

boolean

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

Tardive Dyskinesia

Data type

boolean

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

Urine drug screen positive | Alcohol Screen Positive

Data type

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

Data type

boolean

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

Antidepressive Agents Quantity

Data type

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

Data type

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

Data type

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

Data type

boolean

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

Investigational New Drugs

Data type

boolean

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

Risperidone allergy | Risperidone allergy Suspected

Data type

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

Data type

boolean

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

Eligibility Schizophrenia NCT02086786

1 forms
Name
Type
Description | Question | Decode (Coded Value)
Data type
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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