Esketamine Trial – A Success Story in Patient Recruitment

Written by Chan Wei Quan, Site Manager at Janssen

 

Of all the illnesses out there today, which one would you say is the leading cause of disability around the globe? The answer may surprise you.

It’s depression, which affects more than 15 million adults in the U.S. and more than 300 million worldwide, according to the World Health Organization (WHO). It can cause the affected person to suffer greatly and function poorly at work, at school and in the family. At its worst, depression can lead to suicide. Close to 800 000 people die due to suicide every year.

All existing antidepressants work on the same premise by increasing the brain levels of serotonin and/or norepinephrine—neurotransmitters. However, only about half of the patients receive an adequate response from them, which typically takes four to eight weeks or longer for someone to start feeling better. When you are that depressed and possibly on the point of contemplating suicide, 4 to 8 weeks is a long time….

Janssen is studying a compound that works more quickly to alleviate the symptoms of depression. Just google “Esketamine”. Janssen has received a breakthrough designation from the FDA for its potential use in people with treatment-resistant depression and in those who are suicidal.

In Malaysia, there are five centers participating in the Esketamine trial. Today’s highlight would be the success story from one of the centers, Hospital Kuala Lumpur (HKL), which was led by Dr Hjh Salina Abd Aziz and her team. Janssen approached HKL in the year of 2015 as a potential site for the Esketamine trial. Considering the complexity of the trial and the site resource, Dr Salina was hesitating on the numbers of patients that HKL could enroll in the study. In the end, HKL decided to commit to 3 subjects within a 6 months’ of recruitment timeline. HKL psychiatry department was new to multicentre clinical trials. However, with the combined effort from Clinical Research Malaysia (CRM), Janssen and Dr Tan Lee Khing, one of the main sub-investigators, their journey to becoming one of the best recruiting sites in Malaysia began as they took the lead to recruit the very first patient at site. Unfortunately, the response from the first patient was not favorable, which in turn shook the confidence of the team towards Esketamine.

In spite of the disappointing start of this trial, the spirit of the team to get more patients was not defeated as more evidence was needed on whether Esketamine will still be beneficial. With the help from the medical officers in the Psychiatry Department, another patient was referred to Dr Tan for the trial. This patient responded well to Esketamine, and the patient’s condition showed significant improvement. This patient’s testimonial was shared to other participating centers during a local investigator meeting.

Meanwhile, due to rapid recruitment of the trial globally, study recruitment timeline was shortened from 2 months to 1 week out of a sudden. This hurdle was not a barrier for with teamwork from. Dr Salina and her team who fully utilized the one week period to enroll 3 more patients. Kai Sin, the pharmacist, identified potential patients based on the prescription slips and, Ikram the study coordinator identified patients from the advertisement published on nationwide newspaper. Our investigators, Dr Razak, Dr Nurzurian and Dr Riana, spent their invaluable time to screen the patients on top of their copious routine work.

With proper management, coordination and cooperation between the study team members, HKL managed to recruit 3 more patients, making it a total of 6 patients in the trial, which doubled the digit of our initial commitment. In short, they exceeded their recruitment target in a short period.

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How did they achieve this in such challenging timelines? The answer lies within their great teamwork and time management that is exemplary and commendable. It was challenging but we are inspired and impressed by the potential and teamwork that the HKL Psychiatry team has shown. Special thanks for HKL and encouragement as they are one of the newer clinical trial sites compared to other psychiatry departments/hospitals who have been running clinical trials for more than 10 years. Their efforts will help continue to put Malaysia on the map on being a country that has clinical trial talent and potential.

Country commitment would not be able to achieve with just one single site. Sincere thanks to University Malaya Medical Centre lead by Prof Dr Ahmad Hatim and his team, Hospital Permai lead by Dr Abdul Kadir and his team, Hospital Bahagia Ulu Kinta lead by Dato’ Dr Suarn and his team and the Royal College of Medicine, Perak lead by Dr Esther and her team, for making the Esketamine program a success in Malaysia.

New drug development cannot be achieved without clinical trials and patient participation. The number of patients required in each trial is used to support statistical analysis and study sites which can recruit the number of subjects committed and help contribute towards the success of the drug development process. Every site that achieves or exceeds the patient target planned, helps put the country in a favorable light for more trials to Malaysia.

Lastly, Husseini Manji, M.D., Global Therapeutic Area Head for Neuroscience, Janssen Research & Development said: “At the same time, when people learn that depression can be treated effectively, I believe the attitude toward mental illness will change. My hope is that diseases of the mind will someday be viewed like any other illness—no stigma, no shame, just support and sympathy.”