ID

30498

Description

Efficacy and Safety Study of a Combination Product [Drug:BCI-024 (Buspirone) and Drug:BCI-049 (Melatonin)] to Treat Major Depressive Disorder (MDD); ODM derived from: https://clinicaltrials.gov/show/NCT00705003

Link

https://clinicaltrials.gov/show/NCT00705003

Keywords

Versions (1)
  1. 6/8/18 6/8/18 -
Copyright Holder

See clinicaltrials.gov

Uploaded on

June 8, 2018

DOI

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License

Creative Commons BY 4.0
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Eligibility Major Depressive Disorder NCT00705003

English

Eligibility Major Depressive Disorder NCT00705003

1 forms  
Inclusion Criteria
Description

Inclusion Criteria

Alias
UMLS CUI
C1512693
subjects will be male and female subjects between the ages of 18 to 65 meeting the diagnostic and statistical manual of mental disorders-iv-text revision (dsm-iv-tr) criteria for major depressive disorder with a quick inventory of depressive symptomatology-16 item self report (qids-sr16) score of >14 at the screening and baseline visits.
Description

Age | Major Depressive Disorder | Quick Inventory of Depressive Symptomatology Self-Report Version Questionnaire

Data type

boolean

Alias
UMLS CUI [1]
C0001779
UMLS CUI [2]
C1269683
UMLS CUI [3]
C4331197
female subjects must be on a stable and medically reliable form of birth control, must agree to continue use of this birth control during the study, and must have negative urine pregnancy tests at the screening visit.
Description

Gender Contraceptive methods Stable | Gender Urine pregnancy test negative

Data type

boolean

Alias
UMLS CUI [1,1]
C0079399
UMLS CUI [1,2]
C0700589
UMLS CUI [1,3]
C0205360
UMLS CUI [2,1]
C0079399
UMLS CUI [2,2]
C0430057
Exclusion Criteria
Description

Exclusion Criteria

Alias
UMLS CUI
C0680251
subjects with any other psychiatric axis-i disorder as a principal diagnosis within 6 months of screening or subjects with a history of obsessive compulsive disorder, psychotic disorder, bipolar disorder, or mental retardation at any time are not eligible for the study.
Description

Axis I diagnosis Other Primary | Obsessive-Compulsive Disorder | Psychotic Disorders | Bipolar Disorder | Mental Retardation

Data type

boolean

Alias
UMLS CUI [1,1]
C0270287
UMLS CUI [1,2]
C0205394
UMLS CUI [1,3]
C0332137
UMLS CUI [2]
C0028768
UMLS CUI [3]
C0033975
UMLS CUI [4]
C0005586
UMLS CUI [5]
C0025362
subjects who pose a suicidal risk or who have a history of eating disorder or substance dependence within 6 months of screening, or a history of substance abuse within 3 months of screening are also ineligible.
Description

At risk for suicide | Eating Disorders | Substance Dependence | Substance Use Disorders

Data type

boolean

Alias
UMLS CUI [1]
C0563664
UMLS CUI [2]
C0013473
UMLS CUI [3]
C0038580
UMLS CUI [4]
C0038586
subjects with clinically significant abnormalities on any screening or baseline assessments, including laboratory tests, are excluded.
Description

Abnormality Clinical Significance Screening | Abnormality Clinical Significance Baseline Assessment | Laboratory test result abnormal

Data type

boolean

Alias
UMLS CUI [1,1]
C1704258
UMLS CUI [1,2]
C2826293
UMLS CUI [1,3]
C0220908
UMLS CUI [2,1]
C1704258
UMLS CUI [2,2]
C2826293
UMLS CUI [2,3]
C1442488
UMLS CUI [2,4]
C1516048
UMLS CUI [3]
C0438215
subjects with a known intolerance to either buspirone or melatonin are excluded, as are subjects with clinically significant medical or psychiatric conditions that might be detrimental to the subject should they participate in the study.
Description

Intolerance to Buspirone | Intolerance to Melatonin | Medical condition Clinical Significance compromises Study Subject Participation Status | Mental condition Clinical Significance compromises Study Subject Participation Status

Data type

boolean

Alias
UMLS CUI [1,1]
C1744706
UMLS CUI [1,2]
C0006462
UMLS CUI [2,1]
C1744706
UMLS CUI [2,2]
C0025219
UMLS CUI [3,1]
C3843040
UMLS CUI [3,2]
C2826293
UMLS CUI [3,3]
C2945640
UMLS CUI [3,4]
C2348568
UMLS CUI [4,1]
C3840291
UMLS CUI [4,2]
C2826293
UMLS CUI [4,3]
C2945640
UMLS CUI [4,4]
C2348568
subjects who have used selective serotonin reuptake inhibitors (ssris) within 2 weeks of screening (within 4 weeks for fluoxetine) are excluded as are subjects requiring concomitant use of antipsychotic and anxiolytic medications and any drugs with known psychotropic properties. concomitant medications that are not excluded by the protocol and that are taken chronically must be at a stable dosage for at least 4 weeks prior to screening.
Description

Selective Serotonin Reuptake Inhibitors | Fluoxetine | Patient need for Antipsychotic Agents | Patient need for Anti-Anxiety Agents | Patient need for Psychotropic Drugs

