Psych Congress Roundup: Digital Tx for MDD; Esketamine Rooms; PA Contributions

Research presented at this year’s Psych Congress meeting in Boston included a randomized trial of esketamine (Spravato) monotherapy, long-term data on xanomeline and trospium chloride (Cobenfy), and a longitudinal study on mortality risk in patients with stable schizophrenia.

Below are a few more highlights from the meeting.

Prescription App for Depression

In the phase III MIRAI randomized trial of 386 participants with major depressive disorder (MDD) and an inadequate response to their current antidepressant therapy, 6 weeks of treatment with the prescription digital therapeutic CT-152 (Rejoyn) yielded a 9.03-point drop in Montgomery-Åsberg Depression Rating Scale (MADRS) score from baseline. While a significant improvement from baseline, the difference wasn’t significantly better compared with the sham app group, who had a 7.25-point change in MADRS score (between-group difference -1.78, P=0.0568).

However, significantly more participants treated with CT-152 experienced a partial MADRS response (≥30% or <50% reduction from baseline) or full MADRS response (≥50% reduction) compared with the sham app group (48.3% vs 37.5%, P=0.0485).

Cleared for use by the FDA in April based on results from this trial, CT-152 was the first prescription digital therapeutic authorized for the adjunctive treatment of MDD for adults ages 22 and older on an antidepressant. The program is “designed to enhance cognitive control over emotional informational processing by targeting regions of the brain that are implicated in depression, for example, the amygdala and the dorsolateral prefrontal cortex,” said Tarolyn Carlton, PharmD, of developer Otsuka Pharmaceuticals, during a poster presentation.

CT-152 utilizes cognitive emotional training exercises for the brain plus brief therapeutic lessons, and requires a prescription from a healthcare provider. It is available as an app on iOS and Android.

Participants also had greater improvements in Patient Health Questionnaire-9 scores (-6.68 vs -5.10, P=0.0029) and Clinical Global Impression-Severity scale scores (-1.06 vs -0.80, P=0.0098). General Anxiety Disorder-7 scores improved numerically but not significantly with CT-152.

During the 4-week treatment period, adults ages 22 to 64 (mean age 42-43, 86% women, 78% white) without psychotic features of DSM-5-confirmed MDD participated in three CT-152 or sham sessions per week (18 sessions total). They also received text messages to encourage engagement.

Fewer patients in the CT-152 group experienced treatment-emergent adverse events compared with the sham app group (15% vs 26.3%) during the treatment period, though more participants experienced headache in the CT-152 group (2.1% vs 1.6%).

Impact of Environment on Esketamine Treatment

Approved in March 2019, esketamine is currently indicated for use alongside an oral antidepressant for treatment-resistant depression and for depressive symptoms in adults with MDD with acute suicidal ideation or behavior. However, agency approval came with a Risk Evaluation and Mitigation Strategy (REMS) to restrict esketamine to certified treatment centers where patients are monitored for 2 hours. It is also prohibited from being dispensed directly to patients, and patients have to be enrolled in a registry.

But how does the environment where monitoring takes place impact the patients’ experience? Looking to answer this question, Brittany Albright, MD, MPH, and William Rayburn, MD, MBA, of Sweetgrass Psychiatry in South Carolina, asked 38 patients — accounting for 423 treatment encounters — about their experiences. The researchers said their clinic features four private treatment rooms: two “traditional” rooms and two non-traditional rooms. Patients were allowed to choose their room, adjust window shades, select room temperature, and opt for a blanket or soft music during esketamine treatment sessions.

Traditional rooms featured a zero-gravity reclining massage chair, desk, small chair, end table, and window with adjustable darkening shades. As for the non-traditional rooms, they were larger and “light filled” with three windows, a large couch, desk, chairs, outdoor balcony, and an intercoastal view of boat docks, birds, and dolphins.

Patients who experienced both room types during at least two separate sessions responded to five multiple-choice questions about their preferences. All said the room environment “significantly impacted” their esketamine experience, but found both rooms comfortable. Only three patients (8%) had a strong preference for one room over the other.

“Offering customizable environmental conditions in both traditional and non-traditional rooms enhances patient comfort during esketamine treatment sessions,” the researchers noted. “However, the choice of room did not influence the occurrence of adverse events related to intranasal esketamine.”

Adverse events were rare and included nausea requiring medication, hypertension, sedation, and dissociation.

Contribution of PAs to Mental Health Access

In an analysis of national workforce data from 2023, over 90% of physician assistants/associates (PAs) specializing in psychiatry screened (95.7%), diagnosed (92.7%), initiated treatment (93.2%), and implemented treatment maintenance (94.8%) every day for patients with mental disorders. Over half (55.9%) of PAs said they also make referrals for patients with mental disorders daily.

“PAs in psychiatry are expanding access to mental health services,” Kasey Puckett, MPH, of the National Commission on Certification of Physician Assistants in Johns Creek, Georgia, and co-authors noted in their poster.

A high proportion of PAs specializing in other fields also screened patients for mental disorders daily, including 72.3% of PAs in pediatrics, 70.6% in family medicine/general practice, 63.5% in internal medicine, and 47.7% in emergency medicine.

Out of all the specialties, PAs in psychiatry reported the highest proportion of telemedicine participation (78% vs a range of 16.4% to 63.6%).

The data were reflective of 126,941 PAs who provided or updated responses to the specialty question in the PA Professional Profile within the past 3 years, including 2,999 PAs specializing in psychiatry.

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