A Phase III Long-Term Extension Trial with Optional Additional Doses of CYB003 to Assess the Safety and Long-term Efficacy in Participants with Major Depressive Disorder (EXTEND)

Conditions

Major Depressive Disorder

Brief summary

Time to first relapse from Baseline of EXTEND trial in participants who have had a stable response in either the APPROACH or EMBRACE trial

Detailed description

Percentage of participants who are either responders or non-responders in APPROACH or EMBRACE and require 2 additional doses of IP in EXTEND., Percentage of participants who are either responders or non-responders in APPROACH or EMBRACE and require 3 additional doses of IP in EXTEND., Percentage of participants with sustained response defined as absence of a relapse after administration of 2 doses of IP in APPROACH or EMBRACE to the endpoint of EXTEND with 1 increase in MADRS total score above 50% decrease in MADRS total score permitted., Percentage of participants with sustained remission defined as MADRS total score ≤10 after administration of 2 doses of IP in APPROACH or EMBRACE to the endpoint of EXTEND with 1 increase in MADRS total score >10 permitted., Percentage of responders and remitters to 2 doses of IP administered in EXTEND who later relapse., Change from Baseline to last visit in the total MADRS score in participants who did not respond to IP in APPROACH or EMBRACE

Related papers

No related papers found yet.

Interventions

DRUGCYB003

Eligibility

Sex/Gender

All

Age

18 Years to No maximum

Design outcomes

Primary

Measure	Time frame
Time to first relapse from Baseline of EXTEND trial in participants who have had a stable response in either the APPROACH or EMBRACE trial	—

Secondary

Measure	Time frame
Percentage of participants who are either responders or non-responders in APPROACH or EMBRACE and require 2 additional doses of IP in EXTEND., Percentage of participants who are either responders or non-responders in APPROACH or EMBRACE and require 3 additional doses of IP in EXTEND., Percentage of participants with sustained response defined as absence of a relapse after administration of 2 doses of IP in APPROACH or EMBRACE to the endpoint of EXTEND with 1 increase in MADRS total score above 50% decrease in MADRS total score permitted., Percentage of participants with sustained remission defined as MADRS total score ≤10 after administration of 2 doses of IP in APPROACH or EMBRACE to the endpoint of EXTEND with 1 increase in MADRS total score >10 permitted., Percentage of responders and remitters to 2 doses of IP administered in EXTEND who later relapse., Change from Baseline to last visit in the total MADRS score in participants who did not respond to IP in APPROACH or EMBRACE	—

Measure

Time frame

Percentage of participants who are either responders or non-responders in APPROACH or EMBRACE and require 2 additional doses of IP in EXTEND., Percentage of participants who are either responders or non-responders in APPROACH or EMBRACE and require 3 additional doses of IP in EXTEND., Percentage of participants with sustained response defined as absence of a relapse after administration of 2 doses of IP in APPROACH or EMBRACE to the endpoint of EXTEND with 1 increase in MADRS total score above 50% decrease in MADRS total score permitted., Percentage of participants with sustained remission defined as MADRS total score ≤10 after administration of 2 doses of IP in APPROACH or EMBRACE to the endpoint of EXTEND with 1 increase in MADRS total score >10 permitted., Percentage of responders and remitters to 2 doses of IP administered in EXTEND who later relapse., Change from Baseline to last visit in the total MADRS score in participants who did not respond to IP in APPROACH or EMBRACE

—

Countries

Germany, Greece, Ireland, Poland

Outcome results

None listed

A Phase III Long-Term Extension Trial with Optional Additional Doses of CYB003 to Assess the Safety and Long-term Efficacy in Participants with Major Depressive Disorder (EXTEND)