ID

19075

Description

The Combination of Aripiprazole and Antidepressants in Psychotic Major Depression; ODM derived from: https://clinicaltrials.gov/show/NCT00556140

Link

https://clinicaltrials.gov/show/NCT00556140

Keywords

Versions (1)
  1. 12/4/16 12/4/16 -
Uploaded on

December 4, 2016

DOI

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License

Creative Commons BY 4.0
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Eligibility Psychotic Depression NCT00556140

English

Eligibility Psychotic Depression NCT00556140

1 forms  
Inclusion Criteria
Description

Inclusion Criteria

Alias
UMLS CUI
C1512693
1. men and women aged 18-80 years, inclusive.
Description

Age

Data type

boolean

Alias
UMLS CUI [1]
C0001779
2. drug-free outpatients or inpatients meeting dsm-iv criteria for major depression with psychotic features.
Description

Outpatients Pharmaceutical Preparations Free of | Inpatient Major Depressive Disorder psychotic feature

Data type

boolean

Alias
UMLS CUI [1,1]
C0029921
UMLS CUI [1,2]
C0013227
UMLS CUI [1,3]
C0332296
UMLS CUI [2,1]
C0021562
UMLS CUI [2,2]
C1269683
UMLS CUI [2,3]
C0743076
3. inpatients who undergo a 5-7 day washout period of their medication while concurrently beginning one of the approved ssri's and abilify.
Description

Inpatient Washout Period | Selective Serotonin Reuptake Inhibitors | Abilify

Data type

boolean

Alias
UMLS CUI [1,1]
C0021562
UMLS CUI [1,2]
C1710661
UMLS CUI [2]
C0360105
UMLS CUI [3]
C1170019
4. ham-d-24 score > 16.
Description

Hamilton rating scale for depression

Data type

boolean

Alias
UMLS CUI [1]
C0451203
Exclusion Criteria
Description

Exclusion Criteria

Alias
UMLS CUI
C0680251
1. pregnant women and women of child bearing potential not using a medically accepted means of contraception (oral contraceptives are allowed).
Description

Pregnancy | Childbearing Potential Contraceptive methods | Contraceptives, Oral

Data type

boolean

Alias
UMLS CUI [1]
C0032961
UMLS CUI [2,1]
C3831118
UMLS CUI [2,2]
C0700589
UMLS CUI [3]
C0009905
2. women who are breast-feeding.
Description

Breast Feeding

Data type

boolean

Alias
UMLS CUI [1]
C0006147
3. patients meeting dsm-iv criteria for major depression without psychotic features, or psychosis without major depression at the screen visit.
Description

Major Depressive Disorder | psychotic feature | Psychotic Disorders

Data type

boolean

Alias
UMLS CUI [1]
C1269683
UMLS CUI [2]
C0743076
UMLS CUI [3]
C0033975
4. patients with serious suicidal risk.
Description

At risk for suicide Serious

Data type

boolean

Alias
UMLS CUI [1,1]
C0563664
UMLS CUI [1,2]
C0205404
5. patients with a history of seizure disorder; unstable physical disorders (cardiovascular, hepatic, renal, respiratory, endocrine, neurologic, or hematologic); or any physical disorder judged to significantly affect central nervous system function.
Description

Epilepsy | Disease Unstable | Cardiovascular Diseases | Liver diseases | Kidney Diseases | Respiration Disorders | Endocrine System Diseases | nervous system disorder | Hematological Disease | Disease Significant Affecting central nervous system function

Data type

boolean

Alias
UMLS CUI [1]
C0014544
UMLS CUI [2,1]
C0012634
UMLS CUI [2,2]
C0443343
UMLS CUI [3]
C0007222
UMLS CUI [4]
C0023895
UMLS CUI [5]
C0022658
UMLS CUI [6]
C0035204
UMLS CUI [7]
C0014130
UMLS CUI [8]
C0027765
UMLS CUI [9]
C0018939
UMLS CUI [10,1]
C0012634
UMLS CUI [10,2]
C0750502
UMLS CUI [10,3]
C0392760
UMLS CUI [10,4]
C0683212
6. patients meeting criteria for the following dsm-iv diagnoses: organic mental disorders; substance use disorders, including alcohol, active within the last 6 months; bipolar disorder; schizoaffective disorder; or antisocial personality disorder.
Description

Organic brain syndrome | Substance Use Disorders | Bipolar Disorder | Schizoaffective Disorder | Antisocial Personality Disorder

Data type

boolean

Alias
UMLS CUI [1]
C0029221
UMLS CUI [2]
C0038586
UMLS CUI [3]
C0005586
UMLS CUI [4]
C0036337
UMLS CUI [5]
C0003431
7. patients who are currently taking an antidepressant, antipsychotic, or mood stabilizing drug and who are responding to one or all of these medications. if patients are not responding to these medications, they may go through a washout period of at least one week under the supervision of a study doctor before entering into this study.
Description

Antidepressive Agents Disease Response | Antipsychotic Agents Disease Response | Mood stabilizing agent Disease Response | Washout Period supervision

Data type

boolean

Alias
UMLS CUI [1,1]
C0003289
UMLS CUI [1,2]
C1704632
UMLS CUI [2,1]
C0040615
UMLS CUI [2,2]
C1704632
UMLS CUI [3,1]
C1533054
UMLS CUI [3,2]
C1704632
UMLS CUI [4,1]
C1710661
UMLS CUI [4,2]
C0814286
8. patients who are not able to read and understand the consent form, or who are not capable of understanding or giving informed consent to the procedures of the study
Description

