At a glance
ClinicalIndex Comparison RecordPhase 1Completed· 73 enrolled
Drug / intervention
BI 1358894 +2 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.
A Single Dose, Randomized, Placebo Controlled Phase I Study on the Effects of BI 1358894 on Functional MRI Measurements in an Emotional Processing Paradigm in Patients With Major Depressive Disorder
In Brief
A Phase 1 clinical trial evaluating BI 1358894, Placebo matching BI 1358894, and 1 other intervention for Depressive Disorder, Major. Completed, enrolled 73 participants across 1 site.
Detailed Summary
To assess the effect of a single dose of BI 1358894 compared to placebo on BOLD responses in modulating brain processing of emotional and cognitive stimuli on the amygdala and related brain structure using fMRI in in unmedicated patients with depression.
Study Details
Study Typeinterventional
Allocation--
Masking--
Primary Purpose--
ConditionsDepressive Disorder, Major
CountriesGermany
Collaborators--
Timeline
Phase 1CompletedFinished
20192020202120222023202420252026
First PostedFeb 2019
Enrollment StartMar 2019
Primary CompletionAug 2019
Study CompletionSep 2019
TodayJul 2026
First PostedFeb 26, 2019
Enrollment StartMar 12, 2019
Primary CompletionAug 27, 2019
Study CompletionSep 23, 2019
TodayJul 2, 2026
Enrollment to primary: 6 monthsPosted 7.4 years ago
Interventions
BI 1358894drug
Film-coated tablet
Placebo matching BI 1358894drug
Film-coated tablet
Citalopramdrug
Film-coated tablet