Efficacy and Safety of DOV 21,947 in the Treatment of Major Depressive Disorder
NCT ID: NCT00659347
Last Updated: 2008-12-05
Study Results
The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.
Basic Information
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TERMINATED
PHASE2
200 participants
INTERVENTIONAL
2008-03-31
2008-12-31
Brief Summary
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Detailed Description
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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
Conditions
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Study Design
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RANDOMIZED
PARALLEL
TREATMENT
TRIPLE
Study Groups
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1
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
2
Placebo
Capsules,25 mg,BID,6weeks
Interventions
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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
Placebo
Capsules,25 mg,BID,6weeks
Eligibility Criteria
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Inclusion Criteria
2. Either outpatients or inpatients diagnosed with major depressive disorder (MDD) according to Diagnostic and Statistical Manual of Mental Disorders (DSM-IV-TR, see Appendix 3) and MINI International Neuropsychiatric Interview (MINI).
3. Patients with recurrent depressive episode of at least 2 months in duration. Patients must have previously responded (significant clinical improvement judged by the Principal Investigator) to at least one antidepressant treatment.
4. HAMD-17 total score \* 22 with a severity score of at least 2 on Item 1 at the Placebo Run-In Visit and the Baseline/Day 1 Visit.
5. HAMD-17 score reduction ≤ 15% between the Placebo Run-In Visit and the Baseline/Day 1 Visit.
6. HAM-A total score \< 17 at the Screening Visit.
Exclusion Criteria
2. Patients with a medical history of MDD that consistently did not respond significantly to an adequate treatment regimen of a monoamine oxidase (MAO) inhibitor.
3. Patients who are known to be antidepressant treatment-resistant. Patients are defined as treatment-resistant if in the past they have failed adequate antidepressant treatments (dose level approved in the product labeling and was administered for at least 4 weeks) from two or more different pharmacological classes (e.g., TCA, SSRI, SNRI, MAO-I, etc). Failure to respond to an adequate antidepressant treatment is defined as the absence of at least a 50% improvement in symptoms by patient report or documented history, or lack of significant clinical improvement at the Principal Investigator's discretion.
4. Patients with a medical history of MDD who consistently did not respond significantly to electroconvulsive shock therapy (ECT) or had ECT within a year prior to the Screening Visit regardless of outcome.
5. Patients with psychotic depression
18 Years
65 Years
ALL
No
Sponsors
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DOV Pharmaceutical, Inc.
INDUSTRY
Responsible Party
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DOV Pharmaceutical, Inc.
Principal Investigators
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Nuoyu Huang, MD/PhD
Role: STUDY_DIRECTOR
DOV Pharmaceutical, Inc.
Locations
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Comprehensive Psychiatric Care
Norwich, Connecticut, United States
Future Care Studies
Springfield, Massachusetts, United States
Center for Emotional Fitness
Cherry Hill, New Jersey, United States
CRI Worldwide, LLC
Clementon, New Jersey, United States
Princeton Medical Institute
Princeton, New Jersey, United States
Brooklyn Medical Institute
Brooklyn, New York, United States
Social Psychiatry Research Institute
New York, New York, United States
Richmond Behavorial Associates
Staten Island, New York, United States
CRI Worldwide, LLC
Philadelphia, Pennsylvania, United States
Scranton Medical Institutes
Scranton, Pennsylvania, United States
Spitalul Judetean Arges
Piteşti, Argeş, Romania
Spitalul Clinic de Neurologie si Psihiatrie Oradea
Oradea, Bihor County, Romania
SC Corpores Sana Medical SRL
Bucharest, Bucharest, Romania
Spitalul Clinic "Colentina", Ambulator Specialitate, Sectia Psihiatrie
Bucharest, Bucharest, Romania
Spitalul Clinic de Psihiatrie "Prof. Dr. Alexandru Obregia", pavilion III
Bucharest, Bucharest, Romania
Spitalul Clinic de Psihiatrie "Prof. Dr. Alexandru Obregia", Pavilion IV
Bucharest, Bucharest, Romania
Spitalul Clinic de Psihiatrie "Prof. Dr. Alexandru Obregia", Pavilion X
Bucharest, Bucharest, Romania
Cabinetul Medical Lorentina 2102 S.R.L.
Târgovişte, Dâmbovița County, Romania
Spitalul Clinic de Psihiatrie "Socola"
Lasi, Lasi, Romania
Spitalul Judetean de Urgenta Piatra Neamt
Piatra Neamţ, Piatra Neamt, Romania
Spitalul Clinic Judetean de Urgenta Targu Mures
Târgu Mureş, Targu Mures, Romania
Spitalul Universitar de Psihiatrie "Socola"
Lasi, , Romania
Institut za mentalno zdravlje Palmoticeva 37
Belgrade, , Serbia
Institut za psihijatriju KCS
Belgrade, , Serbia
Klinika za neurologiju i psihijatriju
Kragujevac, , Serbia
Klinika za psihijatriju Vojnomedicinske Akademije
Velgrade, , Serbia
Countries
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Other Identifiers
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DOV 947-010
Identifier Type: -
Identifier Source: org_study_id