- ICH GCP
- Registre américain des essais cliniques
- Essai clinique NCT00220480
A Naturalistic Study of the Efficacy and Safety of Escitalopram in Treatment Resistant Depression
Aperçu de l'étude
Statut
Les conditions
Intervention / Traitement
Type d'étude
Inscription (Anticipé)
Phase
- N'est pas applicable
Contacts et emplacements
Lieux d'étude
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Haifa, Israël
- Recrutement
- Rambam Medical Center
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Contact:
- Leah Fostick, MA
- Numéro de téléphone: +972-3-5357805
- E-mail: Leah.Fostick@sheba.health.gov.il
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Ness Ziona, Israël
- Recrutement
- Ness Ziona Mental Health Center
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Contact:
- Leah Fostick, MA
- Numéro de téléphone: +972-3-5357805
- E-mail: Leah.Fostick@sheba.health.gov.il
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Petach Tikva, Israël
- Recrutement
- Gehah Mental Health Center
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Contact:
- Leah Fostick, MA
- Numéro de téléphone: +972-3-5357805
- E-mail: Leah.Fostick@health.gov.il
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Ramat-Gan, Israël, 52621
- Recrutement
- Chaim Sheba Medical Center
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Contact:
- Leah Fostick, MA
- Numéro de téléphone: +972-3-5357805
- E-mail: Leah.Fostick@sheba.health.gov.il
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Critères de participation
Critère d'éligibilité
Âges éligibles pour étudier
Accepte les volontaires sains
Sexes éligibles pour l'étude
La description
Inclusion Criteria:
Any patient who meets all of the following criteria is eligible for inclusion in the Prospective phase I of the study:
- The patient is able to read and understand the patient information sheet.
- Prior to any screening procedures, the patient must have signed the informed consent form. No study-related procedures may be performed before the patient has signed the form.
- The patient is an in- or outpatient, male or female.
- The patient is between 18 and 65 years of age.
- The patient suffers from a diagnosis of recurrent Major Depressive Disorder (current episode assessed with the MINI), moderate or severe, according to DSM-IV-TR criteria (classification code = 296.3x).
- The patient has a total score of 22 or higher on the MADRS.
- The patient has been treated for the current episode with an antidepressant (other than escitalopram or venlafaxine) prescribed continuously at the optimal dose (see table Appendix 1) for at least the 4 weeks preceding selection (AD1).
- The investigator considers switching treatment to venlafaxine (AD2), prescribing it at its optimal dose, defined by the study protocol.
Exclusion Criteria:
Any patient who meets one or more of the following criteria cannot be included in the screening phase of the study:
- The patient has previously participated in this study.
- Results from blood sampling at selection show for the antidepressant prescribed (AD1), that plasma concentration is below the expected threshold according to time of last intake.
- The patient has taken another antidepressant in combination to the antidepressant to which he/she is considered as non-responder (AD1).
The patient has one or more of the following conditions:
- Any current psychiatric disorder established as the principal diagnosis other than Major depressive episode as defined in the DSM-IV-TR (assessed with the MINI).
- Any Substance disorder (except nicotine and caffeine) within the previous 6 months as defined in the DSM-IV-TR.
- Any severe personality disorder according to investigator clinical judgement, that might compromise the study.
The patient uses disallowed recent or concomitant medication within the specified time periods:
- oral antipsychotic drugs within 2 months and depot antipsychotic preparations within the past 6 months.
- ECT within the past 6 months.
- lithium, carbamazepine, valproate or valpromide within the past month.
- any benzodiazepines at a dose higher than 10 mg diazepam or equivalent, within the last week.
- any non-benzodiazepine anxiolytics within the last week.
- serotonin agonists within the last week.
- any other drug with potential psychotropic effects within the last week.
- any drug known to lower blood pressure in the last week.
- The patient has been treated with any investigational product within 3 months prior to screening.
- The patient has been treated during the current episode with escitalopram or venlafaxine.
