Status:
COMPLETED
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)
Lead Sponsor:
Pfizer
Conditions:
Depressive Disorder, Major
Eligibility:
All Genders
18+ years
Phase:
PHASE2
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 al...
Eligibility Criteria
Inclusion
- 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
- 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.
Key Trial Info
Start Date :
December 1 2005
Trial Type :
INTERVENTIONAL
Allocation :
ACTUAL
End Date :
July 1 2007
Estimated Enrollment :
262 Patients enrolled
Trial Details
Trial ID
NCT00275197
Start Date
December 1 2005
End Date
July 1 2007
Last Update
November 3 2008
Active Locations (19)
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1
Pfizer Investigational Site
Beverly Hills, California, United States, 90210
2
Pfizer Investigational Site
Norwich, Connecticut, United States, 06360
3
Pfizer Investigational Site
New York, New York, United States, 10023
4
Pfizer Investigational Site
Beachwood, Ohio, United States, 44122