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) - Full Text View

Sponsored by:	Pfizer
Information provided by:	Pfizer
ClinicalTrials.gov Identifier:	NCT00275197

Purpose

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	Intervention	Phase
Depressive Disorder, Major	Drug: Sertraline and Elzasonan Combination Drug: Sertraline Drug: Placebo	Phase II

MedlinePlus related topics: Depression

Drug Information available for: Sertraline hydrochloride Sertraline Elzasonan

U.S. FDA Resources

Study Type:	Interventional
Study Design:	Treatment, Randomized, Double-Blind, Placebo Control, Parallel Assignment, Safety/Efficacy Study
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

Further study details as provided by Pfizer:

Primary Outcome Measures:

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:

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.

Enrollment:	262
Study Start Date:	December 2005
Study Completion Date:	July 2007

Eligibility

Ages Eligible for Study:	18 Years and older
Genders Eligible for Study:	Both
Accepts Healthy Volunteers:	No

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.

Contacts and Locations

Please refer to this study by its ClinicalTrials.gov identifier: NCT00275197

Locations

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
Chile, RM
Pfizer Investigational Site
Santiago, RM, Chile
Estonia
Pfizer Investigational Site
Tallinn, Estonia, 10614
Pfizer Investigational Site
Pärnu, Estonia, 80012
Estonia, Viljandi mk.
Pfizer Investigational Site
Viljandi, Viljandi mk., Estonia, 71024
Russian Federation
Pfizer Investigational Site
Moscow, Russian Federation, 115522
Pfizer Investigational Site
Moscow, Russian Federation, 123367
Pfizer Investigational Site
Moscow, Russian Federation, 107076
Pfizer Investigational Site
Smolensk, Russian Federation, 214018
Pfizer Investigational Site
Rostov On Don, Russian Federation, 344010
Pfizer Investigational Site
St Petersburg, Russian Federation, 190121
Pfizer Investigational Site
St. Petersburg, Russian Federation, 197110
Pfizer Investigational Site
St. Petersburg, Russian Federation, 193167
Pfizer Investigational Site
St. Petersburg, Russian Federation, 192019
Pfizer Investigational Site
St. Petersburg, Russian Federation, 191180
Russian Federation, Leningrad region
Pfizer Investigational Site
Gatchina, Leningrad region, Russian Federation, 190121

Sponsors and Collaborators

Pfizer

Investigators

Study Director:

Pfizer CT.gov Call Center

Pfizer

More Information

To obtain contact information for a study center near you, click here. This link exits the ClinicalTrials.gov site

Study ID Numbers:	A7571001
Study First Received:	January 9, 2006
Last Updated:	October 30, 2008
ClinicalTrials.gov Identifier:	NCT00275197
Health Authority:	United States: Food and Drug Administration

Study placed in the following topic categories:

Depression
Mental Disorders
Mood Disorders
Sertraline

Depressive Disorder, Major
Depressive Disorder
Serotonin
Behavioral Symptoms

Additional relevant MeSH terms:

Neurotransmitter Uptake Inhibitors
Neurotransmitter Agents
Disease
Molecular Mechanisms of Pharmacological Action
Physiological Effects of Drugs
Psychotropic Drugs
Serotonin Uptake Inhibitors

Pharmacologic Actions
Pathologic Processes
Serotonin Agents
Therapeutic Uses
Central Nervous System Agents
Antidepressive Agents

ClinicalTrials.gov processed this record on January 16, 2009