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A Research Study to Compare the Treatments of a Combination of Elzasonan With Zoloft, to Zoloft Alone, or Placebo in People With Major Depressive Disorder (MDD)

NCT ID: NCT00275197

Last Updated: 2008-11-03

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

COMPLETED

Clinical Phase

PHASE2

Total Enrollment

262 participants

Study Classification

INTERVENTIONAL

Study Start Date

2005-12-31

Study Completion Date

2007-07-31

Brief Summary

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The major purpose of the study is to help determine whether giving the combination of Elzasonan with Zoloft to people with depression is a better treatment than taking Zoloft alone. This study will also compare the safety and tolerability of Elzasonan and Zoloft combination to Zoloft alone or placebo.

Detailed Description

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Conditions

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Depressive Disorder, Major

Study Design

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Allocation Method

RANDOMIZED

Intervention Model

PARALLEL

Primary Study Purpose

TREATMENT

Blinding Strategy

DOUBLE

Interventions

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Sertraline and Elzasonan Combination

Intervention Type DRUG

Sertraline

Intervention Type DRUG

Placebo

Intervention Type DRUG

Eligibility Criteria

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Inclusion Criteria

* Adult subjects, 18 years of age or older with a diagnosis of recurrent, moderate-to-severe MDD without psychotic features (DSM-IV 296.3x, with a HAMD17 score \>= to 22 and CGI-S \>=4.
* MDD must be the primary psychiatric disorder that motivated the subject to seek treatment and the current episode must be at least 1 month in duration but no longer than 6 months in duration.

Exclusion Criteria

* Subjects who, in the investigator's judgement, would require treatment with electroconvulsive therapy (ECT), or antipsychotics, or would require a change in intensity of psychotherapy, or subjects who would require treatment with any other psychotherapeutic drugs during the course of the trial.
* Subjects who have ever been diagnosed with Panic Disorder, Post-Traumatic Stress Disorder, Obsessive-Compulsive Disorder, Bipolar Affective Disorder, Schizophrenia, Schizoaffective Disorder or othe Psychotic Disorder, MDD with a seasonal pattern, or Dissociative Disorders per DSM-IV criteria.
Minimum Eligible Age

18 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

No

Sponsors

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Pfizer

INDUSTRY

Sponsor Role lead

Principal Investigators

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Pfizer CT.gov Call Center

Role: STUDY_DIRECTOR

Pfizer

Locations

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Pfizer Investigational Site

Beverly Hills, California, United States

Site Status

Pfizer Investigational Site

Norwich, Connecticut, United States

Site Status

Pfizer Investigational Site

New York, New York, United States

Site Status

Pfizer Investigational Site

Beachwood, Ohio, United States

Site Status

Pfizer Investigational Site

Santiago, RM, Chile

Site Status

Pfizer Investigational Site

Viljandi, Viljandi Mk., Estonia

Site Status

Pfizer Investigational Site

Pärnu, , Estonia

Site Status

Pfizer Investigational Site

Tallinn, , Estonia

Site Status

Pfizer Investigational Site

Gatchina, Leningradskaya Oblast', Russia

Site Status

Pfizer Investigational Site

Moscow, , Russia

Site Status

Pfizer Investigational Site

Moscow, , Russia

Site Status

Pfizer Investigational Site

Moscow, , Russia

Site Status

Pfizer Investigational Site

Rostov-on-Don, , Russia

Site Status

Pfizer Investigational Site

Saint Petersburg, , Russia

Site Status

Pfizer Investigational Site

Saint Petersburg, , Russia

Site Status

Pfizer Investigational Site

Saint Petersburg, , Russia

Site Status

Pfizer Investigational Site

Saint Petersburg, , Russia

Site Status

Pfizer Investigational Site

Saint Petersburg, , Russia

Site Status

Pfizer Investigational Site

Smolensk, , Russia

Site Status

Countries

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United States Chile Estonia Russia

Related Links

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https://trialinfoemail.pfizer.com/pages/landing.aspx?StudyID=A7571001&StudyName=A%20research%20study%20to%20compare%20the%20treatments%20of%20a%20combination%20of%20Elzasonan%20with%20Zoloft%2C%20to%20Zoloft%20alone%2C%20or%20placebo%20in%20people%20with

To obtain contact information for a study center near you, click here.

Other Identifiers

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A7571001

Identifier Type: -

Identifier Source: org_study_id