ID

37176

Description

Positron Emission Tomography (PET) Study Investigating Dopamine and Serotonin Receptor Occupancy After Multiple Oral Dosing of Lu AF35700; ODM derived from: https://clinicaltrials.gov/show/NCT02333487

Link

https://clinicaltrials.gov/show/NCT02333487

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 NCT02333487

English

Eligibility Schizophrenia NCT02333487

1 forms  
Inclusion Criteria
Description

Inclusion Criteria

Alias
UMLS CUI
C1512693
1. the patient is a man aged between ≤18 and ≥60 years
Description

Gender | Age

Data type

boolean

Alias
UMLS CUI [1]
C0079399
UMLS CUI [2]
C0001779
2. bmi of ≥19 kg/m2 to ≤ 37 kg/m2
Description

Body mass index

Data type

boolean

Alias
UMLS CUI [1]
C1305855
3. the patient has a primary diagnosis of schizophrenia according to dsm-5™ (code 295.90)
Description

Schizophrenia Principal diagnosis

Data type

boolean

Alias
UMLS CUI [1,1]
C0036341
UMLS CUI [1,2]
C0332137
4. the patient has a clinical global impression - severity of illness (cgi-s) score ≤ 4 (moderately ill) at screening and safety baseline
Description

CGI - Severity of Illness

Data type

boolean

Alias
UMLS CUI [1]
C3639887
5. the patient is currently under oral therapy with one or more of the antipsychotic medications listed in appendix ii.
Description

Antipsychotic drug therapy Oral

Data type

boolean

Alias
UMLS CUI [1,1]
C1319421
UMLS CUI [1,2]
C1527415
6. the patient has a positive and negative syndrome scale (panss) total score ≤ 80
Description

PANSS Clinical Classification

Data type

boolean

Alias
UMLS CUI [1]
C4086747
7. the patient has a score of ≤ 4 (moderate) on the following panss items at screening and at safety baseline: p7 (hostility), g8 (uncooperativeness)
Description

PANSS Clinical Classification Item score | PANSS - Hostility | PANSS - Uncooperativeness

Data type

boolean

Alias
UMLS CUI [1,1]
C4086747
UMLS CUI [1,2]
C0559741
UMLS CUI [2]
C4086697
UMLS CUI [3]
C4086710
Exclusion Criteria
Description

Exclusion Criteria

Alias
UMLS CUI
C0680251
1. the patient experienced an acute exacerbation requiring hospitalization within the last 3 months.
Description

Exacerbation Hospitalization Required

Data type

boolean

Alias
UMLS CUI [1,1]
C4086268
UMLS CUI [1,2]
C1708385
2. the patient experienced an acute exacerbation requiring change in antipsychotic medication (with reference to drug or dose) within the last 4 weeks.
Description

Exacerbation Requirement Change Antipsychotic Agents | Exacerbation Requirement Antipsychotic Agents Dosage change

Data type

boolean

Alias
UMLS CUI [1,1]
C4086268
UMLS CUI [1,2]
C1514873
UMLS CUI [1,3]
C0392747
UMLS CUI [1,4]
C0040615
UMLS CUI [2,1]
C4086268
UMLS CUI [2,2]
C1514873
UMLS CUI [2,3]
C0040615
UMLS CUI [2,4]
C0420247
3. the patient has a diagnosis or history of substance use disorder (except nicotine) according to dsm-5-tr® criteria ≤3 months prior to screening
Description

Substance Use Disorders | Exception Nicotine abuse

Data type

boolean

Alias
UMLS CUI [1]
C0038586
UMLS CUI [2,1]
C1705847
UMLS CUI [2,2]
C2363943
4. the patient is at significant risk of harming himself or others according to the investigator's judgment or as indicated by an answer of "yes" to the question 4 or 5 on the columbia-suicide severity rating scale (c-ssrs) at the screening visit within the last six months on the lifetime version of c-ssrs.
Description

