A Phase II, 6-week, Multicenter, Randomized, Double Blind (Patient and Investigator) or Masked, Placebo Controlled, Dose-finding Trial to Evaluate the Efficacy, Tolerability, and Safety of Different Doses of Oral BI 1569912 as Adjunctive Therapy in MD
Overview
- Phase
- Phase 2
- Intervention
- BI 1569912
- Conditions
- Depressive Disorder, Major
- Sponsor
- Boehringer Ingelheim
- Enrollment
- 84
- Locations
- 53
- Primary Endpoint
- Change from baseline in Montgomery-Åsberg Depression Rating Scale (MADRS) total score at Week 6
- Status
- Completed
- Last Updated
- last year
Overview
Brief Summary
This study is open to adults between 18 and 65 with a type of depression (major depressive disorder) for whom previous treatments for depression did not work. The purpose of the study is to find out whether a medicine called BI 1569912 helps people with depression.
Participants continue their standard therapy throughout the study.
Participants are put into 4 groups by chance. 3 of the 4 groups take different doses of BI 1569912. 1 group takes placebo. Placebo tablets looks like BI 1569912 but do not contain any medicine. Participants take the tablets once a day for 6 weeks.
Participants are in the study for about 2 to 4 and a half months. During this time, they visit the study site at least 6 times. At the visits, doctors ask participants about their symptoms.
The participants answer questions about their depression symptoms. The results are compared between the groups. The doctors also regularly check the general health of participants.
Investigators
Eligibility Criteria
Inclusion Criteria
- Not provided
Exclusion Criteria
- Not provided
Arms & Interventions
BI 1569912 low dose group
Intervention: BI 1569912
BI 1569912 medium dose group
Intervention: BI 1569912
BI 1569912 high dose group
Intervention: BI 1569912
Placebo group
Intervention: Placebo
Outcomes
Primary Outcomes
Change from baseline in Montgomery-Åsberg Depression Rating Scale (MADRS) total score at Week 6
Time Frame: at baseline, at week 6
The MADRS evaluates core symptoms of depression. It is a clinician-rated measure of depression severity and consists of 10 items. MADRS items are rated on a 0-6 continuum (0 = no abnormality, 6 = severe). The possible total score could range from 0 to 60 - from normal with absence of symptoms to severe depression.
Secondary Outcomes
- Change from baseline in MADRS total score at Day 8(at baseline, at day 8)
- Response defined as ≥50% MADRS reduction from baseline at Day 8(at baseline, at day 8)
- Response defined as ≥50% MADRS reduction from baseline at Week 6(at baseline, at week 6)
- Remission defined as MADRS total score ≤10 at Week 6(up to 6 weeks)
- Change from baseline in Symptoms of Major Depressive Disorder Scale (SMDDS) total score at Day 8(at baseline, at day 8)
- Change from baseline in SMDDS total score at Week 4(at baseline, at week 4)