ID

19239

Beschreibung

Depakote ER Plus an Atypical Antipsychotic Vs. an Atypical Antipsychotic Alone in the Treatment of Schizophrenia; ODM derived from: https://clinicaltrials.gov/show/NCT00073164

Link

https://clinicaltrials.gov/show/NCT00073164

Stichworte

Versionen (1)
  1. 14.12.16 14.12.16 -
Hochgeladen am

14. Dezember 2016

DOI

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Lizenz

Creative Commons BY 4.0
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Eligibility Schizophrenia NCT00073164

Englisch

Eligibility Schizophrenia NCT00073164

1 Formulare  
Criteria
Beschreibung

Criteria

acute exacerbation of schizophrenia as defined by: subject recently hospitalized or is in the process of being admitted to a hospital or an acute care inpatient psychiatric treatment facility; and has a panns total score of 70 or greater at the time of screening and at randomization based on a 1-7 point scale; and has a score on any two of the four items from psychosis cluster of the bprs (extracted from the panss) that correspond to the positive symptoms (hallucinatory behavior, unusual thought content, conceptual disorganization and suspiciousness) totaling 8 or greater; and has a total of 6 or greater on one of the following two pairs of items from the bprs (extracted from the panss): hostility and uncooperativeness or excitement and tension.
Beschreibung

Schizophrenia exacerbated | Hospitalization | Psychiatric inpatient | Positive and negative syndrome scale | Brief Psychiatric Rating Scale Psychotic Disorders Cluster | Symptoms Positive | Hallucinatory Behavior | Unusual Thought Content | Conceptual Disorganization | Suspiciousness | Hostility | Uncooperativeness | Excitement | Tension

Datentyp

boolean

Alias
UMLS CUI [1]
C0863109
UMLS CUI [2]
C0019993
UMLS CUI [3]
C0748064
UMLS CUI [4]
C0451383
UMLS CUI [5,1]
C0029941
UMLS CUI [5,2]
C0033975
UMLS CUI [5,3]
C1704332
UMLS CUI [6,1]
C1457887
UMLS CUI [6,2]
C1514241
UMLS CUI [7]
C3639367
UMLS CUI [8]
C3639370
UMLS CUI [9]
C3639359
UMLS CUI [10]
C3639366
UMLS CUI [11]
C3639365
UMLS CUI [12]
C3639369
UMLS CUI [13]
C3639372
UMLS CUI [14]
C0233494
current dsm-iv-tr diagnosis of schizophrenia as confirmed by the scid
Beschreibung

Schizophrenia

Datentyp

boolean

Alias
UMLS CUI [1]
C0036341
positive response to antipsychotics in the previous 2 years
Beschreibung

Antipsychotic Agents | Response Positive

Datentyp

boolean

Alias
UMLS CUI [1]
C0040615
UMLS CUI [2,1]
C1704632
UMLS CUI [2,2]
C1514241
key exclusion criteria:
Beschreibung

Exclusion Criteria Main

Datentyp

boolean

Alias
UMLS CUI [1,1]
C0680251
UMLS CUI [1,2]
C1542147
current diagnosis of schizoaffective disorder, drug-induced psychosis, manic episode or major depressive episode.
Beschreibung

Schizoaffective Disorder | Psychoses, Drug | Manic episode | Major depressive episode

Datentyp

boolean

Alias
UMLS CUI [1]
C0036337
UMLS CUI [2]
C0033937
UMLS CUI [3]
C0349208
UMLS CUI [4]
C0024517
at the time of screening, has been hospitalized for more than 14 days for the current episode
Beschreibung

Hospitalization Duration Depressive episode

Datentyp

boolean

Alias
UMLS CUI [1,1]
C0019993
UMLS CUI [1,2]
C0449238
UMLS CUI [1,3]
C0349217
has ever taken clozapine
Beschreibung

