Deutetrabenazine (Austedo) is approved by the FDA for treatment of tardive dyskinesia (TD) in adults. In the 12-week ARM-TD and AIM-TD studies, deutetrabenazine showed clinically significant improvements in Abnormal Involuntary Movement Scale (AIMS) scores compared with placebo, and there were low rates of overall adverse events (AEs) and discontinuations associated with deutetrabenazine. The objective of this study was to evaluate the long-term safety and tolerability of deutetrabenazine in patients with TD at 3 years.

Patients who completed ARM-TD or AIM-TD were included in this open-label, single-arm extension study, in which all patients restarted/started deutetrabenazine 12 mg/day, titrating up to a maximum total daily dose of 48 mg/day based on dyskinesia control and tolerability. The study comprised a 6-week titration period and a long-term maintenance phase. Safety measures included incidence of AEs, serious AEs (SAEs), and AEs leading to withdrawal, dose reduction, or dose suspension. Exposure-adjusted incidence rates (EAIRs; incidence/patient-years) were used for calculating AE frequencies. This analysis reports results up to Week 158.

A total of 343 patients were enrolled (111 received placebo and 232 received deutetrabenazine in the parent studies). At the time of this analysis, 183 patients were still receiving treatment; 259 completed 1 year, 172 completed 2 years, and 41 completed 3 years. There were 623 patient-years of exposure. More than 40% of patients reached the maximum dose. EAIRs of AEs were comparable to or lower than those observed in the ARM-TD and AIM-TD short-term randomized trials of deutetrabenazine vs. placebo. The frequency of SAEs (EAIR 0.10) was similar to that observed with short-term placebo (0.33) and short-term deutetrabenazine (range 0.06–0.33) treatment. AEs leading to withdrawal (0.06), dose reduction (0.10), and dose suspension (0.05) were uncommon.

These results support the safety outcomes observed in the ARM-TD and AIM-TD parent studies and the safety of deutetrabenazine for long-term use in patients with TD.

Funding Acknowledgements: This study was funded by Teva Pharmaceuticals, Petach Tikva, Israel

Serotonin syndrome is a potentially life-threatening condition associated with increased serotonergic activity in the central nervous system. Serotonin syndrome is underreported complication of pharmacotherapy. The Hunter Criteria for serotonin syndrome (SS) are fulfilled if the patient has taken a serotonergic agent and has one of the following symptoms: 1) spontaneous clonus, 2) inducible clonus and agitation or diaphoresis, 3) ocular clonus and agitation or diaphoresis, 4) tremor and hyperreflexia, 5) hypertonia, or 6) temperature above 38 C and ocular clonus or inducible clonus.

Patient A was a 16-year-old Caucasian male with history of major depressive disorder, social anxiety and OCD who presented to the emergency room with multiple complaints: twitching of bilateral cheeks, intermittent tremor of his hands and feet, mental fogginess/confusion, stuttering when attempting to speak, agitation, profuse sweating and headache. 3 weeks prior, his sertraline dose was increased from 25mg daily to 50 mg daily. His physical exam was remarkable for elevated blood pressure and heart rate as well as hyperreflexia noted on patellar reflex testing. No significant abnormalities were noted on routine labs. He was told his symptoms were likely due to medication side effects. The patient was discharged with instructions to decrease his sertraline dose from 50 mg to 25 mg daily and follow up with his outpatient psychiatrist. 2 days later the patient was seen at the outpatient child psychiatry clinic and he was advised to taper off sertraline completely by taking 12.5mg daily for 3 days before cessation. After stopping the medication, the patient’s symptoms resolved.

Patient B was a 16-year-old female with generalized anxiety disorder and major depressive disorder who presented to the general pediatric clinic with progressively worsening hand tremors and body shaking since her Zoloft dose was increased from 25mg to 50mg daily. She also felt it was more difficult to hold objects. At the physical exam she had an elevated heart rate to 93 and elevated blood pressure to 182/75. Her deep tendon reflexes were 4+ bilaterally. Upon consultation with child psychiatry, the patient was recommended to taper off sertraline. After the discontinuation of sertraline, her symptoms resolved.

These 2 patients developed mild to moderate symptoms of serotonin syndrome with low doses of sertraline. Symptoms resolved after the discontinuation of the SSRI.

In the pediatric patient population, serotonin syndrome can develop even with lower doses of an SSRI. To avoid a missed diagnosis, clinicians should familiarize themselves with the Hunter Criteria for serotonin syndrome. It is also vital to educate parents and caregivers about the toxicities of SSRIs, including serotonin syndrome, so they may monitor treatment and take appropriate action if needed.

