Leah Kuntz

According to the results of a new study, individuals seeking treatment for depression with lower incomes, lower education levels, and those who identify as minorities tend to have worse outcomes even when receiving equal access to treatment.

 Jeffrey Mills, PhD, and Jeffrey Strawn, MD, led the University of Cincinnati cross-college collaborative research.

Investigators analyzed data from a large clinical trial, the Combining Medications to Enhance Depression Outcomes study, that enrolled 665 participants seeking treatment for depression. All participants had the same access to treatment without differences due to health insurance or income. The study also controlled for sex, age, and treatment type. Following 12 weeks of antidepressant medication treatment, participants who were nonwhite improved 11.3% less compared to white patients. Participants who were unemployed saw 6.6% less improvement compared to employed patients. Participants the 25th percentile of income distribution had 4.8% reduced improvement when compared to participants in the 75th percentile. Patients who were nonwhite, unemployed, without degree, and in the 25th income percentile had 26% less improvement compared to patients who were white, employed, with a college degree, and in the 75th income percentile.

“We think about these things in terms of access, we think about them in terms of income inequality, and I realize that education does track with those, but just having a college degree while controlling for all of these other factors still had a significant impact,” said Strawn, professor in the Department of Psychiatry and Behavioral Neuroscience in UC’s College of Medicine and a UC Health adolescent psychiatrist.

Strawn also noted that while the findings are still preliminary, results suggest that participants without a college degree had 9.6% less improvement compared to college graduates. Furthermore, previous research indicates that individuals seeking treatment for depression with lower income and less education have worse outcomes because of a lack of access to quality health care, but socioeconomic factors are hard to isolate.

Mills, professor of economics in UC’s Carl H. Lindner College of Business, said that the findings do not negate the fact that a lack of access makes an impact on treatment outcomes, but it does show the importance of including a patients’ home environment when analyzing the effectiveness of treatment.

“If you’re going home to a wealthy neighborhood with highly educated parents or spouse, then you’re arguably in a much better environment for the treatment to be effective than if you’re going to a poor neighborhood with other problems,” said Mills.

Strawn believes future studies should consider socioeconomic variables that may have been previously overlooked.

“When we don’t control for these variables, which we often do not in our clinical trials because of differences in populations, we may miss detecting an effective treatment because its effect is obscured,” Strawn said. “It can potentially jeopardize our treatment development by not accounting for these factors.”

Moving forward, the investigators want to combine data from other depression trials to produce more powerful results with a larger dataset.

This article originally appeared on Psychiatric Times. 

1. Mills JA, Suresh V, Chang L, et al. Socioeconomic predictors of treatment outcomes among adults with major depressive disorder. 

2. Socioeconomic factors affect response to depression treatment. News release. April 15, 2022. Accessed May 6, 2022. 

https://www.newswise.com/articles/socioeconomic-factors-affect-response-to-depression-treatment

Articles

Home environments have a clear impact on depression treatment outcomes. 

How Socioeconomic Factors Can Impact Depression Treatment

A recent study sought to understand the relationship between dietary patterns of children and their attention-deficit/hyperactivity disorder (ADHD) presentation.

Investigators examined 2 different age groups of children from Spain: 259 preschoolers aged 3 to 6 years old (57 with ADHD and 202 controls) and 475 elementary-school-age children, aged 10 to 12 years old (213 with ADHD and 262 controls). ADHD was assessed in accordance with the DSM-5. Eating data were collected using a food consumption frequency questionnaire. Three types of eating patterns were identified: Western-like, sweet, and healthy.

Western pattern consists of eggs, processed meat, seafood, savory cereals, potatoes, legumes, sodas, and cooked vegetables. Sweet pattern consists of dairy desserts, sweet cereals, preserved fruit, and sweets. Healthy pattern consists of nuts, fish (white and oily), raw vegetables, fresh fruit, and olive oil.

The children and adolescents with ADHD were negatively associated with the healthy pattern (p < 0.001) and positively associated with the Western-like diet (p = 0.004). Furthermore, children with inattentive presentation showed lower adherence (12.2%) to a healthy pattern than that of the control group (39.9%) (p < 0.001). The control group had the highest adherence to the Healthy pattern. However, the two groups had a similar adherence to the sweet dietary pattern.

Previous research explored the association between ADHD diagnosis and the Mediterranean diet—a dietary pattern that includes fiber-rich food such as fruits and vegetables, healthy fatty acids, proteins, and more.

 According to 2 studies, there was less healthy eating and lower adherence to the Mediterranean diet in children and adolescents with ADHD than that in controls.

“We hypothesize that children with ADHD have a low-quality diet with a lower intake of fruits and vegetables than that of their peers without the disorder, and that this shows up specifically in children with combined or hyperactive–impulsive (H–I) ADHD presentations. Moreover, we hypothesize that food consumption generally differs from the established recommendations by dietary guidelines,” wrote the authors.

The authors concluded that there is an association between ADHD and dietary habits, and children with inattentive presentation may be at increased risk of unhealthy eating habits.

This article originally appeared on Psychiatric Times.

Rojo-Marticella M, Arija V, Alda JÁ, et al. 

Do children with attention-deficit/hyperactivity disorder follow a different dietary pattern than that of their control peers?

Rios-Hernandez A, Alda JA, Farran-Codina A, et al. 

The Mediterranean diet and ADHD in children and adolescents.

San Mauro Martín I, Blumenfeld Olivares JA, Garicano Vilar E, et al. 

Nutritional and environmental factors in attention-deficit hyperactivity disorder (ADHD): a cross-sectional study.

A recent study found a negative association between children with ADHD and health eating patterns. 

Relationship Between Unhealthy Eating, ADHD in Children Examined

The FDA has approved BioXcel Therapeutics dexmedetomidine (Igalmi™) sublingual film for the acute treatment of agitation associated with schizophrenia or bipolar I or II disorder in adults.

 Dexmedetomidine can be self-administrated by patients under the supervision of a health care provider.

“There are large numbers of patients who experience agitation associated with schizophrenia and bipolar disorders, and this condition has been a long-standing challenge for health care professionals to treat,” said John Krystal, MD, the Robert L. McNeil, Jr. Professor of Translational Research and Chair of the Department of Psychiatry at Yale School of Medicine. “The approval of Igalmi, a self-administered film with a desirable onset of action, represents a milestone moment. It provides health care teams with an innovative tool to help control agitation. As clinicians, we welcome this much-needed new oral treatment option.”

Dexmedetomidine’s approval is based on data from 2 pivotal randomized, double-blinded, placebo-controlled, parallel group phase 3 trials: SERENITY I and SERENITY II. These trials evaluated dexmedetomidine for the acute treatment of agitation associated with schizophrenia (SERENITY I), and bipolar I or II disorder (SERENITY II).

The primary endpoint was mean change from baseline in the Positive and Negative Syndrome Scale-Excited Component (PEC) total score. Change was assessed 2 hours following dosing. The secondary endpoint was to find the earliest time where efficacy, measured by the change from baseline in PEC score, was statistically separated from placebo.

Dexmedetomidine met the primary endpoint in both trials at 2 hours after the first dose in patients treated with the 120 mcg and 180 mcg doses, demonstrating statistically significant improvements from baseline. IGALMI also met the key secondary endpoint, with statistically significant separation from placebo observed at 20 minutes for both the 180 mcg and 120 mcg doses in SERENITY II and 20 minutes and 30 minutes in SERENITY I.

“IGALMI is the first new acute treatment for schizophrenia or bipolar disorder-associated agitation in nearly a decade and represents a differentiated approach to helping patients manage this difficult and debilitating symptom,” said Vimal Mehta, PhD, CEO of BioXcel Therapeutics.

BioXcel is prepared to launch dexmedetomidine in the US in the second quarter of 2022.

1. BioXcel Therapeutics announces FDA approval of IGALMI™ (dexmedetomidine) sublingual film for acute treatment of agitation associated with schizophrenia or bipolar I or II disorder in adults. BioXcel. News release. April 6, 2022. 

https://ir.bioxceltherapeutics.com/news-releases/news-release-details/bioxcel-therapeutics-announces-fda-approval-igalmitm

The new drug treats acute agitation associated with schizophrenia, bipolar I, or bipolar II in adults. 

FDA Approves Dexmedetomidine Sublingual Film for Acute Agitation

Kafi Friday, BA, PharmD candidate 2023; and Prashant Sakharkar, PharmD, MPH, shared their poster “Examining Health Disparities and Level of Depression among Sexual Minorities: A Population based Cross-sectional Study” at the American Pharmacists Association 2022 Annual Meeting and Exposition.

Friday and Sakharkar argued that sexual minorities, or individuals with nonheterosexual sexual orientation, face increasing challenges in achieving health equity, due to stigma and discrimination.1 In a retrospective cohort study, the investigators sought to examine health disparities and level of depression among sexual minorities; compare the prevalence of sexually transmitted infections, smoking, illicit drug use, and alcohol use in use in sexual minorities; and determine predictors of depression among sexual minorities.

The study’s results painted a grim picture for sexual minorities: sexual minorities were 3 times more likely to have gonorrhea and chlamydia infection, 65% more likely to use illicit drugs, 52% more likely to be a smoker, 3 times more likely to experience severe depression, and 2 times more likely to see a mental health clinician.

