Trial · NCT04602221
A Study in Healthy Men to Test Whether BI 409306, BI 425809 or Lamotrigine Can Reverse the Memory Problems Caused by Ketamine
NCT04602221, Phase 1, Completed, Boehringer Ingelheim; results first posted 2024-03-12
3 sourcestrials-2026-11-12-0.5.0
Cite this record
ConductScience Library. A Study in Healthy Men to Test Whether BI 409306, BI 425809 or Lamotrigine Can Reverse the Memory Problems Caused by Ketamine. Trials, record NCT04602221. Release trials-2026-11-12-0.5.0, 12 Nov 2026. https://conductscience.org/library/trials/NCT04602221
On this page
Trial
As registered on ClinicalTrials.gov, in the graph's capture of the registry.
- Title
- A Study in Healthy Men to Test Whether BI 409306, BI 425809 or Lamotrigine Can Reverse the Memory Problems Caused by Ketamine
- NCT number
- NCT04602221
- Status
- Completed
- Phases
- Phase 1
- Enrollment
- 40 participants, actual
- Lead sponsor
- Boehringer Ingelheim
- Conditions
- Healthy
- Interventions
- Lamotrigine, BI 409306, Placebo, BI 425809
- First posted
- 2020-10-26
- Last updated
- 2024-03-12
- Results first posted
- 2024-03-12
Source ClinicalTrials.gov
Registered outcomes3
Each outcome the trial registered, primary first, in ClinicalTrials.gov's words.
| List | Outcome | Time frame | Description |
|---|---|---|---|
| Primary | Paired Associate Learning (PAL) Total Errors Adjusted (PALTEA28) on Ketamine | 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 subject plus an adjustment for the estimated number of errors they would have made on any stages that were not reached. Calculated across all assessed two, four, six and eight box trials. |
| Secondary | Spatial Working Memory (SWM) Between Errors (BE468) on Ketamine | 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 all assessed four, six and eight token trials. |
| Secondary | Rapid Visual Information Processing A' Prime (RVPA) on Ketamine | 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. |
Source ClinicalTrials.gov
Outcomes3
Each outcome the trial posted results for, in ClinicalTrials.gov's words.
| Type | Outcome | Time frame | Population | Units | Measured as |
|---|---|---|---|---|---|
| PRIMARY | Paired Associate Learning (PAL) Total Errors Adjusted (PALTEA28) on Ketamine | At 4:20 and 5:06 hours:minutes after first drug administration in each treatment period. | Pharmacodynamic (PD) set (PDS): PD analyses were based on the PDS which was defined as all randomised subjects who performed the post ketamine tests in at least one period. Number of participants differs due to incomplete crossover design. | Errors | LEAST_SQUARES_MEAN |
| SECONDARY | Spatial Working Memory (SWM) Between Errors (BE468) on Ketamine | At 4:20 and 5:06 hours:minutes after first drug administration in each treatment period. | Pharmacodynamic (PD) set (PDS): PD analyses were based on the PDS which was defined as all randomised subjects who performed the post ketamine tests in at least one period. Number of participants differs due to incomplete crossover design. | Errors | LEAST_SQUARES_MEAN |
| SECONDARY | Rapid Visual Information Processing A' Prime (RVPA) on Ketamine | At 4:20 and 5:06 hours:minutes after first drug administration in each treatment period. | Pharmacodynamic (PD) set (PDS): PD analyses were based on the PDS which was defined as all randomised subjects who performed the post ketamine tests in at least one period. Number of participants differs due to incomplete crossover design. | Score on a scale | LEAST_SQUARES_MEAN |
Source ClinicalTrials.gov
Results by group12
Each measurement the trial posted, group by group, in the words and numbers it posted.
| Outcome | Group | Category | Value | Spread | Units |
|---|---|---|---|---|---|
| Paired Associate Learning (PAL) Total Errors Adjusted (PALTEA28) on Ketamine | Placebo (R) | 24.169 | Standard Error 2.5972 | Errors | |
| Paired Associate Learning (PAL) Total Errors Adjusted (PALTEA28) on Ketamine | 25 mg BI 425809 (T3) | 23.829 | Standard Error 3.2275 | Errors | |
| Paired Associate Learning (PAL) Total Errors Adjusted (PALTEA28) on Ketamine | 50 mg BI 409306 (T2) | 28.170 | Standard Error 3.2334 | Errors | |
| Paired Associate Learning (PAL) Total Errors Adjusted (PALTEA28) on Ketamine | 300 mg Lamotrigine (T1) | 22.911 | Standard Error 3.0850 | Errors | |
| Spatial Working Memory (SWM) Between Errors (BE468) on Ketamine | Placebo (R) | 15.684 | Standard Error 1.3412 | Errors | |
| Spatial Working Memory (SWM) Between Errors (BE468) on Ketamine | 25mg BI 425809 (T3) | 16.032 | Standard Error 1.5427 | Errors | |
| Spatial Working Memory (SWM) Between Errors (BE468) on Ketamine | 50mg BI 409306 (T2) | 14.600 | Standard Error 1.5704 | Errors | |
| Spatial Working Memory (SWM) Between Errors (BE468) on Ketamine | 300 mg Lamotrigine (T1) | 12.826 | Standard Error 1.5005 | Errors | |
| Rapid Visual Information Processing A' Prime (RVPA) on Ketamine | Placebo (R) | 0.8743 | Standard Error 0.00702 | Score on a scale | |
| Rapid Visual Information Processing A' Prime (RVPA) on Ketamine | 25mg BI 425809 (T3) | 0.8796 | Standard Error 0.00807 | Score on a scale |
1 to 10 of 12Source ClinicalTrials.gov
See all 12 results by groupParticipant flow54
How many started, completed or left each group, period by period.