To describe the effect of supplemental psychotropic medications, specifically anxiolytics with sedative/hypnotics (ASH) combined with lamotrigine (LTG) on stabilization of symptoms in patients with bipolar I disorder.

Symptomatic patients participating in two LTG maintenance trials were classified post-hoc as those initiating LTG as monotherapy (n=313) or as adjunctive therapy (n=814) and further characterized by supplemental add-on therapies received during an open-label treatment phase. Patients were considered stabilized if they reached a stable dose of LTG monotherapy (100–200 mg/day) and had a Clinical Global Impressions-Severity scale score ≤3 for at least 4 weeks. Stabilization rates were compared across initial- and supplemental-treatment groups.

Patients who initiated and were maintained on LTG monotherapy were stabilized at a slightly higher rate compared with those taking LTG adjunctive therapy (55% vs 48%; P=.080). Stabilization rates were numerically higher for LTG monotherapy patients who later received only ASH as supplemental medication compared with LTG monotherapy throughout, but this difference was not significant (66% vs 55%; P=.271). Stabilization rates were significantly higher for monotherapy patients who later received ASH alone versus other psychotropic medications (66% vs 28%; P=.001). For patients initiating LTG as adjunctive therapy, adding ASH alone resulted in significantly higher stabilization rates than adding another psychotropic medication (62% vs 33%; P<.001).

LTG and adjunctive treatment with ASH may be useful in the treatment of acute mood symptoms in patients with bipolar I disorder.

With the improvement of people’s living standards, more and more people are paying attention to their mental health, and many people choose to travel to alleviate the impact of anxiety.

This study selected 20 patients with different levels of anxiety, including mild anxiety, moderate anxiety, and severe anxiety, and divided them equally into an experimental group and a control group. The experimental group was treated with a combination of long and short acting drugs and green ecotourism, while the control group was only treated with a combination of long and short acting drugs. After six months of treatment, follow-up visits will be conducted to investigate the patient’s anxiety relief.

The survey showed that a total of 9 patients with severe anxiety in the experimental group had symptoms relieved, with 4 patients transitioning from severe anxiety to moderate anxiety, and 5 patients transitioning from severe anxiety to mild anxiety Among them, 4 experienced mild anxiety, while the rest were cured. 6 patients with mild anxiety were cured. In the control group, 6 patients with severe anxiety had symptoms relieved, all of whom turned to moderate anxiety. Among patients with moderate anxiety, 4 experienced relief in symptoms, with 3 transitioning from moderate anxiety to mild anxiety and 1 being cured. Four patients with mild anxiety have been cured.

The experimental results indicate that the combination of green ecological tourism industry construction and drug use in the context of rural revitalization has a good therapeutic effect on alleviating anxiety symptoms in anxiety patients

The Henan Provincial Department of Science and Technology (2022 Key R&D and Promotion Special Project), No. 222400410137.

This study explores the effectiveness of Chaihu Hehuan Jieyu Tang (CHT) combined with career guidance to alleviate employment anxiety among college students. Employment anxiety is a common concern among college students, and targeted interventions are necessary to mitigate its negative impact.

One hundred sixty college students with employment anxiety were selected for this study. They were randomly divided into four groups: the CHT combined with the career guidance group (n=40), the CHT alone group (n=40), the career guidance alone group (n=40), and the control group (n=40). The Stanford Acute Stress Response Questionnaire (SASRQ) and the 3-min Confusion Assessment Scale (3D-CAM) measured the participants’ anxiety levels. The intervention was conducted over twelve weeks, with regular sessions twice weekly.

Statistical analysis using SPSS23.0 revealed a significant reduction in anxiety levels in all intervention groups compared to the control group (P<0.001). However, the group receiving the combined intervention of CHT and career guidance exhibited a more substantial decrease in anxiety symptoms than those receiving single interventions (P<0.05), as measured by the SASRQ and 3D-CAM. These findings suggest that the combined intervention has a more substantial effect on alleviating employment anxiety among college students.

This study indicates that combining Chaihu and Huanjieyu Tang with career guidance effectively reduces employment anxiety among college students. These results highlight the importance of combining traditional Chinese medicine interventions such as CHT with career guidance to achieve more comprehensive and effective results.

No funding

Patient preferences in schizophrenia (SCZ), including identification of key goals and outcomes for treatment and relative importance of certain treatment goals to patients, have been assessed by several studies. However, there continues to be a lack of sufficient evidence on US patient attitudes and perceptions towards treatment goals and pharmacotherapy options in SCZ, especially taking into context long-acting injectable antipsychotics (LAIs) in this disease area. This lack of evidence is further pronounced in caregivers of individuals with SCZ. The objective of this analysis was to characterize patients with SCZ on LAIs vs patients on oral antipsychotics (OAPs) and evaluate the treatment goals of patients in each group.

