ID

38909

Beschrijving

Study ID: 111364 Clinical Study ID: 111364 Study Title: A 28-Day, Polysomnographic and subjective assessment of Vestipitant (15mg/day) for the treatment of Primary Insomnia in adult Outpatients Patient Level Data: Study Listed on ClinicalStudyDataRequest.com Clinicaltrials.gov Identifier: NCT00992160 Clinicaltrials.gov Links: https://clinicaltrials.gov/ct2/show/NCT00992160 Sponsor: GlaxoSmithKline Collaborators: N/A Phase: Phase 2 Study Recruitment Status: Completed Generic Name: Vestipitant, Placebo Trade Name: N/A Study Indication: Primary Insomnia, Sleep Disorders This phase II, placebo-controlled, double-blind trial studies the polysomnographic and subjective effect of the neurokinin (NK1) antagonist vestipitant (15mg/day at bedtime) for the treatment of primary insomnia in adult outpatients over a period of four weeks. The study consists of a clinical Screening Visit (Visit 1), up to 21 days before investigational product/placebo initiation, two screening polysomnographies (Visits 2 and 3), followed by a placebo run-in until Visit 4, at which the subject is randomized to vestipitant or placebo, taken every night for 28 days. On Day 1 and 2 (Visits 4 and 5), polysomnographies are performed. Visit 6 is a safety visit on Day 15. On Day 27 and 28, Visits 7 and 8 are performed, which again include polysomnography studies. Subjects then undergo a 7 to 10 day placebo run-out period and have Day 7 and Day 14 Follow-Up Visit (Visits 9 and 10). This form is used to record details about any possible suicidality-related adverse events happening during the study. The event must also be reported on the Adverse Events Form (Non-serious or Serious Adverse Events form as applicable) using the same terminology. Record only 1 event per form.

Link

https://clinicaltrials.gov/ct2/show/NCT00992160

Trefwoorden

Versies (3)
  1. 12-11-19 12-11-19 -
  2. 12-11-19 12-11-19 -
  3. 12-11-19 12-11-19 -
Houder van rechten

GlaxoSmithKline

Geüploaded op

12 november 2019

DOI

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Licentie

Creative Commons BY-NC 3.0
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Polysomnographic Assessment of Vestipitant for the Treatment of Primary Insomnia NCT00992160

Engels

Possible Suicidality-Related Adverse Event

1 Formulieren  
Administrative Data
Beschrijving

Administrative Data

Alias
UMLS CUI-1
C1320722
Date of Visit/Assessment
Beschrijving

Date of Visit/Assessment

Datatype

date

Alias
UMLS CUI [1]
C1320303
UMLS CUI [2]
C2985720
Site
Beschrijving

Study site

Datatype

text

Alias
UMLS CUI [1]
C2825164
Patient
Beschrijving

Patient

Datatype

text

Alias
UMLS CUI [1]
C1299487
Patient No.
Beschrijving

Subject No.

Datatype

text

Alias
UMLS CUI [1]
C2348585
Section 1
Beschrijving

Section 1

Alias
UMLS CUI-1
C1508263
UMLS CUI-2
C2732635
UMLS CUI-3
C0877248
UMLS CUI-4
C3166387
Possible suicidality related AE
Beschrijving

Possible suicidality-related AE

Datatype

text

Alias
UMLS CUI [1,1]
C0877248
UMLS CUI [1,2]
C2732635
UMLS CUI [1,3]
C3166387
Start Date
Beschrijving

Possible suicidality-related AE start date

Datatype

date

Alias
UMLS CUI [1,1]
C2697888
UMLS CUI [1,2]
C2732635
UMLS CUI [1,3]
C3166387
Section 2. Brief description of possible Suicidality-Related Adverse Event
Beschrijving

Section 2. Brief description of possible Suicidality-Related Adverse Event

Alias
UMLS CUI-1
C0877248
UMLS CUI-2
C3166387
UMLS CUI-3
C0678257
Brief description of possible suicidality-related AE
Beschrijving

Provide a Brief Description of the Possible Suicidality-Related Adverse Event

Datatype

text

Alias
UMLS CUI [1,1]
C0877248
UMLS CUI [1,2]
C3166387
UMLS CUI [1,3]
C0678257
Section 3. Possible causes of possible suicidality-related adverse event
Beschrijving

