Eligibility Module
The Eligibility Module contains detailed information about who can participate in the clinical trial. This includes eligibility criteria, age restrictions, gender requirements, healthy volunteer status, and study population descriptions, helping researchers understand who is eligible to participate in the study.
Eligibility Module path is as follows:
Study -> Protocol Section -> Eligibility Module
Eligibility Module
Ignite Creation Date:
2025-12-24 @ 4:08 PM
Ignite Modification Date:
2025-12-24 @ 4:08 PM
NCT ID:
NCT01360866
Eligibility Criteria:
Inclusion Criteria:
* Male and Female outpatients 18-65 years of age
Eligible subjects from Trials 331-10-227, 331-10-228 or 331-12-282:
* Subjects who completed participation in the Double-blind Randomization Phase (i.e. Week 14 visit) in Trial 331-10-227, Trial 331-10-228, or Trial 331-12-282 or
* Subjects who met criteria for a response, but did not meet criteria for remission at Week 14 of either trial
Eligible subjects from other Phase 3, Double-blind, Brexpiprazole MDD trials:
• Subjects who completed the last scheduled visit of the prior Double-blind Randomized Phase 3 trial.
Exclusion Criteria:
* Females who are breast-feeding and/or who have a positive pregnancy test result prior to receiving OPC-34712.
* Subjects with a major protocol violation during the course of their participation in the Double-blind Randomization Phase
Healthy Volunteers:
False
Sex:
ALL
Minimum Age:
18 Years
Maximum Age:
65 Years
Study:
NCT01360866
Study Brief:
Protocol Section:
NCT01360866