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

NCT00220480 | Unknown

• 1 other identifier: SHEBA-04-3434-JZ-CTIL
• Study Type: interventional
• Target: 60
• Locations: 1 country
• Sites: 4

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.

Conditions

Depressive Disorder, Major

Outcome Measures

Primary Outcomes (1)

• MADRS

  8 to 10 weeks

Interventions

escitalopram DRUG

10 to 30 mg / day

Eligibility Criteria

• Age: 18 Years - 65 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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.

You may not qualify if:

• 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.

Sponsors & Collaborators

• Sheba Medical Center: lead

Study Sites (4)

Rambam Medical Center

Haifa, Israel

RECRUITING

Ness Ziona Mental Health Center

Ness Ziona, Israel

RECRUITING

Gehah Mental Health Center

Petah Tikva, Israel

RECRUITING

Chaim Sheba Medical Center

Ramat Gan, 52621, Israel

RECRUITING

MeSH Terms

Conditions

Depressive Disorder, Major

Interventions

Escitalopram

Condition Hierarchy (Ancestors)

Depressive Disorder; Mood Disorders; Mental Disorders

Intervention Hierarchy (Ancestors)

Propylamines; Amines; Organic Chemicals; Nitriles; Benzofurans; Heterocyclic Compounds, 2-Ring; Heterocyclic Compounds, Fused-Ring; Heterocyclic Compounds

Study Officials

• Joseph Zohar, MD

  Tel Aviv University

  PRINCIPAL INVESTIGATOR

Central Study Contacts

Leah Fostick, MA

CONTACT

+972-3-5357805; Leah.Fostick@sheba.health.gov.il

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: NON RANDOMIZED
• Masking: NONE
• Purpose: TREATMENT
• Intervention Model: SINGLE GROUP
• Sponsor Type: OTHER GOV

Study Record Dates

• First Submitted: September 14, 2005
• First Posted: September 22, 2005
• Study Start: February 1, 2005
• Primary Completion: June 1, 2011
• Last Updated: February 9, 2010

Record last verified: 2010-02

Locations

IL (4)