ID

20526

Description

Assessing Treatment Emergent Suicidal Ideation in Patients With Major Depression; ODM derived from: https://clinicaltrials.gov/show/NCT00532103

Link

https://clinicaltrials.gov/show/NCT00532103

Keywords

Versions (1)
  1. 3/1/17 3/1/17 -
Uploaded on

March 1, 2017

DOI

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License

Creative Commons BY 4.0
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Eligibility Depression NCT00532103

English

Eligibility Depression NCT00532103

1 forms  
  1. StudyEvent: Eligibility
    1. Eligibility Depression NCT00532103
Inclusion Criteria
Description

Inclusion Criteria

Alias
UMLS CUI
C1512693
only patients being treated at the participating clinics are eligible for this study
Description

patients being treated at the participating clinics

Data type

boolean

Alias
UMLS CUI [1,1]
C0030705
UMLS CUI [1,2]
C3489408
patients must be enrolled at the primary or specialty care site, and be planning to continue living in the area of that clinic throughout the study
Description

Enrollment; primary care facility; Specialty care unit | Geographic Locations

Data type

boolean

Alias
UMLS CUI [1,1]
C1516879
UMLS CUI [1,2]
C0814517
UMLS CUI [1,3]
C4034258
UMLS CUI [2]
C0017446
patients must be 18-75 years old
Description

age

Data type

boolean

Alias
UMLS CUI [1]
C0001779
patients must meet clinical criteria for mdd, based on clinical interview and dsm iv mdd checklist
Description

Major Depressive Disorder; Structured Clinical Interview; DSM-IV criteria for major depressive diagnosis documented

Data type

boolean

Alias
UMLS CUI [1,1]
C1269683
UMLS CUI [1,2]
C0935589
UMLS CUI [1,3]
C2199206
screening ham-d17 score greater than or equal to 14
Description

ham-d17 score

Data type

boolean

Alias
UMLS CUI [1]
C3639712
patients must give written informed consent
Description

informed consent

Data type

boolean

Alias
UMLS CUI [1]
C0021430
patients with and without current suicidal ideation may be included in the study
Description

suicidal ideation

Data type

boolean

Alias
UMLS CUI [1]
C0424000
patients must not have taken antidepressant medication for at least 2 weeks prior to screen (or 4 weeks in the case of fluoxetine).
Description

antidepressant agent

Data type

boolean

Alias
UMLS CUI [1]
C0003289
Exclusion Criteria
Description

Exclusion Criteria

Alias
UMLS CUI
C0680251
current substance abuse or dependence
Description

substance use disorder

Data type

boolean

Alias
UMLS CUI [1]
C0038586
two past ssri treatment failures within the current episode, or last 2 years if chronic.
Description

ssri treatment failures

Data type

boolean

Alias
UMLS CUI [1,1]
C0360105
UMLS CUI [1,2]
C0162643
patients with a current axis i diagnosis of bipolar disorder or schizophrenia
Description

axis i diagnosis of bipolar disorder or schizophrenia

Data type

boolean

Alias
UMLS CUI [1,1]
C0270287
UMLS CUI [1,2]
C0005586
UMLS CUI [2,1]
C0270287
UMLS CUI [2,2]
C0036341
patients with a current primary axis i diagnosis of obsessive-compulsive disorder, anorexia nervosa or bulimia.
Description

primary axis i diagnosis of obsessive-compulsive disorder, anorexia nervosa or bulimia

Data type

boolean

Alias
UMLS CUI [1,1]
C0270287
UMLS CUI [1,2]
C0028768
UMLS CUI [2,1]
C0270287
UMLS CUI [2,2]
C0003125
UMLS CUI [3,1]
C0270287
UMLS CUI [3,2]
C0006370
women who are sexually active and who are not using adequate contraception, or who are pregnant, trying to become pregnant, or breast feeding.
Description

Sexually active; Childbearing Potential | Pregnancy | Breast Feeding

Data type

boolean

Alias
UMLS CUI [1,1]
C0241028
UMLS CUI [1,2]
C3831118
UMLS CUI [2]
C0032961
UMLS CUI [3]
C0006147
patients with general medical conditions that contraindicate antidepressant medications
Description

contraindication antidepressant medications

Data type

boolean

Alias
UMLS CUI [1,1]
C1301624
UMLS CUI [1,2]
C0003289
patients whose clinical status requires inpatient treatment at the time of baseline interview.
Description

clinical status requires inpatient treatment

Data type

boolean

Alias
UMLS CUI [1,1]
C0449440
UMLS CUI [1,2]
C0019993
patients who cannot read and understand english since all research instruments are not yet translated and validated in spanish or other languages.
Description

able to speak english

Data type

boolean

Alias
UMLS CUI [1]
C0376245
some reports of ssri-induced akathisia-like states have found them to be more highly correlated with either concurrent or previous treatment with a neuroleptic, even in patients with no history of movement disorders therefore, patients who have taken an anti-psychotic medication within 4 months of the screening visit will be excluded from the study.
Description

antipsychotic agents

Data type

boolean

Alias
UMLS CUI [1]
C0040615
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Similar models

