The clinical team running a phase 2 drug trial in a mood disorder needed a solution to help mitigate the impact of placebo effect and ensure high quality endpoint data capture for complex and subjective scales. Cogstate was brought in to provide rater training and central rating for the Montgomery–Åsberg Depression Rating Scale (MADRS). Using a central rating approach, the MADRS scale was administered remotely via telehealth by a small, targeted group of highly trained Cogstate clinicians, thus decreasing the levels of rater variance introduced to the trial. MADRS scores improved with the level of change from baseline found to be clinically significant, favoring the drug over placebo.
Case Examples of Cogstate Mood Disorder Solutions in Action
Ph2 Mood Disorder Trial Leverages Central Rating Approach | Results Showed Improvements in MADRS Scores from Drug vs Placebo
Cognitive Safety Data Utilized in Making Dosing Decisions for Postpartum Depression Drug
A pharmaceutical team developing a drug for the treatment of postpartum depression needed to determine safe doses of the compound in their early phase studies. As part of their evaluation, the team utilized a battery of Cogstate digital cognitive tests in the trial and noted that lower drug doses did not result in any slowing of cognition, whereas higher doses saw some slowing of thinking. Based on this data and information about the drug characteristics, the team selected the dose ultimately shown to be effective in the clinical population and that was approved by the regulatory authority for use in the treatment of postpartum depression.
Phase 1 crossover study of intranasal esketamine and REMS
Cogstate supported the Phase 1, 2-period crossover study of intranasal esketamine to evaluate any potential cognitive effects from the administration of the therapeutic candidate. Subjects were tested using a Cogstate battery of digital assessments multiple times in short succession including at -1 hours, 40 minutes, 2 hours, 4 hours, and 6 hours after dosing. At 40-minutes post-dose there was a significant difference in cognition from placebo, and at 2-hours post-dose no significant difference in cognition was found between groups. This cognitive safety data contributed to the Risk Evaluation and Mitigation Strategy (REMS) of intranasal esketamine. (Bahr, R., et al., Pharmacy and Therapeutics, 2019: PMCID: PMC6534172)
Phase 3 studies of esketamine and FDA safety decision making
Cogstate supported the phase 3 esketamine program that consisted of 5 clinical trials and included 1,700 adults. Given the drug mechanism of action, the pharma team used Cogstate digital tests as part of their research to ensure treatment was safe for use in both the short and long-term. Data gathered via our digital cognitive assessments contributed to the FDA’s decision-making regarding safety in clinical practice and overall risk-benefit evaluation. (Wajs E, et al, j Clin Psychiatry, 2020, doi 10.4088/JCP.19m12891, PMID: 32316080.)
