ID

30483

Description

Efficacy and Safety of DOV 21,947 in the Treatment of Major Depressive Disorder; ODM derived from: https://clinicaltrials.gov/show/NCT00659347

Link

https://clinicaltrials.gov/show/NCT00659347

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 NCT00659347

English

Eligibility Major Depressive Disorder NCT00659347

1 forms  
Inclusion Criteria
Description

Inclusion Criteria

Alias
UMLS CUI
C1512693
1. males or females between 18 and 65 years of age (inclusive).
Description

Age

Data type

boolean

Alias
UMLS CUI [1]
C0001779
2. either outpatients or inpatients diagnosed with major depressive disorder (mdd) according to diagnostic and statistical manual of mental disorders (dsm-iv-tr, see appendix 3) and mini international neuropsychiatric interview (mini).
Description

Outpatients | Inpatients | Major Depressive Disorder

Data type

boolean

Alias
UMLS CUI [1]
C0029921
UMLS CUI [2]
C0021562
UMLS CUI [3]
C1269683
3. patients with recurrent depressive episode of at least 2 months in duration. patients must have previously responded (significant clinical improvement judged by the principal investigator) to at least one antidepressant treatment.
Description

Depressive episode Recurrent Duration | Response Antidepressant therapy Quantity

Data type

boolean

Alias
UMLS CUI [1,1]
C0349217
UMLS CUI [1,2]
C2945760
UMLS CUI [1,3]
C0449238
UMLS CUI [2,1]
C1704632
UMLS CUI [2,2]
C1096649
UMLS CUI [2,3]
C1265611
4. hamd-17 total score * 22 with a severity score of at least 2 on item 1 at the placebo run-in visit and the baseline/day 1 visit.
Description

Hamilton Depression Rating Scale 17 Item Clinical Classification | Run-in Placebo Hamilton Depression Rating Scale 17 Item Clinical Classification | Baseline state Hamilton Depression Rating Scale 17 Item Clinical Classification

Data type

boolean

Alias
UMLS CUI [1]
C3639712
UMLS CUI [2,1]
C3274438
UMLS CUI [2,2]
C0032042
UMLS CUI [2,3]
C3639712
UMLS CUI [3,1]
C1290922
UMLS CUI [3,2]
C3639712
5. hamd-17 score reduction ≤ 15% between the placebo run-in visit and the baseline/day 1 visit.
Description

Hamilton Depression Rating Scale 17 Item Clinical Classification Reduction Percentage | Difference Run-in Placebo Baseline state

Data type

boolean

Alias
UMLS CUI [1,1]
C3639712
UMLS CUI [1,2]
C0392756
UMLS CUI [1,3]
C0439165
UMLS CUI [2,1]
C1705242
UMLS CUI [2,2]
C3274438
UMLS CUI [2,3]
C0032042
UMLS CUI [2,4]
C1290922
6. ham-a total score < 17 at the screening visit.
Description

Hamilton Anxiety Rating Scale Questionnaire

Data type

boolean

Alias
UMLS CUI [1]
C3541258
Exclusion Criteria
Description

Exclusion Criteria

Alias
UMLS CUI
C0680251
1. patients with a hamd-17 total score reduction of more than 15% between the placebo run-in visit and the baseline/day 1 visit (placebo responders).
Description

Hamilton Depression Rating Scale 17 Item Clinical Classification Reduction Percentage | Difference Run-in Placebo Baseline state | Placebo Responder

Data type

boolean

Alias
UMLS CUI [1,1]
C3639712
UMLS CUI [1,2]
C0392756
UMLS CUI [1,3]
C0439165
UMLS CUI [2,1]
C1705242
UMLS CUI [2,2]
C3274438
UMLS CUI [2,3]
C0032042
UMLS CUI [2,4]
C1290922
UMLS CUI [3,1]
C0032042
UMLS CUI [3,2]
C0919876
2. patients with a medical history of mdd that consistently did not respond significantly to an adequate treatment regimen of a monoamine oxidase (mao) inhibitor.
Description

Major Depressive Disorder Unresponsive to Treatment | Monoamine Oxidase Inhibitors