- The patient has a history of severe drug allergy or hypersensitivity, or known hypersensitivity to escitalopram or venlafaxine.
- The patient started (or will start) formal psychotherapy in the month preceding inclusion.
- The patient has a previous history of convulsive disorder other than a single childhood febrile seizure.
- The patient presents evidence of urinary retention or glaucoma.
- The patient has a serious illness and/or serious sequelae thereof, including liver or renal insufficiency, or a cardiovascular, pulmonary, gastrointestinal, endocrine, neurological, infectious, neoplastic, or metabolic disturbance.
- The patient has, in the opinion of the investigator, on the basis of a physical examination, medical history and vital signs, a comorbid conditions(s) that would render inclusion in the study unsafe.
- The patient takes medication that, in the opinion of the investigator, could interfere with the assessments of safety, tolerability, or efficacy.
- The patient, in the opinion of the investigator, is unlikely to comply with the clinical study protocol or is unsuitable for any reason
Plan d'étude
Comment l'étude est-elle conçue ?
Détails de conception
- Objectif principal: Traitement
- Répartition: Non randomisé
- Modèle interventionnel: Affectation à un seul groupe
- Masquage: Aucun (étiquette ouverte)
Que mesure l'étude ?
Principaux critères de jugement
Mesure des résultats |
Délai |
---|---|
MADRS
Délai: 8 to 10 weeks
|
8 to 10 weeks
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Collaborateurs et enquêteurs
Parrainer
Dates d'enregistrement des études
Dates principales de l'étude
Début de l'étude
Achèvement primaire (Anticipé)
Dates d'inscription aux études
Première soumission
Première soumission répondant aux critères de contrôle qualité
Première publication (Estimation)
Mises à jour des dossiers d'étude
Dernière mise à jour publiée (Estimation)
Dernière mise à jour soumise répondant aux critères de contrôle qualité
Dernière vérification
Plus d'information
Termes liés à cette étude
Termes MeSH pertinents supplémentaires
- Les troubles mentaux
- Troubles de l'humeur
- Dépression
- Trouble dépressif majeur
- Effets physiologiques des médicaments
- Agents neurotransmetteurs
- Mécanismes moléculaires de l'action pharmacologique
- Médicaments psychotropes
- Inhibiteurs de l'absorption de la sérotonine
- Inhibiteurs de l'absorption des neurotransmetteurs
- Modulateurs de transport membranaire
- Agents de sérotonine
- Agents antidépresseurs
- Agents antidépresseurs, deuxième génération
- Citalopram
Autres numéros d'identification d'étude
- SHEBA-04-3434-JZ-CTIL
Ces informations ont été extraites directement du site Web clinicaltrials.gov sans aucune modification. Si vous avez des demandes de modification, de suppression ou de mise à jour des détails de votre étude, veuillez contacter register@clinicaltrials.gov. Dès qu'un changement est mis en œuvre sur clinicaltrials.gov, il sera également mis à jour automatiquement sur notre site Web .
Essais cliniques sur escitalopram
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First Affiliated Hospital of Zhejiang UniversityRecrutementAdolescent | DépressionChine
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Perry RenshawRésiliéLa dépression | Consommation de substances | Double diagnosticÉtats-Unis
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Shanghai Mental Health CenterJiangsu Nhwa Pharmaceutical Co., Ltd.Complété
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Rigshospitalet, DenmarkUniversity of Cambridge; Lundbeck FoundationComplété
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Shanghai Mental Health CenterRecrutement
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University of PennsylvaniaWashington University School of MedicineComplété
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Boston UniversityComplétéMaladie de l'artère coronaire
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University of California, Los AngelesInconnueInsomnie | Trouble dépressif majeurÉtats-Unis
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Ryerson UniversityInconnueInsomnie | Trouble dépressif majeurCanada
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Chonnam National University HospitalRecrutementTrouble dépressif majeurCorée, République de