These findings suggest that depression can be a consequence of health and behavioral disparities. Screening—particularly in females who identify as a sexual minority, smoke, use illicit drugs, are under the age of 45, and are poor—might help in early intervention. Furthermore, future research should examine the association of depression, gender, and sexual minority status.

This article originally appeared on Psychaitric Times

Friday K, Sakharkar P. Examining health disparities and level of depressionamong sexual minorities: A population based cross-sectional study. Presented at: American Pharmacists Association 2022 Annual Meeting & Exposition; March 18-21, 2022; San Antonio, TX

According to research examining sexual minority patients, depression can be a consequence of health and behavioral disparities. 

Depression a Consequence of Health Disparities Among Sexual Minorities

Steven Pliszka, MD, chair of The American Professional Society of ADHD (attention-deficit/hyperactivity disorder) and Related Disorders (APSARD) annual program committee, joined Jeffrey Newcorn, MD, APSARD president, in welcoming attendees to their virtual 2022 Annual Meeting, noting the conference was putting attendees “on the ground floor of exciting developments in the field.” Pliszka said the conference would highlight issues in genetics, neuroimaging, psychological variables, and environmental variables. “I think we’re moving to really integrating all these different aspects so we can think much more broadly about where ADHD fits into psychopathology in general,” he added. “And it will get us thinking more about new ways to intervene and to treat people.”

The 4-day meeting was held January 13 to 16, 2022. In-depth coverage can be found online at 

www.psychiatrictimes.com/conferences/apsard

As separate groups, college students with ADHD and college students who identify as a sexuality and gender minority (SGM) have increased risk for functional impairments, psychiatric comorbidities, and risky behaviors.

 According to Destiny Orantes, PhD, from Syracuse University, and colleagues, previous research had not considered if these outcomes are further increased in SGM students who have ADHD. Orantes shared findings from their recent research in a poster presentation.

The study assessed functional impairments, psychiatric comorbidities, and engagement in risky behaviors in 4 groups: (1) SGM students with ADHD, (2) SGM students without ADHD, (3) non-SGM students with ADHD, and (4) non-SGM students without ADHD. Data from the American College Health Association-National College Health Assessment 2019-2021 III were used. The researchers also sought to examine the prevalence of ADHD in SGM college students.

They found ADHD prevalence increased in SGM populations: 15% compared with 8% in non-SGM individuals. Additionally, SGM students with ADHD reported the highest levels of functional impairments, substance use, and psychiatric comorbidities.

The research results suggest, Orantes said, that future studies should consider the underlying reasons for SGM students having high rates of ADHD, and how best to reduce these negative outcomes. Specifically, treatment plans should take into account the separate difficulties students face from their ADHD diagnosis and their SGM identities, as well as how best to target the risky behaviors and comorbidities.

1. Auerbach RP, Mortier P, Bruffaerts R, et al; WHO WMH-ICS Collaborators. 

Mental disorder comorbidity and suicidal thoughts and behaviors in the World Health Organization World Mental Health Surveys International College Student initiative.

“The [APSARD] task force was launched in relation to the amazing societal changes that are happening...in association with the awareness that equity means creating fair, equitable opportunities for all of us,” Martin Katzman, MD, FRCP(C), APSARD Health Equity Task Force chair, told attendees. “We’re hoping to build connections within the APSARD community, to enhance diversity of the organization, and to reach out across boundaries as well as to partner within all of our communities to raise awareness and to increase opportunities for treatment for populations that may not get the same access to treatment.”

Amy Glasofer, DPN, RN, nurse scientist with Virtua, shared an analysis of 41 studies relating to ADHD, race, ethnicity, and disparity; Catherine Dingley, PhD, RN, FNP, FAAN, associate professor in the Nursing Department of the University of Las Vegas, Nevada, also worked on the project.

They found 66.7% of studies noted Black children were significantly less likely than white children to be diagnosed with ADHD, and 65% of Black children with ADHD were significantly less likely than white children to receive medication. In addition, compared to white children, she noted Black children were more likely to discontinue medication and more likely to experience gaps in treatment; less likely to receive an α2 agonist alone; and more likely to receive significantly lower doses of stimulant. The findings suggest that, although diagnostic disparities have been reduced over time, treatment disparities still exist for minority children with ADHD.

1. Katzman M, Higgins N, Glasofer A, et al. Introducing the APSARD Health Equity Task Force. Presented at 2022 APSARD Conference. January 14, 2022.

“ADHD in preschool children is a valid and reliable condition,” reported Ann Childress, MD, president of the Center for Psychiatry and Behavioral Medicine, Inc, in Las Vegas, Nevada.

According to the 2014 National Survey of Diagnosis and Treatment of ADHD and Tourette’s, 30% of children diagnosed with ADHD receive their diagnosis before age 6; 16% receive the diagnosis at 4 years or younger.

