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

Major Depressive Disorder Clinical Trial

Official title:

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

Clinical Trial Details — Status: Terminated

Administrative data

• NCT number: NCT00659347
• Other study ID #: DOV 947-010
• Status: Terminated
• Phase: Phase 2
• First received: April 9, 2008
• Last updated: December 4, 2008
• Start date: March 2008
• Est. completion date: December 2008

Study information

• Verified date: December 2008
• Source: DOV Pharmaceutical, Inc.
• Contact: n/a
• Is FDA regulated: No
• Health authority: United States: Food and Drug Administration
• Study type: Interventional

Clinical Trial Summary

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

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

Recruitment information / eligibility

• Status: Terminated
• Enrollment: 200
• Est. completion date: December 2008
• Est. primary completion date: December 2008
• Accepts healthy volunteers: No
• Gender: Both
• Age group: 18 Years to 65 Years

Eligibility

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 Design

Allocation: Randomized, Endpoint Classification: Safety/Efficacy Study, Intervention Model: Parallel Assignment, Masking: Double Blind (Subject, Caregiver, Investigator), Primary Purpose: Treatment

Related Conditions & MeSH terms

• Depression
• Depressive Disorder
• Depressive Disorder, Major
• Major Depressive Disorder

Intervention

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
Capsules,25 mg,BID,6weeks

Locations

Country	Name	City	State
Romania	SC Corpores Sana Medical SRL	Bucharest
Romania	Spitalul Clinic "Colentina", Ambulator Specialitate, Sectia Psihiatrie	Bucharest
Romania	Spitalul Clinic de Psihiatrie "Prof. Dr. Alexandru Obregia", pavilion III	Bucharest
Romania	Spitalul Clinic de Psihiatrie "Prof. Dr. Alexandru Obregia", Pavilion IV	Bucharest
Romania	Spitalul Clinic de Psihiatrie "Prof. Dr. Alexandru Obregia", Pavilion X	Bucharest
Romania	Spitalul Clinic de Psihiatrie "Socola"	Lasi
Romania	Spitalul Universitar de Psihiatrie "Socola"	Lasi
Romania	Spitalul Clinic de Neurologie si Psihiatrie Oradea	Oradea	Bihor
Romania	Spitalul Judetean de Urgenta Piatra Neamt	Piatra Neamt
Romania	Spitalul Judetean Arges	Pitesti	Arges
Romania	Cabinetul Medical Lorentina 2102 S.R.L.	Targoviste	Dambovita
Romania	Spitalul Clinic Judetean de Urgenta Targu Mures	Targu Mures
Serbia	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
United States	Brooklyn Medical Institute	Brooklyn	New York
United States	Center for Emotional Fitness	Cherry Hill	New Jersey
United States	CRI Worldwide, LLC	Clementon	New Jersey
United States	Social Psychiatry Research Institute	New York	New York
United States	Comprehensive Psychiatric Care	Norwich	Connecticut
United States	CRI Worldwide, LLC	Philadelphia	Pennsylvania
United States	Princeton Medical Institute	Princeton	New Jersey
United States	Scranton Medical Institutes	Scranton	Pennsylvania
United States	Future Care Studies	Springfield	Massachusetts
United States	Richmond Behavorial Associates	Staten Island	New York

Sponsors (1)

Lead Sponsor	Collaborator
DOV Pharmaceutical, Inc.

Countries where clinical trial is conducted

United States,  Romania,  Serbia, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	The primary outcome measure will be the change in tot al score of MADRS scale.		6 weeks	No