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Sponsored by: |
DOV Pharmaceutical, Inc. |
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Information provided by: | DOV Pharmaceutical, Inc. |
ClinicalTrials.gov Identifier: | NCT00659347 |
The primary objectives of this placebo-controlled trial are to evaluate effectiveness and safety of DOV 21,947 at two oral dose levels.
Condition | Intervention | Phase |
---|---|---|
Major Depressive Disorder |
Drug: DOV 21, 947 Drug: Placebo |
Phase II |
Study Type: | Interventional |
Study Design: | Treatment, Randomized, Double Blind (Subject, Caregiver, Investigator), Placebo Control, Parallel Assignment, Safety/Efficacy Study |
Official Title: | A Multi-Center, Randomized, Double-Blind, Placebo-Controlled Study of DOV 21,947 in Patients With Major Depressive Disorder |
Estimated Enrollment: | 200 |
Study Start Date: | March 2008 |
Study Completion Date: | December 2008 |
Primary Completion Date: | December 2008 (Final data collection date for primary outcome measure) |
Arms | Assigned Interventions |
---|---|
1: Active Comparator |
Drug: DOV 21, 947
Capsules, 25 mg, 2 capsules (1 Active/1 Placebo) BID, 2 weeks Capsules, 25 mg, 2 capsules (2 Active) BID, 2 weeks
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2: Placebo Comparator |
Drug: Placebo
Capsules,25 mg,BID,6weeks
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DOV 21,947 is an investigational drug that is being developed for the treatment of depression. The purpose of this study is to evaluate the safety and effectiveness of a flexible dosing schedule of DOV 21,947 (25 mg twice daily for two weeks, then 50 mg twice daily for four weeks as compared to placebo) in the treatment of major depressive disorder. Information about any side effects that may occur will also be collected.
The efficacy evaluation will be based on the change in the total MADRS and HAMD-17 scores from randomization to week 9 .The secondary objective is to determine if DOV 21,947 improves the quality of life for patients with MDD as compared to placebo
Ages Eligible for Study: | 18 Years to 65 Years |
Genders Eligible for Study: | Both |
Accepts Healthy Volunteers: | No |
Inclusion Criteria:
Exclusion Criteria:
United States, Connecticut | |
Comprehensive Psychiatric Care | |
Norwich, Connecticut, United States, 06360 | |
United States, Massachusetts | |
Future Care Studies | |
Springfield, Massachusetts, United States, 01103 | |
United States, New Jersey | |
Center for Emotional Fitness | |
Cherry Hill, New Jersey, United States, 08002 | |
Princeton Medical Institute | |
Princeton, New Jersey, United States, 08540 | |
CRI Worldwide, LLC | |
Clementon, New Jersey, United States, 08021 | |
United States, New York | |
Richmond Behavorial Associates | |
Staten Island, New York, United States, 10312 | |
Brooklyn Medical Institute | |
Brooklyn, New York, United States, 11223 | |
Social Psychiatry Research Institute | |
New York, New York, United States, 10021 | |
United States, Pennsylvania | |
Scranton Medical Institutes | |
Scranton, Pennsylvania, United States, 18503 | |
CRI Worldwide, LLC | |
Philadelphia, Pennsylvania, United States, 19139 | |
Romania | |
Spitalul Clinic de Psihiatrie "Prof. Dr. Alexandru Obregia", pavilion III | |
Bucharest, Romania, 041915 | |
Spitalul Clinic de Psihiatrie "Prof. Dr. Alexandru Obregia", Pavilion X | |
Bucharest, Romania, 041915 | |
Spitalul Universitar de Psihiatrie "Socola" | |
Lasi, Romania | |
Spitalul Clinic "Colentina", Ambulator Specialitate, Sectia Psihiatrie | |
Bucharest, Romania, 020125 | |
Spitalul Clinic de Psihiatrie "Prof. Dr. Alexandru Obregia", Pavilion IV | |
Bucharest, Romania, 041915 | |
SC Corpores Sana Medical SRL | |
Bucharest, Romania, 010604 | |
Spitalul Judetean de Urgenta Piatra Neamt | |
Piatra Neamt, Romania, 610136 | |
Spitalul Clinic Judetean de Urgenta Targu Mures | |
Targu Mures, Romania, 540139 | |
Spitalul Clinic de Psihiatrie "Socola" | |
Lasi, Romania, 700282 | |
Romania, Arges | |
Spitalul Judetean Arges | |
Pitesti, Arges, Romania, 110084 | |
Romania, Bihor | |
Spitalul Clinic de Neurologie si Psihiatrie Oradea | |
Oradea, Bihor, Romania, 410154 | |
Romania, Dambovita | |
Cabinetul Medical Lorentina 2102 S.R.L. | |
Targoviste, Dambovita, Romania, 130081 | |
Serbia | |
Klinika za neurologiju i psihijatriju | |
Kragujevac, Serbia, 34000 | |
Institut za psihijatriju KCS | |
Belgrade, Serbia, 11000 | |
Klinika za psihijatriju Vojnomedicinske Akademije | |
Velgrade, Serbia, 1100 | |
Institut za mentalno zdravlje Palmoticeva 37 | |
Belgrade, Serbia, 11000 |
Study Director: | Nuoyu Huang, MD/PhD | DOV Pharmaceutical, Inc. |
Responsible Party: | DOV Pharmaceutical, Inc. ( Dr. Nuoyo Huang, Vice President Clinical Research and Development ) |
Study ID Numbers: | DOV 947-010 |
Study First Received: | April 9, 2008 |
Last Updated: | December 4, 2008 |
ClinicalTrials.gov Identifier: | NCT00659347 |
Health Authority: | United States: Food and Drug Administration |
Depression Mental Disorders Mood Disorders |
Depressive Disorder, Major Depressive Disorder Behavioral Symptoms |
Pathologic Processes Disease |