Clinical trial NCT00659347: 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
Overall status: TERMINATED
Phase: PHASE2
Conditions: Major Depressive Disorder
Lead sponsor: DOV Pharmaceutical, Inc.
Sponsor class: INDUSTRY
First posted: 2008-04-16
Enrollment: 200
Sex: ALL
Minimum age (years): 18
Maximum age (years): 65
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: TREATMENT

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

Eligibility 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

Primary outcomes:
measure: The primary outcome measure will be the change in tot al score of MADRS scale.
timeFrame: 6 weeks
Secondary outcomes:
Other outcomes:
Locations:
city: Norwich
country: United States
facility: Comprehensive Psychiatric Care
state: Connecticut
city: Springfield
country: United States
facility: Future Care Studies
state: Massachusetts
city: Cherry Hill
country: United States
facility: Center for Emotional Fitness
state: New Jersey
city: Clementon
country: United States
facility: CRI Worldwide, LLC
state: New Jersey
city: Princeton
country: United States
facility: Princeton Medical Institute
state: New Jersey
city: Brooklyn
country: United States
facility: Brooklyn Medical Institute
state: New York
city: New York
country: United States
facility: Social Psychiatry Research Institute
state: New York
city: Staten Island
country: United States
facility: Richmond Behavorial Associates
state: New York
city: Philadelphia
country: United States
facility: CRI Worldwide, LLC
state: Pennsylvania
city: Scranton
country: United States
facility: Scranton Medical Institutes
state: Pennsylvania
city: Pitesti
country: Romania
facility: Spitalul Judetean Arges
state: Arges
city: Oradea
country: Romania
facility: Spitalul Clinic de Neurologie si Psihiatrie Oradea
state: Bihor
city: Targoviste
country: Romania
facility: Cabinetul Medical Lorentina 2102 S.R.L.
state: Dambovita
city: Bucharest
country: Romania
facility: SC Corpores Sana Medical SRL
city: Bucharest
country: Romania
facility: Spitalul Clinic "Colentina", Ambulator Specialitate, Sectia Psihiatrie
city: Bucharest
country: Romania
facility: Spitalul Clinic de Psihiatrie "Prof. Dr. Alexandru Obregia", pavilion III
city: Bucharest
country: Romania
facility: Spitalul Clinic de Psihiatrie "Prof. Dr. Alexandru Obregia", Pavilion IV
city: Bucharest
country: Romania
facility: Spitalul Clinic de Psihiatrie "Prof. Dr. Alexandru Obregia", Pavilion X
city: Lasi
country: Romania
facility: Spitalul Clinic de Psihiatrie "Socola"
city: Lasi
country: Romania
facility: Spitalul Universitar de Psihiatrie "Socola"
city: Piatra Neamt
country: Romania
facility: Spitalul Judetean de Urgenta Piatra Neamt
city: Targu Mures
country: Romania
facility: Spitalul Clinic Judetean de Urgenta Targu Mures
city: Belgrade
country: Serbia
facility: Institut za mentalno zdravlje Palmoticeva 37
city: Belgrade
country: Serbia
facility: Institut za psihijatriju KCS
city: Kragujevac
country: Serbia
facility: Klinika za neurologiju i psihijatriju
city: Velgrade
country: Serbia
facility: Klinika za psihijatriju Vojnomedicinske Akademije
Study officials:
affiliation: DOV Pharmaceutical, Inc.
name: Nuoyu Huang, MD/PhD
role: STUDY_DIRECTOR
References: