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)

• Register: ClinicalTrials.gov
• Last refreshed on: 19 February 2015
• Main ID: NCT00275197
• Date of registration: 09/01/2006
• Prospective Registration: No
• Primary sponsor: Pfizer
• Public title: 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)
• Scientific 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
• Date of first enrolment: December 2005
• Target sample size: 262
• Recruitment status: Completed
• URL: http://clinicaltrials.gov/show/NCT00275197
• Study type: Interventional
• Study design: Allocation: Randomized, Endpoint Classification: Safety/Efficacy Study, Intervention Model: Parallel Assignment, Masking: Double-Blind, Primary Purpose: Treatment
• Phase: Phase 2

Countries of recruitment

Chile, Estonia, Russian Federation, United States

Contacts

• Name: Pfizer CT.gov Call Center
• Affiliation: Pfizer

Key inclusion & exclusion 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.



Age minimum: 18 Years
Age maximum: N/A
Gender: Both

Health Condition(s) or Problem(s) studied

Depressive Disorder, Major

Intervention(s)

Drug: Sertraline

Drug: Placebo

Drug: Sertraline and Elzasonan Combination

Primary Outcome(s)

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 Outcome(s)

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.

Secondary ID(s)

A7571001

Source(s) of Monetary Support

Please refer to primary and secondary sponsors