ID

30483

Descripción

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

Palabras clave

Versiones (1)
  1. 8/6/18 8/6/18 -
Titular de derechos de autor

See clinicaltrials.gov

Subido en

8 de junio de 2018

DOI

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Licencia

Creative Commons BY 4.0
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Eligibility Major Depressive Disorder NCT00659347

Inglés

Eligibility Major Depressive Disorder NCT00659347

1 formularios  
Inclusion Criteria
Descripción

Inclusion Criteria

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

Age

Tipo de datos

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).
Descripción

Outpatients | Inpatients | Major Depressive Disorder

Tipo de datos

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.
Descripción

Depressive episode Recurrent Duration | Response Antidepressant therapy Quantity

Tipo de datos

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.
Descripción

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

Tipo de datos

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.
Descripción

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

Tipo de datos

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.
Descripción

Hamilton Anxiety Rating Scale Questionnaire

Tipo de datos

boolean

Alias
UMLS CUI [1]
C3541258
Exclusion Criteria
Descripción

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).
Descripción

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

Tipo de datos

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.
Descripción

Major Depressive Disorder Unresponsive to Treatment | Monoamine Oxidase Inhibitors

Tipo de datos

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.
Descripción

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

Tipo de datos

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.
Descripción

Major Depressive Disorder Unresponsive to Electroconvulsive Therapy | Electroconvulsive Therapy Previous

Tipo de datos

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
Descripción

Depression, psychotic

Tipo de datos

boolean

Alias
UMLS CUI [1]
C0743072
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Similar models

Eligibility Major Depressive Disorder NCT00659347

1 formularios
Name
Tipo
Description | Question | Decode (Coded Value)
Tipo de datos
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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