At risk for deliberate self harm Columbia suicide severity rating scale | Risk of harm to others Columbia suicide severity rating scale

Data type

boolean

Alias
UMLS CUI [1,1]
C1276053
UMLS CUI [1,2]
C3888485
UMLS CUI [2,1]
C0549013
UMLS CUI [2,2]
C3888485
5. based on investigators judgment the patient has a medical or neurological disorder or treatment for such disorder that could interfere with the study treatment or impair treatment compliance.
Description

Disease Interferes with Investigational Therapy | Nervous system disorder Interferes with Investigational Therapy | Disease Impairing Treatment Compliance | Nervous system disorder Impairing Treatment Compliance

Data type

boolean

Alias
UMLS CUI [1,1]
C0012634
UMLS CUI [1,2]
C0521102
UMLS CUI [1,3]
C0949266
UMLS CUI [2,1]
C0027765
UMLS CUI [2,2]
C0521102
UMLS CUI [2,3]
C0949266
UMLS CUI [3,1]
C0012634
UMLS CUI [3,2]
C0221099
UMLS CUI [3,3]
C4319828
UMLS CUI [4,1]
C0027765
UMLS CUI [4,2]
C0221099
UMLS CUI [4,3]
C4319828
6. the patient has had past episodes of extrapyramidal symptoms (eps) under current medication within the last 6 month
Description

Episode of Extrapyramidal symptoms | Pharmacotherapy

Data type

boolean

Alias
UMLS CUI [1,1]
C0332189
UMLS CUI [1,2]
C0234133
UMLS CUI [2]
C0013216
7. the patient takes other medication than those listed as allowed concomitant medication in appendix iii
Description

Illicit medication use

Data type

boolean

Alias
UMLS CUI [1]
C0281875
8. the patient is occupationally exposed to significant levels of ionizing radiation.
Description

Exposure Occupational Ionizing radiation

Data type

boolean

Alias
UMLS CUI [1,1]
C0332157
UMLS CUI [1,2]
C0521127
UMLS CUI [1,3]
C0034538
other protocol-defined inclusion and exclusion criteria may apply
Description

Eligibility Criteria Study Protocol

Data type

boolean

Alias
UMLS CUI [1,1]
C1516637
UMLS CUI [1,2]
C2348563
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Similar models

