Major Depressive Disorder Clinical Trial
Official title:
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
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.
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 Major Depressive Disorder (MDD) and experiencing a Major Depressive
Episode (MDE) who the investigator wishes to consider for enrollment in the study and who
provide written informed consent will initially be evaluated by the Inventory of Depressive
Symptomatology 30 item -Self Report (IDS-SR30) administered via Interactive Voice Response
System (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 Week 1, 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:
- CX157 60mg three times a day (TID) for a total daily dose of 180 mg, or
- Placebo administered three times a day.
Subjects who discontinue from the study for any reason will not be replaced.
;
Allocation: Randomized, Endpoint Classification: Safety/Efficacy Study, Intervention Model: Parallel Assignment, Masking: Double Blind (Subject, Caregiver, Investigator, Outcomes Assessor), Primary Purpose: Treatment
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