A Study of CX157 (TriRima) for the Treatment of Depression (CX157-200)
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ClinicalTrials.gov Identifier: NCT00739908 |
Recruitment Status :
Completed
First Posted : August 22, 2008
Results First Posted : June 27, 2012
Last Update Posted : June 27, 2012
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Sponsor:
CeNeRx BioPharma Inc.
Information provided by (Responsible Party):
CeNeRx BioPharma Inc.
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Study Type | Interventional |
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Study Design | Allocation: Randomized; Intervention Model: Parallel Assignment; Masking: Quadruple (Participant, Care Provider, Investigator, Outcomes Assessor); Primary Purpose: Treatment |
Condition |
Major Depressive Disorder |
Interventions |
Drug: CX157 (TriRima) Drug: Placebo |
Enrollment | 285 |
Participant Flow
Recruitment Details | The study was conducted at 14 out-patient medical centers in the United States (US) from 16 September 2008 (date of first subject randomized) to 09 July 2009 (last subject’s last visit). |
Pre-assignment Details | A total of 587 subjects were screened. Three hundred and two (302) subjects failed to meet study entry criteria, and thus were screen failures. The top three reasons for screen failure were: IDS-SR30 total score cut-off for randomization not met (204 pts); presence of cardiovascular abnormality (18 pts) and Laboratory Abnormalities (14 pts). |
Baseline Characteristics
Outcome Measures
Adverse Events
Limitations and Caveats
Subjects were asked to take 6 capsules 3 times a day for 6 weeks. Non-adherence with the study medication was high based on the population PK data. This likely contributed to the results in CX157 treatment group.
More Information
Principal Investigators are NOT employed by the organization sponsoring the study.
There IS an agreement between Principal Investigators and the Sponsor (or its agents) that restricts
the PI's rights to discuss or publish trial results after the trial is completed.
The investigators were informed that the first publication or disclosure of study results shall be a complete, joint multicenter publication or disclosure coordinated by CeNeRx. Thereafter, any secondary publications will reference the original publication(s).
Results Point of Contact
Name/Title: | Mahnaz Asgharnejad, Pharm.D.; Daniel Burch, M.D. |
Organization: | CeNeRx BioPharma Inc. |
Phone: | (919) 655 1435; (919) 674 6041 |
EMail: | masgharnejad@cenerx.com; danburch@cenerx.com |
Publications automatically indexed to this study by ClinicalTrials.gov Identifier (NCT Number):
Responsible Party: | CeNeRx BioPharma Inc. |
ClinicalTrials.gov Identifier: | NCT00739908 History of Changes |
Other Study ID Numbers: |
CX157-200 |
First Submitted: | August 20, 2008 |
First Posted: | August 22, 2008 |
Results First Submitted: | February 14, 2012 |
Results First Posted: | June 27, 2012 |
Last Update Posted: | June 27, 2012 |