Charles Bowden, M.D., professor and former chairman of the Department of Psychiatry, is principal investigator of the bipolar study.
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SAN ANTONIO – The University of Texas Health Science Center at San Antonio is leading a large, multicenter clinical research study comparing two oral medication regimens for persons with bipolar disorder. Also known as manic-depressive illness, this disorder affects about 5.7 million American adults, or about 2.6 percent of the population age 18 and older in any given year, according to the National Institute of Mental Health (NIMH).

The Department of Psychiatry study, which will randomly assign 735 participants nationwide to two treatment groups, will test whether giving a combination of the medication aripiprazole with a second medication, lamotrigine, is more effective at reducing the number and severity of manic and depressive episodes than giving lamotrigine and placebo alone.

First phase to stabilize symptoms
According to the study inclusion criteria, participants will have suffered at least one episode of the disorder within the last three months. Applicants will be screened during the first phase of the study, and psychiatric medications other than lamotrigine will be cleared from the subjects. This phase is designed to stabilize any symptoms of bipolar disorder.

Second phase to monitor relapses
The second phase will monitor relapses among the two study groups. Subjects will be followed for a maximum of 52 weeks or until a relapse occurs.

Department of Psychiatry one of two NIMH bipolar study centers in nation
The Department of Psychiatry is one of the two National Institute of Mental Health (NIMH) bipolar study centers in the U.S. and is one of the sites for this research clinical trial.

Vivek Singh, M.D., assistant professor in the Department of Psychiatry, is co-principal investigator.

The study principal investigator at the Health Science Center is Charles Bowden, M.D., and the co-principal investigator is Vivek Singh, M.D. Dr. Bowden, professor and former chairman of the Department of Psychiatry, is supported by the Nancy Ullman Karren Chair in Psychiatry. Dr. Singh is assistant professor in the Department of Psychiatry.

Most patients benefit from a combination approach, Dr. Bowden says
Lamotrigine is a mood stabilizer, while aripiprazole acts like a thermostat increasing or decreasing the function of dopamine, a chemical that transmits signals between neurons. “Because bipolar disorders generally involve a group of symptoms, not just one type of symptom, most patients need combinations of drugs with different targets of benefit to obtain the best outcomes,” Dr. Bowden said.

Lamotrigine/aripiprazole combination may lower risk of side effects
Dr. Singh added: “Lamotrigine shows effectiveness in the prevention of depressive episodes associated with bipolar illness, while aripiprazole’s role is confined essentially to the prevention of manic episodes. Use of combination treatments may allow using lower doses of medications that have different ways of acting on the illness, which may lead to a lower risk of side effects.”

For more information
To inquire about study eligibility or for more information, call (210) 567-0956.

Funding is from the NIMH. Health Science Center researchers will enroll about a dozen people from San Antonio and the surrounding area.

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The University of Texas Health Science Center at San Antonio is the leading research institution in South Texas and one of the major health sciences universities in the world. With an operating budget of $576 million, the Health Science Center is the chief catalyst for the $15.3 billion biosciences and health care sector in San Antonio’s economy. The Health Science Center has had an estimated $35 billion impact on the region since inception and has expanded to six campuses in San Antonio, Laredo, Harlingen and Edinburg. More than 22,000 graduates (physicians, dentists, nurses, scientists and allied health professionals) serve in their fields, including many in Texas. Health Science Center faculty are international leaders in cancer, cardiovascular disease, diabetes, aging, stroke prevention, kidney disease, orthopaedics, research imaging, transplant surgery, psychiatry and clinical neurosciences, pain management, genetics, nursing, allied health, dentistry and many other fields.