Eligibility Schizophrenia NCT02333487

1 forms
Name
Type
Description | Question | Decode (Coded Value)
Data type
Alias
Item Group
C1512693 (UMLS CUI)
Gender | Age
Item
1. the patient is a man aged between ≤18 and ≥60 years
boolean
C0079399 (UMLS CUI [1])
C0001779 (UMLS CUI [2])
Body mass index
Item
2. bmi of ≥19 kg/m2 to ≤ 37 kg/m2
boolean
C1305855 (UMLS CUI [1])
Schizophrenia Principal diagnosis
Item
3. the patient has a primary diagnosis of schizophrenia according to dsm-5™ (code 295.90)
boolean
C0036341 (UMLS CUI [1,1])
C0332137 (UMLS CUI [1,2])
CGI - Severity of Illness
Item
4. the patient has a clinical global impression - severity of illness (cgi-s) score ≤ 4 (moderately ill) at screening and safety baseline
boolean
C3639887 (UMLS CUI [1])
Antipsychotic drug therapy Oral
Item
5. the patient is currently under oral therapy with one or more of the antipsychotic medications listed in appendix ii.
boolean
C1319421 (UMLS CUI [1,1])
C1527415 (UMLS CUI [1,2])
PANSS Clinical Classification
Item
6. the patient has a positive and negative syndrome scale (panss) total score ≤ 80
boolean
C4086747 (UMLS CUI [1])
PANSS Clinical Classification Item score | PANSS - Hostility | PANSS - Uncooperativeness
Item
7. the patient has a score of ≤ 4 (moderate) on the following panss items at screening and at safety baseline: p7 (hostility), g8 (uncooperativeness)
boolean
C4086747 (UMLS CUI [1,1])
C0559741 (UMLS CUI [1,2])
C4086697 (UMLS CUI [2])
C4086710 (UMLS CUI [3])
Item Group
C0680251 (UMLS CUI)
Exacerbation Hospitalization Required
Item
1. the patient experienced an acute exacerbation requiring hospitalization within the last 3 months.
boolean
C4086268 (UMLS CUI [1,1])
C1708385 (UMLS CUI [1,2])
Exacerbation Requirement Change Antipsychotic Agents | Exacerbation Requirement Antipsychotic Agents Dosage change
Item
2. the patient experienced an acute exacerbation requiring change in antipsychotic medication (with reference to drug or dose) within the last 4 weeks.
boolean
C4086268 (UMLS CUI [1,1])
C1514873 (UMLS CUI [1,2])
C0392747 (UMLS CUI [1,3])
C0040615 (UMLS CUI [1,4])
C4086268 (UMLS CUI [2,1])
C1514873 (UMLS CUI [2,2])
C0040615 (UMLS CUI [2,3])
C0420247 (UMLS CUI [2,4])
Substance Use Disorders | Exception Nicotine abuse
Item
3. the patient has a diagnosis or history of substance use disorder (except nicotine) according to dsm-5-tr® criteria ≤3 months prior to screening
boolean
C0038586 (UMLS CUI [1])
C1705847 (UMLS CUI [2,1])
C2363943 (UMLS CUI [2,2])
At risk for deliberate self harm Columbia suicide severity rating scale | Risk of harm to others Columbia suicide severity rating scale
Item
4. the patient is at significant risk of harming himself or others according to the investigator's judgment or as indicated by an answer of "yes" to the question 4 or 5 on the columbia-suicide severity rating scale (c-ssrs) at the screening visit within the last six months on the lifetime version of c-ssrs.
boolean
C1276053 (UMLS CUI [1,1])
C3888485 (UMLS CUI [1,2])
C0549013 (UMLS CUI [2,1])
C3888485 (UMLS CUI [2,2])
Disease Interferes with Investigational Therapy | Nervous system disorder Interferes with Investigational Therapy | Disease Impairing Treatment Compliance | Nervous system disorder Impairing Treatment Compliance
Item
5. based on investigators judgment the patient has a medical or neurological disorder or treatment for such disorder that could interfere with the study treatment or impair treatment compliance.
boolean
C0012634 (UMLS CUI [1,1])
C0521102 (UMLS CUI [1,2])
C0949266 (UMLS CUI [1,3])
C0027765 (UMLS CUI [2,1])
C0521102 (UMLS CUI [2,2])
C0949266 (UMLS CUI [2,3])
C0012634 (UMLS CUI [3,1])
C0221099 (UMLS CUI [3,2])
C4319828 (UMLS CUI [3,3])
C0027765 (UMLS CUI [4,1])
C0221099 (UMLS CUI [4,2])
C4319828 (UMLS CUI [4,3])
Episode of Extrapyramidal symptoms | Pharmacotherapy
Item
6. the patient has had past episodes of extrapyramidal symptoms (eps) under current medication within the last 6 month
boolean
C0332189 (UMLS CUI [1,1])
C0234133 (UMLS CUI [1,2])
C0013216 (UMLS CUI [2])
Illicit medication use
Item
7. the patient takes other medication than those listed as allowed concomitant medication in appendix iii
boolean
C0281875 (UMLS CUI [1])
Exposure Occupational Ionizing radiation
Item
8. the patient is occupationally exposed to significant levels of ionizing radiation.
boolean
C0332157 (UMLS CUI [1,1])
C0521127 (UMLS CUI [1,2])
C0034538 (UMLS CUI [1,3])
Eligibility Criteria Study Protocol
Item
other protocol-defined inclusion and exclusion criteria may apply
boolean
C1516637 (UMLS CUI [1,1])
C2348563 (UMLS CUI [1,2])
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