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

NCT00659347 | Terminated Phase 2

• 1 other identifier: DOV 947-010
• Study Type: interventional
• Target: 200
• Locations: 3 countries
• Sites: 26

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.

Conditions

Major Depressive Disorder

Outcome Measures

Primary Outcomes (1)

• The primary outcome measure will be the change in tot al score of MADRS scale.

  6 weeks

Study Arms (2)

1

ACTIVE COMPARATOR

Drug: DOV 21, 947

2

PLACEBO COMPARATOR

Drug: Placebo

Interventions

DOV 21, 947 DRUG

Capsules, 25 mg, 2 capsules (1 Active/1 Placebo) BID, 2 weeks Capsules, 25 mg, 2 capsules (2 Active) BID, 2 weeks

1

Placebo DRUG

Capsules,25 mg,BID,6weeks

2

Eligibility Criteria

• Age: 18 Years - 65 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

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

Sponsors & Collaborators

• DOV Pharmaceutical, Inc.: lead

Study Sites (26)

Comprehensive Psychiatric Care

Norwich, Connecticut, 06360, United States

Location

Future Care Studies

Springfield, Massachusetts, 01103, United States

Location

Center for Emotional Fitness

Cherry Hill, New Jersey, 08002, United States

Location

CRI Worldwide, LLC

Clementon, New Jersey, 08021, United States

Location

Princeton Medical Institute

Princeton, New Jersey, 08540, United States

Location

Brooklyn Medical Institute

Brooklyn, New York, 11223, United States

Location

Social Psychiatry Research Institute

New York, New York, 10021, United States

Location

Richmond Behavorial Associates

Staten Island, New York, 10312, United States

Location

CRI Worldwide, LLC

Philadelphia, Pennsylvania, 19139, United States

Location

Scranton Medical Institutes

Scranton, Pennsylvania, 18503, United States

Location

Spitalul Judetean Arges

Piteşti, Argeş, 110084, Romania

Location

Spitalul Clinic de Neurologie si Psihiatrie Oradea

Oradea, Bihor County, 410154, Romania

Location

SC Corpores Sana Medical SRL

Bucharest, Bucharest, 010604, Romania

Location

Spitalul Clinic "Colentina", Ambulator Specialitate, Sectia Psihiatrie

Bucharest, Bucharest, 020125, Romania

Location

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

Bucharest, Bucharest, 041915, Romania

Location

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

Bucharest, Bucharest, 041915, Romania

Location

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

Bucharest, Bucharest, 041915, Romania

Location

Cabinetul Medical Lorentina 2102 S.R.L.

Târgovişte, Dâmbovița County, 130081, Romania

Location

Spitalul Clinic de Psihiatrie "Socola"

Lasi, Lasi, 700282, Romania

Location

Spitalul Judetean de Urgenta Piatra Neamt

Piatra Neamţ, Piatra Neamt, 610136, Romania

Location

Spitalul Clinic Judetean de Urgenta Targu Mures

Târgu Mureş, Targu Mures, 540139, Romania

Location

Spitalul Universitar de Psihiatrie "Socola"

Lasi, Romania

Location

Institut za mentalno zdravlje Palmoticeva 37

Belgrade, 11000, Serbia

Location

Institut za psihijatriju KCS

Belgrade, 11000, Serbia

Location

Klinika za neurologiju i psihijatriju

Kragujevac, 34000, Serbia

Location

Klinika za psihijatriju Vojnomedicinske Akademije

Velgrade, 1100, Serbia

Location

MeSH Terms

Conditions

Depressive Disorder, Major

Condition Hierarchy (Ancestors)

Depressive Disorder; Mood Disorders; Mental Disorders

Study Officials

• Nuoyu Huang, MD/PhD

  DOV Pharmaceutical, Inc.

  STUDY DIRECTOR

Study Design

• Study Type: interventional
• Phase: phase 2
• Allocation: RANDOMIZED
• Masking: TRIPLE
• Who Masked: PARTICIPANT, CARE PROVIDER, INVESTIGATOR
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: INDUSTRY

Study Record Dates

• First Submitted: April 9, 2008
• First Posted: April 16, 2008
• Study Start: March 1, 2008
• Primary Completion: December 1, 2008
• Study Completion: December 1, 2008
• Last Updated: December 5, 2008

Record last verified: 2008-12

Locations

US (10); RO (12); SE (4)