ID

32230

Descripción

Lithium Drug-Drug Interaction Study With Lurasidone HCl; ODM derived from: https://clinicaltrials.gov/show/NCT01074073

Link

https://clinicaltrials.gov/show/NCT01074073

Palabras clave

Versiones (1)
  1. 24/10/18 24/10/18 -
Titular de derechos de autor

See clinicaltrials.gov

Subido en

24 de octubre de 2018

DOI

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Licencia

Creative Commons BY 4.0
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Eligibility Schizophrenia NCT01074073

Inglés

Eligibility Schizophrenia NCT01074073

1 formularios  
Inclusion Criteria
Descripción

Inclusion Criteria

Alias
UMLS CUI
C1512693
1. diagnosis of schizophrenia, schizoaffective disorder, or schizophreniform.
Descripción

Schizophrenia | Schizoaffective Disorder | Schizophreniform Disorders

Tipo de datos

boolean

Alias
UMLS CUI [1]
C0036341
UMLS CUI [2]
C0036337
UMLS CUI [3]
C0036358
2. females who participate in this study:
Descripción

Gender

Tipo de datos

boolean

Alias
UMLS CUI [1]
C0079399
are unable to have children-or-
Descripción

Infertility

Tipo de datos

boolean

Alias
UMLS CUI [1]
C0021359
are willing to remain abstinent from day -5 until 90 days after discharge;
Descripción

Sexual Abstinence Willing

Tipo de datos

boolean

Alias
UMLS CUI [1,1]
C0036899
UMLS CUI [1,2]
C0600109
3. males must be willing to remain sexually abstinent or use an effective method of birth control (e.g. condom) from day -5 until 90 days after discharge.
Descripción

Gender Sexual Abstinence Willing | Gender Contraceptive methods | Condoms, Male

Tipo de datos

boolean

Alias
UMLS CUI [1,1]
C0079399
UMLS CUI [1,2]
C0036899
UMLS CUI [1,3]
C0600109
UMLS CUI [2,1]
C0079399
UMLS CUI [2,2]
C0700589
UMLS CUI [3]
C0009653
4. able and agree to remain off of prior antipsychotic medication for the duration of the study.
Descripción

Antipsychotic Agents Absent

Tipo de datos

boolean

Alias
UMLS CUI [1,1]
C0040615
UMLS CUI [1,2]
C0332197
Exclusion Criteria
Descripción

Exclusion Criteria

Alias
UMLS CUI
C0680251
1. presence or history (within the last year) of a medical or surgical condition (e.g. gastrointestinal disease) that might interfere with the absorption, metabolism, or excretion of orally administered lurasidone.
Descripción

Medical condition Interferes with Absorption Lurasidone Oral Product | Medical condition Interferes with Metabolism Lurasidone Oral Product | Medical condition Interferes with Excretion Lurasidone Oral Product | Gastrointestinal Diseases | Operative Surgical Procedure Interferes with Absorption Lurasidone Oral Product | Operative Surgical Procedure Interferes with Metabolism Lurasidone Oral Product | Operative Surgical Procedure Interferes with Excretion Lurasidone Oral Product

Tipo de datos

boolean

Alias
UMLS CUI [1,1]
C3843040
UMLS CUI [1,2]
C0521102
UMLS CUI [1,3]
C0237442
UMLS CUI [1,4]
C3218141
UMLS CUI [2,1]
C3843040
UMLS CUI [2,2]
C0521102
UMLS CUI [2,3]
C0025519
UMLS CUI [2,4]
C3218141
UMLS CUI [3,1]
C3843040
UMLS CUI [3,2]
C0521102
UMLS CUI [3,3]
C0221102
UMLS CUI [3,4]
C3218141
UMLS CUI [4]
C0017178
UMLS CUI [5,1]
C0543467
UMLS CUI [5,2]
C0521102
UMLS CUI [5,3]
C0237442
UMLS CUI [5,4]
C3218141
UMLS CUI [6,1]
C0543467
UMLS CUI [6,2]
C0521102
UMLS CUI [6,3]
C0025519
UMLS CUI [6,4]
C3218141
UMLS CUI [7,1]
C0543467
UMLS CUI [7,2]
C0521102
UMLS CUI [7,3]
C0221102
UMLS CUI [7,4]
C3218141
2. positive test results within 30 days prior to the start of the study for:
Descripción

Positive Laboratory Test Result

Tipo de datos

boolean

Alias
UMLS CUI [1]
C1335447
3. participated in another clinical trial or receiving an investigational product within 30 days prior to drug administration.
Descripción

Study Subject Participation Status | Investigational New Drugs

Tipo de datos

boolean

Alias
UMLS CUI [1]
C2348568
UMLS CUI [2]
C0013230
4. use of concomitant medications that prolong the qt/qtc interval within 14 days prior to day - 5 to follow-up
Descripción

Pharmaceutical Preparations Causing Prolonged QT interval | Pharmaceutical Preparations Causing Prolonged QTc interval

Tipo de datos

boolean

Alias
UMLS CUI [1,1]
C0013227
UMLS CUI [1,2]
C0678227
UMLS CUI [1,3]
C0151878
UMLS CUI [2,1]
C0013227
UMLS CUI [2,2]
C0678227
UMLS CUI [2,3]
C1560305
5. use of a monoamine oxidase inhibitor within 21 days prior to day 1 to restabilization.
Descripción

