ID

15705

Description

Risperidone vs. Olanzapine as add-on Treatment in Treatment Resistant Depression; ODM derived from: https://clinicaltrials.gov/show/NCT01282632

Link

https://clinicaltrials.gov/show/NCT01282632

Keywords

Versions (1)
  1. 6/8/16 6/8/16 -
Uploaded on

June 8, 2016

DOI

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License

Creative Commons BY 4.0
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Eligibility Subjects Had Unipolar, Non-psychotic Major Depression NCT01282632

English

Eligibility Subjects Had Unipolar, Non-psychotic Major Depression NCT01282632

1 forms  
Inclusion Criteria
Description

Inclusion Criteria

Alias
UMLS CUI
C1512693
1. male or female out-patients;
Description

subjects who meet all of the following criteria are eligible for this trial:

Data type

boolean

Alias
UMLS CUI [1]
C0079399
2. aged between 18 and 65 years (extremes included);
Description

age

Data type

boolean

Alias
UMLS CUI [1]
C0001779
3. subjects suffering from a current episode of non-psychotic, unipolar depression as determined by the depression section of the scid-iv.
Description

unipolar depression

Data type

boolean

Alias
UMLS CUI [1]
C0041696
4. subjects with treatment resistant depression defined as failure to respond to two successive courses of monotherapy given in adequate doses for a minimum of 4 weeks with different antidepressants (the current course of antidepressant can be considered to second failed course) and;
Description

two successive courses with different antidepressants

Data type

boolean

Alias
UMLS CUI [1]
C2063866
5. subjects currently taking a ssri or a snri for at least 4 weeks, at adequate dosage and not responding, as defined by a score of 3 or more on the cgi-i. and no dose change for 2 weeks prior to entry.
Description

taking a ssri or a snri

Data type

boolean

Alias
UMLS CUI [1]
C0360105
UMLS CUI [2]
C1579361
6. a minimum score of 16 on the 17 item ham-d
Description

ham-d score

Data type

boolean

Alias
UMLS CUI [1]
C0451203
7. ability to provide informed consent.
Description

informed consent

Data type

boolean

Alias
UMLS CUI [1]
C0021430
Exclusion Criteria
Description

Exclusion Criteria

Alias
UMLS CUI
C0680251
1. subjects who are actively suicidal as determined by a score of 3 on the suicide item on the ham-d or in the opinion of the treating physician;
Description

subjects meeting one or more of the following criteria cannot be selected:

Data type

boolean

Alias
UMLS CUI [1]
C0438696
2. other current (active symptomatology within the last 2 months) axis i dsm iv diagnosis other than nicotine or caffeine dependence or other than an anxiety disorder.
Description

other mental disorder

Data type

boolean

Alias
UMLS CUI [1,1]
C0004936
UMLS CUI [1,2]
C0205394
3. use of disallowed concomitant therapy; or other psychotropic medication except occasional benzodiazepines. (see "rescue medication");
Description

disallowed concomitant therapy

Data type

boolean

Alias
UMLS CUI [1]
C1707479
4. history of alcohol or drug abuse or dependence, within 3 months of entry into the trial);
Description

alcohol or drug abuse

Data type

boolean

Alias
UMLS CUI [1]
C0038586
5. seizure disorder requiring medication;
Description

seizure disorder

Data type

boolean

Alias
UMLS CUI [1]
C0014544
6. active medical condition that requires urgent attention or that would contra-indicate the use of risperidone or olanzapine. for example stable thyroid disease or asthma would be acceptable, whereas acute hepatitis would not;
Description

active medical condition that requires urgent attention

Data type

boolean

Alias
UMLS CUI [1]
C0009488
7. participation in an investigational drug trial within 30 days prior to the start of the trial
Description

participation in an investigational drug trial

Data type

boolean

Alias
UMLS CUI [1]
C2348568
8. known sensitivity to risperidone, olanzapine or the antidepressant;
Description

sensitivity to risperidone olanzapine or the antidepressant

Data type

boolean

Alias
UMLS CUI [1,1]
C0020517
UMLS CUI [1,2]
C0073393
UMLS CUI [2,1]
C0020517
UMLS CUI [2,2]
C0171023
UMLS CUI [3,1]
C0020517
UMLS CUI [3,2]
C0003289
9. history of neuroleptic malignant syndrome (nms);
Description

neuroleptic malignant syndrome

Data type

boolean

Alias
UMLS CUI [1]
C0027849
10. subjects who are at imminent risk of injury to self or others, or causing significant damage to property, as judged by the investigator;
Description

imminent risk of injury to self or others

Data type

boolean

Alias
UMLS CUI [1]
C0419435
11. female subjects who are pregnant or breast-feeding;
Description

pregnancy or breast-feeding

Data type

boolean

Alias
UMLS CUI [1]
C0032961
UMLS CUI [2]
C0006147
12. female subject of childbearing potential without adequate contraception (sterilization, barrier, iud, oral contraceptives, intramuscular or subdermal administration of depot-progestagens);
Description

adequate contraception

Data type

boolean

Alias
UMLS CUI [1]
C0700589
15. previous exposure to risperidone or olanzapine during the current episode.
Description

exposure to risperidone or olanzapine

Data type

boolean

Alias
UMLS CUI [1]
C0073393
UMLS CUI [2]
C0171023
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Similar models

