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)

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

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.

Study Overview

• Status: Completed
• Conditions: Depressive Disorder, Major
• Intervention / Treatment: Drug: Placebo; Drug: Sertraline; Drug: Sertraline and Elzasonan Combination

• Study Type: Interventional
• Enrollment (Actual): 262
• Phase: Phase 2

Contacts and Locations

Study Locations

• Chile
  • RM
    • Santiago, RM, Chile
      • Pfizer Investigational Site
• Estonia
  • Pärnu, Estonia, 80012
    • Pfizer Investigational Site
  • Tallinn, Estonia, 10614
    • Pfizer Investigational Site
  • Viljandi mk.
    • Viljandi, Viljandi mk., Estonia, 71024
      • Pfizer Investigational Site
• Russian Federation
  • Moscow, Russian Federation, 115522
    • Pfizer Investigational Site
  • Moscow, Russian Federation, 107076
    • 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, 192019
    • Pfizer Investigational Site
  • St. Petersburg, Russian Federation, 193167
    • Pfizer Investigational Site
  • St. Petersburg, Russian Federation, 191180
    • Pfizer Investigational Site
  • St. Petersburg, Russian Federation, 197110
    • Pfizer Investigational Site
  • Leningrad region
    • Gatchina, Leningrad region, Russian Federation, 190121
      • Pfizer Investigational Site
• United States
  • California
    • Beverly Hills, California, United States, 90210
      • Pfizer Investigational Site
  • Connecticut
    • Norwich, Connecticut, United States, 06360
      • Pfizer Investigational Site
  • New York
    • New York, New York, United States, 10023
      • Pfizer Investigational Site
  • Ohio
    • Beachwood, Ohio, United States, 44122
      • Pfizer Investigational Site

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 18 years and older (ADULT, OLDER_ADULT)
• Accepts Healthy Volunteers: No
• Genders Eligible for Study: All

Description

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.

Study Plan

How is the study designed?

Design Details

• Primary Purpose: TREATMENT
• Allocation: RANDOMIZED
• Interventional Model: PARALLEL
• Masking: DOUBLE

What is the study measuring?

Primary Outcome Measures

Outcome Measure
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

Outcome Measure
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.

Collaborators and Investigators

• Sponsor: Pfizer

Publications and helpful links

Helpful Links

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

Study record dates

Study Major Dates

• Study Start: December 1, 2005
• Study Completion (ACTUAL): July 1, 2007

Study Registration Dates

• First Submitted: January 9, 2006
• First Submitted That Met QC Criteria: January 9, 2006
• First Posted (ESTIMATE): January 11, 2006

Study Record Updates

• Last Update Posted (ESTIMATE): November 2, 2008
• Last Update Submitted That Met QC Criteria: October 30, 2008
• Last Verified: October 1, 2008

More Information

Terms related to this study

• Additional Relevant MeSH Terms: Behavioral Symptoms; Mental Disorders; Mood Disorders; Depression; Depressive Disorder; Depressive Disorder, Major; Physiological Effects of Drugs; Neurotransmitter Agents; Molecular Mechanisms of Pharmacological Action; Psychotropic Drugs; Serotonin Uptake Inhibitors; Neurotransmitter Uptake Inhibitors; Membrane Transport Modulators; Serotonin Agents; Antidepressive Agents; Sertraline
• Other Study ID Numbers: A7571001