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)

NCT00275197

Last updated date
Study Location
Pfizer Investigational Site
Beverly Hills, California, 90210, United States
Contact
1-800-718-1021

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Eligibility Criteria
condition
The disease, disorder, syndrome, illness, or injury that is being studied.
Major Depressive Disorder
Sex
Females and Males
Age
Pediatric Trials: 0-17 Years
Adult Trials: 18+ Years
18 + years
Inclusion Criteria
The factors, or reasons, that allow a person to participate in a clinical study.
Show details

- 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
The factors, or reasons, that prevent a person from participating in a clinical study.
Show details


- 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.

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Advanced Information
Descriptive Information
Brief Title  ICMJE 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  ICMJE 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
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.
Detailed Description Not Provided
Study Type  ICMJE Interventional
Study Phase  ICMJE Phase 2
Study Design  ICMJE Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Double
Primary Purpose: Treatment
Condition  ICMJE Depressive Disorder, Major
Intervention  ICMJE
  • Drug: Sertraline and Elzasonan Combination
  • Drug: Sertraline
  • Drug: Placebo
Study Arms  ICMJE Not Provided
Publications * Not Provided

*   Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline.
 
Recruitment Information
Recruitment Status  ICMJE Completed
Actual Enrollment  ICMJE
 (submitted: October 30, 2008)
262
Original Enrollment  ICMJE
 (submitted: January 9, 2006)
264
Actual Study Completion Date  ICMJE July 2007
Primary Completion Date Not Provided
Eligibility Criteria  ICMJE

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.
Sex/Gender  ICMJE
Sexes Eligible for Study:All
Ages  ICMJE 18 Years and older   (Adult, Older Adult)
Accepts Healthy Volunteers  ICMJE No
Contacts  ICMJE Contact information is only displayed when the study is recruiting subjects
Listed Location Countries  ICMJE Chile,   Estonia,   Russian Federation,   United States
Removed Location Countries  
 
Administrative Information
NCT Number  ICMJE NCT00275197
Other Study ID Numbers  ICMJE A7571001
Has Data Monitoring Committee Not Provided
U.S. FDA-regulated Product Not Provided
IPD Sharing Statement  ICMJE Not Provided
Responsible Party Not Provided
Study Sponsor  ICMJE Pfizer
Collaborators  ICMJE Not Provided
Investigators  ICMJE
Study Director:Pfizer CT.gov Call CenterPfizer
PRS Account Pfizer
Verification Date October 2008

ICMJE     Data element required by the International Committee of Medical Journal Editors and the World Health Organization ICTRP