A Naturalistic Study of the Efficacy and Safety of Escitalopram in Treatment Resistant Depression

Sheba Medical Center4 sites in 1 country60 target enrollmentFebruary 2005

ConditionsDepressive Disorder, Major

Drugsescitalopram

Overview

Phase: Not Applicable
Intervention: Not specified
Conditions: Depressive Disorder, Major
Sponsor: Sheba Medical Center
Enrollment: 60
Locations: 4
Primary Endpoint: MADRS
Last Updated: 16 years ago

Overview Investigators Eligibility Criteria Outcomes Sites Similar Trials

Overview

Brief Summary

The primary objective of this multicenter study is to evaluate the efficacy of escitalopram in treatment resistant depression (TRD), assessed by 2 consecutive failed antidepressant treatments from different classes. The last treatment received is a 6 week prospective trial with venlafaxine.

Registry

clinicaltrials.gov

Start Date

February 2005

End Date

June 2011

Last Updated

16 years ago

Study Type

Interventional

Study Design

Single Group

Sex

All

Investigators

Sponsor

Sheba Medical Center

Eligibility Criteria

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.