Adults 18 to 55, male only, with Healthy. Patients with the condition only — healthy volunteers not accepted.
Results — posted to ClinicalTrials.gov
Per-arm endpoint measurements with 95% confidence intervals where reported. Source: trial results section.
Paired Associate Learning (PAL) Total Errors Adjusted (PALTEA28) on KetaminePrimary· At 4:20 and 5:06 hours:minutes after first drug administration in each treatment period.
Paired Associate Learning (PAL) assesses visual memory and new learning. Boxes are displayed on the screen and open in turn to reveal a number of patterns. Participants are instructed to try to remember the location in which each pattern was shown. After all the boxes have been opened, each pattern is then shown in the center of the screen in a randomised order, and the participant touches the box in which the pattern was located. If an error is made, all the patterns are re-presented to remind the participant of their locations.
The PALTEA28 evaluates the number of errors committed by the su
Group
Value
95% CI
Placebo (R)
24.169
± 2.5972
25 mg BI 425809 (T3)
23.829
± 3.2275
50 mg BI 409306 (T2)
28.170
± 3.2334
300 mg Lamotrigine (T1)
22.911
± 3.0850
Spatial Working Memory (SWM) Between Errors (BE468) on KetamineSecondary· At 4:20 and 5:06 hours:minutes after first drug administration in each treatment period.
SWM assesses the ability of the participant to retain spatial information and manipulate it in working memory. A number of coloured boxes are presented on the screen, and the computer hides a token in these boxes one at a time. The participant is instructed to touch the boxes in turn to search for the token that has been hidden. The key task instruction is that the computer will never hide a token in the same coloured box twice in the same problem.
The SWMBE468 evaluates the number of times the subject incorrectly revisits a box in which a token has previously been found. Calculated across al
Group
Value
95% CI
Placebo (R)
15.684
± 1.3412
25mg BI 425809 (T3)
16.032
± 1.5427
50mg BI 409306 (T2)
14.600
± 1.5704
300 mg Lamotrigine (T1)
12.826
± 1.5005
Rapid Visual Information Processing A' Prime (RVPA) on KetamineSecondary· At 4:20 and 5:06 hours:minutes after first drug administration in each treatment period.
Rapid Visual Information Processing (RVP) is a sensitive measure of sustained attention, outputting measures of response accuracy, target sensitivity and reaction times.
The RVPA is a quantitative measure for a subject's sensitivity to the target sequence regardless of response tendency. The RVPA ranges from 0.00 to 1.00. The higher the RVPA value, the better the sensitivity to the target sequence one has.
Group
Value
95% CI
Placebo (R)
0.8743
± 0.00702
25mg BI 425809 (T3)
0.8796
± 0.00807
50mg BI 409306 (T2)
0.8800
± 0.00810
300 mg Lamotrigine (T1)
0.9075
± 0.00782
Adverse events — posted to ClinicalTrials.gov
Time frame: From intake of first study drug (00:00h planned time) up to Day 11 (03:00h planned time); Residual Effect Period (REP) of 11 days was used for each study treatment..
Reporting threshold: 5%.
Adverse-event reports describe events observed during the trial — not all are caused by the drug.
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.
Publications & conference data
1 peer-reviewed publication reference this trial (live from Europe PMC):
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Publications: Europe PMC API search by NCT ID, retrieved 10 June 2026
Drug + disease cross-links: matched in real time against Drug Landscape's normalised drug + company + condition tables
Sponsor: as reported to ClinicalTrials.gov by Boehringer Ingelheim
Last refreshed: 12 March 2024
Drug Landscape aggregates and links these public records for informational use only. Always verify against the primary source before clinical or regulatory decisions. Canonical URL: https://druglandscape.com/trial/NCT04602221.