ID

23103

Beschrijving

Add-On Therapy to Risperidonein Schizophrenia; ODM derived from: https://clinicaltrials.gov/show/NCT01189006

Link

https://clinicaltrials.gov/show/NCT01189006

Trefwoorden

Versies (1)
  1. 23-06-17 23-06-17 -
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23 juni 2017

DOI

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Creative Commons BY 4.0
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Eligibility Schizophrenia NCT01189006

Engels

Eligibility Schizophrenia NCT01189006

1 Formulieren  
Inclusion Criteria
Beschrijving

Inclusion Criteria

Alias
UMLS CUI
C1512693
1. male or female patient aged ≧18 and ≦60 years.
Beschrijving

Age

Datatype

boolean

Alias
UMLS CUI [1]
C0001779
2. a diagnosis of schizophrenia or schizoaffective disorder according to dsm-iv criteria made by a specialist in psychiatry.
Beschrijving

Schizophrenia | Schizoaffective Disorder

Datatype

boolean

Alias
UMLS CUI [1]
C0036341
UMLS CUI [2]
C0036337
3. acute exacerbation of schizophrenia.
Beschrijving

Schizophrenia Exacerbation

Datatype

boolean

Alias
UMLS CUI [1,1]
C0036341
UMLS CUI [1,2]
C4086268
4. a total of panss score of at least 60 at screen.
Beschrijving

Positive and negative syndrome scale

Datatype

boolean

Alias
UMLS CUI [1]
C0451383
5. history of schizophrenia ≦ 15 years (from onset of prodromal symptoms).
Beschrijving

Schizophrenia disease length | Onset of Prodromal Symptoms

Datatype

boolean

Alias
UMLS CUI [1,1]
C0036341
UMLS CUI [1,2]
C0872146
UMLS CUI [2,1]
C0332162
UMLS CUI [2,2]
C3494358
6. signed informed consent by patient or legal representative
Beschrijving

Informed Consent | Informed Consent Patient Representative

Datatype

boolean

Alias
UMLS CUI [1]
C0021430
UMLS CUI [2,1]
C0021430
UMLS CUI [2,2]
C0030701
7. patient or a reliable caregiver can be expected to ensure acceptable compliance and visit attendance for the duration of the study.
Beschrijving

Protocol Compliance | Protocol Compliance Caregiver

Datatype

boolean

Alias
UMLS CUI [1]
C0525058
UMLS CUI [2,1]
C0525058
UMLS CUI [2,2]
C0085537
Exclusion Criteria
Beschrijving

Exclusion Criteria

Alias
UMLS CUI
C0680251
1. women of childbearing potential not using adequate contraception as per investigator judgement or not willing to comply with contraception for duration of study.
Beschrijving

Childbearing Potential Contraceptive methods Inadequate | Childbearing Potential Contraceptive methods Unwilling

Datatype

boolean

Alias
UMLS CUI [1,1]
C3831118
UMLS CUI [1,2]
C0700589
UMLS CUI [1,3]
C0205412
UMLS CUI [2,1]
C3831118
UMLS CUI [2,2]
C0700589
UMLS CUI [2,3]
C0558080
2. less than a full cycle has lapsed at time of screening following the last injection of a depot antipsychotic
Beschrijving

Injection of depot antipsychotic agent | Elapsed Time Less Than Course

Datatype

boolean

Alias
UMLS CUI [1]
C2585377
UMLS CUI [2,1]
C2826303
UMLS CUI [2,2]
C0439092
UMLS CUI [2,3]
C0750729
3. females who are pregnant or nursing.
Beschrijving

Pregnancy | Breast Feeding

Datatype

boolean

Alias
UMLS CUI [1]
C0032961
UMLS CUI [2]
C0006147
4. patient has received dextromethorphan, or other selective cyclo- oxygenase 2 inhibitors, or other anti-inflammatory medication within 1 week prior to first dose of double-blind medication.
Beschrijving

Dextromethorphan | Cyclooxygenase 2 Inhibitors | Anti-Inflammatory Agents

Datatype

boolean

Alias
UMLS CUI [1]
C0011816
UMLS CUI [2]
C1257954
UMLS CUI [3]
C0003209
5. axis-i dsm-iv diagnosis other than schizophrenia or schizoaffective disorder.
Beschrijving

Axis I diagnosis | Schizophrenia Excluded | Schizoaffective Disorder Excluded

Datatype

boolean

Alias
UMLS CUI [1]
C0270287
UMLS CUI [2,1]
C0036341
UMLS CUI [2,2]
C2828389
UMLS CUI [3,1]
C0036337
UMLS CUI [3,2]
C2828389
6. current evidence of an uncontrolled and/or clinically significant medical condition, e.g., cardiac, hepatic and renal failure that in the judgement of the investigator, would compromise patient safety or preclude study participation.
Beschrijving

