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

A Multi-Center, Randomized, Double-Blind, Placebo-Controlled Study of DOV 21,947 in Patients With Major Depressive Disorder

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

Study Overview

• Status: Terminated
• Conditions: Major Depressive Disorder
• Intervention / Treatment: Drug: DOV 21, 947; Drug: Placebo

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 Type: Interventional
• Enrollment (Anticipated): 200
• Phase: Phase 2

Contacts and Locations

Study Locations

• Romania
  • Bucharest, Romania, 010604
    • SC Corpores Sana Medical SRL
  • Bucharest, Romania, 020125
    • Spitalul Clinic "Colentina", Ambulator Specialitate, Sectia Psihiatrie
  • Bucharest, Romania, 041915
    • 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
  • Lasi, Romania, 700282
    • Spitalul Clinic de Psihiatrie "Socola"
  • Lasi, Romania
    • Spitalul Universitar de Psihiatrie "Socola"
  • Piatra Neamt, Romania, 610136
    • Spitalul Judetean de Urgenta Piatra Neamt
  • Targu Mures, Romania, 540139
    • Spitalul Clinic Judetean de Urgenta Targu Mures
  • Arges
    • Pitesti, Arges, Romania, 110084
      • Spitalul Judetean Arges
  • Bihor
    • Oradea, Bihor, Romania, 410154
      • Spitalul Clinic de Neurologie si Psihiatrie Oradea
  • Dambovita
    • Targoviste, Dambovita, Romania, 130081
      • Cabinetul Medical Lorentina 2102 S.R.L.
• Serbia
  • Belgrade, Serbia, 11000
    • Institut za mentalno zdravlje Palmoticeva 37
  • Belgrade, Serbia, 11000
    • Institut za psihijatriju KCS
  • Kragujevac, Serbia, 34000
    • Klinika za neurologiju i psihijatriju
  • Velgrade, Serbia, 1100
    • Klinika za psihijatriju Vojnomedicinske Akademije
• United States
  • Connecticut
    • Norwich, Connecticut, United States, 06360
      • Comprehensive Psychiatric Care
  • Massachusetts
    • Springfield, Massachusetts, United States, 01103
      • Future Care Studies
  • New Jersey
    • Cherry Hill, New Jersey, United States, 08002
      • Center for Emotional Fitness
    • Clementon, New Jersey, United States, 08021
      • CRI Worldwide, LLC
    • Princeton, New Jersey, United States, 08540
      • Princeton Medical Institute
  • New York
    • Brooklyn, New York, United States, 11223
      • Brooklyn Medical Institute
    • New York, New York, United States, 10021
      • Social Psychiatry Research Institute
    • Staten Island, New York, United States, 10312
      • Richmond Behavorial Associates
  • Pennsylvania
    • Philadelphia, Pennsylvania, United States, 19139
      • CRI Worldwide, LLC
    • Scranton, Pennsylvania, United States, 18503
      • Scranton Medical Institutes

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 18 years to 65 years (ADULT, OLDER_ADULT)
• Accepts Healthy Volunteers: No
• Genders Eligible for Study: All

Description

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

Study Plan

How is the study designed?

Design Details

• Primary Purpose: TREATMENT
• Allocation: RANDOMIZED
• Interventional Model: PARALLEL
• Masking: TRIPLE

Number of Arms

2

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
Placebo Comparator: 2	Drug: Placebo; Capsules,25 mg,BID,6weeks
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

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Time Frame
The primary outcome measure will be the change in tot al score of MADRS scale.	6 weeks

Collaborators and Investigators

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

Study record dates

Study Major Dates

• Study Start: March 1, 2008
• Primary Completion (Actual): December 1, 2008
• Study Completion (Actual): December 1, 2008

Study Registration Dates

• First Submitted: April 9, 2008
• First Submitted That Met QC Criteria: April 15, 2008
• First Posted (Estimate): April 16, 2008

Study Record Updates

• Last Update Posted (Estimate): December 5, 2008
• Last Update Submitted That Met QC Criteria: December 4, 2008
• Last Verified: December 1, 2008

More Information

Terms related to this study

• Additional Relevant MeSH Terms: Behavioral Symptoms; Mental Disorders; Mood Disorders; Depression; Depressive Disorder; Depressive Disorder, Major
• Other Study ID Numbers: DOV 947-010