5 posts tagged “clinical research”

Can ketamine help when antidepressants don’t? A closer look at the off-label drug that’s in the spotlight

Posted May 21st, 2018 by

You may have seen ketamine making headlines recently as a promising drug therapy for treatment-resistant depression, or “TRD.” (What’s TRD? Health care professionals define it as receiving at least two different antidepressants– for at least six weeks in a row, and at an adequate dosage – but experiencing less than a 50% improvement in depressive symptoms.)

So, how does it work and what does the research show so far? Get the facts below — plus find some helpful insight on side effects and more from PatientsLikeMe members who have tried ketamine.

Let’s back up — what is ketamine?

Ketamine has been around since the 1960s, and over the years it has been used as an anesthetic, treatment for some types of pain and a sedative in certain instances. It’s also been abused as a “party drug” due to its hallucinogenic high. But in the 2000s, researchers discovered that ketamine could also have rapid antidepressant effects — in as little as 24 hours — for those with TRD when administered in a small, single dose IV infusion.

A number of clinical trials have since linked the effects of ketamine with improvement in symptoms of major depressive disorder (MDD), as researchers continue to find the optimal dose and the best administration routes (like potentially a nasal spray). Ketamine continues to be studied further in other mood disorders like PTSD and OCD with a focus on its long-term safety.

How does ketamine work?

Researchers are still figuring out the specifics, but the drug seems to affect receptors in the brain, including two called NMDA and AMPA:

  • Ketamine stimulates the AMPA receptor, which increases levels of the protein BDNF (brain-derived neurotrophic factor). This protein helps form new neurons and synapses in the brain, which is thought to improve certain mood conditions such as MDD.
  • Ketamine also blocks the NMDA receptor, which in turn causes an increase in glutamate levels (glutamate is an important neurotransmitter in the brain) and results in a cascade of positive neurobiological changes.
  • Both of these pathways and possibly others that still aren’t fully understood are related to the way ketamine works as an antidepressant.

The research looks promising…

There are currently several ongoing clinical trials involving ketamine and MDD and PTSD — and here’s a breakdown of what other recent research has found:

  • One Cochrane review looked at 25 randomized controlled trials involving ketamine’s effects on brain receptors in people with severe depression. It found that while other antidepressants can take 6 to 8 weeks to become effective, ketamine may offer rapid effects in comparison to a placebo. The authors noted that the initial studies are small and there’s uncertainty about how long ketamine’s effects last.
  • Another 2016 study of 14 patients with TRD found that after 3 weeks of twice-weekly ketamine infusions, 7 (50%) experienced remission from suicidal thoughts. Two of these 7 people maintained remission for 3 months.
  • There isn’t quite as much data about the use of ketamine to treat PTSD, but one trial that has been published showed a significant reduction in PTSD symptoms.

The patient perspective: Real-world reviews of ketamine

  • “I am currently receiving IV racemic ketamine once every 2-2.5 weeks at a 0.5mg/kg dose,” says one PatientsLikeMe member. “I haven’t been successful at spacing treatments further out than once every three weeks and 2-2.5 weeks seems to be the sweet spot for me, and I don’t have significant crashes.”
  • Another member says, “Ketamine has saved my life. After failing so many medication trials and ECT, I thought I had run out of options. I am so lucky to be able to access this treatment.”
  • “I am currently receiving IV ketamine 0.5mg/kg every other week in an outpatient setting,” says one member. “I am feeling very well, probably better than I ever have in my life. Ketamine has been a game changer for me.”

Ketamine’s long-term effectiveness

Despite positive findings on ketamine’s rapid effectiveness, researchers are unsure if the antidepressant effects are sustained beyond two weeks and what the consequences of relapse are. Take one PatientsLikeMe member’s experience:

“I received ketamine as part of a clinical trial. Within 24 hours I felt like ‘myself’ again and was able to experience pleasure and internalize positive experiences. The effects lasted about 9 days and then all my previous symptoms returned.”

Side effects, cost, and other things to consider

Ketamine is currently only FDA-approved for surgical anesthesia, so it must be prescribed off-label (not for its intended use). And because it’s off label, it must be administered by a specialty clinic, which means it may not be covered by insurance and can come with a hefty price tag at $400-$800 per infusion. Learn more about available clinical trials here (and be sure to talk to your doctor before changing anything about your treatment regimen).

