Mood Disorders

Disruptions in emotion, as well as impairments in cognition, are part of the daily struggle for individuals with mood disorders. Drug development teams are actively working to tackle these complex and interconnected symptoms.

Cogstate helps your team answer key drug development questions by providing highly sensitive and reliable digital cognitive tests, as well as tailored endpoint data quality programs for conventional assessments such as the MADRS, MINI, HAM-D, and HAM-A.

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Improve Strategic Study Design and Execution

The Cogstate team of clinical psychologists, neuropsychologists, data scientists, and statisticians have the expertise to advise your team on vital study considerations, help you answer key drug development questions, and reduce risk and uncertainty in your trial.

With access to thousands of cognitive data profiles—and from decades supporting drug development work—Cogstate can advise your team on endpoint selection, powering decisions, and interpretation of study results supportive of product efficacy, safety, and differentiating claims.

Implement Robust Endpoint Data Quality Programs

From helping you establish rater qualification criteria, to tailored certification pathways that credit the experience of expert raters, to central monitoring programs that target clinician reviews where they’re needed most, Cogstate supports all aspects of rater training and endpoint data quality programs. Studies benefit from our global network of 200 highly trained expert clinicians who provide assessment support in 40+ languages.

Cogstate also supports Central Rating administration for common mood disorder scales (MADRS, MINI, HAM-D, C-SSRS). In this approach, a Cogstate team of highly qualified raters administer scales via telehealth (video or phone), increasing data accuracy and supporting patient centric trial design.

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Leverage Sensitive and Reliable Digital Tests 

Cogstate digital tests provide valid and reliable measurement of distinct domains of cognition and enable you to capture a complete and nuanced picture of a subject’s cognitive state.

Cogstate tests are culture- and education-neutral and designed for repeated administration with minimal practice or learning effects, making them ideal for use in global clinical trials. Normative data is available for both clinical samples and healthy controls. Study teams can choose the tests that best suit their research questions. Each test has been used in drug trials.

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Sample Mood Disorder Battery

The tests included are a sample battery. Final battery recommendations vary based on study needs.

Cogstate Tests:• Detection (Psychomotor Function)
• Identification (Attention)
• One Back (Working Memory)
• One Card Learning (Visual Learning)
• International Digit Symbol Substitution (Processing Speed)
Length:Approx 20 minutes
(depending on the number of tests included in the battery)
Administration:Standardized
Data Processing and Scoring:Automated
Application:Phase I-IV
Culture and Language Neutral:Yes

Case Examples of Cogstate Mood Disorder Solutions in Action

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.)

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