Clinical trial NCT00275197: 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)
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 type: INTERVENTIONAL
Overall status: COMPLETED
Phase: PHASE2
Conditions: Depressive Disorder, Major
Lead sponsor: Pfizer
Sponsor class: INDUSTRY
First posted: 2006-01-11
Enrollment: 262
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: TREATMENT

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 also compare the safety and tolerability of Elzasonan and Zoloft combination to Zoloft alone or placebo.


Eligibility 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.

Primary outcomes:
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 outcomes:
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.
Other outcomes:
Locations:
city: Beverly Hills
country: United States
facility: Pfizer Investigational Site
state: California
city: Norwich
country: United States
facility: Pfizer Investigational Site
state: Connecticut
city: New York
country: United States
facility: Pfizer Investigational Site
state: New York
city: Beachwood
country: United States
facility: Pfizer Investigational Site
state: Ohio
city: Santiago
country: Chile
facility: Pfizer Investigational Site
state: RM
city: Viljandi
country: Estonia
facility: Pfizer Investigational Site
state: Viljandi mk.
city: Pärnu
country: Estonia
facility: Pfizer Investigational Site
city: Tallinn
country: Estonia
facility: Pfizer Investigational Site
city: Gatchina
country: Russian Federation
facility: Pfizer Investigational Site
state: Leningrad region
city: Moscow
country: Russian Federation
facility: Pfizer Investigational Site
city: Moscow
country: Russian Federation
facility: Pfizer Investigational Site
city: Moscow
country: Russian Federation
facility: Pfizer Investigational Site
city: Rostov On Don
country: Russian Federation
facility: Pfizer Investigational Site
city: Smolensk
country: Russian Federation
facility: Pfizer Investigational Site
city: St Petersburg
country: Russian Federation
facility: Pfizer Investigational Site
city: St. Petersburg
country: Russian Federation
facility: Pfizer Investigational Site
city: St. Petersburg
country: Russian Federation
facility: Pfizer Investigational Site
city: St. Petersburg
country: Russian Federation
facility: Pfizer Investigational Site
city: St. Petersburg
country: Russian Federation
facility: Pfizer Investigational Site
Study officials:
affiliation: Pfizer
name: Pfizer CT.gov Call Center
role: STUDY_DIRECTOR
References: