Primary care providers spend much of their workday trying to help patients with depression. What many clinicians do not realize, however, is that an estimated two-thirds of patients have a suboptimal response to antidepressants.
These patients—and those with several other conditions, ranging from HIV to Alzheimer’s disease—may benefit from medical foods, a growing trend in medicine. As more companies bring such products to market, health care providers are gradually incorporating them into their day-to-day practice.
These products are not traditional drugs, and yet they are stronger than vitamins and dietary supplements. They are regulated under the FDA’s Orphan Drug program. Consumers can use them only if they have a prescription.
Nurse practitioners and physician assistants can prescribe medical foods, just as they can most drugs. “We clinicians need more and more tools to help our patients,” says Rakesh Jain, MD, MPH, a psychiatrist in Lake Jackson, Texas. “If this will bring someone out of a depression sooner, of course I’m going to use it.”
“It Certainly Can’t Hurt”
Recent research has shown that patients with depression who experience persistent symptoms may have insufficient levels of folate in the brain. For patients who have not achieved sufficient response to antidepressants, Jain, Director of Psychiatric Drug Research at R/D Clinical Research Center in Lake Jackson, often prescribes a product called Deplin®, made by Louisiana-based Pamlab.
Deplin, described as an augmentation to depression treatment, is a trimonoamine modulator. Its active ingredient, L-methylfolate, is the only active form of folate that can cross the blood-brain barrier, and regulates the synthesis of serotonin, norepinephrine, and dopamine. Deplin essentially helps to boost levels of folate in a patient’s brain; the folate, in turn, helps to activate the neurotransmitters in the brain that are associated with mood.
Studies have demonstrated that when folate levels rise, patients start to feel better within a few weeks or months. That’s because their brain is able to access the benefits of their antidepressant medication more effectively.
“If I’m sitting in front of a patient who is suffering at work and suffering at home, I will try Deplin,” Jain says. “The data do predict they will have a better response.” And since patients have not reported any adverse effects, it certainly can’t hurt to try it, he adds.
Sometimes patients wonder if they can just eat more green vegetables, such as spinach. But Jain says these patients’ folate deficits are so great that they would have to eat bags and bags of spinach every day to make up for it. Instead, Deplin offers a highly concentrated dose of the ingredient.
Details about Deplin and its effect in patients with depression can be found at www.deplin.com.
An “Elegantly Simple” Approach to Alzheimer’s
In the Rocky Mountains of Colorado, a Broomfield-based company, Accera, focuses on medical foods for central nervous system disorders, such as Alzheimer’s disease and Parkinson’s disease. Clinical studies show their new medical food product, Axona™, can significantly improve cognitive functioning and memory in patients with mild to moderate Alzheimer’s disease.
Scientists who developed the product knew that one cause of Alzheimer’s disease is the brain’s reduced ability to properly metabolize glucose. The resulting glucose deficits lead to symptoms such as memory loss.
As the body digests Axona, it causes the liver to produce extra ketones, compounds that occur naturally in the body. In a brain with insufficient glucose, ketones provide an “alternative energy source” that helps the brain continue to function despite the deficit.
Accera CEO Steve Orndorff, PhD, and company cofounder Sam Henderson, PhD, both had a personal interest in finding better therapies for Alzheimer’s disease: They both had seen parents and grandparents develop the condition and try to live with it. “We saw the need firsthand,” Orndorff says.
Henderson, who was conducting research on the genetics of aging at the University of Colorado at Boulder, showed Orndorff data from several NIH studies that showed ketones have a neuroprotective effect. “He thought if we give patients these medium-chain triglycerides, the body will produce ketones and it will basically rescue those cells from the hypometabolism of glucose,” Orndorff explains. “It’s an elegantly simple approach to the disease.”
If the brain is allowed to function with a deficient amount of glucose, Orndorff adds, neurons begin to die—and memory loss begins. That is why the ketones are so essential for prevention of this form of dementia.
The two scientists formed their company in 2001 and brought Axona to the market in March 2009. A clinical trial of their product yielded very positive results. Patients who took Axona (in the form of a sweet drink packet) had a sevenfold improvement on cognitive function tests. By comparison, Orndorff says, patients using Alzheimer’s disease drugs currently on the market tend to experience about a 2.7-fold improvement. “We were more than double the efficacy of those drugs,” he explains.