At a glance
ClinicalIndex Comparison RecordPhase 2Completed· 285 enrolled
Drug / intervention
CX157 (TriRima) +1 moredrug
Likely dose
Not stated in record
Structured eligibility isn't available for this trial yet — see the full criteria in the Eligibility tab below.
Standardized by ClinicalIndex from the ClinicalTrials.gov record · verify against the source.
A Randomized, Double-Blind, Placebo-Controlled Parallel-Group, Assessment of the Efficacy, Safety and Tolerability of CX157 (TriRima) 60mg Three Times a Day (TID) in Subjects With Major Depressive Disorder
In Brief
A Phase 2 clinical trial evaluating CX157 (TriRima) and Placebo for Major Depressive Disorder. Completed, enrolled 285 participants across 14 sites.
Detailed Summary
The purpose of this study is to examine the efficacy of CX157 60 mg administered three times a day (180 mg daily dose) 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.
Study Details
Study Typeinterventional
Allocation--
Masking--
Primary Purpose--
ConditionsMajor Depressive Disorder
CountriesUnited States
Collaborators--
Timeline
Phase 2CompletedFinished
200920102011201220132014201520162017201820192020202120222023202420252026
First PostedAug 2008
Enrollment StartSep 2008
Primary CompletionJul 2009
TodayJul 2026
First PostedAug 22, 2008
Enrollment StartSep 1, 2008
Primary CompletionJul 1, 2009
TodayJul 2, 2026
Enrollment to primary: 10 monthsPosted 17.9 years ago
Interventions
CX157 (TriRima)drug
Six capsules administered three times a day for six weeks.
Placebodrug
Six capsules administered three times a day for six weeks.