The 283 women (59% of the study) were more likely to report having spent a greater percentage of time depressed in the previous year, although the percentage of time spent in manic or hypomanic states was equal across both genders.
"This study was composed of sick individuals who had been sick for a considerable period of time," Dr. Friedman said.
For example, in the CHOICE study, 47% had been hospitalized for their bipolar disorder previously, vs. 43% in the LITMUS study. CHOICE participants had an attempted suicide rate of 36%, which fell between the 41% in the LITMUS trial and the 33.3% in an efficacy study conducted by Dr. Joseph R. Calabrese and his colleagues (J. Clin. Psychiatry 1999;60:79-88).
The average age for the first depressive episode for CHOICE participants was 16.4 years; the first manic episode tended to be at 20 years; and the first mood episode tended to be around 15.5 years. These data were similar to those in the LITMUS study, but differed from data in several efficacy studies such as the one by Dr. Calabrese, where the average age was 31.3 years.
"You might anticipate that in these specialty clinics we would have very few medication-naive patients, and yet we did," Dr. Friedman said during a postpanel audience participation session. "Looking for patients with a low threshold, we brought in patients who were very sick. They were also older, with lots of previous episodes. Maybe we missed younger patients who didn’t have as many previous episodes."
"These are the patients you would see in your practice," Dr. Nierenberg said before asking the audience what they think should be studied next in a comparative effectiveness trial. "We could look at the use of different antipsychotics, the combinations we use, with or without lamotrigine," he said.
"Most of the decisions that are made in medicine are made without evidence. Most of the things that are done are done without evidence. You have combinations that were never studied before or never even used before, and it’s across all medicine." Because medicine needs to be learning more, he said the audience needed to participate. "What are the questions that need to be asked?"
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