Data type

boolean

Alias
UMLS CUI [1,1]
C1269683
UMLS CUI [1,2]
C0205269
UMLS CUI [2]
C0026457
3. patients who are known to be antidepressant treatment-resistant. patients are defined as treatment-resistant if in the past they have failed adequate antidepressant treatments (dose level approved in the product labeling and was administered for at least 4 weeks) from two or more different pharmacological classes (e.g., tca, ssri, snri, mao-i, etc). failure to respond to an adequate antidepressant treatment is defined as the absence of at least a 50% improvement in symptoms by patient report or documented history, or lack of significant clinical improvement at the principal investigator's discretion.
Description

Antidepressant therapy Resistant | Antidepressant therapy failed | Class pharmacological different Quantity | Tricyclic Antidepressant | Selective Serotonin Reuptake Inhibitors | Serotonin and Norepinephrine Reuptake Inhibitors (SNRIs) | Monoamine Oxidase Inhibitors

Data type

boolean

Alias
UMLS CUI [1,1]
C1096649
UMLS CUI [1,2]
C0332325
UMLS CUI [2,1]
C1096649
UMLS CUI [2,2]
C0231175
UMLS CUI [3,1]
C0456387
UMLS CUI [3,2]
C0205464
UMLS CUI [3,3]
C1705242
UMLS CUI [3,4]
C1265611
UMLS CUI [4]
C3536819
UMLS CUI [5]
C0360105
UMLS CUI [6]
C1579361
UMLS CUI [7]
C0026457
4. patients with a medical history of mdd who consistently did not respond significantly to electroconvulsive shock therapy (ect) or had ect within a year prior to the screening visit regardless of outcome.
Description

Major Depressive Disorder Unresponsive to Electroconvulsive Therapy | Electroconvulsive Therapy Previous

Data type

boolean

Alias
UMLS CUI [1,1]
C1269683
UMLS CUI [1,2]
C0205269
UMLS CUI [1,3]
C0013806
UMLS CUI [2,1]
C0013806
UMLS CUI [2,2]
C0205156
5. patients with psychotic depression
Description

Depression, psychotic

Data type

boolean

Alias
UMLS CUI [1]
C0743072
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Similar models