Eligibility Depression NCT00532103

1 forms
  1. StudyEvent: Eligibility
    1. Eligibility Depression NCT00532103
Name
Type
Description | Question | Decode (Coded Value)
Data type
Alias
Item Group
C1512693 (UMLS CUI)
patients being treated at the participating clinics
Item
only patients being treated at the participating clinics are eligible for this study
boolean
C0030705 (UMLS CUI [1,1])
C3489408 (UMLS CUI [1,2])
Enrollment; primary care facility; Specialty care unit | Geographic Locations
Item
patients must be enrolled at the primary or specialty care site, and be planning to continue living in the area of that clinic throughout the study
boolean
C1516879 (UMLS CUI [1,1])
C0814517 (UMLS CUI [1,2])
C4034258 (UMLS CUI [1,3])
C0017446 (UMLS CUI [2])
age
Item
patients must be 18-75 years old
boolean
C0001779 (UMLS CUI [1])
Major Depressive Disorder; Structured Clinical Interview; DSM-IV criteria for major depressive diagnosis documented
Item
patients must meet clinical criteria for mdd, based on clinical interview and dsm iv mdd checklist
boolean
C1269683 (UMLS CUI [1,1])
C0935589 (UMLS CUI [1,2])
C2199206 (UMLS CUI [1,3])
ham-d17 score
Item
screening ham-d17 score greater than or equal to 14
boolean
C3639712 (UMLS CUI [1])
informed consent
Item
patients must give written informed consent
boolean
C0021430 (UMLS CUI [1])
suicidal ideation
Item
patients with and without current suicidal ideation may be included in the study
boolean
C0424000 (UMLS CUI [1])
antidepressant agent
Item
patients must not have taken antidepressant medication for at least 2 weeks prior to screen (or 4 weeks in the case of fluoxetine).
boolean
C0003289 (UMLS CUI [1])
Item Group
C0680251 (UMLS CUI)
substance use disorder
Item
current substance abuse or dependence
boolean
C0038586 (UMLS CUI [1])
ssri treatment failures
Item
two past ssri treatment failures within the current episode, or last 2 years if chronic.
boolean
C0360105 (UMLS CUI [1,1])
C0162643 (UMLS CUI [1,2])
axis i diagnosis of bipolar disorder or schizophrenia
Item
patients with a current axis i diagnosis of bipolar disorder or schizophrenia
boolean
C0270287 (UMLS CUI [1,1])
C0005586 (UMLS CUI [1,2])
C0270287 (UMLS CUI [2,1])
C0036341 (UMLS CUI [2,2])
primary axis i diagnosis of obsessive-compulsive disorder, anorexia nervosa or bulimia
Item
patients with a current primary axis i diagnosis of obsessive-compulsive disorder, anorexia nervosa or bulimia.
boolean
C0270287 (UMLS CUI [1,1])
C0028768 (UMLS CUI [1,2])
C0270287 (UMLS CUI [2,1])
C0003125 (UMLS CUI [2,2])
C0270287 (UMLS CUI [3,1])
C0006370 (UMLS CUI [3,2])
Sexually active; Childbearing Potential | Pregnancy | Breast Feeding
Item
women who are sexually active and who are not using adequate contraception, or who are pregnant, trying to become pregnant, or breast feeding.
boolean
C0241028 (UMLS CUI [1,1])
C3831118 (UMLS CUI [1,2])
C0032961 (UMLS CUI [2])
C0006147 (UMLS CUI [3])
contraindication antidepressant medications
Item
patients with general medical conditions that contraindicate antidepressant medications
boolean
C1301624 (UMLS CUI [1,1])
C0003289 (UMLS CUI [1,2])
clinical status requires inpatient treatment
Item
patients whose clinical status requires inpatient treatment at the time of baseline interview.
boolean
C0449440 (UMLS CUI [1,1])
C0019993 (UMLS CUI [1,2])
able to speak english
Item
patients who cannot read and understand english since all research instruments are not yet translated and validated in spanish or other languages.
boolean
C0376245 (UMLS CUI [1])
antipsychotic agents
Item
some reports of ssri-induced akathisia-like states have found them to be more highly correlated with either concurrent or previous treatment with a neuroleptic, even in patients with no history of movement disorders therefore, patients who have taken an anti-psychotic medication within 4 months of the screening visit will be excluded from the study.
boolean
C0040615 (UMLS CUI [1])
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