Our approach and expertise
At Parexel, we are committed to understanding the journey through our patients’ eyes. Living with psychiatric disorders can be isolating, frustrating, and sometimes traumatic, and many people have suffered without diagnosis for years. Therefore, recruitment programs, site selection, and trial design for psychiatry clinical trials must be strategically and sensitively crafted – and endpoints scrupulously protected – to attract and retain these participants and deliver on expectations.
Close alliances with patient advocacy groups enable us to understand the needs of patients and caregivers and how to reduce their burden, and to raise awareness of opportunities and educate stakeholders about psychiatry clinical trials. We ensure quality and consistency of study endpoints through proactive and carefully coordinated study oversight, data surveillance, and quality management.
Toward that end, Parexel has attracted some of the world’s most preeminent leaders in neuroscience to support you in developing treatments for psychiatric disorders, across every phase of the development lifecycle. Our board-certified psychiatrists (including pediatric psychiatrists) work in collaboration with biostatisticians and regulatory experts. Our experience includes the use of novel treatments targeting serious unmet medical needs, such as negative and cognitive symptoms in schizophrenia, treatment-resistant depression, and studies in both acutely ill and stable patient populations. In addition, Parexel’s expertise includes eating disorders; neurodevelopment disorders (ADHD, autism); post-traumatic stress disorder (PTSD); and personality disorders.
We have deep expertise in placebo response mitigation, precision psychiatry medicine, psychedelics, cognitive battery testing, medication adherence solutions, central rating by independent rater, off-site monitoring of raters, and psychotropics lab-screening levels.
Mood disorders
Major depressive disorder (MDD), treatment-resistant depression, and bipolar disorder are highly active areas of clinical research at Parexel, as innovative treatments are bringing relief to patients suffering from these debilitating conditions. These include dopamine receptor agonists, hydroxytryptamine receptor modulators, and serotonin and norepinephrine reuptake inhibitors, just as a few examples.
One of our more challenging projects involved delivery of a placebo-controlled Phase II/III and rollover trial for adults with MDD in Japan, involving more than 1,000 patients and 150 sites. Strict protocol inclusion and exclusion criteria included 9 scales. Conducted during the COVID-19 pandemic, the trial faced a high dropout rate and delays in rater certification. Despite these obstacles, we achieved last-patient-in 17 days ahead of target and database lock two months earlier than scheduled. Success was attributed to our strong site relationships with a high enrollment database of patients, as well as a placebo response training, eligibility checklist, and a strong prescreening questionnaire.
In the past five years, we have conducted over 60 studies in mood disorders, including major depressive disorder, treatment-resistant depression, bipolar disorder/mania, anxiety, and post-partum depression in all phases of research.
Drug addiction and substance abuse
Drug addiction has far-reaching impacts on communities and families as well as the individuals affected. Many struggle with relapses, withdrawal, and overdoses, and some with stabilizing their lives after incarceration. The emergence of novel treatments for treating opioid use disorder, as well as nicotine and alcohol addiction, is bringing relief to people worldwide. Parexel has deep experience in this area, covering opioid kappa receptor antagonists, tumor necrosis factor alpha agonists, neuronal nicotinic receptor agonists, and more.
We believe that site engagement is central to delivering these studies, as demonstrated by a Phase IIIB trial we conducted in Australia, involving 120 patients and six sites. In this case, ensuring that patients adhered to study visits in-clinic and on time was critical. The study was conducted at busy teaching hospitals with resource limitations. Yet Parexel succeeded in 17% higher enrollment than originally projected and a low attrition rate. We achieved last-patient-in within five months, a full month earlier than projected.
In the past five years, we have conducted 16 studies for addiction in regions across the globe, involving more than 5,000 patients and 120 sites.
Schizophrenia
Our experience has revealed that schizophrenia patients and their families want better treatment options with fewer undesirable side effects. As such, they are often willing to participate in a clinical trial as a meaningful way to achieve this objective for themselves and others. Parexel is at the forefront of many of the recent advances in treatment of schizophrenia, working on therapeutic classes including dopamine receptor agonists, glycine transporter inhibitors, phosphodiesterase inhibitors, opioid receptor antagonists, and more.
Our Los Angeles Early Phase Unit has enrolled approximately 210 healthy volunteers and 120 schizophrenia patients across multiple studies (in Phase I-IIb studies with compounds intended for use in the treatment of schizophrenia, schizoaffective disorder, or cognitive impairment associated with schizophrenia). Specialized assessments include cognitive and psychomotor function tests, patient-reported outcomes, and clinical rating scales. Our capabilities encompass advanced neuroimaging and cerebral spine fluid sampling, including single via lumbar puncture and continuous via catheter.
Over the past five years, we have conducted more than 20 studies for schizophrenia involving more than 1,900 patients (including in-patient trials), 96 sites, and 20 countries.