Eligibility Major Depressive Disorder NCT00659347

1 forms
Name
Type
Description | Question | Decode (Coded Value)
Data type
Alias
Item Group
C1512693 (UMLS CUI)
Age
Item
1. males or females between 18 and 65 years of age (inclusive).
boolean
C0001779 (UMLS CUI [1])
Outpatients | Inpatients | Major Depressive Disorder
Item
2. either outpatients or inpatients diagnosed with major depressive disorder (mdd) according to diagnostic and statistical manual of mental disorders (dsm-iv-tr, see appendix 3) and mini international neuropsychiatric interview (mini).
boolean
C0029921 (UMLS CUI [1])
C0021562 (UMLS CUI [2])
C1269683 (UMLS CUI [3])
Depressive episode Recurrent Duration | Response Antidepressant therapy Quantity
Item
3. patients with recurrent depressive episode of at least 2 months in duration. patients must have previously responded (significant clinical improvement judged by the principal investigator) to at least one antidepressant treatment.
boolean
C0349217 (UMLS CUI [1,1])
C2945760 (UMLS CUI [1,2])
C0449238 (UMLS CUI [1,3])
C1704632 (UMLS CUI [2,1])
C1096649 (UMLS CUI [2,2])
C1265611 (UMLS CUI [2,3])
Hamilton Depression Rating Scale 17 Item Clinical Classification | Run-in Placebo Hamilton Depression Rating Scale 17 Item Clinical Classification | Baseline state Hamilton Depression Rating Scale 17 Item Clinical Classification
Item
4. hamd-17 total score * 22 with a severity score of at least 2 on item 1 at the placebo run-in visit and the baseline/day 1 visit.
boolean
C3639712 (UMLS CUI [1])
C3274438 (UMLS CUI [2,1])
C0032042 (UMLS CUI [2,2])
C3639712 (UMLS CUI [2,3])
C1290922 (UMLS CUI [3,1])
C3639712 (UMLS CUI [3,2])
Hamilton Depression Rating Scale 17 Item Clinical Classification Reduction Percentage | Difference Run-in Placebo Baseline state
Item
5. hamd-17 score reduction ≤ 15% between the placebo run-in visit and the baseline/day 1 visit.
boolean
C3639712 (UMLS CUI [1,1])
C0392756 (UMLS CUI [1,2])
C0439165 (UMLS CUI [1,3])
C1705242 (UMLS CUI [2,1])
C3274438 (UMLS CUI [2,2])
C0032042 (UMLS CUI [2,3])
C1290922 (UMLS CUI [2,4])
Hamilton Anxiety Rating Scale Questionnaire
Item
6. ham-a total score < 17 at the screening visit.
boolean
C3541258 (UMLS CUI [1])
Item Group
C0680251 (UMLS CUI)
Hamilton Depression Rating Scale 17 Item Clinical Classification Reduction Percentage | Difference Run-in Placebo Baseline state | Placebo Responder
Item
1. patients with a hamd-17 total score reduction of more than 15% between the placebo run-in visit and the baseline/day 1 visit (placebo responders).
boolean
C3639712 (UMLS CUI [1,1])
C0392756 (UMLS CUI [1,2])
C0439165 (UMLS CUI [1,3])
C1705242 (UMLS CUI [2,1])
C3274438 (UMLS CUI [2,2])
C0032042 (UMLS CUI [2,3])
C1290922 (UMLS CUI [2,4])
C0032042 (UMLS CUI [3,1])
C0919876 (UMLS CUI [3,2])
Major Depressive Disorder Unresponsive to Treatment | Monoamine Oxidase Inhibitors
Item
2. patients with a medical history of mdd that consistently did not respond significantly to an adequate treatment regimen of a monoamine oxidase (mao) inhibitor.
boolean
C1269683 (UMLS CUI [1,1])
C0205269 (UMLS CUI [1,2])
C0026457 (UMLS CUI [2])
Antidepressant therapy Resistant | Antidepressant therapy failed | Class pharmacological different Quantity | Tricyclic Antidepressant | Selective Serotonin Reuptake Inhibitors | Serotonin and Norepinephrine Reuptake Inhibitors (SNRIs) | Monoamine Oxidase Inhibitors
Item
3. patients who are known to be antidepressant treatment-resistant. patients are defined as treatment-resistant if in the past they have failed adequate antidepressant treatments (dose level approved in the product labeling and was administered for at least 4 weeks) from two or more different pharmacological classes (e.g., tca, ssri, snri, mao-i, etc). failure to respond to an adequate antidepressant treatment is defined as the absence of at least a 50% improvement in symptoms by patient report or documented history, or lack of significant clinical improvement at the principal investigator's discretion.
boolean
C1096649 (UMLS CUI [1,1])
C0332325 (UMLS CUI [1,2])
C1096649 (UMLS CUI [2,1])
C0231175 (UMLS CUI [2,2])
C0456387 (UMLS CUI [3,1])
C0205464 (UMLS CUI [3,2])
C1705242 (UMLS CUI [3,3])
C1265611 (UMLS CUI [3,4])
C3536819 (UMLS CUI [4])
C0360105 (UMLS CUI [5])
C1579361 (UMLS CUI [6])
C0026457 (UMLS CUI [7])
Major Depressive Disorder Unresponsive to Electroconvulsive Therapy | Electroconvulsive Therapy Previous
Item
4. patients with a medical history of mdd who consistently did not respond significantly to electroconvulsive shock therapy (ect) or had ect within a year prior to the screening visit regardless of outcome.
boolean
C1269683 (UMLS CUI [1,1])
C0205269 (UMLS CUI [1,2])
C0013806 (UMLS CUI [1,3])
C0013806 (UMLS CUI [2,1])
C0205156 (UMLS CUI [2,2])
Depression, psychotic
Item
5. patients with psychotic depression
boolean
C0743072 (UMLS CUI [1])
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