Back to resultsEfficacy and Safety of DOV 21,947 in the Treatment of Major Depressive Disorder
Primary Purpose
Major Depressive Disorder
Status
Terminated
Phase
Phase 2
Locations
International
Study Type
Interventional
Intervention
DOV 21, 947
Placebo
Sponsored by
About this trial
This is an interventional treatment trial for Major Depressive Disorder
Eligibility Criteria
Inclusion Criteria:
- 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.
Exclusion Criteria:
- 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
Sites / Locations
- Comprehensive Psychiatric Care
- Future Care Studies
- Center for Emotional Fitness
- CRI Worldwide, LLC
- Princeton Medical Institute
- Brooklyn Medical Institute
- Social Psychiatry Research Institute
- Richmond Behavorial Associates
- CRI Worldwide, LLC
- Scranton Medical Institutes
- Spitalul Judetean Arges
- Spitalul Clinic de Neurologie si Psihiatrie Oradea
- Cabinetul Medical Lorentina 2102 S.R.L.
- SC Corpores Sana Medical SRL
- Spitalul Clinic "Colentina", Ambulator Specialitate, Sectia Psihiatrie
- Spitalul Clinic de Psihiatrie "Prof. Dr. Alexandru Obregia", pavilion III
- Spitalul Clinic de Psihiatrie "Prof. Dr. Alexandru Obregia", Pavilion IV
- Spitalul Clinic de Psihiatrie "Prof. Dr. Alexandru Obregia", Pavilion X
- Spitalul Clinic de Psihiatrie "Socola"
- Spitalul Universitar de Psihiatrie "Socola"
- Spitalul Judetean de Urgenta Piatra Neamt
- Spitalul Clinic Judetean de Urgenta Targu Mures
- Institut za mentalno zdravlje Palmoticeva 37
- Institut za psihijatriju KCS
- Klinika za neurologiju i psihijatriju
- Klinika za psihijatriju Vojnomedicinske Akademije
Arms of the Study
Arm 1
Arm 2
Arm Type
Active Comparator
Placebo Comparator
Arm Label
1
2
Arm Description
Outcomes
Primary Outcome Measures
The primary outcome measure will be the change in tot al score of MADRS scale.
Secondary Outcome Measures
Full Information
NCT ID
NCT00659347
First Posted
April 9, 2008
Last Updated
December 4, 2008
Sponsor
DOV Pharmaceutical, Inc.
1. Study Identification
Unique Protocol Identification Number
NCT00659347
Brief Title
Efficacy and Safety of DOV 21,947 in the Treatment of Major Depressive Disorder
Official Title
A Multi-Center, Randomized, Double-Blind, Placebo-Controlled Study of DOV 21,947 in Patients With Major Depressive Disorder
Study Type
Interventional
2. Study Status
Record Verification Date
December 2008
Overall Recruitment Status
Terminated
Study Start Date
March 2008 (undefined)
Primary Completion Date
December 2008 (Actual)
Study Completion Date
December 2008 (Actual)
3. Sponsor/Collaborators
Name of the Sponsor
DOV Pharmaceutical, Inc.
4. Oversight
Data Monitoring Committee
No
5. 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.
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
6. Conditions and Keywords
Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Major Depressive Disorder
7. Study Design
Primary Purpose
Treatment
Study Phase
Phase 2
Interventional Study Model
Parallel Assignment
Masking
ParticipantCare ProviderInvestigator
Allocation
Randomized
Enrollment
200 (Anticipated)
8. Arms, Groups, and Interventions
Arm Title
1
Arm Type
Active Comparator
Arm Title
2
Arm Type
Placebo Comparator
Intervention Type
Drug
Intervention Name(s)
DOV 21, 947
Intervention Description
Capsules, 25 mg, 2 capsules (1 Active/1 Placebo) BID, 2 weeks Capsules, 25 mg, 2 capsules (2 Active) BID, 2 weeks
Intervention Type
Drug
Intervention Name(s)
Placebo
Intervention Description
Capsules,25 mg,BID,6weeks
Primary Outcome Measure Information:
Title
The primary outcome measure will be the change in tot al score of MADRS scale.
Time Frame
6 weeks
10. Eligibility
Sex
All
Minimum Age & Unit of Time
18 Years
Maximum Age & Unit of Time
65 Years
Accepts Healthy Volunteers
No
Eligibility Criteria
Inclusion Criteria:
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.
