Assessing cognitive function in bipolar disorder: challenges and recommendations for clinical trial design

Area of Science:

• Neuroscience
• Psychiatry
• Clinical Psychology

Background:

• Neurocognitive impairment is a recognized feature of schizophrenia.
• Significant neurocognitive deficits are increasingly recognized in bipolar disorder.
• Cognitive problems in bipolar disorder significantly impact quality of life, necessitating targeted interventions.

Purpose of the Study:

• To provide a preliminary guide for designing clinical trials focused on cognitive deficits in bipolar disorder.
• To highlight methodological challenges and propose solutions for future research.

Main Methods:

• A consensus panel of experts in bipolar disorder was convened.
• A literature review identified illness-specific challenges for neurocognitive trials.
• Expert opinion and consensus discussions informed the recommendations.

Main Results:

• Bipolar disorder clinical trials face unique design challenges due to heterogeneity, comorbidities, and polypharmacy.
• Recommendations include excluding certain comorbidities, restricting medications, and prescreening for cognitive impairment.
• These modifications aim to increase the likelihood of demonstrating cognitive remediation effects.

Conclusions:

• Distinctive design modifications are essential for clinical trials targeting cognitive deficits in bipolar disorder.
• Formalizing best practice guidelines is a critical next step for advancing the field.
• Addressing these challenges will improve the demonstration of cognitive remediation efficacy.