drugset / Trial / NCT04602221
A Study in Healthy Men to Test Whether BI 409306, BI 425809 or Lamotrigine Can Reverse the Memory Problems Caused by Ketamine
RandomizedCrossoverTriple-blindTreatment
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.
Timeline
- Start
- 2020-12-01
- Primary completion
- 2022-08-01
- Completion
- 2022-08-12
Outcome
Missed primary endpoint
registry analysis (other test); Placebo (R) vs 25 mg BI 425809 (T3); p = 0.9296; Difference of adjusted means -0.339 (95% CI -7.975 to 7.297); ANCOVA NCT04602221 ↗
registry analysis (other test); Placebo (R) vs 50 mg BI 409306 (T2); p = 0.2990; Difference of adjusted means 4.002 (95% CI -3.631 to 11.634); ANCOVA NCT04602221 ↗
registry analysis (other test); Placebo (R) vs 300 mg Lamotrigine (T1); p = 0.7322; Difference of adjusted means -1.258 (95% CI -8.565 to 6.050); ANCOVA NCT04602221 ↗
Drugs
| Evaluation | Drug | Modality | Dose | Route |
|---|---|---|---|---|
| Subject | BI 425809 | Unknown | — | — |
| Subject | Lamotrigine | Small molecule | — | — |
| Subject | OSORESNONTRINE | Small molecule | — | — |
Indications
No indication recorded.