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)

Condition(s) targeted: Depressive Disorder, Major

Intervention: Sertraline and Elzasonan Combination (Drug); Sertraline (Drug); Placebo (Drug)

Phase: Phase 2

Status: Completed

Sponsored by: Pfizer

Official(s) and/or principal investigator(s):
Pfizer CT.gov Call Center, Study Director, Affiliation: Pfizer

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.

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 design: Treatment, Randomized, Double-Blind, Placebo Control, Parallel Assignment, Safety/Efficacy Study

Primary outcome: 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: 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.

Minimum age: 18 Years. Maximum age: N/A. Gender(s): Both.

Criteria:

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.

Pfizer Investigational Site, Tallinn 10614, Estonia

Pfizer Investigational Site, Pärnu 80012, Estonia

Pfizer Investigational Site, Moscow 115522, Russian Federation

Pfizer Investigational Site, Moscow 123367, Russian Federation

Pfizer Investigational Site, Moscow 107076, Russian Federation

Pfizer Investigational Site, Smolensk 214018, Russian Federation

Pfizer Investigational Site, Rostov On Don 344010, Russian Federation

Pfizer Investigational Site, St Petersburg 190121, Russian Federation

Pfizer Investigational Site, St. Petersburg 197110, Russian Federation

Pfizer Investigational Site, St. Petersburg 193167, Russian Federation

Pfizer Investigational Site, St. Petersburg 192019, Russian Federation

Pfizer Investigational Site, St. Petersburg 191180, Russian Federation

Pfizer Investigational Site, Beverly Hills, California 90210, United States

Pfizer Investigational Site, Norwich, Connecticut 06360, United States

Pfizer Investigational Site, Gatchina, Leningrad region 190121, Russian Federation

Pfizer Investigational Site, New York, New York 10023, United States

Pfizer Investigational Site, BEACHWOOD, Ohio 44122, United States

Pfizer Investigational Site, Santiago, RM, Chile

Pfizer Investigational Site, Viljandi, Viljandi mk. 71024, Estonia

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

Starting date: December 2005
Ending date: July 2007
Last updated: August 16, 2007