PARIS – Clinical trials can show meaningful results after 5 weeks, and many trials should include more women, according to findings from the NEWMEDS program.

NEWMEDS, which is short for Novel Methods Leading to New Medications in Depression and Schizophrenia, is a consortium of scientists from around the world. The consortium is funded by the Innovative Medicines Initiative, a large-scale partnership between the European Union (represented by the European Commission) and the pharmaceutical industry (represented by the European Federation of Pharmaceutical Industries and Associations), according to the NEWMEDS website.

A primary goal of NEWMEDS is to look at ways of addressing the bottleneck that often slows drug development, said Jonathan Rabinowitz, Ph.D., who presented results of NEWMEDS research at the annual congress of the European College of Neuropsychopharmacology.

To date, the NEWMEDS repository of data from randomized controlled trials of antipsychotics in patients with schizophrenia includes 60 studies: 59 industry-sponsored studies from 5 drug companies and 1 from the National Institute of Mental Health (NIMH). The industry-sponsored studies included 29 placebo-controlled trials and 30 active comparator trials for a total of 23,401 patients. The NIMH trial added an additional 1,493 patients, reported Dr. Rabinowitz of Bar Ilan University in Ramat Gan, Israel.

The NEWMEDS team has reviewed 29 of these studies (including 6,971 patients on active treatment and 2,200 on placebo), with the goal of addressing four questions:

• Can clinical trials be shorter?

• What outcomes might predict treatment success?

• Do clinical trials have an overrepresentation of "eligibility creepers," meaning patients who don’t quite meet eligibility criteria?

• Do eligibility creepers have treatment responses that are different from those of patients who fall within the eligibility criteria?

The studies included in the review were sponsored by AstraZeneca, Janssen, Lilly, Lundbeck, and Pfizer.

In 37% of the studies lasting 6 weeks or longer, the effects of the week 5 results were larger than those at week 6, based on the LOCF (last observation carried forward) differences in Positive and Negative Syndrome Scale (PANSS) scores between the placebo and active patients. And in about half of the studies, at least 80% of week 6 effects were detectable at week 3, Dr. Rabinowitz said.

To determine whether certain subgroups of patients would show a stronger active treatment response, the NEWMEDS team examined variables, including sex, age, race, body mass index, age at disease onset, number of previous psychiatric hospitalizations, and the region where patients lived.

A review of study demographics showed that, on average, 71% of the participants in schizophrenia clinical trials were male, Dr. Rabinowitz said. However, "females had considerably less placebo response and slightly more treatment response than males," based on PANSS scores, he said.

Also of interest was the finding that patients in Eastern Europe showed a 19% greater active treatment response than did those in North America, Dr. Rabinowitz said. However, the reasons for this difference remain unclear and require further study, he added.

In addition, "people aged 30 years and older with 4 or more years of illness showed considerably better treatment response," Dr. Rabinowitz said.

09/07/11  

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FROM THE ANNUAL CONGRESS OF THE EUROPEAN COLLEGE OF NEUROPSYCHO-PHARMACOLOGY

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