Informed Consent Unable

Data type

boolean

Alias
UMLS CUI [1,1]
C0021430
UMLS CUI [1,2]
C1299582
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Similar models

Eligibility Psychotic Depression NCT00556140

1 forms
Name
Type
Description | Question | Decode (Coded Value)
Data type
Alias
Item Group
C1512693 (UMLS CUI)
Age
Item
1. men and women aged 18-80 years, inclusive.
boolean
C0001779 (UMLS CUI [1])
Outpatients Pharmaceutical Preparations Free of | Inpatient Major Depressive Disorder psychotic feature
Item
2. drug-free outpatients or inpatients meeting dsm-iv criteria for major depression with psychotic features.
boolean
C0029921 (UMLS CUI [1,1])
C0013227 (UMLS CUI [1,2])
C0332296 (UMLS CUI [1,3])
C0021562 (UMLS CUI [2,1])
C1269683 (UMLS CUI [2,2])
C0743076 (UMLS CUI [2,3])
Inpatient Washout Period | Selective Serotonin Reuptake Inhibitors | Abilify
Item
3. inpatients who undergo a 5-7 day washout period of their medication while concurrently beginning one of the approved ssri's and abilify.
boolean
C0021562 (UMLS CUI [1,1])
C1710661 (UMLS CUI [1,2])
C0360105 (UMLS CUI [2])
C1170019 (UMLS CUI [3])
Hamilton rating scale for depression
Item
4. ham-d-24 score > 16.
boolean
C0451203 (UMLS CUI [1])
Item Group
C0680251 (UMLS CUI)
Pregnancy | Childbearing Potential Contraceptive methods | Contraceptives, Oral
Item
1. pregnant women and women of child bearing potential not using a medically accepted means of contraception (oral contraceptives are allowed).
boolean
C0032961 (UMLS CUI [1])
C3831118 (UMLS CUI [2,1])
C0700589 (UMLS CUI [2,2])
C0009905 (UMLS CUI [3])
Breast Feeding
Item
2. women who are breast-feeding.
boolean
C0006147 (UMLS CUI [1])
Major Depressive Disorder | psychotic feature | Psychotic Disorders
Item
3. patients meeting dsm-iv criteria for major depression without psychotic features, or psychosis without major depression at the screen visit.
boolean
C1269683 (UMLS CUI [1])
C0743076 (UMLS CUI [2])
C0033975 (UMLS CUI [3])
At risk for suicide Serious
Item
4. patients with serious suicidal risk.
boolean
C0563664 (UMLS CUI [1,1])
C0205404 (UMLS CUI [1,2])
Epilepsy | Disease Unstable | Cardiovascular Diseases | Liver diseases | Kidney Diseases | Respiration Disorders | Endocrine System Diseases | nervous system disorder | Hematological Disease | Disease Significant Affecting central nervous system function
Item
5. patients with a history of seizure disorder; unstable physical disorders (cardiovascular, hepatic, renal, respiratory, endocrine, neurologic, or hematologic); or any physical disorder judged to significantly affect central nervous system function.
boolean
C0014544 (UMLS CUI [1])
C0012634 (UMLS CUI [2,1])
C0443343 (UMLS CUI [2,2])
C0007222 (UMLS CUI [3])
C0023895 (UMLS CUI [4])
C0022658 (UMLS CUI [5])
C0035204 (UMLS CUI [6])
C0014130 (UMLS CUI [7])
C0027765 (UMLS CUI [8])
C0018939 (UMLS CUI [9])
C0012634 (UMLS CUI [10,1])
C0750502 (UMLS CUI [10,2])
C0392760 (UMLS CUI [10,3])
C0683212 (UMLS CUI [10,4])
Organic brain syndrome | Substance Use Disorders | Bipolar Disorder | Schizoaffective Disorder | Antisocial Personality Disorder
Item
6. patients meeting criteria for the following dsm-iv diagnoses: organic mental disorders; substance use disorders, including alcohol, active within the last 6 months; bipolar disorder; schizoaffective disorder; or antisocial personality disorder.
boolean
C0029221 (UMLS CUI [1])
C0038586 (UMLS CUI [2])
C0005586 (UMLS CUI [3])
C0036337 (UMLS CUI [4])
C0003431 (UMLS CUI [5])
Antidepressive Agents Disease Response | Antipsychotic Agents Disease Response | Mood stabilizing agent Disease Response | Washout Period supervision
Item
7. patients who are currently taking an antidepressant, antipsychotic, or mood stabilizing drug and who are responding to one or all of these medications. if patients are not responding to these medications, they may go through a washout period of at least one week under the supervision of a study doctor before entering into this study.
boolean
C0003289 (UMLS CUI [1,1])
C1704632 (UMLS CUI [1,2])
C0040615 (UMLS CUI [2,1])
C1704632 (UMLS CUI [2,2])
C1533054 (UMLS CUI [3,1])
C1704632 (UMLS CUI [3,2])
C1710661 (UMLS CUI [4,1])
C0814286 (UMLS CUI [4,2])
Informed Consent Unable
Item
8. patients who are not able to read and understand the consent form, or who are not capable of understanding or giving informed consent to the procedures of the study
boolean
C0021430 (UMLS CUI [1,1])
C1299582 (UMLS CUI [1,2])
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