Enabling Discovery, Development, and Translation of Treatments for Cognitive Dysfunction in Depression Workshop Summary (2015) / Chapter Skim
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1 Introduction and Overview
1 Introduction and Overview
Pages 1-8
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Perhaps most troubling is the fact that depression often goes untreated or undertreated. The WHO World Mental Health Surveys showed that even in the United States, only about one-third of patients receive treatment in the first year of the disease, and face a median delay of 4 years before treatment is provided (Wang et al., 2007)
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Forum on Neuroscience and Nervous Disorders convened key stakeholders at a workshop in Washington, DC, to explore how best to enable the discovery, development, and translation of treatments for cognitive dysfunction in depression, including a focus on the regulatory path forward (see Box 1-1)
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Moreover, currently available pharmacologic treatments for depression may fail to address or even worsen the cognitive aspects of this crippling disease. Pharmaceutical companies have begun to take an interest in developing drugs that target cognition in depression, said Thomas Laughren, director of Laughren Psychopharm Consulting, LLC, and formerly director of the Division of Psychiatry Products in the Office of New Drugs in the Center for Drug Evaluation and Research at the Food and Drug Administration (FDA)
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Both cold and hot cognition4 appear to be affect ed, leading to reduced function, and it seems important to sepa rately consider cognitive biases and cognitive deficits.5 Several participants, including regulators, noted that the lack of a con sensus on the cognitive domains leads to methodologic differ 3 The following list highlights topics discussed throughout this workshop, but should not be construed as reflecting a consensus of workshop participants or any endorsement by the Institute of Medicine or the Forum on Neuroscience and Nervous System Disorders. 4 Cold cognition refers to information processing that is independent of emotion, while hot cognition refers to constructs that are affected by emotional state.
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After dis cussing a range of pharmacologic and nonpharmacologic treat ment approaches, including neurostimulation and cognitive remediation, several participants concluded that effective treat ment will require combinations of drugs and other treatments that target multiple neurobiological mechanisms and cognitive domains and that ensure good functional outcomes in the work place and home environments. • Improving early diagnosis and early treatment: Earlier diag nosis of depression and early effective treatment could improve response to treatment, emphasized some participants, noting that delayed treatment leads to poorer response to antidepressant therapy and more frequent relapses.
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• Heterogeneity and stratifying study participants: Heterogene ity presents challenges in developing treatments, and stratifying study participants into subgroups can be beneficial although it limits generalizability, noted various workshop participants. Pa tients with depression constitute a diverse group in terms of both symptomatology and response to treatment, and these aspects al so vary with gender and across the lifespan.
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• Enhancing clarity in the regulatory pathway: Clarity in the regulatory pathway for approval of treatments would be benefi cial, noted some participants. No treatment targeting cognitive impairment in depression has yet received regulatory approval.
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In his concluding remarks, Insel said he was initially skeptical that there was a need for new cognitive interventions and cognitive measures for depression. However, he said the proceedings had convinced him that even cognitive interventions that have been available for some time may not be adequate to address the cognitive concerns of patients with depression.
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