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The effects of vortioxetine versus placebo on cognitive functioning in mild cognitive impairment: a placebo-controlled, randomized, double-blind study
Matev V, Rothenberg M, Donath J, Cukaci C, Klöbl M, Al Barede K, Stöhrmann P, Dörl G et al.. medRxiv, 2025-12-11
Topic: Drug trials: efficacy and safety
In a recent open-label, single-arm study, vortioxetine, an antidepressant, was associated with improved cognitive function in patients with MCI, however, no placebo-controlled studies have been conducted to support these findings. Results LMM results showed a significant increase in VLMT test scores from baseline to week 12 in the 10 mg (p = 0.02) and 20 mg vortioxetine groups (p = 0.017). The placebo group showed a significant increase in test scores from baseline to week 4 (p = 0.009), followed by a significant decrease in test performance observed from week 4 to week 8 (p = 0.006). Both the vortioxetine and placebo groups showed statistically significant DSST test score changes over 12 weeks (10mg: p = 0.004; 20mg: p <.0001; placebo: p <.0001). Similarly, ADAS-Cog test performance significantly increased from baseline to week 12 in both the 10 mg vortioxetine group (p = 0.02) and the placebo group (p = 0.002). MMSE test results showed significant improvement over 8 weeks in the 20 mg vortioxetine group (p = 0.011), compared to no significant findings in the 10 mg and placebo groups. A significant improvement of QOLS scores was observed from week 8 to week 12 in the 10 mg vortioxetine group only (p = 0.033). Conclusion The results of this study indicate a potential treatment effect of vortioxetine on verbal learning and memory processes in patients with MCI.
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APA 7th
Matev, V., Rothenberg, M., Donath, J., Cukaci, C., Klöbl, M., Al Barede, K., et al. (2025). The effects of vortioxetine versus placebo on cognitive functioning in mild cognitive impairment: a placebo-controlled, randomized, double-blind study. medRxiv. https://doi.org/10.64898/2025.12.10.25341977
Vancouver
Matev V, Rothenberg M, Donath J, Cukaci C, Klöbl M, Al Barede K, et al. The effects of vortioxetine versus placebo on cognitive functioning in mild cognitive impairment: a placebo-controlled, randomized, double-blind study. medRxiv. 2025. doi:10.64898/2025.12.10.25341977.
BibTeX
@article{matev2025-d7d29632,
author = {Matev, V. and Rothenberg, M. and Donath, J. and Cukaci, C. and Klöbl, M. and Al Barede, K. and Stöhrmann, P. and Dörl, G. and others},
title = {{The effects of vortioxetine versus placebo on cognitive functioning in mild cognitive impairment: a placebo-controlled, randomized, double-blind study}},
journal = {medRxiv},
year = {2025},
doi = {10.64898/2025.12.10.25341977},
url = {https://doi.org/10.64898/2025.12.10.25341977}
}
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Key findings
- In a recent open-label, single-arm study, vortioxetine, an antidepressant, was associated with improved cognitive function in patients with MCI, however, no placebo-controlled studies have been conducted to support these findings.
- Results LMM results showed a significant increase in VLMT test scores from baseline to week 12 in the 10 mg (p = 0.02) and 20 mg vortioxetine groups (p = 0.017).
- The placebo group showed a significant increase in test scores from baseline to week 4 (p = 0.009), followed by a significant decrease in test performance observed from week 4 to week 8 (p = 0.006).
- Both the vortioxetine and placebo groups showed statistically significant DSST test score changes over 12 weeks (10mg: p = 0.004; 20mg: p <.0001; placebo: p <.0001).
- Similarly, ADAS-Cog test performance significantly increased from baseline to week 12 in both the 10 mg vortioxetine group (p = 0.02) and the placebo group (p = 0.002).
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Study details
- Study designrandomized controlled trial
- Evidence strengthHigh
How this study scored 16/100
Preprint — not yet peer-reviewed. It scored 47 on the same rubric, but non-peer-reviewed sources are capped at 16, so it shows as 16. Scored zero for sample size, effect reported and studied in people because the record does not state it. We have no data on times cited, citations per year, impact for its field and year, cited by studies here, still being cited, senior author's track record, institution's track record and multi-centre collaboration, so those were left out: it earned 29 of the 62 points we could judge it on, which is 47 out of 100.
| Component | Points | Why |
|---|---|---|
| Journal tier | 2 / 10 | Tier 4 — not a peer-reviewed journal (medRxiv) |
| Journal's citation record | 0 / 4 | Not a journal article, so the journal's record does not count |
| Study design | 11 / 12 | A randomised controlled trial |
| Strength of evidence | 5 / 5 | Rated “high” in our summary |
| Peer-review validation | 4 / 10 | Preprint — not yet peer-reviewed. Hosted on a preprint server. |
| How recent | 4 / 5 | 2025 — within 3 year(s) of the newest study here |
| Sample size | 0 / 4 | Participant count not stated — scores zero (not stated in the record — scored 0) |
| Effect reported | 0 / 3 | No effect size reported — scores zero (not stated in the record — scored 0) |
| Studied in people | 0 / 3 | Not stated whether this was studied in people — scores zero (not stated in the record — scored 0) |
| Randomised / blinded | 2 / 2 | Randomised and blinded or placebo-controlled (as stated in the record) |
| Times cited | — / 7 | No citation count (not found in OpenAlex) — left out of this score |
| Citations per year | — / 5 | No citation count or no year — left out of this score |
| Impact for its field and year | — / 6 | No field-weighted citation impact (OpenAlex has none yet) — left out of this score |
| Cited by studies here | — / 6 | Not yet checked against this library's citation graph — left out of this score |
| Still being cited | — / 4 | No yearly citation counts — left out of this score |
| Senior author's track record | — / 4 | Senior author's record not available — left out of this score |
| Institution's track record | — / 3 | No institution listed in OpenAlex — left out of this score |
| Multi-centre collaboration | — / 3 | Institutions not listed — left out of this score |
| Indexed in PubMed | 1 / 2 | Not in PubMed, but has a DOI |
| Free to read | 0 / 2 | Behind a paywall — scores zero |
| Points | 29 / 62 | Scored on 12 of 20 parts. We have no data for the rest, so they are left out: 29 of the 62 points we could judge it on is 47 out of 100. |
| Total | 47 / 100 | Capped to 16 because this is not a peer-reviewed article. |
What each of these 20 components measures, and what this score is not →
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