NCT00275197

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.

Trial Health

90
On Track

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
262

participants targeted

Target at P75+ for phase_2

Timeline
Completed

Started Dec 2005

Geographic Reach
4 countries

19 active sites

Status
completed

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

Study Start

First participant enrolled

December 1, 2005

Completed
1 month until next milestone

First Submitted

Initial submission to the registry

January 9, 2006

Completed
2 days until next milestone

First Posted

Study publicly available on registry

January 11, 2006

Completed
1.5 years until next milestone

Study Completion

Last participant's last visit for all outcomes

July 1, 2007

Completed
Last Updated

November 3, 2008

Status Verified

October 1, 2008

First QC Date

January 9, 2006

Last Update Submit

October 30, 2008

Conditions

Depressive Disorder, Major

Outcome Measures

Primary Outcomes (1)

  • 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 (1)

  • 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.

Interventions

Sertraline and Elzasonan CombinationDRUG
SertralineDRUG
PlaceboDRUG

Eligibility Criteria

Age18 Years+
Sexall
Healthy VolunteersNo
Age GroupsAdult (18-64), Older Adult (65+)

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.

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (19)

Pfizer Investigational Site

Beverly Hills, California, 90210, United States

Location

Pfizer Investigational Site

Norwich, Connecticut, 06360, United States

Location

Pfizer Investigational Site

New York, New York, 10023, United States

Location

Pfizer Investigational Site

Beachwood, Ohio, 44122, United States

Location

Pfizer Investigational Site

Santiago, RM, Chile

Location

Pfizer Investigational Site

Viljandi, Viljandi Mk., 71024, Estonia

Location

Pfizer Investigational Site

Pärnu, 80012, Estonia

Location

Pfizer Investigational Site

Tallinn, 10614, Estonia

Location

Pfizer Investigational Site

Gatchina, Leningradskaya Oblast', 190121, Russia

Location

Pfizer Investigational Site

Moscow, 107076, Russia

Location

Pfizer Investigational Site

Moscow, 115522, Russia

Location

Pfizer Investigational Site

Moscow, 123367, Russia

Location

Pfizer Investigational Site

Rostov-on-Don, 344010, Russia

Location

Pfizer Investigational Site

Saint Petersburg, 190121, Russia

Location

Pfizer Investigational Site

Saint Petersburg, 191180, Russia

Location

Pfizer Investigational Site

Saint Petersburg, 192019, Russia

Location

Pfizer Investigational Site

Saint Petersburg, 193167, Russia

Location

Pfizer Investigational Site

Saint Petersburg, 197110, Russia

Location

Pfizer Investigational Site

Smolensk, 214018, Russia

Location

Related Links

MeSH Terms

Conditions

Depressive Disorder, Major

Interventions

Sertraline

Condition Hierarchy (Ancestors)

Depressive DisorderMood DisordersMental Disorders

Intervention Hierarchy (Ancestors)

1-NaphthylamineAminesOrganic ChemicalsNaphthalenesPolycyclic Aromatic HydrocarbonsHydrocarbons, AromaticHydrocarbons, CyclicHydrocarbonsPolycyclic Compounds

Study Officials

  • Pfizer CT.gov Call Center

    Pfizer

    STUDY DIRECTOR

Study Design

Study Type
interventional
Phase
phase 2
Allocation
RANDOMIZED
Masking
DOUBLE
Purpose
TREATMENT
Intervention Model
PARALLEL
Sponsor Type
INDUSTRY

Study Record Dates

First Submitted

January 9, 2006

First Posted

January 11, 2006

Study Start

December 1, 2005

Study Completion

July 1, 2007

Last Updated

November 3, 2008

Record last verified: 2008-10

Locations

CL(1)RU(11)ES(3)US(4)