This was a real-world, cross-sectional survey of US psychiatrists, patients =18 years old with a diagnosis of SCZ, and caregivers. Data was collected using the Disease Specific Programme (DSP) methodology, which has been previously published. Psychiatrists (n=120) completed detailed record forms for next 8 consecutive outpatients and 2 inpatients matching inclusion criteria, including non-interventional clinical and subjective assessments. The same patients and their caregivers, if present, were invited by their psychiatrist to voluntarily complete a separate survey.

Of 1135 patients on treatment where the physician provided survey data; 251 were on an LAI, and 884 were on an OAP. Mean (SD) time to SCZ diagnosis for those on an LAI was 10.3 (12.0) years vs 7.8 (10.5) years for those on OAPs. More patients in the LAI vs OAP group were being treated as an inpatient (27.1% vs 15.7%, respectively; p<0.0001). Patients on an LAI reported being on their current medication regimen for less time (mean 1.7 years) vs those on OAPs (mean 2.5 years) (p=0.0093). More patients on LAIs were unemployed due to disability vs those on OAPs (56.1% vs 39.5%, respectively), and less patients on LAIs were able to work part-time or full-time (21.1% or 4.1%) vs those on OAPs (23.2% or 11.4%). More patients on an LAI had a caregiver vs those on OAPs (37.3% vs 26.1%, respectively; p=0.0011). Regarding the most important treatment goals reported by patients, both groups reported similar preferences for decrease in disease symptoms (62% on LAI vs 65% on OAPs) and thinking more clearly (53% on LAI vs 46% on OAPs); however, a numerically higher proportion of LAI patients reported that the current medication helped decrease hospitalizations due to relapse vs those on OAPs (38% vs 32%, respectively).

Given the characteristics of patients participating in this real-world survey, those on LAIs exhibited qualities which indicate a higher severity of illness vs those on OAPs. Results suggest that treatment with LAIs is still mainly being provided to patients later in the disease course and/or who have adherence problems, despite a growing body of evidence of utility in younger patients earlier in the course of illness.

Otsuka Pharmaceutical Development & Commercialization, Inc. and Lundbeck LLC

Glycolimia is observed in a plethora of medical conditions including burning mouth syndrome, opioid withdrawal, as well as from a variety of medications including vortioxetine, l-methylfolate, lisdexamfetamine, and gabapentin. While vilazodone, an antidepressant with agonist like effects on 5-HT1A receptors, has been found to induce hyperglycemia, it has not heretofore been reported to induce glycolimia. Such a case is described.

Case study: A 60-year-old, left-handed (pathological) male presented with a past history of depression, minimally responsive to a variety of antidepressant medications, was begun on vilazodone, initially 20 mg and gradually increased to 60 mg a day. On 60 mg a day he noticed severe cravings for sweets, which he had never experienced prior to starting vilazodone. He found he had increased consumption, craving sweet foods including cookies and candy. For instance, in a typical day, he would eat eight Oreos, chocolate-covered graham crackers, one pint of ice cream a day, and he would crave sweets even after feeling satiated after consuming a meal. Along with this increased eating, he gained 20 pounds over the 3 months while on the vilazodone. Upon discontinuing the vilazodone, although the weight didn’t change, the sweet cravings resolved.

Abnormalities on: Neurological examination: Mental status examination: Immediate recall: able to remember 6 digits forwards and 3 digits backwards. Motor examination: Drift testing: right inward drift. Gait examination: unstable tandem gait. Neuropsychiatric examination: Go-No-Go test: 6/6 (normal). Animal Fluency Test: 22 (normal).

There are myriad mechanisms whereby vilazodone may have induced glycolimia. Possibly due to its antidepressant effects, it increased hedonics, generating appetitive behaviors, including enhanced socialization, sexual, and other consumptive behaviors, including eating. Peradventure it may have enhanced motivation and socialization. Along with socialization, there is escalation in social intercourse, with accompanying commensalism. Along with such consumptive behaviors, we could anticipate glycolimia. As a 5-HT1A receptor agonist, possibly vilazodone may have acted on the arcuate pro-opiomelanocortin neurons associated with hyperphagia, with modulation of energy homeostasis in the serotonin pathway. Alternatively, vilazodone may have triggered an enhanced insulin response with secondary reduction in blood sugar, leading to a homeostatic behavioral response of increased glucose intake. In those who are treated with vilazodone, query as to glycolimia is warranted and warning as to potential manifestations of hyperglycemia should be entertained.

No Funding