Clozapine

Datentyp

boolean

Alias
UMLS CUI [1]
C0009079
has had more than 3 psychiatric hospitalizations in the previous 6 months or has had more than 8 weeks of psychiatric hospitalization in the previous 12 months
Beschreibung

psychiatric hospitalization Quantity | psychiatric hospitalization Duration

Datentyp

boolean

Alias
UMLS CUI [1,1]
C0748061
UMLS CUI [1,2]
C1265611
UMLS CUI [2,1]
C0748061
UMLS CUI [2,2]
C0449238
has serious violent, homicidal, suicidal ideation
Beschreibung

Violent ideation Serious | Homicidal thoughts Serious | Feeling suicidal Serious

Datentyp

boolean

Alias
UMLS CUI [1,1]
C1868823
UMLS CUI [1,2]
C0205404
UMLS CUI [2,1]
C0455204
UMLS CUI [2,2]
C0205404
UMLS CUI [3,1]
C0424000
UMLS CUI [3,2]
C0205404
has received depot medications fluphenazine decanoate and/or haloperidol decanoate within 2 or 4 weeks prior to randomization respectively
Beschreibung

fluphenazine decanoate | haloperidol decanoate

Datentyp

boolean

Alias
UMLS CUI [1]
C0060580
UMLS CUI [2]
C0062103
urine toxicology screen is positive for phencyclidine (pcp), opiates, cocaine or amphetamines
Beschreibung

Urine drug screen positive Phencyclidine | Urine drug screen positive Opiates | Urine drug screen positive Cocaine | Urine drug screen positive Amphetamines

Datentyp

boolean

Alias
UMLS CUI [1,1]
C0743300
UMLS CUI [1,2]
C0031381
UMLS CUI [2,1]
C0743300
UMLS CUI [2,2]
C0376196
UMLS CUI [3,1]
C0743300
UMLS CUI [3,2]
C0009170
UMLS CUI [4,1]
C0743300
UMLS CUI [4,2]
C0002667
history of alcohol or substance dependence within the past month
Beschreibung

Substance Dependence

Datentyp

boolean

Alias
UMLS CUI [1]
C0038580
has taken any valproate product for a psychiatric indication within the previous 30 days
Beschreibung

Indication Psychiatric Valproate

Datentyp

boolean

Alias
UMLS CUI [1,1]
C3146298
UMLS CUI [1,2]
C0205487
UMLS CUI [1,3]
C0080356
has received an investigational drug within the last 30 days
Beschreibung

Investigational New Drugs

Datentyp

boolean

Alias
UMLS CUI [1]
C0013230
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Ähnliche Modelle

