Study to test NAC and aspirin for people diagnosed with bipolar disorder

A commonly available pharmaceutical drug with anti-inflammatory properties and a nutritional supplement thought to have antioxidant effects are now being tested at The University of Texas Health Science Center at Houston (UTHealth) as add-on therapies for people diagnosed with bipolar disorder.

Aspirin, an anti-inflammatory medication, will be tested for its potential to decrease inflammation in the brain that may be involved in the development of symptoms in bipolar disorder. The study will also test N-acetyl cysteine (NAC) an over-the-counter antioxidant that is being studied to treat a wide range of disorders and diseases, including autism spectrum disorders, obsessive-compulsive disorder, renal failure and diabetes.

In two placebo-controlled Australian studies, NAC was shown to reduce the symptoms of schizophrenia and bipolar disorder. The exact mechanism is not known yet, but researchers believe that NAC's antioxidant properties may improve the functioning of brain cells and chemicals involved in bipolar disorder and depression.

"The study is interesting because we're looking at a commonly available medication that might help bipolar disorder. There's a growing body of literature that suggests depression involves some mild inflammation, and stress has a role as well," said Jair Soares, M.D., principal investigator and professor and chair of the Department of Psychiatry and Behavioral Sciences at the UTHealth Medical School. "NAC may help the brain remain fresher longer. Aspirin, by alleviating possible inflammation in brain neurons, may keep these cells healthier and functioning better."

Bipolar disorder is a brain disorder that causes unusual shifts in mood, energy, activity levels and the ability to carry out daily tasks, according to the National Institute of Mental Health (NIMH), part of the National Institutes of Health. According to the NIMH, it affects 5.7 million adults in the United States. It has two mood episodes: an overly joyful or excited state called a manic episode and an extremely sad or hopeless state called a depressive episode. Current medications are successful in treating 50 to 60 percent of patients, Soares said.

"Bipolar depression causes substantial problems for people, affecting their concentration, memory, sleep and energy level," said Soares, co-director of the UT Center of Excellence on Mood Disorders. "Sometimes they try the medications currently available with poor results. This is an adjunctive treatment to see if it helps in combination with the medications they are already taking."

The study is double-blinded, randomized and placebo-controlled. In addition to their current medications, patients will receive NAC, aspirin, placebo, or NAC and aspirin together.