At a glance
ClinicalIndex Comparison RecordPhase 1Completed· 40 enrolled
Drug / intervention
Lamotrigine +3 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 Randomized, Placebo Controlled, Double-blind, Double-dummy Three-way Cross Over Trial to Investigate the Effect of BI 409306, BI 425809 and Lamotrigine on Ketamine-induced Cognitive Deficits in Healthy Male Subjects
In Brief
A Phase 1 clinical trial evaluating Lamotrigine, BI 409306, and 2 other interventions for Healthy. Completed, enrolled 40 participants across 2 sites.
Detailed Summary
The main objective of this trail is to investigate if and to what extent BI 409306, BI 425809 and lamotrigine attenuate ketamine induced cognitive deficits.
Study Details
Study Typeinterventional
Allocation--
Masking--
Primary Purpose--
ConditionsHealthy
CountriesUnited States
Collaborators--
Timeline
Phase 1CompletedFinished
202120222023202420252026
First PostedOct 2020
Enrollment StartDec 2020
Primary CompletionAug 2022
Study CompletionAug 2022
TodayJul 2026
First PostedOct 26, 2020
Enrollment StartDec 1, 2020
Primary CompletionAug 1, 2022
Study CompletionAug 12, 2022
TodayJul 2, 2026
Enrollment to primary: 1.7 yearsPosted 5.7 years ago
Interventions
Lamotriginedrug
Tablet
BI 409306drug
Film-coated tablet
Placebodrug
Tablet, Film-coated tablet
BI 425809drug
Film-coated tablet