Not Signed In -
Sertraline |
Zoloft |
Clinical Trial: Multicentre Trial to Evaluate the Safety and Efficacy of Investigational Study Drug in Major Depressive Disorder
This study is currently recruiting patients.
Verified by Pfizer August 2005
|
Purpose
A six week, fixed dose, double-blind, double-dummy, placebo, and active controlled, muticentre trial to evaluate the safety and efficacy of investigational study drug in outpatients with major depressive disorder.
| Condition | Intervention | Phase |
|---|---|---|
| Major Depressive Disorder, Recurrent | Drug: INVESTIGATIONAL STUDY DRUG Drug: PLACEBO Drug: SERTRALINE | Phase II |
MedlinePlus related topics: Mental Health
Study Type: Interventional
Study Design: Treatment, Randomized, Double-Blind, Placebo Control, Parallel Assignment, Safety/Efficacy Study
Official Title: A Six-Week, Fixed Dose, Double-Blind, Double-Dummy, Placebo and Sertraline Controlled, Multicentre Trial to Evaluate the Safety and Efficacy of Investigational Study Drug in Outpatients with Major Depressive Disorder
Further Study Details:
Primary Outcomes: Change from baseline in depression symptoms at the week 6 visit
Secondary Outcomes: Incidence and magnitude of ECG changes, adverse events, and the rate of laboratory and vital sign abnormalities in subjects treated with investigational study drug relative to placebo.Change from baseline in the Clinical Global Impression of Improvement
Expected Total Enrollment: 200
Secondary Outcomes: Incidence and magnitude of ECG changes, adverse events, and the rate of laboratory and vital sign abnormalities in subjects treated with investigational study drug relative to placebo.Change from baseline in the Clinical Global Impression of Improvement
Expected Total Enrollment: 200
Study start: April 2005
Eligibility
Ages Eligible for Study: 18 Years and above, Genders Eligible for Study: Both
Criteria
Inclusion Criteria:
- OUTPATIENTS WITH DSM-IV MAJOR DEPRESSIVE DISORDER
Exclusion Criteria:
- WOMEN OF CHILD BEARING POTENTIAL
Location and Contact Information
Please refer to this study by ClinicalTrials.gov identifier NCT00143091
Pfizer CT.gov Call Center 1-800-718-1021
Washington
Pfizer Investigational Site, Bellevue, Washington, 98004, United States; Recruiting
Pfizer Investigational Site, Seattle, Washington, 98104, United States; Recruiting
Study chairs or principal investigators
Pfizer CT.gov Call Center, Study Director, Pfizer
More Information
Study ID Numbers: A2211002
Last Updated: September 1, 2005
Record first received: August 31, 2005
ClinicalTrials.gov Identifier: NCT00143091
Health Authority: United States: Food and Drug Administration
ClinicalTrials.gov processed this record on 2005-09-06
Last Updated: September 1, 2005
Record first received: August 31, 2005
ClinicalTrials.gov Identifier: NCT00143091
Health Authority: United States: Food and Drug Administration
ClinicalTrials.gov processed this record on 2005-09-06
Resources
- Sertraline (Drug Digest)
- Zoloft (Drug Digest)
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