Monoamine Oxidase Inhibitors

Tipo de datos

boolean

Alias
UMLS CUI [1]
C0026457
6. received depot neuroleptics unless the last injection was at least 1 treatment cycle before day -5.
Descripción

Injection of depot antipsychotic agent

Tipo de datos

boolean

Alias
UMLS CUI [1]
C2585377
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Similar models

Eligibility Schizophrenia NCT01074073

1 formularios
Name
Tipo
Description | Question | Decode (Coded Value)
Tipo de datos
Alias
Item Group
C1512693 (UMLS CUI)
Schizophrenia | Schizoaffective Disorder | Schizophreniform Disorders
Item
1. diagnosis of schizophrenia, schizoaffective disorder, or schizophreniform.
boolean
C0036341 (UMLS CUI [1])
C0036337 (UMLS CUI [2])
C0036358 (UMLS CUI [3])
Gender
Item
2. females who participate in this study:
boolean
C0079399 (UMLS CUI [1])
Infertility
Item
are unable to have children-or-
boolean
C0021359 (UMLS CUI [1])
Sexual Abstinence Willing
Item
are willing to remain abstinent from day -5 until 90 days after discharge;
boolean
C0036899 (UMLS CUI [1,1])
C0600109 (UMLS CUI [1,2])
Gender Sexual Abstinence Willing | Gender Contraceptive methods | Condoms, Male
Item
3. males must be willing to remain sexually abstinent or use an effective method of birth control (e.g. condom) from day -5 until 90 days after discharge.
boolean
C0079399 (UMLS CUI [1,1])
C0036899 (UMLS CUI [1,2])
C0600109 (UMLS CUI [1,3])
C0079399 (UMLS CUI [2,1])
C0700589 (UMLS CUI [2,2])
C0009653 (UMLS CUI [3])
Antipsychotic Agents Absent
Item
4. able and agree to remain off of prior antipsychotic medication for the duration of the study.
boolean
C0040615 (UMLS CUI [1,1])
C0332197 (UMLS CUI [1,2])
Item Group
C0680251 (UMLS CUI)
Medical condition Interferes with Absorption Lurasidone Oral Product | Medical condition Interferes with Metabolism Lurasidone Oral Product | Medical condition Interferes with Excretion Lurasidone Oral Product | Gastrointestinal Diseases | Operative Surgical Procedure Interferes with Absorption Lurasidone Oral Product | Operative Surgical Procedure Interferes with Metabolism Lurasidone Oral Product | Operative Surgical Procedure Interferes with Excretion Lurasidone Oral Product
Item
1. presence or history (within the last year) of a medical or surgical condition (e.g. gastrointestinal disease) that might interfere with the absorption, metabolism, or excretion of orally administered lurasidone.
boolean
C3843040 (UMLS CUI [1,1])
C0521102 (UMLS CUI [1,2])
C0237442 (UMLS CUI [1,3])
C3218141 (UMLS CUI [1,4])
C3843040 (UMLS CUI [2,1])
C0521102 (UMLS CUI [2,2])
C0025519 (UMLS CUI [2,3])
C3218141 (UMLS CUI [2,4])
C3843040 (UMLS CUI [3,1])
C0521102 (UMLS CUI [3,2])
C0221102 (UMLS CUI [3,3])
C3218141 (UMLS CUI [3,4])
C0017178 (UMLS CUI [4])
C0543467 (UMLS CUI [5,1])
C0521102 (UMLS CUI [5,2])
C0237442 (UMLS CUI [5,3])
C3218141 (UMLS CUI [5,4])
C0543467 (UMLS CUI [6,1])
C0521102 (UMLS CUI [6,2])
C0025519 (UMLS CUI [6,3])
C3218141 (UMLS CUI [6,4])
C0543467 (UMLS CUI [7,1])
C0521102 (UMLS CUI [7,2])
C0221102 (UMLS CUI [7,3])
C3218141 (UMLS CUI [7,4])
Positive Laboratory Test Result
Item
2. positive test results within 30 days prior to the start of the study for:
boolean
C1335447 (UMLS CUI [1])
Study Subject Participation Status | Investigational New Drugs
Item
3. participated in another clinical trial or receiving an investigational product within 30 days prior to drug administration.
boolean
C2348568 (UMLS CUI [1])
C0013230 (UMLS CUI [2])
Pharmaceutical Preparations Causing Prolonged QT interval | Pharmaceutical Preparations Causing Prolonged QTc interval
Item
4. use of concomitant medications that prolong the qt/qtc interval within 14 days prior to day - 5 to follow-up
boolean
C0013227 (UMLS CUI [1,1])
C0678227 (UMLS CUI [1,2])
C0151878 (UMLS CUI [1,3])
C0013227 (UMLS CUI [2,1])
C0678227 (UMLS CUI [2,2])
C1560305 (UMLS CUI [2,3])
Monoamine Oxidase Inhibitors
Item
5. use of a monoamine oxidase inhibitor within 21 days prior to day 1 to restabilization.
boolean
C0026457 (UMLS CUI [1])
Injection of depot antipsychotic agent
Item
6. received depot neuroleptics unless the last injection was at least 1 treatment cycle before day -5.
boolean
C2585377 (UMLS CUI [1])
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