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Sponsored by: |
CeNeRx BioPharma Inc. |
Information provided by: | CeNeRx BioPharma Inc. |
ClinicalTrials.gov Identifier: | NCT00739908 |
The purpose of this study is to examine the efficacy of CX157 as compared to placebo in subjects with Major Depressive Disorder (MDD). Secondary objectives are to evaluate the safety and tolerability and steady state pharmacokinetic profile of CX157 in these subjects.
Condition | Intervention | Phase |
Major Depressive Disorder |
Drug: CX157 Drug: Placebo |
Phase II |
MedlinePlus related topics: | Depression |
Study Type: | Interventional |
Study Design: | Treatment, Randomized, Double Blind (Subject, Caregiver, Investigator, Outcomes Assessor), Parallel Assignment, Safety/Efficacy Study |
Official Title: | A Randomized, Double-Blind, Placebo-Controlled Parallel-Group, Assessment of the Efficacy, Safety and Tolerability of CX157 60mg TID in Subjects With Major Depressive Disorder |
Estimated Enrollment: | 272 |
Study Start Date: | September 2008 |
Estimated Study Completion Date: | July 2009 |
Estimated Primary Completion Date: | July 2009 (Final data collection date for primary outcome measure) |
Arms | Assigned Interventions |
CX157: Experimental |
Drug: CX157
60mg three times a day
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Placebo: Placebo Comparator |
Drug: Placebo
Administered three times a day
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This is a Phase II, randomized, double-blind, placebo-controlled, parallel-group, multi-center study comparing the efficacy, safety and tolerability of CX157 60mg TID and placebo. This study will be conducted at approximately 12 investigative sites in the US.
Subjects with suspected MDD and experiencing an MDE who the investigator wishes to consider for enrollment in the study and who provide written informed consent will initially be evaluated by the IDS-SR30 administered via IVRS. Subjects who meet the minimum score of 40 on the IDS-SR30 will proceed with the remaining study related assessments at the Screening visit. Those subjects who meet all inclusion criteria and none of the exclusion criteria will enter a one to two week Screening period to confirm eligibility and to capture Screening data prior to Randomization. At the Randomization visit, all eligibility requirements will be reconfirmed. The subjects who meet all criteria will be randomized to study medication and enter into a six-week treatment period and a subsequent one week Follow-Up period. The total duration of participation for subjects who complete all phases of the study will be approximately 8-9 weeks. During the treatment period, clinic visits will occur at Week1, Week 2, Week 4, and Week 6. A subsequent clinic visit will occur at the end of the one week Follow-Up period. The clinical site will contact the subjects via telephone at Weeks 3 and 5 to inquire about their wellbeing, query about adverse events and administer the suicidality scale.
Eligible subjects will be randomized (1:1) to receive:
Ages Eligible for Study: | 18 Years to 60 Years |
Genders Eligible for Study: | Both |
Accepts Healthy Volunteers: | No |
Inclusion Criteria:
Exclusion Criteria:
Current diagnosis of Obsessive-Compulsive Disorder;
History within past 2 years of: Significant head trauma;
Presence of any medical history which includes:
Contact: Lauren Kargher | (610) 354 0404 ext 121 | lkargher@qdservices.com |
Contact: Pam Hill | (610) 354 0404 | phill@qdservices.com |
United States, California | |||||
Southwestern Research, Inc. | Recruiting | ||||
Beverly Hills, California, United States | |||||
Contact 888-444-1104 murphy@435.com | |||||
United States, District of Columbia | |||||
The George Washington University | Recruiting | ||||
Washington, District of Columbia, United States | |||||
Contact 202-994-2273 cfrnab@gwumc.edu | |||||
Contact cfrkpw@gwumc.edu | |||||
United States, Illinois | |||||
Midwest Center for Neurobehavioral Medicine | Recruiting | ||||
Oakbrook Terrace, Illinois, United States | |||||
Contact 630-705-1501 anxiety@mcnm.com | |||||
United States, Maryland | |||||
Capital Clinical Research Associates | Recruiting | ||||
Rockville, Maryland, United States | |||||
Contact 301-770-7375 jurran@ccraresearch.com | |||||
United States, Massachusetts | |||||
McLean Hospital | Recruiting | ||||
Belmont, Massachusetts, United States | |||||
Contact 617-855-2988 tmann@mclean.org | |||||
United States, New Jersey | |||||
CRI Worldwide, LLC | Recruiting | ||||
Clementon, New Jersey, United States | |||||
Contact 856-566-9000 ext 232 asauer@criww.com | |||||
United States, New York | |||||
Fieve Clinical Services | Recruiting | ||||
New York, New York, United States | |||||
Contact 212-772-3570 fieve@fieveclinical.com | |||||
United States, North Carolina | |||||
Richard H. Weisler, M.D., P.A. | Recruiting | ||||
Raleigh, North Carolina, United States | |||||
Contact 919-878-0942 rweisler@weislermd.com | |||||
United States, Pennsylvania | |||||
University of Pennsylvania School of Medicine | Recruiting | ||||
Philadelphia, Pennsylvania, United States | |||||
Contact 215-573-8582 a.pesiridou@gmail.com | |||||
United States, Texas | |||||
FutureSearch Trials | Recruiting | ||||
Austin, Texas, United States, 78756 | |||||
Contact 512-380-9925 christopherc@fstrials.com | |||||
United States, Washington | |||||
Summit Research Network (Seattle), LLC | Recruiting | ||||
Seattle, Washington, United States | |||||
Contact 206-315-1066 saraj@summitnetwork.com | |||||
United States, Wisconsin | |||||
Northbrooke Research Center | Recruiting | ||||
Brown Deer, Wisconsin, United States | |||||
Contact 414-357-9444 mollymsimon@aol.com |
CeNeRx BioPharma Inc. |
Study Director: | Daniel Burch, MD | CeNeRx BioPharma Inc. |
Responsible Party: | CeNeRx BioPharma Inc. ( Daniel Burch, M.D., EVP R&D and Chief Medical Officer ) |
Study ID Numbers: | CX157-200 |
First Received: | August 20, 2008 |
Last Updated: | October 2, 2008 |
ClinicalTrials.gov Identifier: | NCT00739908 |
Health Authority: | United States: Food and Drug Administration |
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