Efficacy and Safety of DOV 21,947 in the Treatment of Major Depressive Disorder

Stopped early · Phase 2 · Has a placebo group

Conditions studied: Major Depressive Disorder

In brief

The primary objectives of this placebo-controlled trial are to evaluate effectiveness and safety of DOV 21,947 at two oral dose levels.

Key facts

Study ID

NCT00659347

Run by

DOV Pharmaceutical, Inc.

People needed

200

Starts

2008-03-01

Expected to finish

2008-12-01

Last updated by the study team

2008-12-05

Who can join

Age: 18 and older, up to 65. Sex: any. Healthy volunteers: not accepted.

You may qualify if…

• Males or females between 18 and 65 years of age (inclusive).
• 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).
• 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.
• 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.
• HAMD-17 score reduction ≤ 15% between the Placebo Run-In Visit and the Baseline/Day 1 Visit.
• HAM-A total score < 17 at the Screening Visit.

You may not qualify if…

• Patients with a HAMD-17 total score reduction of more than 15% between the Placebo Run-In Visit and the Baseline/Day 1 Visit (placebo responders).
• Patients with a medical history of MDD that consistently did not respond significantly to an adequate treatment regimen of a monoamine oxidase (MAO) inhibitor.
• 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.
• 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.
• Patients with psychotic depression

Where it is running

• 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. — Targoviste, 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

Full record on ClinicalTrials.gov

Trial information comes from ClinicalTrials.gov and is refreshed daily. TrialsForMe does not provide medical care and does not run the studies it lists.