Section 3. Possible causes of possible suicidality-related adverse event

Alias
UMLS CUI-1
C0877248
UMLS CUI-2
C2732635
UMLS CUI-3
C3166387
UMLS CUI-4
C0015127
Disease under study
Beschrijving

Possible causes of possible suicidality-related adverse event: Disease under study

Datatype

boolean

Alias
UMLS CUI [1,1]
C2732635
UMLS CUI [1,2]
C0877248
UMLS CUI [1,3]
C3166387
UMLS CUI [1,4]
C0015127
UMLS CUI [2,1]
C0008976
UMLS CUI [2,2]
C0012634
Concomitant medications
Beschrijving

Record in Section 8

Datatype

boolean

Alias
UMLS CUI [1,1]
C2732635
UMLS CUI [1,2]
C0877248
UMLS CUI [1,3]
C3166387
UMLS CUI [1,4]
C0015127
UMLS CUI [2]
C2347852
Comorbid psychiatric condition(s)
Beschrijving

Record in Section 8

Datatype

boolean

Alias
UMLS CUI [1,1]
C2732635
UMLS CUI [1,2]
C0877248
UMLS CUI [1,3]
C3166387
UMLS CUI [1,4]
C0015127
UMLS CUI [2,1]
C0004936
UMLS CUI [2,2]
C0009488
Medical condition(s)
Beschrijving

Record in Section 8:

Datatype

boolean

Alias
UMLS CUI [1,1]
C2732635
UMLS CUI [1,2]
C0877248
UMLS CUI [1,3]
C3166387
UMLS CUI [1,4]
C0015127
UMLS CUI [2]
C0009488
Psycho-social stressors
Beschrijving

Possible causes of possible suicidality-related adverse event: Psycho-social stressors

Datatype

boolean

Alias
UMLS CUI [1,1]
C2732635
UMLS CUI [1,2]
C0877248
UMLS CUI [1,3]
C3166387
UMLS CUI [1,4]
C0015127
UMLS CUI [2]
C0748073
Withdrawal of investigational product(s)
Beschrijving

Possible causes of possible suicidality-related adverse event: Withdrawal of investigational product(s)

Datatype

boolean

Alias
UMLS CUI [1,1]
C0877248
UMLS CUI [1,2]
C2732635
UMLS CUI [1,3]
C3166387
UMLS CUI [1,4]
C0015127
UMLS CUI [2,1]
C0304229
UMLS CUI [2,2]
C2349954
Investigational product dose change
Beschrijving

Possible causes of possible suicidality-related adverse event: Investigational product dose change

Datatype

boolean

Alias
UMLS CUI [1,1]
C0877248
UMLS CUI [1,2]
C2732635
UMLS CUI [1,3]
C3166387
UMLS CUI [1,4]
C0015127
UMLS CUI [2,1]
C0304229
UMLS CUI [2,2]
C1707811
Lack of efficacy
Beschrijving

Possible causes of possible suicidality-related adverse event: Lack of efficacy

Datatype

boolean

Alias
UMLS CUI [1,1]
C0877248
UMLS CUI [1,2]
C2732635
UMLS CUI [1,3]
C3166387
UMLS CUI [1,4]
C0015127
UMLS CUI [2]
C0235828
Investigational product(s)
Beschrijving

Possible causes of possible suicidality-related adverse event: Investigational product(s)

Datatype

boolean

Alias
UMLS CUI [1,1]
C0877248
UMLS CUI [1,2]
C2732635
UMLS CUI [1,3]
C3166387
UMLS CUI [1,4]
C0015127
UMLS CUI [2]
C0304229
Other
Beschrijving

If yes, specify

Datatype

boolean

Alias
UMLS CUI [1,1]
C0205394
UMLS CUI [1,2]
C0877248
UMLS CUI [1,3]
C2732635
UMLS CUI [1,4]
C3166387
UMLS CUI [1,5]
C0015127
Other, specify
Beschrijving

if applicable

Datatype

text

Alias
UMLS CUI [1,1]
C1521902
UMLS CUI [1,2]
C0877248
UMLS CUI [1,3]
C2732635
UMLS CUI [1,4]
C3166387
UMLS CUI [1,5]
C0205394
UMLS CUI [1,6]
C0015127
Section 4. Provide Information
Beschrijving

