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)

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

Status

Completed

Phases

Phase 2

Study type

Interventional

Source

ClinicalTrials.gov

Registry ID

NCT00275197

Enrollment

262

Registered

2006-01-11

Start date

2005-12-31

Completion date

2007-07-31

Last updated

2008-11-03

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

Depressive Disorder, Major

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.

Interventions

DRUGSertraline and Elzasonan Combination

DRUGSertraline

DRUGPlacebo

Study design

Allocation

RANDOMIZED

Intervention model

PARALLEL

Primary purpose

TREATMENT

Masking

DOUBLE

Eligibility

Sex/Gender

ALL

Age

18 Years to No maximum

Healthy volunteers

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.

Design outcomes

Primary

Measure	Time frame
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

Measure	Time frame
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.	—

Countries

Chile, Estonia, Russia, United States

Outcome results

None listed

Source: ClinicalTrials.gov · Data processed: Feb 4, 2026