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)
This study has been completed.
Sponsor:
Pfizer
Information provided by:
Pfizer
ClinicalTrials.gov Identifier:
NCT00275197
First received: January 9, 2006
Last updated: October 30, 2008
Last verified: October 2008
- Full Text View
- Tabular View
- No Study Results Posted
- Disclaimer
- How to Read a Study Record
Purpose
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.
| Condition | Intervention | Phase |
|---|---|---|
|
Depressive Disorder, Major |
Drug: Sertraline and Elzasonan Combination Drug: Sertraline Drug: Placebo |
Phase 2 |
| Study Type: | Interventional |
| Study Design: | Allocation: Randomized Endpoint Classification: Safety/Efficacy Study Intervention Model: Parallel Assignment Masking: Double-Blind Primary Purpose: Treatment |
| 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 |
Resource links provided by NLM:
Further study details as provided by Pfizer:
Primary Outcome Measures:
- 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 Measures:
- 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.
| Enrollment: | 262 |
| Study Start Date: | December 2005 |
| Study Completion Date: | July 2007 |
Eligibility| Ages Eligible for Study: | 18 Years and older |
| Genders Eligible for Study: | Both |
| Accepts Healthy Volunteers: | No |
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.
Contacts and Locations
Please refer to this study by its ClinicalTrials.gov identifier: NCT00275197
Locations
| United States, California | |
| Pfizer Investigational Site | |
| Beverly Hills, California, United States, 90210 | |
| United States, Connecticut | |
| Pfizer Investigational Site | |
| Norwich, Connecticut, United States, 06360 | |
| United States, New York | |
| Pfizer Investigational Site | |
| New York, New York, United States, 10023 | |
| United States, Ohio | |
| Pfizer Investigational Site | |
| Beachwood, Ohio, United States, 44122 | |
| Chile | |
| Pfizer Investigational Site | |
| Santiago, RM, Chile | |
| Estonia | |
| Pfizer Investigational Site | |
| Viljandi, Viljandi mk., Estonia, 71024 | |
| Pfizer Investigational Site | |
| Pärnu, Estonia, 80012 | |
| Pfizer Investigational Site | |
| Tallinn, Estonia, 10614 | |
| Russian Federation | |
| Pfizer Investigational Site | |
| Gatchina, Leningrad region, Russian Federation, 190121 | |
| Pfizer Investigational Site | |
| Moscow, Russian Federation, 115522 | |
| Pfizer Investigational Site | |
| Moscow, Russian Federation, 107076 | |
| Pfizer Investigational Site | |
| Moscow, Russian Federation, 123367 | |
| Pfizer Investigational Site | |
| Rostov On Don, Russian Federation, 344010 | |
| Pfizer Investigational Site | |
| Smolensk, Russian Federation, 214018 | |
| Pfizer Investigational Site | |
| St Petersburg, Russian Federation, 190121 | |
| Pfizer Investigational Site | |
| St. Petersburg, Russian Federation, 193167 | |
| Pfizer Investigational Site | |
| St. Petersburg, Russian Federation, 192019 | |
| Pfizer Investigational Site | |
| St. Petersburg, Russian Federation, 191180 | |
| Pfizer Investigational Site | |
| St. Petersburg, Russian Federation, 197110 | |
Sponsors and Collaborators
Pfizer
Investigators
| Study Director: | Pfizer CT.gov Call Center | Pfizer |
More Information
Additional Information:
No publications provided
| ClinicalTrials.gov Identifier: | NCT00275197 History of Changes |
| Other Study ID Numbers: | A7571001 |
| Study First Received: | January 9, 2006 |
| Last Updated: | October 30, 2008 |
| Health Authority: | United States: Food and Drug Administration |
Additional relevant MeSH terms:
|
Depressive Disorder Depression Depressive Disorder, Major Mood Disorders Mental Disorders Behavioral Symptoms Sertraline Antidepressive Agents Psychotropic Drugs |
Central Nervous System Agents Therapeutic Uses Pharmacologic Actions Serotonin Uptake Inhibitors Neurotransmitter Uptake Inhibitors Neurotransmitter Agents Molecular Mechanisms of Pharmacological Action Serotonin Agents Physiological Effects of Drugs |
ClinicalTrials.gov processed this record on May 21, 2013