Section 4. Provide Information

Alias
UMLS CUI-1
C0748059
Has the subject had any psychiatric conditions in the past?
Beschrijving

History of psychiatric conditions

Datatype

boolean

Alias
UMLS CUI [1]
C0455498
Has the subject had any suicidal ideation, behaviour or self-harm in the past?
Beschrijving

Previous suicidal ideation/behaviour or self-harm

Datatype

boolean

Alias
UMLS CUI [1,1]
C0424000
UMLS CUI [1,2]
C0205156
UMLS CUI [2,1]
C0205156
UMLS CUI [2,2]
C1760428
UMLS CUI [3,1]
C0424366
UMLS CUI [3,2]
C0205156
Subject's current use of llicit drugs?
Beschrijving

Current use of iIllicit drugs

Datatype

boolean

Alias
UMLS CUI [1,1]
C0086190
UMLS CUI [1,2]
C0521116
Subject's current use of alcohol?
Beschrijving

Current alcohol consumption

Datatype

boolean

Alias
UMLS CUI [1,1]
C0001948
UMLS CUI [1,2]
C0521116
Family history of suicidality?
Beschrijving

Family history of suicidality

Datatype

text

Alias
UMLS CUI [1,1]
C0241889
UMLS CUI [1,2]
C3166387
Family history of psychiatric disorders?
Beschrijving

Family history of psychiatric disorders

Datatype

text

Alias
UMLS CUI [1,1]
C0241889
UMLS CUI [1,2]
C0004936
Section 5. Provide information on the subject's current psycho-social stressors
Beschrijving

Section 5. Provide information on the subject's current psycho-social stressors

Alias
UMLS CUI-1
C0748073
Provide information on the subject's current psycho-social stressors
Beschrijving

For example, isolation, problems with family, relationships, work, finances, stress, etc.

Datatype

text

Alias
UMLS CUI [1,1]
C0748073
UMLS CUI [1,2]
C0521116
Section 6. Relevant and/or recent suicidal ideation
Beschrijving

Section 6. Relevant and/or recent suicidal ideation

Alias
UMLS CUI-1
C0424000
Relevant/recent suicidal ideation
Beschrijving

Provide information on any relevant and/or recent suicidal ideation, not associated with suicidal bebavior, as assessed by the investigator, for this index event i.e., provide details, including any suicidal thoughts, and associated frequency, severity and duration, as well as likelihood of the subject acting upon these thoughts.

Datatype

text

Alias
UMLS CUI [1,1]
C0424000
UMLS CUI [1,2]
C0332185
UMLS CUI [2,1]
C0424000
UMLS CUI [2,2]
C0750502
Section 7. Suicidal behaviour present during study
Beschrijving

Section 7. Suicidal behaviour present during study

Alias
UMLS CUI-1
C1760428
UMLS CUI-2
C0347984
UMLS CUI-3
C2347804
Suicidal behaviour present during study
Beschrijving

Provide information on any suicidal behaviour present during the study, as assessed by the investigator, for this index event, i.e. Details of any suicidal behaviour, iincluding any plan, preparations, and/or attempt Description of the associated frequency, severity and duration of these behaviours Likelihood of the subject acting upon plans and preparations If possible, description of the subject's intent (or evidence of attention seeking behaviour) Description of the degree of impulsivity or premeditation Description of the subject's mood and thoughts before and after the behaviour

Datatype

text

Alias
UMLS CUI [1,1]
C1760428
UMLS CUI [1,2]
C0347984
UMLS CUI [1,3]
C2347804
Section 8. Comments on medical and psychiatric treatment
Beschrijving

Section 8. Comments on medical and psychiatric treatment

Alias
UMLS CUI-1
C0237726
UMLS CUI-3
C0204523
Comments on medical/psych treatment
Beschrijving

Provide any additional comments or explanation, including, but not limited to, both medical and psychiatric treatment, outcome and follow-up.