| Period | Milestone | Group | Participants | Units counted |
|---|---|---|---|---|
| Overall Study | STARTED | Treatment Sequence: R-T3-T2 | 3 | |
| Overall Study | STARTED | Treatment Sequence: R-T3-T1 | 2 | |
| Overall Study | STARTED | Treatment Sequence: R-T2-T3 | 2 | |
| Overall Study | STARTED | Treatment Sequence: R-T2-T1 | 2 | |
| Overall Study | STARTED | Treatment Sequence: R-T1-T3 | 2 | |
| Overall Study | STARTED | Treatment Sequence: R-T1-T2 | 2 | |
| Overall Study | STARTED | Treatment Sequence: T3-R-T2 | 2 | |
| Overall Study | STARTED | Treatment Sequence: T3-R-T1 | 2 | |
| Overall Study | STARTED | Treatment Sequence: T3-T2-R | 2 | |
| Overall Study | STARTED | Treatment Sequence: T3-T1-R | 2 |
1 to 10 of 54Source ClinicalTrials.gov
See all 54 participant flowAdverse events20
Each adverse event the trial posted, group by group: the participants affected out of those at risk.
| Type | Event | Organ system | Group | Affected | At risk | Events |
|---|---|---|---|---|---|---|
| other | Nausea | Gastrointestinal disorders | Placebo (R) | 2 | 37 | |
| other | Nausea | Gastrointestinal disorders | 25mg BI 425809 (T3) | 4 | 24 | |
| other | Nausea | Gastrointestinal disorders | 50mg BI 409306 (T2) | 4 | 25 | |
| other | Nausea | Gastrointestinal disorders | 300 mg Lamotrigine (T1) | 1 | 26 | |
| other | Vomiting | Gastrointestinal disorders | Placebo (R) | 3 | 37 | |
| other | Vomiting | Gastrointestinal disorders | 25mg BI 425809 (T3) | 2 | 24 | |
| other | Vomiting | Gastrointestinal disorders | 50mg BI 409306 (T2) | 3 | 25 | |
| other | Vomiting | Gastrointestinal disorders | 300 mg Lamotrigine (T1) | 1 | 26 | |
| other | Diarrhoea | Gastrointestinal disorders | Placebo (R) | 2 | 37 | |
| other | Diarrhoea | Gastrointestinal disorders | 25mg BI 425809 (T3) | 0 | 24 |
1 to 10 of 20Source ClinicalTrials.gov
See all 20 adverse eventsAdverse event totals12
The totals the trial posted for each group.
| Total | Group | Affected | At risk |
|---|---|---|---|
| Total, all-cause mortality | Placebo (R) | 0 | 37 |
| Total, all-cause mortality | 25mg BI 425809 (T3) | 0 | 24 |
| Total, all-cause mortality | 50mg BI 409306 (T2) | 0 | 25 |
| Total, all-cause mortality | 300 mg Lamotrigine (T1) | 0 | 26 |
| Total, other adverse events | Placebo (R) | 10 | 37 |
| Total, other adverse events | 25mg BI 425809 (T3) | 5 | 24 |
| Total, other adverse events | 50mg BI 409306 (T2) | 5 | 25 |
| Total, other adverse events | 300 mg Lamotrigine (T1) | 2 | 26 |
| Total, serious adverse events | Placebo (R) | 0 | 37 |
| Total, serious adverse events | 25mg BI 425809 (T3) | 0 | 24 |
1 to 10 of 12Source ClinicalTrials.gov
See all 12 adverse event totalsPapers0
The papers the trial lists on ClinicalTrials.gov.
None in this release.
Grants0
The grants NIH RePORTER links to the trial, newest funded first: NIH's, and some of AHRQ's, CDC's, FDA's and VA's. Each shows its title, principal investigators, organization and funder in its newest year.
None in this release.
Trial comparisons0
Comparisons of the trial's two groups, calculated by ConductScience from the counts it posted.
None in this release.
Tests2
The ConductCognition tests this trial's registered outcomes name, as ScienceGraph matched them in trial-tests-2026-11-12-0.2.1.
| Test | Named as | Source |
|---|---|---|
| Paired Associate Learning | Primary outcome | ConductCognition |
| Rapid Visual Information Processing | Secondary outcome | ConductCognition |
Data dates
The day each source was copied for this release.
Sources 3
- ClinicalTrials.gov's posted results, through CTTI's AACTFreely available. Acknowledgement requested
- ClinicalTrials.govNo license stated
- NIH RePORTER's clinical studies and project filesPublic domain
Each source's terms
- ClinicalTrials.gov's posted results, through CTTI's AACTClinicalTrials.gov data via Aggregate Analysis of ClinicalTrials.gov (AACT), CTTI. CTTI makes its materials freely available and requests acknowledgement. https://aact.ctti-clinicaltrials.org/documentation/299
- ClinicalTrials.govnone stated
- NIH RePORTER's clinical studies and project filesPublic domain (NIH RePORTER)
ClinicalTrials.gov's data carry an international copyright outside the United States: https://clinicaltrials.gov/about-site/terms-conditions.
For software
Read this trial from software.
The record and each of its lists are JSON, twenty rows a page. No key.
GET https://conductscience.org/api/trials/v1/NCT04602221
GET https://conductscience.org/api/trials/v1/NCT04602221/flow?page=2