CI

At a glance

ClinicalIndex Comparison Record
Phase 3Completed· 412 enrolled
Drug / intervention
ASC-01 +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.

Search/NCT02046564
NCT02046564Phase 3Completed
CompareCT.gov

A Multicenter, Randomized, Double-blind Trial to Assess the Efficacy and Safety of ASC-01 in Patients With Major Depressive Disorder

Otsuka Pharmaceutical Co., Ltd.·interventional·Posted Jan 28, 2014·Updated May 21, 2018

In Brief

A Phase 3 clinical trial evaluating ASC-01 and Placebo for Major Depressive Disorder. Completed, enrolled 412 participants across 29 sites in 5 countries.

Detailed Summary

To evaluate the efficacy and the safety of ASC-01 (aripiprazole/sertraline combination) compared to sertraline monotherapy in patients with major depressive disorders who have responded incompletely to sertraline monotherapy.

Study Details

Study Typeinterventional
Allocation--
Masking--
Primary Purpose--
ConditionsMajor Depressive Disorder
CountriesAustralia, Japan, Malaysia, South Korea, Taiwan
Collaborators--

Timeline

Phase 3CompletedFinished
2014201520162017201820192020202120222023202420252026
First PostedJan 28, 2014
Enrollment StartFeb 1, 2014
Primary CompletionSep 1, 2016
TodayJul 2, 2026
Enrollment to primary: 2.6 yearsPosted 12.4 years ago

Interventions

ASC-01drug

Placebodrug