Exclusion Criteria:
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
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Nuoyu Huang, MD/PhD
Organizational Affiliation
DOV Pharmaceutical, Inc.
Official's Role
Study Director
Facility Information:
Facility Name
Comprehensive Psychiatric Care
City
Norwich
State/Province
Connecticut
ZIP/Postal Code
06360
Country
United States
Facility Name
Future Care Studies
City
Springfield
State/Province
Massachusetts
ZIP/Postal Code
01103
Country
United States
Facility Name
Center for Emotional Fitness
City
Cherry Hill
State/Province
New Jersey
ZIP/Postal Code
08002
Country
United States
Facility Name
CRI Worldwide, LLC
City
Clementon
State/Province
New Jersey
ZIP/Postal Code
08021
Country
United States
Facility Name
Princeton Medical Institute
City
Princeton
State/Province
New Jersey
ZIP/Postal Code
08540
Country
United States
Facility Name
Brooklyn Medical Institute
City
Brooklyn
State/Province
New York
ZIP/Postal Code
11223
Country
United States
Facility Name
Social Psychiatry Research Institute
City
New York
State/Province
New York
ZIP/Postal Code
10021
Country
United States
Facility Name
Richmond Behavorial Associates
City
Staten Island
State/Province
New York
ZIP/Postal Code
10312
Country
United States
Facility Name
CRI Worldwide, LLC
City
Philadelphia
State/Province
Pennsylvania
ZIP/Postal Code
19139
Country
United States
Facility Name
Scranton Medical Institutes
City
Scranton
State/Province
Pennsylvania
ZIP/Postal Code
18503
Country
United States
Facility Name
Spitalul Judetean Arges
City
Pitesti
State/Province
Arges
ZIP/Postal Code
110084
Country
Romania
Facility Name
Spitalul Clinic de Neurologie si Psihiatrie Oradea
City
Oradea
State/Province
Bihor
ZIP/Postal Code
410154
Country
Romania
Facility Name
Cabinetul Medical Lorentina 2102 S.R.L.
City
Targoviste
State/Province
Dambovita
ZIP/Postal Code
130081
Country
Romania
Facility Name
SC Corpores Sana Medical SRL
City
Bucharest
ZIP/Postal Code
010604
Country
Romania
Facility Name
Spitalul Clinic "Colentina", Ambulator Specialitate, Sectia Psihiatrie
City
Bucharest
ZIP/Postal Code
020125
Country
Romania
Facility Name
Spitalul Clinic de Psihiatrie "Prof. Dr. Alexandru Obregia", pavilion III
City
Bucharest
ZIP/Postal Code
041915
Country
Romania
Facility Name
Spitalul Clinic de Psihiatrie "Prof. Dr. Alexandru Obregia", Pavilion IV
City
Bucharest
ZIP/Postal Code
041915
Country
Romania
Facility Name
Spitalul Clinic de Psihiatrie "Prof. Dr. Alexandru Obregia", Pavilion X
City
Bucharest
ZIP/Postal Code
041915
Country
Romania
Facility Name
Spitalul Clinic de Psihiatrie "Socola"
City
Lasi
ZIP/Postal Code
700282
Country
Romania
Facility Name
Spitalul Universitar de Psihiatrie "Socola"
City
Lasi
Country
Romania
Facility Name
Spitalul Judetean de Urgenta Piatra Neamt
City
Piatra Neamt
ZIP/Postal Code
610136
Country
Romania
Facility Name
Spitalul Clinic Judetean de Urgenta Targu Mures
City
Targu Mures
ZIP/Postal Code
540139
Country
Romania
Facility Name
Institut za mentalno zdravlje Palmoticeva 37
City
Belgrade
ZIP/Postal Code
11000
Country
Serbia
Facility Name
Institut za psihijatriju KCS
City
Belgrade
ZIP/Postal Code
11000
Country
Serbia
Facility Name
Klinika za neurologiju i psihijatriju
City
Kragujevac
ZIP/Postal Code
34000
Country
Serbia
Facility Name
Klinika za psihijatriju Vojnomedicinske Akademije
City
Velgrade
ZIP/Postal Code
1100
Country
Serbia
12. IPD Sharing Statement
Learn more about this trial
Efficacy and Safety of DOV 21,947 in the Treatment of Major Depressive Disorder
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