Clinical Scorecard: Looking Beyond Symptoms in Psychiatric Drug Development

At a Glance

Key Highlights

• Psychiatric R&D has expanded from reliance on symptom clusters and clinical observations to include tools for investigating underlying biology, according to Tanya Wallace, PhD.
• EEG assessments are used preclinically and in early clinical studies to compare effects across settings; receptor occupancy imaging is used to assess whether investigational drugs reach intended brain targets and can support dose selection.
• Resting-state fMRI is being explored to assess drug effects on neuronal networks, while task-based fMRI may help assess modulation of circuits associated with psychiatric symptoms.
• Computational and multimodal approaches, including fluid biomarkers, EEG, imaging, and clinical diagnosis, are being explored to characterize patient heterogeneity and potential disease subcategories.
• Wallace notes that some patients with depression may have an immunometabolic profile, including elevated inflammatory cytokines and other inflammatory biomarkers, which could help define a subpopulation for study.

Guideline-Based Recommendations

Diagnosis

• The interview describes symptom-based diagnosis as essential to recognition and treatment, while noting that it provides limited visibility into underlying biology.
• Multimodal data, including fluid biomarkers, EEG, imaging, and clinical diagnosis, are being explored to characterize patient heterogeneity.

Management

• The interview discusses EEG and imaging as tools in psychiatric drug research and development, not as clinical treatment recommendations.
• Receptor occupancy imaging has been used in drug development to assess whether investigational drugs reach intended brain targets and can support dose selection.

Monitoring & Follow-up

• EEG assessments may be conducted preclinically and carried into early clinical studies to compare observed effects across settings.
• Receptor occupancy imaging is used to assess brain target engagement; the source does not describe combining it with plasma biomarker measurements.

Risks

• The interview describes the brain as difficult to access directly and notes the historical reliance on symptom-based diagnoses, subjective ratings, and observational assessments.
• The source excerpt does not discuss whether peripheral biomarker changes represent brain biology or recommend cross-validation; remove this claim unless supported by additional source text.

Patient & Prescribing Data

No prescribing population or treatment regimen is specified. The interview discusses psychiatric drug development, potential patient subgroups, and studies that may include healthy volunteers or patients.

No specific medicine, dose, or prescribing recommendation is provided. Translational assessments are discussed as tools for evaluating mechanisms, target engagement, and patient biology during drug development.

Clinical Best Practices

• The interview describes carrying EEG assessments from preclinical studies into early clinical studies to compare observed effects across settings.
• The interview describes receptor occupancy imaging as a way to assess whether investigational drugs reach intended brain targets and as a potential aid to dose selection.
• The interview describes multimodal data and computational approaches as being explored to investigate patient heterogeneity and potential biological subgroups.

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