(RxWiki News) Bipolar disorder is characterized by periods of extreme energy and activity, called the manic phase, and periods of major depression. There are few medications approved to treat this type of depression.
Bipolar disorder can be a disabling condition. Controlling the severe depression associated with bipolar disorder is one of the goals of treatment.
"Seek professional help for depression."
This multi-center international study was conducted by Sunovion Pharmaceuticals, manufacturers of lurasidone. The lead author of the published study was Antony Loebel, MD.
A total of 505 people, ages 18 to 75 years old, with bipolar 1 disorder were enrolled in this study. Bipolar 1 disorder is a subcategory of bipolar disorders that involves extreme manic phases that last at least a week, sometimes so severe as to require hospitalization, and depressive episodes that last at least two weeks.
The study subjects were divided into three groups. One group received a dose of lurasidone from 20 to 60 mg, one group got 80 to 120 mg of lurasidone and one group received a placebo (fake medication). All treatments lasted six weeks.
"Lurasidone (Latuda) is a second generation antipsychotic that has been used to treat schizophrenia and is also being explored as a treatment option for patients suffering from major depression associated with bipolar disorder," explained E. Lee Carter, RPh, Clinical Pharmacy Specialist at the Department of Veterans Affairs in Prestonsburg, Kentucky.
The patients' depression was evaluated at the beginning and throughout the study with several different depression rating systems. Their quality of life was assessed by answers to surveys about employment, disability and satisfaction with life.
Analysis of the study data showed that both depression severity and depression symptoms were significantly decreased after six weeks in the groups treated with lurasidone compared to placebo.
Patients treated with lurasidone reported less anxiety and better satisfaction with life than those people who took the placebo.
Effects seen in the study were similar between the groups treated with the 20 to 60 mg lurasidone and with 80 to 120 mg lurasidone.
Thoughts of suicide were low, but were unchanged regardless of whether the patients were treated with lurasidone or placebo.
Approximately 6 to 7 percent of the people in each group left the study because of adverse events. Reactions were experienced by 62 percent of the patients who received 20 to 60 mg of lurasidone, 65 percent of those who took 80 to 120 mg of lurasidone and 57 percent of the placebo group. Nausea and headache were the most commonly reported reactions.
According to Carter, who was not involved in this study, "Possible side effects of lurasidone include headache, insomnia, nausea, sedation, and tremor, although most patients appear to tolerate therapy well. Lurasidone can also increase serum triglycerides, serum glucose, and serum cholesterol."
Carter went on to explain, "Many clinicians recommend taking lurasidone with a meal (at least 350 calories) to minimize the potential of gastrointestinal side-effects. Other considerations for patients include possible weight-gain as well as possible kidney and liver function impairment. Frequent lab testing is usually required with lurasidone therapy to ensure safe and effective therapy for patients."
He added, "Those patients currently taking the blood thinner warfarin (Coumadin), the blood pressure medicine diltiazem (Cardizem), or the antibiotic rifampicin (Rifampin) should discuss possible interactions with these medications with their healthcare provider. It is still unclear at this time if lurasidone will be effective in bipolar-2 disorders."
A limitation of this study cited by the authors was the fact that only patients with bipolar 1 disorder were studied, so it is not known if lurasidone will be effective with bipolar 2 disorder.
Despite this limitation, the authors concluded that "lurasidone may be a valuable addition to the therapeutic armamentarium for the treatment of patients with bipolar depression."
This study was published in the February issue of the American Journal of Psychiatry.
Sunovion Pharmaceuticals sponsored the study, and Dr. Loebel is the Executive Vice President and Chief Medical Officer at Sunovion.