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

Lien

https://clinicaltrials.gov/show/NCT00659347

Mots-clés

Versions (1)
  1. 08/06/2018 08/06/2018 -
Détendeur de droits

See clinicaltrials.gov

Téléchargé le

8 juin 2018

DOI

Pour une demande vous connecter.

Licence

Creative Commons BY 4.0
Modèle Commentaires :

Ici, vous pouvez faire des commentaires sur le modèle. À partir des bulles de texte, vous pouvez laisser des commentaires spécifiques sur les groupes Item et les Item.

Retour au modèle Commentaires
Groupe Item commentaires pour :

Item commentaires pour :

Vous devez être connecté pour pouvoir télécharger des formulaires. Veuillez vous connecter ou s’inscrire gratuitement.

Eligibility Major Depressive Disorder NCT00659347

Anglais

Eligibility Major Depressive Disorder NCT00659347

1 Formulaires  
Inclusion Criteria
Description

Inclusion Criteria

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

Age

Type de données

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

Type de données

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

Type de données

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

Type de données

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

Type de données

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

Type de données

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

Type de données

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

Type de données

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

Type de données

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

Type de données

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

Type de données

boolean

Alias
UMLS CUI [1]
C0743072
Retour au début de la page

Similar models

Eligibility Major Depressive Disorder NCT00659347

1 Formulaires
Name
Type
Description | Question | Decode (Coded Value)
Type de données
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])
Retour au début de la page 

Contact

Utilisez ce formulaire pour les retours, les questions et les améliorations suggérées.

Les champs marqués d’un * sont obligatoires.

Aide

Do you need help on how to use the search function? Please watch the corresponding tutorial video for more details and learn how to use the search function most efficiently.

Watch Tutorial