ID

37173

Descrição

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

Link

https://clinicaltrials.gov/show/NCT02086786

Palavras-chave

Versões (1)
  1. 06/07/2019 06/07/2019 -
Titular dos direitos

See clinicaltrials.gov

Transferido a

6 de julho de 2019

DOI

Para um pedido faça login.

Licença

Creative Commons BY 4.0
Comentários do modelo :

Aqui pode comentar o modelo. Pode comentá-lo especificamente através dos balões de texto nos grupos de itens e itens.

Voltar para os comentários do modelo
Comentários do grupo de itens para :

Comentários do item para :

Para descarregar formulários, precisa de ter uma sessão iniciada. Por favor faça login ou registe-se gratuitamente.

Eligibility Schizophrenia NCT02086786

Inglês

Eligibility Schizophrenia NCT02086786

1 Formulários  
Inclusion Criteria
Descrição

Inclusion Criteria

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

Informed Consent

Tipo de dados

boolean

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

Age

Tipo de dados

boolean

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

Schizophrenia

Tipo de dados

boolean

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

Body mass index

Tipo de dados

boolean

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

Stable status Medical | Stable status Psychiatric

Tipo de dados

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.
Descrição

Risperidone Dose Stable U/day | Maintenance therapy

Tipo de dados

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.
Descrição

PANSS Clinical Classification

Tipo de dados

boolean

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

Use of Contraceptive method

Tipo de dados

boolean

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

Washout Illicit medication

Tipo de dados

boolean

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

Exclusion Criteria

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

Informed Consent Third Party

Tipo de dados

boolean

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

Prisoners

Tipo de dados

boolean

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

Breast Feeding | Pregnancy test positive

Tipo de dados

boolean

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

Medical condition Unstable Uncontrolled

Tipo de dados

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.
Descrição

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

Tipo de dados

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.
Descrição

Neuroleptic Malignant Syndrome

Tipo de dados

boolean

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

Tardive Dyskinesia

Tipo de dados

boolean

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

Urine drug screen positive | Alcohol Screen Positive

Tipo de dados

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.
Descrição

At risk for deliberate self harm Columbia suicide severity rating scale

Tipo de dados

boolean

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

Antidepressive Agents Quantity

Tipo de dados

boolean

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

Depot Antipsychotic Agents

Tipo de dados

boolean

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

CYP3A4 Inducers Strong | CYP3A4 Inducers Moderate

Tipo de dados

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.
Descrição

Electroconvulsive Therapy

Tipo de dados

boolean

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

Investigational New Drugs

Tipo de dados

boolean

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

Risperidone allergy | Risperidone allergy Suspected

Tipo de dados

boolean

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

Risperidone Therapy non-responder Previous

Tipo de dados

boolean

Alias
UMLS CUI [1,1]
C0073393
UMLS CUI [1,2]
C0919875
UMLS CUI [1,3]
C0205156
Voltar ao início da página

Similar models

Eligibility Schizophrenia NCT02086786

1 Formulários
Name
Tipo
Description | Question | Decode (Coded Value)
Tipo de dados
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])
Voltar ao início da página 

Contacto

Use este formulário para feedback, perguntas e sugestões de aperfeiçoamento.

Campos marcados com * são obrigatórios.

Ajuda

Do you need help on how to use the search function? Please watch the corresponding tutorial video for more details and learn how to use the search function most efficiently.

Watch Tutorial