Approval Probability
TA Base Rate
Adjusted LOA
ML Risk
Vortioxetine · 2 trials · 5 indications
This measures the least square mean change in baseline-to-end point on z-score on the combined DSST. Depicted is the least square (LS) mean \[standard error of mean (SEM)\] change in DSST z-scores from baseline to week 8 using an independent covariance matrix with time as a categorical variable, adjusted for the type of cognitive test (Pen/Paper versus Online CogState version). Larger least squares mean indicates a higher predicted or adjusted average outcome for that group or condition compared to others. In other words, if you have a higher least squares mean for a treatment group, it suggests that, after adjusting for the effects of other variables, that group tends to have a higher average outcome, indicating better performance. A least squares mean of 0 indicates that the groups has no difference in average outcome. There is no fixed maximum or minimum for LS Means. They are derived from the data and can, in principle, take any real value (positive, negative, or zero)
Change in cognition as measured by the objective assessments of cognition within the THINC-it tool. "THINC-it" is the name of the cognition tool and is not an acronym. The objective measurements that comprise the THINC-it tool include the Spotter task (Choice Reaction Time), Symbol Check task(1-back test),Trails task(Trails Making Test B), and Codebreaker task (Digit Symbol Substitution Test). The composite score from all four tests were converted to standard z-score. Higher z-scores indicate better cognition. A z-score of zero indicates population mean.
| Arm | Type | Description |
|---|---|---|
| Vortioxetine | EXPERIMENTAL | Participants aged 18-64 years: start at 10 mg vortioxetine once daily for the first 2 weeks, then dosed up to 20 mg vortioxetine once daily for weeks 2-8. Participants aged 65+ years: start at 5 mg vortioxetine once daily for the first 2 weeks, then dosed up to 10 mg vortioxetine once daily for weeks 2-8. |
| Placebo | PLACEBO_COMPARATOR | Placebo capsule taken once daily for weeks 0-8. |
| Major Depressive Disorder Population | EXPERIMENTAL | 100 Individuals with DSM-5-defined MDD, aged 18-65 All participants receiving vortioxetine for a total of 8 weeks. Participants will receive10 mg/day on days 1-14 of the study treatment period, with the option to increase to vortioxetine 20 mg/day at the end of Week 2 based on physician's judgment. For the remaining 6 weeks, the dose of vortioxetine will be flexible at 10 or 20 mg/day as decided by a research doctor. Patients will receive the THINC-it over 3 time frame periods. The THINC-it comprised of: Spotter, Symbol Check, Codebreaker, Trails, and PDQ-5-D. |
| Healthy Control Population | OTHER | 50 Healthy Controls (18-65 years of age) matched on sex, age, and years of education |
| Name | Type | Description |
|---|---|---|
| Vortioxetine | DRUG | Participants aged 18-64 years receiving vortioxetine will be provided 10 mg/day on days 1-14 of the treatment period, and will be titrated to 20 mg/day at the start of week 3 (day 15) based on study clinician judgment. For the remaining 6 weeks, the dose of vortioxetine will be 20 mg/day, unless adjudicated otherwise by a study clinician. Per product monograph, participants aged 65+ years receiving vortioxetine will be provided 5 mg/day on days 1-14 of the treatment period, and will be titrated to 10 mg/day at the start of week 3 (day 15) based on study clinician judgment. For the remaining 6 weeks, the dose of vortioxetine will be 10 mg/day, unless adjudicated otherwise by a study clinician. |
| Placebo | DRUG | A placebo pill will be taken once daily. |
| THINC-it Tool | OTHER | Digitalized cognitive test application administering the following cognitive test components: Digit Symbol Substitution Test (DSST) Choice Reaction Time (CRT) One-back working memory tool Trail Making Test B (TMT-B) Perceived Deficits Questionnaire-5 Depression (PDQ-5-D) |
Inclusion Criteria * Age 18+ * Meets WHO-defined post-COVID-19 condition (WHO definition: 'Post COVID-19 condition occurs in individuals with a history of probable or confirmed SARS-CoV-2 infection, usually 3 months from the onset of COVID-19 with symptoms that last for at least 2 months and cannot...
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Vortioxetine is a small molecule being studied for Major Depressive Disorder and Post-COVID-19 Condition. In Major Depressive Disorder, it is being evaluated for its effects on cognitive change. In Post-COVID-19 Condition, it is being studied for cognitive impairment associated with the condition.
Cognition Therapeutics, Inc. (CGTX) is developing Vortioxetine. The company is conducting clinical trials to evaluate the drug for psychiatric and cognitive indications.
Vortioxetine is in Phase 2 clinical development. It is an investigational drug and has not been approved by regulatory authorities. Two Phase 2 trials have been completed, one in Major Depressive Disorder and one in Post-COVID-19 Condition.
Vortioxetine has been studied in two completed Phase 2 trials. NCT03053362 evaluated Vortioxetine in Major Depressive Disorder with cognitive change, enrolling 158 participants in Canada. NCT05047952 evaluated Vortioxetine in Post-COVID-19 Condition with cognitive impairment, enrolling 149 participants in Canada.
Vortioxetine is a distinct small molecule being investigated by Cognition Therapeutics. It is being studied specifically for cognitive symptoms in Major Depressive Disorder and Post-COVID-19 Condition, differentiating it from other depression treatments that may not target cognitive impairment.