What NIMH Should Be Doing

The roots of the National Institute of Mental Health (NIMH) date to a congressional hearing on the institute’s creation in September 1945, immediately following World War II (1). During this and subsequent congressional hearings, the need for NIMH was justified because of two contemporary clinical problems. The first was challenges to military recruitment and retention: 18% of the men rejected by the draft and 38% of servicemen discharged because of disability were rejected or discharged because of mental illness. Second, the number of people in state psychiatric hospitals had tripled since the turn of the century. The hospitals were therefore grossly overcrowded and understaffed, especially during the war, when many hospital personnel were needed for military duty. Therefore, NIMH’s primary purpose originally was to help persons currently affected by mental illness. From the beginning, it was envisioned that basic brain research would also be part of NIMH’s research portfolio, and in 1950, Congress created the National Science Foundation specifically to focus on basic research, including basic brain research.

A Problematic Shift in Research Focus

For the first half-century of its existence, NIMH maintained a research portfolio that had a reasonable balance between clinical and basic research. However, over the past two decades, NIMH has markedly decreased its support for clinical research in favor of funding of basic brain studies. This shift has been documented elsewhere (2), including studies of current NIMH research on schizophrenia (3) and bipolar disorder (4) that found that no more than 10% of the studies are likely to help anybody currently affected by these illnesses within the next 20 years. Dr. Joshua Gordon, the current NIMH director, has claimed that the skewing toward basic brain research was justified by the assumption that “psychiatric disorders are disorders of the brain, and to make progress in treating them we really have to understand the brain” (5).

We question this assumption. Much useful clinical research can take place, and help people currently affected with psychiatric disorders, without an understanding of how the brain works. To illustrate this, we asked some clinical colleagues with a special interest in serious mental illness what research projects they would suggest NIMH support in order to provide clinical improvement to individuals with serious mental illness within 5 years. The following 12 research tasks (listed in the order in which they were received) are examples of such projects.

• Investigate the use of long-acting injectable antipsychotic (LAI) medications, which are greatly underused in the United States, by conducting a multicenter study based on the CATIE (Clinical Antipsychotic Trials for Intervention Effectiveness) framework to compare different LAI formulations and to assess which patients do well with LAI treatment.

• Reduce risk for reoffending among individuals with serious mental illnesses who are being released from prisons and jails by conducting a multicenter study that uses existing databases to compare the effects of psychiatric security review boards, forensic assertive community treatment teams, and conditional release on reoffending.

• Improve the treatment of bipolar depression by undertaking a multicenter study comparing traditional antidepressants, esketamine, electroconvulsive therapy (ECT), and transcranial magnetic stimulation to identify patient characteristics that predict success of each treatment type.

• Improve the treatment of drug-resistant major depression by performing a study to assess the role of evidence-based psychotherapies in treating this condition.

• Identify the appropriate duration of psychiatric inpatient stays, especially of the initial hospitalization, by undertaking a multicenter study using existing databases to determine the optimal length of stay for individuals with various clinical characteristics and to analyze costs and benefits of early discharge.

• Improve the treatment of depression among patients with cancer by conducting a study comparing the efficacies of antidepressants and evidence-based psychotherapies in this patient population.

• Examine the use of clozapine, also greatly underused in the United States, by funding a multicenter trial to collect clinical and serological biomarker data that could be used to predict which patients are most likely to respond to this medication.

• Study the efficacies of treatments consisting of combinations of clozapine with other antipsychotic medications as well as ECT for the approximately 10% of patients with schizophrenia and other psychoses who do not respond to antipsychotic medication.

• Improve the use of the limited professional psychiatric resources in the United States by conducting a study that uses existing clinical databases to investigate which patients do well with telepsychiatry (which has markedly increased during the COVID-19 pandemic) and which patients do better with in-person visits.

• Systematically assess probiotics and other low-toxicity, immune-based therapies, which have shown preliminary promise in the treatment of bipolar disorder and prevention of mania.

• Systematically evaluate anti-inflammatory medications that have shown early promise in the treatment of psychosis, focusing especially on those patients who have neuroinflammatory serological markers.

• Conduct several pilot studies to investigate how teams providing assertive community treatment (ACT)—which for 40 years has been known to optimally treat individuals with serious psychiatric disorders by improving quality of life and patient satisfaction but is available to only 40% of those needing ACT—can be more cost-effective and therefore become more widespread.

All of these proposed clinical projects are good reasons for NIMH to maintain a balanced portfolio of clinical and basic research. They also make good economic sense. In 2013, RAND Corporation published a study on schizophrenia research in the United States, the United Kingdom, and Canada, comparing the effectiveness of basic versus clinical research over a 20-year period (6). The study concluded that “clinical research has a larger payback than basic research in terms of health, social and economic benefit over periods up to 20 years.” The study’s authors specifically cited the larger impact clinical research had on patient care.

Recommendations

Given the ongoing and increasing failure of NIMH to support research that is likely to help anyone who currently has a serious mental illness, we recommend that NIMH be required to direct a minimum of 50% of its research funds to clinical research that has a significant chance of helping patients currently affected. We further recommend that the percentage of research funds going to clinical and basic research be calculated and published on an annual basis by individuals not directly connected to, nor funded by, NIMH. Such individuals could be appointed, for example, by the National Academy of Medicine or by the assistant secretary for mental health under the Department of Health and Human Services. The important point is to restore the original balanced research portfolio for NIMH as intended by Congress. Individuals currently affected with a serious mental illness have a right to research that addresses their needs.