A Study in Healthy Men to Test Whether BI 409306, BI 425809 or Lamotrigine Can Reverse the Memory Problems Caused by Ketamine

This randomised, placebo-controlled, double-blind, double-dummy three-way crossover trial (n=40) aims to investigate the effect of BI 409306, BI 425809, and Lamotrigine on ketamine-induced cognitive deficits in healthy male subjects.

The study, conducted by Boehringer Ingelheim, seeks to understand whether BI 409306, BI 425809, or Lamotrigine can reverse the memory problems caused by ketamine. Healthy male subjects aged 18 to 55, with a BMI of 18.5 to 32 kg/m2, are eligible for participation. They must provide written informed consent and meet specific criteria regarding contraception and health status.

Participants will undergo a 3-treatment period design, with various sequences of Lamotrigine, BI 409306, BI 425809, and placebo administered. Primary outcome measures include Paired Associate Learning (PAL) Total Errors Adjusted (PALTEA28) on Ketamine, evaluated at specific time frames after drug administration. Secondary outcome measures include Spatial Working Memory (SWM) Between Errors (BE468) on Ketamine and Rapid Visual Information Processing A’ Prime (RVPA) on Ketamine.

The study is in Phase I and commenced on December 1, 2020, with completion on August 12, 2022. It’s conducted at locations in California and New Jersey, USA.

Topic Neurocognitive Disorders
Compound Ketamine
Country United States of America
Visit trial
Status Completed
Results Published Yes
Start date 01 December 2020
End date 12 August 2022
Phase Phase I
Design Blinded
Type Interventional
Generation Second
Participants 40
Sex Male
Age 18- 55
Therapy No

Trial Details

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.

NCT Number NCT04602221

Data attribution

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