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Treating Bipolar Depression Depends on Evidence, Judgment
By: MITCHEL L. ZOLER, Clinical Psychiatry News Digital Network
EXPERT ANALYSIS FROM THE ANNUAL CONGRESS OF THE EUROPEAN COLLEGE OF NEURO- PSYCHOPHARMACOLOGY
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PARIS – Existing evidence on the best ways to treat bipolar depression is limited, and must balance against what works in the real world based on empirical experience. When treating bipolar depression "we are in the land of the uncertain, where [psychiatrists] must improvise and do their best with what’s available," Dr. Andrew A. Nierenberg said at the annual congress of the European College of Neuropsychopharmacology.
The trials that get drugs approved by the Food and Drug Administration often do not inform routine care. Patients in trials often differ from "real" patients, generally have milder disease, and are less susceptible to the worst outcomes. The published evidence base for treating bipolar depression should not be viewed as synonymous with best practice. Treatment is not a cookbook, and evidence-based medicine is very difficult to actually implement, said Dr. Nierenberg, medical director of the bipolar clinic and research program at Massachusetts General Hospital, and professor of psychiatry at Harvard Medical School, both in Boston.
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Dr. Andrew A. Nierenberg
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Treatment of patients with bipolar disorder in actual practice requires personalization, including prescribing agents that work and expecting patients to continue to take them despite possible adverse effects. Published evidence leaves it unclear how best to treat any specific patient, he said. That requires not only evidence but also clinical experience and knowledge of the results obtained by others, followed by feedback and outcomes assessment to guide future changes in treatment.
Perhaps the biggest question in the treatment of bipolar depression today is whether antidepressants work. A 2004 meta-analysis said they did (Am. J. Psychiatry 2004;161:1537-47), but this was "a terrible" meta-analysis because the overall numbers of patients were small, and the results from a single study heavily influenced the overall meta-analysis results, Dr. Nierenberg said. In addition, results from the STEP-BD (Systematic Treatment Enhancement Program for Bipolar Disorder) trial showed that adding an antidepressant to the mood stabilizer lithium gave no significant added benefit (N. Engl. J. Med. 2007;356:1711-22).
Taken together, the literature provides insufficient evidence to document a beneficial role for antidepressants in the treatment of bipolar depression, along with some evidence against any efficacy, yet Dr. Nierenberg said he prescribes an antidepressant as monotherapy or as an add-on treatment to many patients, as do many other psychiatrists. Psychiatrists generally feel that the data against adding an antidepressant are unconvincing, because they have seen antidepressants work on many prior patients. "The data are inconsistent with their clinical experience," he noted.
The roles of several other drugs or drug combinations also feature conflicts between the evidence base and their use in everyday practice.
The combination of olanzapine and fluoxetine showed efficacy in a highly influential 2003 study (Arch. Gen. Psychiatry 2003;60:1079-88). But the olanzapine and fluoxetine pairing is seldom used today because of concerns that it causes weight gain and tends to trigger metabolic syndrome. It’s ironic that olanzapine and fluoxetine is an FDA-approved combination that few patients actually receive, he said. Patients don’t like to gain weight, and when they do, they often stop taking the drugs.
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