Medical condition compromises Patient safety | Medical condition Study Subject Participation Status Excluded | Medical condition Uncontrolled compromises Patient safety | Medical condition Uncontrolled Study Subject Participation Status Excluded | Heart failure | Liver Failure | Kidney Failure

Datatype

boolean

Alias
UMLS CUI [1,1]
C3843040
UMLS CUI [1,2]
C2945640
UMLS CUI [1,3]
C1113679
UMLS CUI [2,1]
C3843040
UMLS CUI [2,2]
C2348568
UMLS CUI [2,3]
C2828389
UMLS CUI [3,1]
C3843040
UMLS CUI [3,2]
C0205318
UMLS CUI [3,3]
C2945640
UMLS CUI [3,4]
C1113679
UMLS CUI [4,1]
C3843040
UMLS CUI [4,2]
C0205318
UMLS CUI [4,3]
C2348568
UMLS CUI [4,4]
C2828389
UMLS CUI [5]
C0018801
UMLS CUI [6]
C0085605
UMLS CUI [7]
C0035078
7. history of intolerance to risperidone or dextromethorphan or other cox-2 inhibitors.
Beschrijving

Intolerance to Risperidone | Intolerance to Dextromethorphan | Intolerance to Cyclooxygenase 2 Inhibitors

Datatype

boolean

Alias
UMLS CUI [1,1]
C1744706
UMLS CUI [1,2]
C0073393
UMLS CUI [2,1]
C1744706
UMLS CUI [2,2]
C0011816
UMLS CUI [3,1]
C1744706
UMLS CUI [3,2]
C1257954
8. history of sensitivity reaction (e.g., urticaria, angioedema, bronchospasm, severe rhinitis, anaphylactic shock) precipitated by dextromethorphan.
Beschrijving

Sensitivity reaction Dextromethorphan induced | Urticaria | Angioedema | Bronchial Spasm | Rhinitis Severe | anaphylaxis

Datatype

boolean

Alias
UMLS CUI [1,1]
C1533294
UMLS CUI [1,2]
C0011816
UMLS CUI [1,3]
C0205263
UMLS CUI [2]
C0042109
UMLS CUI [3]
C0002994
UMLS CUI [4]
C0006266
UMLS CUI [5,1]
C0035455
UMLS CUI [5,2]
C0205082
UMLS CUI [6]
C0002792
9. patient has received electroconvulsive therapy (ect) within 4 weeks prior to first dose of double-blind medication.
Beschrijving

Electroconvulsive Therapy

Datatype

boolean

Alias
UMLS CUI [1]
C0013806
10. diagnosis of or treatment for oesophageal, gastric, pyloric channel, or duodenal ulceration or related complications (bleeding and/or perforation) within 30 days prior to receiving first dose of double-blind medication.
Beschrijving

Ulcer of esophagus | Gastric ulcer | GASTRIC ULCER PYLORIC CHANNEL | Duodenal Ulcer | Esophageal bleeding | Gastric hemorrhage | Duodenal hemorrhage | Esophageal Perforation | Perforation of stomach | PYLORIC CHANNEL PERFORATION | Duodenal perforation

Datatype

boolean

Alias
UMLS CUI [1]
C0151970
UMLS CUI [2]
C0038358
UMLS CUI [3]
C0744303
UMLS CUI [4]
C0013295
UMLS CUI [5]
C0239293
UMLS CUI [6]
C0235325
UMLS CUI [7]
C0521595
UMLS CUI [8]
C0014860
UMLS CUI [9]
C0235884
UMLS CUI [10]
C0744304
UMLS CUI [11]
C0267356
11. inclusion in another schizophrenia study or study for another indication with psychotropics within the last 30 days prior to start of study.
Beschrijving

Study Subject Participation Status | Schizophrenia | Psychotropic Drugs

Datatype

boolean

Alias
UMLS CUI [1]
C2348568
UMLS CUI [2]
C0036341
UMLS CUI [3]
C0033978
12. increase in total sgot, sgpt, gamma-gt, bun and creatinine by more than 3x uln (upper limit of normal).
Beschrijving

Aspartate aminotransferase increased | Alanine aminotransferase increased | Gamma-glutamyl transferase raised | Blood urea increased | Serum creatinine raised

Datatype

boolean

Alias
UMLS CUI [1]
C0151904
UMLS CUI [2]
C0151905
UMLS CUI [3]
C0151662
UMLS CUI [4]
C0151539
UMLS CUI [5]
C0700225
13. history of idiopathic or drug-induced agranulocytosis.
Beschrijving