 Impairment can be great for these patients, Childress said. For example, an epidemiological review of preschoolers diagnosed with ADHD found more than 40% had been suspended from school or daycare and about 16% had been expelled.

 In comparison, less than 1% of young children without ADHD were suspended.

The actions of young children with ADHD pose safety risks to themselves due the higher levels of hyperactive impulsivity, she said. “These are kids who are running out in traffic. They’re jumping off of things and breaking bones. They’re doing things that are dangerous, and they really need treatment for their safety,” she explained.

Childress reviewed efficacy and safety data for a number of common medications, noting some small behavior improvements as a result of the study medications. However, medications were associated with adverse events, including insomnia, gastrointestinal issues, irritability, sedation, and repetitive behaviors and thoughts. She also noted not all of these medications have been approved for the youngest patients.

Fortunately, there is good evidence for the efficacy of nonpharmacological interventions for preschoolers with ADHD, Childress reported. The New Forest Therapy, Helping the Noncompliant Child, and the Incredible Years series were among the programs she noted that have demonstrated efficacy. Furthermore, she spoke highly of parent training models that foster the implementation of positive reinforcement to promote positive behaviors; ignoring low-level provocative behaviors; and responding in a clear, consistent, and safe manner to unacceptable behaviors.

“You have to carefully consider both developmental aspects and comorbidity when you’re establishing a diagnosis, and the medication efficacy and tolerability profile may not look as good in the little guys as it does in older children,” she concluded.

1. Visser SN, Zablotsky B, Holbrook JR, et al. 

Diagnostic experiences of children with attention-deficit/hyperactivity disorder.

The epidemiology and diagnostic issues in preschool attention-deficit/hyperactivity disorder: a review.

Catch up on all the latest in ADHD from the virtual APSARD 2022 Annual Meeting. 

Spotlight: Issues in ADHD

Sage Therapeutics and Biogen recently announced the CORAL Study examining zuranolone treatment in patients with major depressive disorder (MDD) demonstrated a rapid and statistically significant reduction in depressive symptoms at day 3 and over the 2-week treatment period.

This significance was demonstrated at day 3, with zuranolone 50 mg initiated concurrently with an open-label standard of care antidepressant. Significance was assessed by change from baseline in the 17-item Hamilton Rating Scale for Depression (HAMD-17). Zuranolone with a standard of care antidepressant also demonstrated a statistically significant improvement in depressive symptoms compared to ADT with placebo over the 2-week treatment period. Zuranolone was well-tolerated overall.

By meeting its objectives, the CORAL Study supports the potential usefulness of zuranolone.

Priya Singhal, MD, MPH, Head of Global Safety and Regulatory Sciences and Interim Head of R&D at Biogen, said this of the results: “These positive results from the CORAL Study indicate that zuranolone co-initiated with standard of care may offer more rapid relief from depressive symptoms than current standard of care taken alone. Based on the collective results observed across the LANDSCAPE clinical development program, we believe that zuranolone has the potential to offer a new clinically meaningful treatment option for people with major depressive disorder.”

“We believe the CORAL Study is clinically meaningful and with the addition of this data, the LANDSCAPE program now demonstrates zuranolone has 3 potential real world uses for the treatment of MDD. The LANDSCAPE data support zuranolone as a monotherapy, and since many people in the previously completed studies were already on maintenance antidepressants, we believe our data also support zuranolone as additive therapy. The CORAL Study further supports the use of zuranolone to accelerate the benefit of conventional antidepressants in treating MDD with a well-tolerated safety profile,” added Barry Greene, Chief Executive Officer at Sage.

“Including the CORAL Study, zuranolone now has 6 positive clinical studies, and we remain on track to start the rolling submission for a New Drug Application in MDD early this year with completion targeted for the second half of 2022,” Greene said further.

“The CORAL Study results were particularly interesting because the data demonstrated that zuranolone worked within days to provide rapid reduction in depressive symptoms as compared to current antidepressants, which in clinical practice can take weeks or months to work,” said Sagar Parikh, MD, Professor of Depression and Clinical Neuroscience, and Psychiatry Sciences, University of Michigan. “In my experience, people with MDD deserve to feel better as soon as possible with a treatment with tolerable side effects. These data suggest that zuranolone has the potential to offer this option and to provide physicians the opportunity to think differently about treating MDD.”

This article originally appeared on PsychiatricTimes.

1. Sage Therapeutics and Biogen announce the phase 3 CORAL Study met its primary and key secondary endpoints. BioSpace. News release. February 16, 2022. 

https://www.biospace.com/article/sage-therapeutics-and-biogen-announce-the-phase-3-coral-study-met-its-primary-and-key-secondary-endpoints/

Zuranolone treatment in patients with major depressive disorder demonstrates a rapid and statistically significant reduction in depressive symptoms. 