Datatype

text

Alias
UMLS CUI [1]
C0237726
UMLS CUI [2]
C0204523
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Similar models

Possible Suicidality-Related Adverse Event

1 Formulieren
Name
Type
Description | Question | Decode (Coded Value)
Datatype
Alias
Item Group
Administrative Data
C1320722 (UMLS CUI-1)
Date of Visit/Assessment
Item
Date of Visit/Assessment
date
C1320303 (UMLS CUI [1])
C2985720 (UMLS CUI [2])
Study site
Item
Site
text
C2825164 (UMLS CUI [1])
Patient
Item
Patient
text
C1299487 (UMLS CUI [1])
Subject No.
Item
Patient No.
text
C2348585 (UMLS CUI [1])
Item Group
Section 1
C1508263 (UMLS CUI-1)
C2732635 (UMLS CUI-2)
C0877248 (UMLS CUI-3)
C3166387 (UMLS CUI-4)
Possible suicidality-related AE
Item
Possible suicidality related AE
text
C0877248 (UMLS CUI [1,1])
C2732635 (UMLS CUI [1,2])
C3166387 (UMLS CUI [1,3])
Possible suicidality-related AE start date
Item
Start Date
date
C2697888 (UMLS CUI [1,1])
C2732635 (UMLS CUI [1,2])
C3166387 (UMLS CUI [1,3])
Item Group
Section 2. Brief description of possible Suicidality-Related Adverse Event
C0877248 (UMLS CUI-1)
C3166387 (UMLS CUI-2)
C0678257 (UMLS CUI-3)
Suicidality-Related Adverse Event description
Item
Brief description of possible suicidality-related AE
text
C0877248 (UMLS CUI [1,1])
C3166387 (UMLS CUI [1,2])
C0678257 (UMLS CUI [1,3])
Item Group
Section 3. Possible causes of possible suicidality-related adverse event
C0877248 (UMLS CUI-1)
C2732635 (UMLS CUI-2)
C3166387 (UMLS CUI-3)
C0015127 (UMLS CUI-4)
Possible causes of possible suicidality-related adverse event: Disease under study
Item
Disease under study
boolean
C2732635 (UMLS CUI [1,1])
C0877248 (UMLS CUI [1,2])
C3166387 (UMLS CUI [1,3])
C0015127 (UMLS CUI [1,4])
C0008976 (UMLS CUI [2,1])
C0012634 (UMLS CUI [2,2])
Possible causes of possible suicidality-related adverse event: Concomitant medications
Item
Concomitant medications
boolean
C2732635 (UMLS CUI [1,1])
C0877248 (UMLS CUI [1,2])
C3166387 (UMLS CUI [1,3])
C0015127 (UMLS CUI [1,4])
C2347852 (UMLS CUI [2])
Possible causes of possible suicidality-related adverse event: Comorbid psychiatric condition(s)
Item
Comorbid psychiatric condition(s)
boolean
C2732635 (UMLS CUI [1,1])
C0877248 (UMLS CUI [1,2])
C3166387 (UMLS CUI [1,3])
C0015127 (UMLS CUI [1,4])
C0004936 (UMLS CUI [2,1])
C0009488 (UMLS CUI [2,2])
Possible causes of possible suicidality-related adverse event: Medical condition(s)
Item
Medical condition(s)
boolean
C2732635 (UMLS CUI [1,1])
C0877248 (UMLS CUI [1,2])
C3166387 (UMLS CUI [1,3])
C0015127 (UMLS CUI [1,4])
C0009488 (UMLS CUI [2])
Possible causes of possible suicidality-related adverse event: Psycho-social stressors
Item
Psycho-social stressors
boolean
C2732635 (UMLS CUI [1,1])
C0877248 (UMLS CUI [1,2])
C3166387 (UMLS CUI [1,3])
C0015127 (UMLS CUI [1,4])
C0748073 (UMLS CUI [2])
Possible causes of possible suicidality-related adverse event: Withdrawal of investigational product(s)
Item
Withdrawal of investigational product(s)
boolean
C0877248 (UMLS CUI [1,1])
C2732635 (UMLS CUI [1,2])
C3166387 (UMLS CUI [1,3])
C0015127 (UMLS CUI [1,4])
C0304229 (UMLS CUI [2,1])
C2349954 (UMLS CUI [2,2])
Possible causes of possible suicidality-related adverse event: Investigational product dose change
Item
Investigational product dose change
boolean
C0877248 (UMLS CUI [1,1])
C2732635 (UMLS CUI [1,2])
C3166387 (UMLS CUI [1,3])
C0015127 (UMLS CUI [1,4])
