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

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details.
 
ClinicalTrials.gov Identifier: NCT00659347
Recruitment Status : Terminated
First Posted : April 16, 2008
Last Update Posted : December 5, 2008
Sponsor:
Information provided by:
DOV Pharmaceutical, Inc.

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


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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

Resource links provided by the National Library of Medicine


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




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


Information from the National Library of Medicine

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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

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT00659347


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

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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    Key Record Dates
Last Update Posted: December 5, 2008
Last Verified: December 2008
Additional relevant MeSH terms:
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Depressive Disorder
Depression
Depressive Disorder, Major
Mood Disorders
Mental Disorders
Behavioral Symptoms