Therapeutic Expertise
Psychiatry
Discover how our expert team ensures data quality in complex psychiatric scenarios. We specialise in clinical trials that consider unique assessments and minimise biases.
Mental health clinical trials pose challenges from multiple perspectives. A CRO must ensure it has the requisite skills to recruit the correct population, minimise placebo effects, standardise (subjective) rating scales, and ensure patient safety.
We help design studies that consider the unique nature of psychiatric assessments, which often rely on patient-reported outcomes and observer ratings. Strategies to minimise placebo effect and neurobehavioural biases are built into all our mental health trials, and our team ensures data quality using expert psychiatric evaluators and advanced data capture technologies.
Addressing common pain points in psychiatry clinical trials
Subjectivity of assessments
Many psychiatric symptoms are self-reported, leading to potential biases and variability in data.
We develop and implement objective biomarkers, such as advanced imaging and blood-based diagnostics, to reduce reliance on subjective self-reports and improve accuracy.
Heterogeneity of disorders
There's often a wide range of symptoms within a single diagnosis, making it challenging to assess treatment effects across a broad patient population.
We employ advanced patient stratification techniques to identify specific subtypes, allowing targeted interventions and more meaningful clinical outcomes.
Placebo effect
Psychiatric trials frequently experience strong placebo responses, making it difficult to demonstrate the true efficacy of an investigational treatment.
We use adaptive designs that allow real-time modifications based on interim data, improving the ability to detect genuine treatment responses.
Recruitment challenges
Psychiatric studies often face recruitment and retention difficulties due to stigma, symptom severity, or concerns about experimental treatments.
We collaborate with patient advocacy groups, integrate digital recruitment, and offer decentralised trial options to improve accessibility and retention.
Ethical concerns
Balancing the risks and benefits of psychiatric trials — particularly for vulnerable populations or novel therapies — can be complex.
We work closely with ethics committees and implement patient-centric methodologies to protect participant wellbeing while facilitating scientific progress.
Resources
Psychiatry clinical trial resources
ADHD
Bridging the past and future of treatment strategies — from pivotal endpoints to trial success.
Bipolar Disorder
Epidemiology, clinical implications, and strategies for clinical trial success.
Schizophrenia
Evolving insights into schizophrenia diagnosis and treatments.
Binge Eating Disorder
Optimising clinical trial design for binge eating disorder.
Panic Disorder
Insights into panic disorder trial design, from FDA approvals to improved protocols.
Evidence & insights
Psychiatry white papers
Open-access reports from our physicians and data science teams — free, no sign-in.
Generalized Anxiety Disorder - Clinical Endpoints, FDA Approvals, and Trial Enhancements
White paper · PDF ↗Understanding ADHD Clinical Trials
White paper · PDF ↗Optimizing Clinical Trial Design for Binge Eating Disorder
White paper · PDF ↗Critical Endpoints in Bipolar Disorder Research
White paper · PDF ↗Major Depressive Disorder - An Alarmingly High Failure Rate of Efficacy Endpoints in Clinical Trials
White paper · PDF ↗Enhancing Success in Panic Disorder Clinical Trials
White paper · PDF ↗Frequently asked questions
Psychiatry clinical trials — FAQs
How does iNGENū improve endpoint reliability in psychiatry trials?
Which psychiatric indications does iNGENū cover?
Is Australian psychiatry trial data accepted by the FDA?
The iNGENū CRO difference
Australian expertise, direct FDA submission
We uniquely combine Australian expertise with direct FDA submission capabilities, offering a streamlined path for sponsors to achieve global approval. Trial data from Australia can be submitted directly to the FDA via our E-Gateway, eliminating the need for third-party intermediaries.
iNGENū takes a highly strategic and disciplined approach to clinical research, ensuring every dollar is directed toward generating meaningful outcomes — eliminating unnecessary costs while maintaining the highest scientific and regulatory standards across the Asia-Pacific region.
“We have been using iNGENū for a Phase 1, first-in-human trial of our investigational drug — medical writing, project management, clinical data management and full end-to-end execution and monitoring. We have been particularly impressed by the out-of-the-box creative solutions to speed up and reduce overheads during this clinical trial.”
Giles MossChief Executive Officer
Ready to discuss your Psychiatry clinical trial?
Talk to our team about how iNGENū CRO can accelerate your research.
Request a proposal