And what about side effects? In short, more data and research is needed. But here’s what other members who have tried ketamine for MDD have said:

  • “The worst side effect is nausea, but I receive ondansetron before the infusion and that helps significantly. I have only had one ‘bad trip’ or ‘K-hole’ while getting the infusion, but it quickly subsided.”
  • “I have found that during an infusion, external stimuli intensifies and I can get quickly overwhelmed. To avoid this, I always wear headphones and have music that is very familiar to me playing, and I typically have my eyes closed for much of the time. This also mitigates most of the perceptual disturbances that might occur during an infusion. I am a person who does not like feeling out of control, so I limit my exposure to external stimuli and that helps significantly.”

Have you tried ketamine or been involved in a ketamine clinical study? Join or sign in to PatientsLikeMe to jump in the conversation today.

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PatientsLikeMe and inVentiv Health Partner to Accelerate Clinical Trial Research

Posted June 17th, 2013 by

First Agreement Between the Online Patient Network and Global Clinical Research Organization Promises to Help Speed Recruitment for Drug Development 

BURLINGTON, MASS.  June 17, 2013 — inVentiv Health, offering best-in-class clinical, commercial and consulting services, today announced a partnership with the innovative online patient network PatientsLikeMe to bring more people more quickly into medical research and clinical trials.

This is the first such agreement between the global patient recruitment organization for inVentiv Health Clinical and PatientsLikeMe, whose 200,000 members share information and experiences on more than 1,500 different diseases and conditions. PatientsLikeMe members, already interested in the development of new treatments, can now become even more active in medical research by accessing information on clinical trials conducted by inVentiv’s pharmaceutical customers.

”inVentiv Health will be able to quickly recruit potential trial participants by tapping into one of the fastest growing and most active patient networks online, so that our customers can speed up the development of drugs, devices and treatments to improve patients’ lives,” said Raymond Hill, President of inVentiv Health Clinical.

PatientsLikeMe members share their experiences so that they can learn more about disease, help others, and contribute data to real-time healthcare research.

“We’ve pioneered a way for people to learn from, share and contribute health data, and removed traditional barriers between researchers and patients,” said Michael Evers, Executive Vice President of Marketing and Patient Advocacy at PatientsLikeMe. “inVentiv Health is a critical partner who shares our goal of streamlining research to quickly get better treatments to the people who need them.”

This agreement is the second recent announcement of a novel partnership focused on accelerating clinical trials.  In March, inVentiv announced that it had taken an equity stake in Mytrus, which has been expanding the boundaries of traditional clinical trial research with technology that allows trial sponsors to use electronic informed consent, a significant improvement in efficiency and speed.  The company expects to make a third announcement of a major technology partnership within the next few weeks.

About PatientsLikeMe
PatientsLikeMe is a patient network that improves lives and a real-time research platform that advances medicine. Through the network, patients connect with others who have the same disease or condition and track and share their own experiences. In the process, they generate data about the real-world nature of disease that help researchers, pharmaceutical companies, regulators, providers and nonprofits develop more effective products, services and care. PatientsLikeMe is a trusted source for real-world disease information and a clinically robust resource that has published more than 30 peer-reviewed research studies. Visit us at www.patientslikeme.com or follow us on our blog, on Twitter or via Facebook.

 

About inVentiv Health
inVentiv Health, Inc. is a leading global provider of best-in-class clinical, commercial and consulting services to companies seeking to accelerate performance. inVentiv offers convergent services that deliver extraordinary outcomes to clients whose goal is improving human life. In 40 countries around the world, inVentiv’s [13,000] employees help clients rapidly transform promising ideas into commercial reality. inVentiv clients include more than 550 pharmaceutical, biotech and life sciences companies, as well as companies that now see health as part of their mission. inVentiv Health, Inc. is privately owned by inVentiv Group Holdings, Inc., an organization sponsored by affiliates of Thomas H. Lee Partners, L.P., Liberty Lane Partners and members of the inVentiv management team. For more information, visit http://www.inventivhealth.com.

 

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