Efficacy and safety of iclepertin with cognitive training in schizophrenia
Author Information
Author(s): Harvey Philip D., McDonald Sean, Fu Eric, Reuteman-Fowler Corey
Primary Institution: University of Miami Miller School of Medicine
Hypothesis
The low-level cognitive stimulation provided by at-home CCT would augment the effects of iclepertin in treating the symptoms of CIAS in patients with schizophrenia on stable antipsychotic treatment.
Conclusion
Although efficacy was not demonstrated, the safety profile of iclepertin 10 mg was consistent with previous studies and no new risks were identified.
Supporting Evidence
- This trial is the largest of its kind combining daily pharmacotherapy for CIAS with at-home CCT.
- 154 out of 200 randomized patients completed the trial.
- 39% of patients in the iclepertin group reported adverse events, compared to 56% in the placebo group.
Takeaway
This study tested a new drug combined with brain training for people with schizophrenia, but it didn't show that the drug helped improve thinking skills.
Methodology
This was a double-blind, placebo-controlled, parallel-group Phase II trial with patients randomized to receive either iclepertin 10 mg or placebo for 12 weeks, alongside computerized cognitive training.
Potential Biases
The trial site selection was restricted to English and French speakers, which may limit generalizability.
Limitations
The study was exploratory and not powered to detect differences beyond the primary measure; high baseline scores on the VRFCAT may indicate a selection bias.
Participant Demographics
Of the 200 randomized patients, 136 (68.0%) were male, and 98 (49.0%) were white.
Statistical Information
P-Value
0.3101
Confidence Interval
(−2.6, 0.8)
Statistical Significance
p=0.3101
Digital Object Identifier (DOI)
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