Data type

boolean

Alias
UMLS CUI [1]
C0360105
UMLS CUI [2]
C0016365
UMLS CUI [3,1]
C0686904
UMLS CUI [3,2]
C0040615
UMLS CUI [4,1]
C0686904
UMLS CUI [4,2]
C0040616
UMLS CUI [5,1]
C0686904
UMLS CUI [5,2]
C0033978
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Similar models

Eligibility Major Depressive Disorder NCT00705003

1 forms
Name
Type
Description | Question | Decode (Coded Value)
Data type
Alias
Item Group
C1512693 (UMLS CUI)
Age | Major Depressive Disorder | Quick Inventory of Depressive Symptomatology Self-Report Version Questionnaire
Item
subjects will be male and female subjects between the ages of 18 to 65 meeting the diagnostic and statistical manual of mental disorders-iv-text revision (dsm-iv-tr) criteria for major depressive disorder with a quick inventory of depressive symptomatology-16 item self report (qids-sr16) score of >14 at the screening and baseline visits.
boolean
C0001779 (UMLS CUI [1])
C1269683 (UMLS CUI [2])
C4331197 (UMLS CUI [3])
Gender Contraceptive methods Stable | Gender Urine pregnancy test negative
Item
female subjects must be on a stable and medically reliable form of birth control, must agree to continue use of this birth control during the study, and must have negative urine pregnancy tests at the screening visit.
boolean
C0079399 (UMLS CUI [1,1])
C0700589 (UMLS CUI [1,2])
C0205360 (UMLS CUI [1,3])
C0079399 (UMLS CUI [2,1])
C0430057 (UMLS CUI [2,2])
Item Group
C0680251 (UMLS CUI)
Axis I diagnosis Other Primary | Obsessive-Compulsive Disorder | Psychotic Disorders | Bipolar Disorder | Mental Retardation
Item
subjects with any other psychiatric axis-i disorder as a principal diagnosis within 6 months of screening or subjects with a history of obsessive compulsive disorder, psychotic disorder, bipolar disorder, or mental retardation at any time are not eligible for the study.
boolean
C0270287 (UMLS CUI [1,1])
C0205394 (UMLS CUI [1,2])
C0332137 (UMLS CUI [1,3])
C0028768 (UMLS CUI [2])
C0033975 (UMLS CUI [3])
C0005586 (UMLS CUI [4])
C0025362 (UMLS CUI [5])
At risk for suicide | Eating Disorders | Substance Dependence | Substance Use Disorders
Item
subjects who pose a suicidal risk or who have a history of eating disorder or substance dependence within 6 months of screening, or a history of substance abuse within 3 months of screening are also ineligible.
boolean
C0563664 (UMLS CUI [1])
C0013473 (UMLS CUI [2])
C0038580 (UMLS CUI [3])
C0038586 (UMLS CUI [4])
Abnormality Clinical Significance Screening | Abnormality Clinical Significance Baseline Assessment | Laboratory test result abnormal
Item
subjects with clinically significant abnormalities on any screening or baseline assessments, including laboratory tests, are excluded.
boolean
C1704258 (UMLS CUI [1,1])
C2826293 (UMLS CUI [1,2])
C0220908 (UMLS CUI [1,3])
C1704258 (UMLS CUI [2,1])
C2826293 (UMLS CUI [2,2])
C1442488 (UMLS CUI [2,3])
C1516048 (UMLS CUI [2,4])
C0438215 (UMLS CUI [3])
Intolerance to Buspirone | Intolerance to Melatonin | Medical condition Clinical Significance compromises Study Subject Participation Status | Mental condition Clinical Significance compromises Study Subject Participation Status
Item
subjects with a known intolerance to either buspirone or melatonin are excluded, as are subjects with clinically significant medical or psychiatric conditions that might be detrimental to the subject should they participate in the study.
boolean
C1744706 (UMLS CUI [1,1])
C0006462 (UMLS CUI [1,2])
C1744706 (UMLS CUI [2,1])
C0025219 (UMLS CUI [2,2])
C3843040 (UMLS CUI [3,1])
C2826293 (UMLS CUI [3,2])
C2945640 (UMLS CUI [3,3])
C2348568 (UMLS CUI [3,4])
C3840291 (UMLS CUI [4,1])
C2826293 (UMLS CUI [4,2])
C2945640 (UMLS CUI [4,3])
C2348568 (UMLS CUI [4,4])
Selective Serotonin Reuptake Inhibitors | Fluoxetine | Patient need for Antipsychotic Agents | Patient need for Anti-Anxiety Agents | Patient need for Psychotropic Drugs
Item
subjects who have used selective serotonin reuptake inhibitors (ssris) within 2 weeks of screening (within 4 weeks for fluoxetine) are excluded as are subjects requiring concomitant use of antipsychotic and anxiolytic medications and any drugs with known psychotropic properties. concomitant medications that are not excluded by the protocol and that are taken chronically must be at a stable dosage for at least 4 weeks prior to screening.
boolean
C0360105 (UMLS CUI [1])
C0016365 (UMLS CUI [2])
C0686904 (UMLS CUI [3,1])
C0040615 (UMLS CUI [3,2])
C0686904 (UMLS CUI [4,1])
C0040616 (UMLS CUI [4,2])
C0686904 (UMLS CUI [5,1])
C0033978 (UMLS CUI [5,2])
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