AzTrials
AzTrials

Depressive Disorder, MajorNCT00220480

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

A study testing escitalopram in people with Depressive Disorder, Major, run by Sheba Medical Center at 4 sites in Israel.

Unknown status

Status not confirmed. The sponsor has not verified this record for over two years, so it may be out of date.

Official record
Search all trials

Trial 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. Read more about this study

Who is it for?
Ages 18 to 65 years
Conditions the study is for
Depressive Disorder, Major
What is being tested?
escitalopram
How many people
60 participants
Where
4 sitesIsrael
Study dates
Feb 2005to Jun 2011
Phase
Interventional
Are there results?
None posted in the registry

Key requirements

Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.

  • Ages 18 to 65 years
  • All sexes
  • No healthy volunteers
  • Adult, Older adult

Who may be able to join

  • 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).
Show all 9Show fewer
  • 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.

Who cannot join

  • 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).
Show all 27Show fewer
  • 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

Trial locations and contacts

4 sites in 1 country.

Leah Fostick, MA contact

+972-3-5357805

Leah.Fostick@sheba.health.gov.il

Israel4 sites, 4 recruiting

  • Rambam Medical Center

    Haifa

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

    Recruiting

  • Ness Ziona Mental Health Center

    Ness Ziona

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

    Recruiting

  • Gehah Mental Health Center

    Petah Tikva

    Leah Fostick, MA, +972-3-5357805, Leah.Fostick@health.gov.il

    Recruiting

  • Chaim Sheba Medical Center

    Ramat Gan, 52621

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

    Recruiting

Other trials in Israel

About this study

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.

Being tested
escitalopram
Medical subject headings
Depressive Disorder, Major

What participants receive

What participants receive. In a randomised study each person is assigned to one group by chance.

What is being measured

The primary outcome is the main question the study is designed to answer.

  1. MADRS

    Measured: 8 to 10 weeks

Timeline

From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.

  1. First posted22 Sep 2005 (estimated)
  2. Study startFeb 2005
  3. Primary completionJun 2011 (estimated)

Resources

More details

For doctors and researchers: how the study is designed, who runs it, and its registry IDs.

Study design
Study type
Interventional
Phase
Phase N/A
Primary purpose
Treatment
Allocation
Non-randomised
Intervention model
Single group
Masking
None (open label)
Enrolment
60 participants (estimated)
IDs, dates and publications
ClinicalTrials.gov ID
NCT00220480
Sponsor's protocol ID
SHEBA-04-3434-JZ-CTIL
Status last verified
Feb 2010
First submitted
14 Sep 2005
Last updated
9 Feb 2010
Results posted
No
Data monitoring committee
No

Questions about this trial

What is this clinical trial studying?

A study testing escitalopram in people with Depressive Disorder, Major, run by Sheba Medical Center at 4 sites in Israel.

The full registered description is in the About this study section and the official record.

Who may be eligible to take part?

The sponsor lists 9 inclusion and 27 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.

Is this clinical trial currently recruiting?

The record says: status not confirmed, as of the sponsor's last update on 9 Feb 2010. Status can change between updates, so confirm with the study contact before making plans.

Where is the study taking place?

The record lists 4 sites in Israel. Whether a site is taking part right now should be confirmed with that site. See every site.

What are the possible benefits and risks?

They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.

Are results available for this study?

Results are not available in the source record.

How can a doctor refer a patient or contact the research team?

Contact Leah Fostick, MA (+972-3-5357805, Leah.Fostick@sheba.health.gov.il), or a site near the patient. AzTrials does not enrol participants or take referrals.

What does the primary outcome measure?

MADRS (time frame: 8 to 10 weeks). It is what the study was designed to measure, not a finding.

Where can I read the original study information?

On the ClinicalTrials.gov record for NCT00220480.

Does a listing mean the treatment is approved or proven to work?

No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.

How often is this information updated?

AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 9 Feb 2010.

AzTrials uses cookies for analytics and advertising. You can accept or reject them; the site works either way. Privacy Policy.

Free account

Log in to keep searching

You’ve used your 3 free searches. AzTrials is free: log in or create a free account to keep searching clinical trials and save the ones you want to follow.

Create a free accountLog in