NIMH Council Highlights Findings from Practical Clinical Trials
On September 15, NIMH Director Tom Insel, MD, began the open policy session of the National Advisory Mental Health Council meeting by taking a moment of silence in recognition of the recent death of Wayne Fenton, MD, former Director of the Division of Adult Translational Research (DATR). NIH Director Elias Zerhouni, MD, then addressed the Council and provided an explanation of the current and future NIH budget situation and the impact on individual investigators. Focusing on the positives, Dr. Zerhouni noted that because of increased applications per applicant (up from 1.2 to 1.5) the success rate is actually higher than it appears. To illustrate that point, Dr. Zerhouni explained that in 2006, the overall success rates were roughly 19.8% for applications, but 25% for an individual applicant. He also sought to combat the perception that NIH is overly focused on clinical research by stating that NIH devotes about 60% of its resources to basic science, 25% to translational science and only 15% to clinical research.
Ironically, the remainder of the Council meeting was spent discussing NIMH's clinical trials research, including the results of the nearly $145 million spent over the past six years on four of the largest clinical trials ever undertaken by the Institute, which were: 1) the Clinical Antipsychotic Trials of Intervention Effectiveness (CATIE) Study; 2) the Systematic Treatment Enhancement Program for Bipolar Disorder (STEP-BD); 3) the Treatment for Adolescents with Depression Study (TADS); and 4) the Sequenced Treatment Alternatives to Relieve Depression (STAR*D) Study. While many of the findings from these trials have been featured in the mainstream press, Council member Karen Wagner, MD, PhD, noted that the TADS study found not only that a combination of pharmacological treatment and cognitive behavioral therapy (CBT) worked best for adolescent patients with moderate to severe depression in the short term, but that after 36 weeks, those treated with CBT alone fared just as well as those receiving pharmacological treatment alone or in combination with CBT. This is a significant finding that may not have drawn as much press as is warranted.
Dr. Insel indicated that the networks created by these trials provide opportunities to pave the road for future research, but that researchers need to create the traffic by proposing new research projects to build upon this knowledge. Rather than looking for small effect sizes in large trials, NIMH would like to see research proposals that seek to elucidate which patients will respond to which therapies. Use the links below for more information about these clinical trials and their findings.