Agranulocytosis idiopathic | Drug-induced neutropenia

Datatype

boolean

Alias
UMLS CUI [1,1]
C0001824
UMLS CUI [1,2]
C0332240
UMLS CUI [2]
C0272178
14. alcohol, illegal or other substance-abuse within 6 months prior to study start, as defined by dsm-iv criteria.
Beschrijving

Substance Use Disorders

Datatype

boolean

Alias
UMLS CUI [1]
C0038586
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Similar models

Eligibility Schizophrenia NCT01189006

1 Formulieren
Name
Type
Description | Question | Decode (Coded Value)
Datatype
Alias
Item Group
C1512693 (UMLS CUI)
Age
Item
1. male or female patient aged ≧18 and ≦60 years.
boolean
C0001779 (UMLS CUI [1])
Schizophrenia | Schizoaffective Disorder
Item
2. a diagnosis of schizophrenia or schizoaffective disorder according to dsm-iv criteria made by a specialist in psychiatry.
boolean
C0036341 (UMLS CUI [1])
C0036337 (UMLS CUI [2])
Schizophrenia Exacerbation
Item
3. acute exacerbation of schizophrenia.
boolean
C0036341 (UMLS CUI [1,1])
C4086268 (UMLS CUI [1,2])
Positive and negative syndrome scale
Item
4. a total of panss score of at least 60 at screen.
boolean
C0451383 (UMLS CUI [1])
Schizophrenia disease length | Onset of Prodromal Symptoms
Item
5. history of schizophrenia ≦ 15 years (from onset of prodromal symptoms).
boolean
C0036341 (UMLS CUI [1,1])
C0872146 (UMLS CUI [1,2])
C0332162 (UMLS CUI [2,1])
C3494358 (UMLS CUI [2,2])
Informed Consent | Informed Consent Patient Representative
Item
6. signed informed consent by patient or legal representative
boolean
C0021430 (UMLS CUI [1])
C0021430 (UMLS CUI [2,1])
C0030701 (UMLS CUI [2,2])
Protocol Compliance | Protocol Compliance Caregiver
Item
7. patient or a reliable caregiver can be expected to ensure acceptable compliance and visit attendance for the duration of the study.
boolean
C0525058 (UMLS CUI [1])
C0525058 (UMLS CUI [2,1])
C0085537 (UMLS CUI [2,2])
Item Group
C0680251 (UMLS CUI)
Childbearing Potential Contraceptive methods Inadequate | Childbearing Potential Contraceptive methods Unwilling
Item
1. women of childbearing potential not using adequate contraception as per investigator judgement or not willing to comply with contraception for duration of study.
boolean
C3831118 (UMLS CUI [1,1])
C0700589 (UMLS CUI [1,2])
C0205412 (UMLS CUI [1,3])
C3831118 (UMLS CUI [2,1])
C0700589 (UMLS CUI [2,2])
C0558080 (UMLS CUI [2,3])
Injection of depot antipsychotic agent | Elapsed Time Less Than Course
Item
2. less than a full cycle has lapsed at time of screening following the last injection of a depot antipsychotic
boolean
C2585377 (UMLS CUI [1])
C2826303 (UMLS CUI [2,1])
C0439092 (UMLS CUI [2,2])
C0750729 (UMLS CUI [2,3])
Pregnancy | Breast Feeding
Item
3. females who are pregnant or nursing.
boolean
C0032961 (UMLS CUI [1])
C0006147 (UMLS CUI [2])
Dextromethorphan | Cyclooxygenase 2 Inhibitors | Anti-Inflammatory Agents
Item
4. patient has received dextromethorphan, or other selective cyclo- oxygenase 2 inhibitors, or other anti-inflammatory medication within 1 week prior to first dose of double-blind medication.
boolean
C0011816 (UMLS CUI [1])
C1257954 (UMLS CUI [2])
C0003209 (UMLS CUI [3])
Axis I diagnosis | Schizophrenia Excluded | Schizoaffective Disorder Excluded
Item
5. axis-i dsm-iv diagnosis other than schizophrenia or schizoaffective disorder.
boolean
C0270287 (UMLS CUI [1])
C0036341 (UMLS CUI [2,1])
C2828389 (UMLS CUI [2,2])
C0036337 (UMLS CUI [3,1])
C2828389 (UMLS CUI [3,2])
Medical condition compromises Patient safety | Medical condition Study Subject Participation Status Excluded | Medical condition Uncontrolled compromises Patient safety | Medical condition Uncontrolled Study Subject Participation Status Excluded | Heart failure | Liver Failure | Kidney Failure
