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

• Sponsor: DOV Pharmaceutical, Inc. (Industry)
• Overall Status: Terminated
• CT.gov ID: NCT00659347
• Collaborator: (none)
• Enrollment: 200
• Locations: 26
• Arms: 2
• Duration (Months): 9
• Patients Per Site: 7.7
• Patients Per Site Per Month: 0.9

Study Details

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.

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

Study Design

• Study Type: Interventional
• Anticipated 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: Mar 1, 2008
• Actual Primary Completion Date: Dec 1, 2008
• Actual Study Completion Date: Dec 1, 2008

Arms and Interventions

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

Outcome Measures

Primary Outcome Measures

1. The primary outcome measure will be the change in tot al score of MADRS scale. [6 weeks]

Eligibility Criteria

Criteria

• Ages Eligible for Study: 18 Years to 65 Years
• Sexes Eligible for Study: All
• Accepts Healthy Volunteers: No

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

Contacts and Locations

Locations

	Site	City	State	Country	Postal Code
1	Comprehensive Psychiatric Care	Norwich	Connecticut	United States	06360
2	Future Care Studies	Springfield	Massachusetts	United States	01103
3	Center for Emotional Fitness	Cherry Hill	New Jersey	United States	08002
4	CRI Worldwide, LLC	Clementon	New Jersey	United States	08021
5	Princeton Medical Institute	Princeton	New Jersey	United States	08540
6	Brooklyn Medical Institute	Brooklyn	New York	United States	11223
7	Social Psychiatry Research Institute	New York	New York	United States	10021
8	Richmond Behavorial Associates	Staten Island	New York	United States	10312
9	CRI Worldwide, LLC	Philadelphia	Pennsylvania	United States	19139
10	Scranton Medical Institutes	Scranton	Pennsylvania	United States	18503
11	Spitalul Judetean Arges	Pitesti	Arges	Romania	110084
12	Spitalul Clinic de Neurologie si Psihiatrie Oradea	Oradea	Bihor	Romania	410154
13	Cabinetul Medical Lorentina 2102 S.R.L.	Targoviste	Dambovita	Romania	130081
14	SC Corpores Sana Medical SRL	Bucharest		Romania	010604
15	Spitalul Clinic "Colentina", Ambulator Specialitate, Sectia Psihiatrie	Bucharest		Romania	020125
16	Spitalul Clinic de Psihiatrie "Prof. Dr. Alexandru Obregia", pavilion III	Bucharest		Romania	041915
17	Spitalul Clinic de Psihiatrie "Prof. Dr. Alexandru Obregia", Pavilion IV	Bucharest		Romania	041915
18	Spitalul Clinic de Psihiatrie "Prof. Dr. Alexandru Obregia", Pavilion X	Bucharest		Romania	041915
19	Spitalul Clinic de Psihiatrie "Socola"	Lasi		Romania	700282
20	Spitalul Universitar de Psihiatrie "Socola"	Lasi		Romania
21	Spitalul Judetean de Urgenta Piatra Neamt	Piatra Neamt		Romania	610136
22	Spitalul Clinic Judetean de Urgenta Targu Mures	Targu Mures		Romania	540139
23	Institut za mentalno zdravlje Palmoticeva 37	Belgrade		Serbia	11000
24	Institut za psihijatriju KCS	Belgrade		Serbia	11000
25	Klinika za neurologiju i psihijatriju	Kragujevac		Serbia	34000
26	Klinika za psihijatriju Vojnomedicinske Akademije	Velgrade		Serbia	1100

Sponsors and Collaborators

• DOV Pharmaceutical, Inc.

Investigators

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

Study Documents (Full-Text)

None provided.

More Information

Publications

None provided.

• ClinicalTrials.gov Identifier: NCT00659347
• Other Study ID Numbers: DOV 947-010
• First Posted: Apr 16, 2008
• Last Update Posted: Dec 5, 2008
• Last Verified: Dec 1, 2008

• Additional relevant MeSH terms: Depressive Disorder; Depression; Depressive Disorder, Major

Study Results

No Results Posted as of Dec 5, 2008