Ashleigh Williams from Lakeland Clinical Trials where some of the trials will be taking place. Photo / Ben Fraser
Ashleigh Williams from Lakeland Clinical Trials where some of the trials will be taking place. Photo / Ben Fraser
A "first-class" antidepressant using a slow release of ketamine is now being trialled in Rotorua and Tauranga.
Ketamine is mainly used for starting and maintaining anaesthesia but can be used for pain. It was developed in 2016 as an antidepressant. Clinical trials started the following year.
New Zealand company DouglasPharmaceuticals enlisted Dr Mike Williams to lead the trials in Tauranga and Rotorua.
The Lakeland Clinical Trials director of Rotorua will work with Dr Caleb Armstrong, director of Anteris Clinical Research in Tauranga.
Dr Mike Williams from Lakeland Clinical Trials. Photo / Supplied
"Some people might be on an antidepressant but they are still getting significant symptoms. They might have had a couple of tries of medications, and sometimes it's hard to find the right fit, the right medicine for the right person," Williams told NZME.
"This clinical trial has been another option for their treatment."
He said intravenous or a nasal spray were options, but a slow-release tablet made the most "clinical sense".
Williams has been involved in clinical research for 20 years and has helped develop medicines for diabetes, cholesterol and osteoarthritis.
Working in mental health and with a New Zealand company is new for him.
"Usually we work with people in the United States. And it's quite cool to have a Zealand company. We've visited them and have a really close relationship."
The slow-release ketamine antidepressant which has been given the name R107 for the trial. Photo / Supplied
Williams said the New Zealand partnership, fitting the "support local" movement, was only possible because of Covid-19.
"It has affected a lot of medication development, as companies have been busy fighting the Covid response.
"It's good to actually be in New Zealand, where we have patients that are relatively free to move in the community, and able to see us easily."
Williams said the trial would keep him and his team busy until the end of next year.
Three sites in Auckland, Dunedin and Christchurch have been trialling the drug since 2017, Douglas Pharmaceuticals chief scientific officer Dr Peter Surman said. However because of Covid-19, regional sites are now a focus.
"Our sites in Australia and Asia are slowed by movement restrictions because of Covid-19. It makes a lot of sense to open additional sites in New Zealand where, thankfully, it is essentially virus-free."
Douglas Pharmaceuticals chief scientific officer Dr Peter Surman. Photo / Supplied
The drug, named R107, would be a rapidly acting antidepressant for patients suffering treatment-resistant depression, which occurs in about 30 per cent of patients, Surman said. or at least 50,000 people in New Zealand.
"So far, we have treated around 120 patients with R107 and within one week of daily open-label treatment [information is not withheld from trial participants] about 75 per cent have become well.
"This is a higher rate than we expected to see based on previous ketamine studies. The response appears to be durable with most patients electing to enter a six-month maintenance phase where they are treated with R107 for a further six months."
Treatment-resistant depression occurs commonly in up to 30 per cent of the treated major depressive disorder patient population, Surman said.
If studies continue to be positive, Surman hoped the treatment would be in the market from 2024.
"Side effects are being monitored and reviewed as part of the clinical programme by an independent drug safety monitoring board.
"Some patients experience some dissociation, feeling spaced out the first time but this generally resolves on repeated dosing."
Registered clinical psychologist Jacquie Maguire said new medications trials were never a bad thing.
"I think as an industry, whether that be pharmaceutical or the psychological community, it's really important we continue to investigate. Because there is a portion of the population that are really struggling and they hope that new products will come out, they might make a difference."
Endogenous pervasive depression, or "biological depression" not caused by stress and trauma, leadd to many needing medications, she said.
"If we've got a severe mental illness the gold standard would be a combination of pharmacological and psychological treatment."
She said if someone suffered from diabetes and did not take insulin, it would be "dire". It was exactly the same with mental illness, she said.
"If you have a genetic predisposition, if you have a biological component to your mental illness, there is no shame or stigma in having pharmacological support.
"If you are so depressed that you can't reach baseline, it's very difficult to engage with a psychologist or psychotherapy. So it's almost like you need to get your body, your hormones in check, to be in a space to benefit from the psychological intervention."
How to get involved:
If you are between 18 and 81, have major depressive disorder and have not responded to at least two prescribed antidepressants you may qualify.
Contact either Lakeland Clinical Trials or Douglas Pharmaceuticals.