Item
6. current evidence of an uncontrolled and/or clinically significant medical condition, e.g., cardiac, hepatic and renal failure that in the judgement of the investigator, would compromise patient safety or preclude study participation.
boolean
C3843040 (UMLS CUI [1,1])
C2945640 (UMLS CUI [1,2])
C1113679 (UMLS CUI [1,3])
C3843040 (UMLS CUI [2,1])
C2348568 (UMLS CUI [2,2])
C2828389 (UMLS CUI [2,3])
C3843040 (UMLS CUI [3,1])
C0205318 (UMLS CUI [3,2])
C2945640 (UMLS CUI [3,3])
C1113679 (UMLS CUI [3,4])
C3843040 (UMLS CUI [4,1])
C0205318 (UMLS CUI [4,2])
C2348568 (UMLS CUI [4,3])
C2828389 (UMLS CUI [4,4])
C0018801 (UMLS CUI [5])
C0085605 (UMLS CUI [6])
C0035078 (UMLS CUI [7])
Intolerance to Risperidone | Intolerance to Dextromethorphan | Intolerance to Cyclooxygenase 2 Inhibitors
Item
7. history of intolerance to risperidone or dextromethorphan or other cox-2 inhibitors.
boolean
C1744706 (UMLS CUI [1,1])
C0073393 (UMLS CUI [1,2])
C1744706 (UMLS CUI [2,1])
C0011816 (UMLS CUI [2,2])
C1744706 (UMLS CUI [3,1])
C1257954 (UMLS CUI [3,2])
Sensitivity reaction Dextromethorphan induced | Urticaria | Angioedema | Bronchial Spasm | Rhinitis Severe | anaphylaxis
Item
8. history of sensitivity reaction (e.g., urticaria, angioedema, bronchospasm, severe rhinitis, anaphylactic shock) precipitated by dextromethorphan.
boolean
C1533294 (UMLS CUI [1,1])
C0011816 (UMLS CUI [1,2])
C0205263 (UMLS CUI [1,3])
C0042109 (UMLS CUI [2])
C0002994 (UMLS CUI [3])
C0006266 (UMLS CUI [4])
C0035455 (UMLS CUI [5,1])
C0205082 (UMLS CUI [5,2])
C0002792 (UMLS CUI [6])
Electroconvulsive Therapy
Item
9. patient has received electroconvulsive therapy (ect) within 4 weeks prior to first dose of double-blind medication.
boolean
C0013806 (UMLS CUI [1])
Ulcer of esophagus | Gastric ulcer | GASTRIC ULCER PYLORIC CHANNEL | Duodenal Ulcer | Esophageal bleeding | Gastric hemorrhage | Duodenal hemorrhage | Esophageal Perforation | Perforation of stomach | PYLORIC CHANNEL PERFORATION | Duodenal perforation
Item
10. diagnosis of or treatment for oesophageal, gastric, pyloric channel, or duodenal ulceration or related complications (bleeding and/or perforation) within 30 days prior to receiving first dose of double-blind medication.
boolean
C0151970 (UMLS CUI [1])
C0038358 (UMLS CUI [2])
C0744303 (UMLS CUI [3])
C0013295 (UMLS CUI [4])
C0239293 (UMLS CUI [5])
C0235325 (UMLS CUI [6])
C0521595 (UMLS CUI [7])
C0014860 (UMLS CUI [8])
C0235884 (UMLS CUI [9])
C0744304 (UMLS CUI [10])
C0267356 (UMLS CUI [11])
Study Subject Participation Status | Schizophrenia | Psychotropic Drugs
Item
11. inclusion in another schizophrenia study or study for another indication with psychotropics within the last 30 days prior to start of study.
boolean
C2348568 (UMLS CUI [1])
C0036341 (UMLS CUI [2])
C0033978 (UMLS CUI [3])
Aspartate aminotransferase increased | Alanine aminotransferase increased | Gamma-glutamyl transferase raised | Blood urea increased | Serum creatinine raised
Item
12. increase in total sgot, sgpt, gamma-gt, bun and creatinine by more than 3x uln (upper limit of normal).
boolean
C0151904 (UMLS CUI [1])
C0151905 (UMLS CUI [2])
C0151662 (UMLS CUI [3])
C0151539 (UMLS CUI [4])
C0700225 (UMLS CUI [5])
Agranulocytosis idiopathic | Drug-induced neutropenia
Item
13. history of idiopathic or drug-induced agranulocytosis.
boolean
C0001824 (UMLS CUI [1,1])
C0332240 (UMLS CUI [1,2])
C0272178 (UMLS CUI [2])
Substance Use Disorders
Item
14. alcohol, illegal or other substance-abuse within 6 months prior to study start, as defined by dsm-iv criteria.
boolean
C0038586 (UMLS CUI [1])
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