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Pioneering drug study at KU Wichita Center for Clinical Research seeks to improve livelihood of patients with depression

November 07, 2018

Dr. Matthew Macaluso talks to research participant, Center for Clinical Research

Matthew Macaluso, D.O., talks to patient Trish Rink, who is taking part in research that may lead to relief from depression.

By Joe Stumpe

Trish Rink remembers well how depression robbed her of the life she wanted to lead. Coming home from her job, she lost the desire to participate in any of the usual things her husband and children were doing.

"I would come home and just go to bed," she said. "I was absolutely exhausted all the time. I just didn't feel like doing anything."

The Goddard woman took medication for her depression. But as millions of other depression sufferers have discovered, drugs currently on the market either didn't work or quickly lost their effectiveness in combating the disease.

Now Rink and Matthew Macaluso, D.O., of KU School of Medicine-Wichita are taking part in research that may lead to relief from depression for some people. Rink is a subject in a study of a new experimental drug, while Macaluso is one of the principle investigators.

Nearly every week for the past four years, Rink has come to the KU Wichita Psychiatry & Behavioral Sciences Clinic to be dosed with a "novel mechanism of action" drug, as Macaluso describes it. And it's eliminated her depression in a way no other drug did before. Or as Rink says, "I have felt like myself. I don't ever want to go back to where I was."

Major depression disorder affects about 16.1 million Americans, or 6.7 percent of the population, each year, making it the leading cause of disability for people aged 15 to 44.3, according to the Anxiety and Depression Association of America. While depression can strike at any age, the median age for onset is 32.5 years, which is near Rink's age when she first experienced it. Women are more likely than men to suffer.

Rink's depression set in after a 2001 event she "just never recovered from," but prefers not to discuss publicly. Although the depression lifted for months at a time, she never really felt out of its grip and always feared, correctly, that it would return. One time it always seemed to visit was in the fall, when the weather changed and her children returned to school.

Physicians who treated Rink prescribed different medications but, she said, "I was allergic to a lot of them and just didn't have success with them."

In 2014, Rink's sister, who's a health care professional, told her about an experimental drug study that Macaluso was spearheading at the clinic. Macaluso examined Rink, listened to her case history and decided she qualified for the study.

Rink said she began benefiting from the experimental drug almost immediately, continued to avoid depression and never suffered any side effects, aside from one short period when her sleep wasn't good. The medication "just keeps me steady," she said. "I don't have ups and downs."

In addition to administering the drug, Macaluso would ask her a series of questions designed to gauge her emotional well-being during each visit to the clinic. The experiment also required that Rink undergo an EKG and full physical with blood work four times a year to ensure her safety.

Macaluso, an associate professor, director of the residency program in the Department of Psychiatry & Behavioral Sciences and assistant dean of research, is a board-certified psychiatrist who completed additional training in psychopharmacology research and clinical trials. Focusing primarily on treatment-resistant major depression, he's had a decade of continuous funding and completed studies for pharmaceutical companies, private foundations and the National Institute for Mental Health.

Macaluso said that in the largest study of depression to date, involving thousands of patients, it was found that 39 percent of patients were still symptomatic after four rounds of medication.

"Clearly we need new and better medications to help patients suffering from depression, which is a devastating disease that impacts their ability to function in life."

Success isn't always guaranteed in experimental studies, any more than it is in traditional medical practice, he noted.

"In clinical practice, a physician makes a judgment about what treatment is best for a patient. In a clinical trial, a physician makes a judgment about whether a trial is appropriate (for a particular patient). Once prescribed, a physician must follow a protocol."

Rink is glad the protocol eliminated her depression, calling Macaluso and the rest of the clinic staff "just awesome" to work with. As she nears the end of her participation in the study - she can continue to receive the medication free of charge - Rink says she's back to enjoying yardwork and being with her family.

"I love going to their activities. I'm the mom and wife I want to be to them."

KU School of Medicine-Wichita
Last modified: Nov 08, 2018
Media Inquiries:

Belinda Venters
316-293-3536
bventers@kumc.edu

KU School of Medicine–Wichita
Public Affairs
1010 N. Kansas
Wichita, KS, 67214

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