Eligibility Schizophrenia NCT00073164

1 Formulare
Name
Typ
Description | Question | Decode (Coded Value)
Datentyp
Alias
Item Group
Schizophrenia exacerbated | Hospitalization | Psychiatric inpatient | Positive and negative syndrome scale | Brief Psychiatric Rating Scale Psychotic Disorders Cluster | Symptoms Positive | Hallucinatory Behavior | Unusual Thought Content | Conceptual Disorganization | Suspiciousness | Hostility | Uncooperativeness | Excitement | Tension
Item
acute exacerbation of schizophrenia as defined by: subject recently hospitalized or is in the process of being admitted to a hospital or an acute care inpatient psychiatric treatment facility; and has a panns total score of 70 or greater at the time of screening and at randomization based on a 1-7 point scale; and has a score on any two of the four items from psychosis cluster of the bprs (extracted from the panss) that correspond to the positive symptoms (hallucinatory behavior, unusual thought content, conceptual disorganization and suspiciousness) totaling 8 or greater; and has a total of 6 or greater on one of the following two pairs of items from the bprs (extracted from the panss): hostility and uncooperativeness or excitement and tension.
boolean
C0863109 (UMLS CUI [1])
C0019993 (UMLS CUI [2])
C0748064 (UMLS CUI [3])
C0451383 (UMLS CUI [4])
C0029941 (UMLS CUI [5,1])
C0033975 (UMLS CUI [5,2])
C1704332 (UMLS CUI [5,3])
C1457887 (UMLS CUI [6,1])
C1514241 (UMLS CUI [6,2])
C3639367 (UMLS CUI [7])
C3639370 (UMLS CUI [8])
C3639359 (UMLS CUI [9])
C3639366 (UMLS CUI [10])
C3639365 (UMLS CUI [11])
C3639369 (UMLS CUI [12])
C3639372 (UMLS CUI [13])
C0233494 (UMLS CUI [14])
Schizophrenia
Item
current dsm-iv-tr diagnosis of schizophrenia as confirmed by the scid
boolean
C0036341 (UMLS CUI [1])
Antipsychotic Agents | Response Positive
Item
positive response to antipsychotics in the previous 2 years
boolean
C0040615 (UMLS CUI [1])
C1704632 (UMLS CUI [2,1])
C1514241 (UMLS CUI [2,2])
Exclusion Criteria Main
Item
key exclusion criteria:
boolean
C0680251 (UMLS CUI [1,1])
C1542147 (UMLS CUI [1,2])
Schizoaffective Disorder | Psychoses, Drug | Manic episode | Major depressive episode
Item
current diagnosis of schizoaffective disorder, drug-induced psychosis, manic episode or major depressive episode.
boolean
C0036337 (UMLS CUI [1])
C0033937 (UMLS CUI [2])
C0349208 (UMLS CUI [3])
C0024517 (UMLS CUI [4])
Hospitalization Duration Depressive episode
Item
at the time of screening, has been hospitalized for more than 14 days for the current episode
boolean
C0019993 (UMLS CUI [1,1])
C0449238 (UMLS CUI [1,2])
C0349217 (UMLS CUI [1,3])
Clozapine
Item
has ever taken clozapine
boolean
C0009079 (UMLS CUI [1])
psychiatric hospitalization Quantity | psychiatric hospitalization Duration
Item
has had more than 3 psychiatric hospitalizations in the previous 6 months or has had more than 8 weeks of psychiatric hospitalization in the previous 12 months
boolean
C0748061 (UMLS CUI [1,1])
C1265611 (UMLS CUI [1,2])
C0748061 (UMLS CUI [2,1])
C0449238 (UMLS CUI [2,2])
Violent ideation Serious | Homicidal thoughts Serious | Feeling suicidal Serious
Item
has serious violent, homicidal, suicidal ideation
boolean
C1868823 (UMLS CUI [1,1])
C0205404 (UMLS CUI [1,2])
C0455204 (UMLS CUI [2,1])
C0205404 (UMLS CUI [2,2])
C0424000 (UMLS CUI [3,1])
C0205404 (UMLS CUI [3,2])
fluphenazine decanoate | haloperidol decanoate
Item
has received depot medications fluphenazine decanoate and/or haloperidol decanoate within 2 or 4 weeks prior to randomization respectively
boolean
C0060580 (UMLS CUI [1])
C0062103 (UMLS CUI [2])
Urine drug screen positive Phencyclidine | Urine drug screen positive Opiates | Urine drug screen positive Cocaine | Urine drug screen positive Amphetamines
Item
urine toxicology screen is positive for phencyclidine (pcp), opiates, cocaine or amphetamines
boolean
C0743300 (UMLS CUI [1,1])
C0031381 (UMLS CUI [1,2])
C0743300 (UMLS CUI [2,1])
C0376196 (UMLS CUI [2,2])
C0743300 (UMLS CUI [3,1])
C0009170 (UMLS CUI [3,2])
C0743300 (UMLS CUI [4,1])
C0002667 (UMLS CUI [4,2])
Substance Dependence
Item
history of alcohol or substance dependence within the past month
boolean
C0038580 (UMLS CUI [1])
Indication Psychiatric Valproate
Item
has taken any valproate product for a psychiatric indication within the previous 30 days
boolean
C3146298 (UMLS CUI [1,1])
C0205487 (UMLS CUI [1,2])
C0080356 (UMLS CUI [1,3])
Investigational New Drugs
Item
has received an investigational drug within the last 30 days
boolean
C0013230 (UMLS CUI [1])
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