C0304229 (UMLS CUI [2,1])
C1707811 (UMLS CUI [2,2])
Possible causes of possible suicidality-related adverse event: Lack of efficacy
Item
Lack of efficacy
boolean
C0877248 (UMLS CUI [1,1])
C2732635 (UMLS CUI [1,2])
C3166387 (UMLS CUI [1,3])
C0015127 (UMLS CUI [1,4])
C0235828 (UMLS CUI [2])
Possible causes of possible suicidality-related adverse event: Investigational product(s)
Item
Investigational product(s)
boolean
C0877248 (UMLS CUI [1,1])
C2732635 (UMLS CUI [1,2])
C3166387 (UMLS CUI [1,3])
C0015127 (UMLS CUI [1,4])
C0304229 (UMLS CUI [2])
Other possible causes of possible suicidality-related adverse event
Item
Other
boolean
C0205394 (UMLS CUI [1,1])
C0877248 (UMLS CUI [1,2])
C2732635 (UMLS CUI [1,3])
C3166387 (UMLS CUI [1,4])
C0015127 (UMLS CUI [1,5])
Specify other possible causes of possible suicidality-related adverse event
Item
Other, specify
text
C1521902 (UMLS CUI [1,1])
C0877248 (UMLS CUI [1,2])
C2732635 (UMLS CUI [1,3])
C3166387 (UMLS CUI [1,4])
C0205394 (UMLS CUI [1,5])
C0015127 (UMLS CUI [1,6])
Item Group
Section 4. Provide Information
C0748059 (UMLS CUI-1)
History of psychiatric conditions
Item
Has the subject had any psychiatric conditions in the past?
boolean
C0455498 (UMLS CUI [1])
Previous suicidal ideation/behaviour or self-harm
Item
Has the subject had any suicidal ideation, behaviour or self-harm in the past?
boolean
C0424000 (UMLS CUI [1,1])
C0205156 (UMLS CUI [1,2])
C0205156 (UMLS CUI [2,1])
C1760428 (UMLS CUI [2,2])
C0424366 (UMLS CUI [3,1])
C0205156 (UMLS CUI [3,2])
Current use of iIllicit drugs
Item
Subject's current use of llicit drugs?
boolean
C0086190 (UMLS CUI [1,1])
C0521116 (UMLS CUI [1,2])
Current alcohol consumption
Item
Subject's current use of alcohol?
boolean
C0001948 (UMLS CUI [1,1])
C0521116 (UMLS CUI [1,2])
Item
Family history of suicidality?
text
C0241889 (UMLS CUI [1,1])
C3166387 (UMLS CUI [1,2])
Family history of suicidality
Code List
Family history of suicidality?
CL Item
Yes (Yes)
CL Item
No (No)
CL Item
Unknown (Unknown)
Item
Family history of psychiatric disorders?
text
C0241889 (UMLS CUI [1,1])
C0004936 (UMLS CUI [1,2])
Family history of suicidality
Code List
Family history of psychiatric disorders?
CL Item
Yes (Yes)
CL Item
No (No)
CL Item
Unknown (Unknown)
Item Group
Section 5. Provide information on the subject's current psycho-social stressors
C0748073 (UMLS CUI-1)
Current psycho-social stressors
Item
Provide information on the subject's current psycho-social stressors
text
C0748073 (UMLS CUI [1,1])
C0521116 (UMLS CUI [1,2])
Item Group
Section 6. Relevant and/or recent suicidal ideation
C0424000 (UMLS CUI-1)
Significant/recent suicidal ideation
Item
Relevant/recent suicidal ideation
text
C0424000 (UMLS CUI [1,1])
C0332185 (UMLS CUI [1,2])
C0424000 (UMLS CUI [2,1])
C0750502 (UMLS CUI [2,2])
Item Group
Section 7. Suicidal behaviour present during study
C1760428 (UMLS CUI-1)
C0347984 (UMLS CUI-2)
C2347804 (UMLS CUI-3)
Suicidal behaviour during study
Item
Suicidal behaviour present during study
text
C1760428 (UMLS CUI [1,1])
C0347984 (UMLS CUI [1,2])
C2347804 (UMLS CUI [1,3])
Item Group
Section 8. Comments on medical and psychiatric treatment
C0237726 (UMLS CUI-1)
C0204523 (UMLS CUI-3)
Medical and psychiatric treatment
Item
Comments on medical/psych treatment
text
C0237726 (UMLS CUI [1])
C0204523 (UMLS CUI [2])
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