Development of new chemical entities (NCEs) for the treatment of psychiatric disorders can be challenging, with many compounds in clinical development failing across the phases of development. Numerous challenges to successful clinical trials in psychiatry include poor understanding of the biological substrates, high placebo response rates, patient heterogeneity within a psychiatric diagnosis, and inter-rater reliability with symptom-based assessments and clinical endpoints. These challenges have led to many Sponsors incorporating novel pharmacodynamic (PD) measures to supplement traditional assessment measures of behavior and cognition that include methods such as electrophysiology and imaging.
To improve success, particularly in Phase I and II trials, Apex has leveraged the NIMH Research Domain Criteria (RDoC)-like strategy with many novel molecules. Apex has worked directly with Sponsors and various academic key opinion leaders (KOLs) in adapting novel paradigms using both electrophysiology and neuroimaging that measure phenotypic domains associated with various psychiatric disorders.
Having conducted over 1,000 psychiatry studies, Apex is a widely recognized leader in psychiatric research. With inpatient and outpatient capabilities, we conduct studies across all major psychiatric disorder populations. Our team includes board certified psychiatrists, licensed psychologists, and psychiatric pharmacists with decades of experience in clinical research. Our investigators and scientific leaders – extensively published in peer-reviewed psychiatric journals – are adept at providing pharmaceutical companies with strategic direction for study design and program planning from pre-IND to NDA.
- Attention Deficit Hyperactivity Disorder (ADHD)
- Binge Eating Disorder
- Bipolar Disorder
- Borderline Personality Disorder
- Generalized Anxiety Disorder (GAD)
- Major Depressive Disorder (MDD), including Treatment-Resistant Depression (TRD)
- Obsessive-Compulsive Disorder (OCD)
- Post-traumatic Stress Disorder (PTSD)
- Postpartum Depression
- Social Anxiety Disorder (SAD)
Specialized Services and Capabilities
- Inpatient units with separate areas for healthy volunteers and patient populations
- Integration of complex pharmacodynamic (PD) assessments that may include neuroimaging and electrophysiology methods (standardized PD procedures across our Apex sites)
- Behavioral and Cognitive assessments
- Inclusion of psychiatric patient populations in early phase clinical development plans (e.g., Phase I SAD/MAD studies)
- Psychedelics and ketamine research
- Human abuse potential testing and driving simulation studies (commonly required for psychoactive substances)
Quality Clinical Raters
Our psychometric raters, most of whom have a Ph.D. or M.D., average almost 20 years of direct central nervous system-focused clinical experience and over 10 years of experience administering psychiatric rating scales typically used in clinical trials. Apex has a systemic approach to psychometric rater training – developed by our thought leaders in clinical rater assessment services – that all new raters are required to complete. Additionally, raters and site staff continuously receive industry-leading placebo response mitigation training.
We have an outstanding track record of success in the conduct of Phase I-IV trials across the central nervous system and internal medicine disorders.