Eligibility Subjects Had Unipolar, Non-psychotic Major Depression NCT01282632

1 forms
Name
Type
Description | Question | Decode (Coded Value)
Data type
Alias
Item Group
C1512693 (UMLS CUI)
gender
Item
1. male or female out-patients;
boolean
C0079399 (UMLS CUI [1])
age
Item
2. aged between 18 and 65 years (extremes included);
boolean
C0001779 (UMLS CUI [1])
unipolar depression
Item
3. subjects suffering from a current episode of non-psychotic, unipolar depression as determined by the depression section of the scid-iv.
boolean
C0041696 (UMLS CUI [1])
two successive courses with different antidepressants
Item
4. subjects with treatment resistant depression defined as failure to respond to two successive courses of monotherapy given in adequate doses for a minimum of 4 weeks with different antidepressants (the current course of antidepressant can be considered to second failed course) and;
boolean
C2063866 (UMLS CUI [1])
taking a ssri or a snri
Item
5. subjects currently taking a ssri or a snri for at least 4 weeks, at adequate dosage and not responding, as defined by a score of 3 or more on the cgi-i. and no dose change for 2 weeks prior to entry.
boolean
C0360105 (UMLS CUI [1])
C1579361 (UMLS CUI [2])
ham-d score
Item
6. a minimum score of 16 on the 17 item ham-d
boolean
C0451203 (UMLS CUI [1])
informed consent
Item
7. ability to provide informed consent.
boolean
C0021430 (UMLS CUI [1])
Item Group
C0680251 (UMLS CUI)
actively suicidal
Item
1. subjects who are actively suicidal as determined by a score of 3 on the suicide item on the ham-d or in the opinion of the treating physician;
boolean
C0438696 (UMLS CUI [1])
other mental disorder
Item
2. other current (active symptomatology within the last 2 months) axis i dsm iv diagnosis other than nicotine or caffeine dependence or other than an anxiety disorder.
boolean
C0004936 (UMLS CUI [1,1])
C0205394 (UMLS CUI [1,2])
disallowed concomitant therapy
Item
3. use of disallowed concomitant therapy; or other psychotropic medication except occasional benzodiazepines. (see "rescue medication");
boolean
C1707479 (UMLS CUI [1])
alcohol or drug abuse
Item
4. history of alcohol or drug abuse or dependence, within 3 months of entry into the trial);
boolean
C0038586 (UMLS CUI [1])
seizure disorder
Item
5. seizure disorder requiring medication;
boolean
C0014544 (UMLS CUI [1])
active medical condition that requires urgent attention
Item
6. active medical condition that requires urgent attention or that would contra-indicate the use of risperidone or olanzapine. for example stable thyroid disease or asthma would be acceptable, whereas acute hepatitis would not;
boolean
C0009488 (UMLS CUI [1])
participation in an investigational drug trial
Item
7. participation in an investigational drug trial within 30 days prior to the start of the trial
boolean
C2348568 (UMLS CUI [1])
sensitivity to risperidone olanzapine or the antidepressant
Item
8. known sensitivity to risperidone, olanzapine or the antidepressant;
boolean
C0020517 (UMLS CUI [1,1])
C0073393 (UMLS CUI [1,2])
C0020517 (UMLS CUI [2,1])
C0171023 (UMLS CUI [2,2])
C0020517 (UMLS CUI [3,1])
C0003289 (UMLS CUI [3,2])
neuroleptic malignant syndrome
Item
9. history of neuroleptic malignant syndrome (nms);
boolean
C0027849 (UMLS CUI [1])
imminent risk of injury to self or others
Item
10. subjects who are at imminent risk of injury to self or others, or causing significant damage to property, as judged by the investigator;
boolean
C0419435 (UMLS CUI [1])
pregnancy or breast-feeding
Item
11. female subjects who are pregnant or breast-feeding;
boolean
C0032961 (UMLS CUI [1])
C0006147 (UMLS CUI [2])
adequate contraception
Item
12. female subject of childbearing potential without adequate contraception (sterilization, barrier, iud, oral contraceptives, intramuscular or subdermal administration of depot-progestagens);
boolean
C0700589 (UMLS CUI [1])
exposure to risperidone or olanzapine
Item
15. previous exposure to risperidone or olanzapine during the current episode.
boolean
C0073393 (UMLS CUI [1])
C0171023 (UMLS CUI [2])
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