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)

Completed · Phase 2 · Has a placebo group

Conditions studied: Depressive Disorder, Major

In brief

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.

Key facts

Study ID

NCT00275197

Run by

Pfizer

People needed

262

Starts

2005-12-01

Expected to finish

2007-07-01

Last updated by the study team

2008-11-03

Who can join

Age: 18 and older. Sex: any. Healthy volunteers: not accepted.

You may qualify if…

• 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.

You may not qualify if…

• 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.

Where it is running

• Pfizer Investigational Site — Beverly Hills, California, United States
• Pfizer Investigational Site — Norwich, Connecticut, United States
• Pfizer Investigational Site — New York, New York, United States
• Pfizer Investigational Site — Beachwood, Ohio, United States
• Pfizer Investigational Site — Santiago, RM, Chile
• Pfizer Investigational Site — Viljandi, Viljandi Mk., Estonia
• Pfizer Investigational Site — Pärnu, Estonia
• Pfizer Investigational Site — Tallinn, Estonia
• Pfizer Investigational Site — Gatchina, Leningradskaya Oblast', Russia
• Pfizer Investigational Site — Moscow, Russia
• Pfizer Investigational Site — Moscow, Russia
• Pfizer Investigational Site — Moscow, Russia
• Pfizer Investigational Site — Rostov-on-Don, Russia
• Pfizer Investigational Site — Saint Petersburg, Russia
• Pfizer Investigational Site — Saint Petersburg, Russia
• Pfizer Investigational Site — Saint Petersburg, Russia
• Pfizer Investigational Site — Saint Petersburg, Russia
• Pfizer Investigational Site — Saint Petersburg, Russia
• Pfizer Investigational Site — Smolensk, Russia

Full record on ClinicalTrials.gov

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