New Relief for Veterans With Treatment-Resistant Depression

The effectiveness of esketamine and aripiprazole to enhance the effect of standard antidepressants will be compared in people suffering from treatment-resistant depression.

A new study evaluated the comparative effectiveness and cost-effectiveness of esketamine for Veterans suffering from treatment-resistant depression (TRD). The Department of Veterans Affairs (VA) has given $40 million in funding for this study.

Esketamine is one form of ketamine, an FDA-approved anesthetic. While ketamine has not been approved for depression treatment, the US Food and Drug Administration (FDA) approved a nasal spray formulation of esketamine for the treatment of resistant depression in adults.

Holistic Management for Depression
Depression is a common disorder and many worldwide suffer from depression. Early recognition of symptoms and signs of depression can help in taking a holistic approach to the management of depression.

‘Esketamine being the only FDA-approved drug at present for treating treatment-resistant depression will be beneficial to thousands of Veterans and millions of other patients.’

People with TRD, a form of depression that has not responded to multiple previous treatments, are at the highest risk to become chronically ill, developing a substance abuse disorder, attempting suicide, or any combination of the three.

Determining the Best Drug for Treatment-Resistant Depression

The study is the first to evaluate the comparative effectiveness and cost-effectiveness of esketamine as compared to aripiprazole. The researchers suggest that participants who receive an intranasal dose of esketamine to enhance the effect of standard antidepressants will be significantly more likely to achieve remission for their depression after six weeks of treatment, than those adding aripiprazole.

In 2019, the U.S. Food and Drug Administration (FDA) reviewed intranasal esketamine as a new therapy treatment that can lead to a rapid reduction in symptoms of TRD. The safety and efficacy of esketamine were evaluated in a series of phase III studies that ultimately led to its approval by the FDA for treatment in adults but did not compare it with other effective strategies.

The newly funded study will be a randomized clinical trial in which more than 900 Veterans across 25 VA sites will receive either intranasal esketamine or oral aripiprazole for up to six months of treatment. This study will assess the efficacy, safety, and acceptability of esketamine in direct comparison to aripiprazole for TRD therapy.

Depressive symptoms will be assessed by using the Quick Inventory of Depressive Symptomatology clinician rating tool, which is a well-validated tool that is easily translated across other depression inventory scales.

In a previous multisite VA study, researchers showed the addition of aripiprazole resulted in a significantly greater likelihood of depression remission, compared to switching to bupropion.

Later analyses demonstrated that the benefit of using adjunctive aripiprazole among 12-week remitters was sustained for up to six additional months of therapy and was evident whether patients had co-occur PTSD or not.

This was the first study to show one strategy of TRD treatment had some advantage over another, but the gains were small in magnitude and left room for improvement. With this large, multisite study, VA’s role as a leader in improving the treatment for depression would be firmly established.

Source-Eurekalert