COVID-19 is an emerging, rapidly evolving situation.
Get the latest public health information from CDC:

Get the latest research information from NIH: Menu

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)

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details. Identifier: NCT00275197
Recruitment Status : Completed
First Posted : January 11, 2006
Last Update Posted : November 3, 2008
Information provided by:

Brief Summary:
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.

Condition or disease Intervention/treatment Phase
Depressive Disorder, Major Drug: Sertraline and Elzasonan Combination Drug: Sertraline Drug: Placebo Phase 2

Layout table for study information
Study Type : Interventional  (Clinical Trial)
Actual Enrollment : 262 participants
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Double
Primary Purpose: Treatment
Official Title: An Eight-Week, Double-Blind, Group-Sequential Design, Placebo Controlled Trial To Evaluate The Safety And Efficacy Of The Co- Administration Of Sertraline And Elzasonan (CP-448,187) In Outpatients With Major Depressive Disorder
Study Start Date : December 2005
Actual Study Completion Date : July 2007

Resource links provided by the National Library of Medicine

Primary Outcome Measures :
  1. The estimated treatment difference (elzasonan plus sertraline - sertraline monotherapy) in MADRS (Montgomery-Asberg Depression Rating Scale) remission rates at Week 8 in patients with MDD.

Secondary Outcome Measures :
  1. Change from baseline in: MADRS, CGI-I, CGI-S, HAMA, HAMD17, CSFQ, SOS-10 and PGID-D total scores at Week 8. Treatment differences in MADRS response rates at Week 8.

Information from the National Library of Medicine

Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the contacts provided below. For general information, Learn About Clinical Studies.

Layout table for eligibility information
Ages Eligible for Study:   18 Years and older   (Adult, Older Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No

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.

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its identifier (NCT number): NCT00275197

Layout table for location information
United States, California
Pfizer Investigational Site
Beverly Hills, California, United States, 90210
United States, Connecticut
Pfizer Investigational Site
Norwich, Connecticut, United States, 06360
United States, New York
Pfizer Investigational Site
New York, New York, United States, 10023
United States, Ohio
Pfizer Investigational Site
Beachwood, Ohio, United States, 44122
Pfizer Investigational Site
Santiago, RM, Chile
Pfizer Investigational Site
Viljandi, Viljandi mk., Estonia, 71024
Pfizer Investigational Site
Pärnu, Estonia, 80012
Pfizer Investigational Site
Tallinn, Estonia, 10614
Russian Federation
Pfizer Investigational Site
Gatchina, Leningrad region, Russian Federation, 190121
Pfizer Investigational Site
Moscow, Russian Federation, 107076
Pfizer Investigational Site
Moscow, Russian Federation, 115522
Pfizer Investigational Site
Moscow, Russian Federation, 123367
Pfizer Investigational Site
Rostov On Don, Russian Federation, 344010
Pfizer Investigational Site
Smolensk, Russian Federation, 214018
Pfizer Investigational Site
St Petersburg, Russian Federation, 190121
Pfizer Investigational Site
St. Petersburg, Russian Federation, 191180
Pfizer Investigational Site
St. Petersburg, Russian Federation, 192019
Pfizer Investigational Site
St. Petersburg, Russian Federation, 193167
Pfizer Investigational Site
St. Petersburg, Russian Federation, 197110
Sponsors and Collaborators
Layout table for investigator information
Study Director: Pfizer Call Center Pfizer

Additional Information:
Layout table for additonal information Identifier: NCT00275197    
Other Study ID Numbers: A7571001
First Posted: January 11, 2006    Key Record Dates
Last Update Posted: November 3, 2008
Last Verified: October 2008
Additional relevant MeSH terms:
Layout table for MeSH terms
Depressive Disorder
Depressive Disorder, Major
Mood Disorders
Mental Disorders
Behavioral Symptoms
Antidepressive Agents
Psychotropic Drugs
Serotonin Uptake Inhibitors
Neurotransmitter Uptake Inhibitors
Membrane Transport Modulators
Molecular Mechanisms of Pharmacological Action
Neurotransmitter Agents
Serotonin Agents
Physiological Effects of Drugs