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

• ClinicalTrials.gov Identifier: NCT00659347
• Recruitment Status: Terminated
• First Posted: April 16, 2008
• Last Update Posted: December 5, 2008
• Sponsor: DOV Pharmaceutical, Inc.
• Information provided by: DOV Pharmaceutical, Inc.

Study Description

Brief Summary:

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

Condition or disease	Intervention/treatment	Phase
Major Depressive Disorder	Drug: DOV 21, 947; Drug: Placebo	Phase 2

Detailed Description:

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

Study Design

• Study Type: Interventional (Clinical Trial)
• Estimated Enrollment: 200 participants
• Allocation: Randomized
• Intervention Model: Parallel Assignment
• Masking: Triple (Participant, Care Provider, Investigator)
• Primary Purpose: Treatment
• Official Title: A Multi-Center, Randomized, Double-Blind, Placebo-Controlled Study of DOV 21,947 in Patients With Major Depressive Disorder
• Study Start Date: March 2008
• Actual Primary Completion Date: December 2008
• Actual Study Completion Date: December 2008

Arms and Interventions

Arm	Intervention/treatment
Active Comparator: 1	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
Placebo Comparator: 2	Drug: Placebo; Capsules,25 mg,BID,6weeks

Outcome Measures

Primary Outcome Measures :

1. The primary outcome measure will be the change in tot al score of MADRS scale. [ Time Frame: 6 weeks ]

Eligibility Criteria

• Ages Eligible for Study: 18 Years to 65 Years (Adult, Older Adult)
• Sexes Eligible for Study: All
• Accepts Healthy Volunteers: No

Criteria

Inclusion Criteria:

1. Males or females between 18 and 65 years of age (inclusive).
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:

1. 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).
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

Contacts and Locations

Locations

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

CRI Worldwide, LLC

Clementon, New Jersey, United States, 08021

Princeton Medical Institute

Princeton, New Jersey, United States, 08540

United States, New York

Brooklyn Medical Institute

Brooklyn, New York, United States, 11223

Social Psychiatry Research Institute

New York, New York, United States, 10021

Richmond Behavorial Associates

Staten Island, New York, United States, 10312

United States, Pennsylvania

CRI Worldwide, LLC

Philadelphia, Pennsylvania, United States, 19139

Scranton Medical Institutes

Scranton, Pennsylvania, United States, 18503

Romania

Spitalul Judetean Arges

Pitesti, Arges, Romania, 110084

Spitalul Clinic de Neurologie si Psihiatrie Oradea

Oradea, Bihor, Romania, 410154

Cabinetul Medical Lorentina 2102 S.R.L.

Targoviste, Dambovita, Romania, 130081

SC Corpores Sana Medical SRL

Bucharest, Romania, 010604

Spitalul Clinic "Colentina", Ambulator Specialitate, Sectia Psihiatrie

Bucharest, Romania, 020125

Spitalul Clinic de Psihiatrie "Prof. Dr. Alexandru Obregia", pavilion III

Bucharest, Romania, 041915

Spitalul Clinic de Psihiatrie "Prof. Dr. Alexandru Obregia", Pavilion IV

Bucharest, Romania, 041915

Spitalul Clinic de Psihiatrie "Prof. Dr. Alexandru Obregia", Pavilion X

Bucharest, Romania, 041915

Spitalul Clinic de Psihiatrie "Socola"

Lasi, Romania, 700282

Spitalul Universitar de Psihiatrie "Socola"

Lasi, Romania

Spitalul Judetean de Urgenta Piatra Neamt

Piatra Neamt, Romania, 610136

Spitalul Clinic Judetean de Urgenta Targu Mures

Targu Mures, Romania, 540139

Serbia

Institut za mentalno zdravlje Palmoticeva 37

Belgrade, Serbia, 11000

Institut za psihijatriju KCS

Belgrade, Serbia, 11000

Klinika za neurologiju i psihijatriju

Kragujevac, Serbia, 34000

Klinika za psihijatriju Vojnomedicinske Akademije

Velgrade, Serbia, 1100

Sponsors and Collaborators

DOV Pharmaceutical, Inc.

Investigators

• Study Director: Nuoyu Huang, MD/PhD; DOV Pharmaceutical, Inc.

More Information

• Responsible Party: Dr. Nuoyo Huang, Vice President Clinical Research and Development, DOV Pharmaceutical, Inc.
• ClinicalTrials.gov Identifier: NCT00659347 History of Changes
• Other Study ID Numbers: DOV 947-010
• First Posted: April 16, 2008
• Last Update Posted: December 5, 2008
• Last Verified: December 2008

Additional relevant MeSH terms:

Depressive Disorder; Depression; Depressive Disorder, Major; Mood Disorders; Mental Disorders; Behavioral Symptoms