Treatment of attention deficit hyperactivity disorder (ADHD) includes pharmacological and non-pharmacological interventions, both of which have demonstrated short-term efficacy. While efficacious, there are limitations to both modalities of treatment. Due partly to these limitations, there has been considerable interest in additional approaches to augmenting ADHD management. Digital therapeutics may offer improved access, minimal side effects, and low potential for abuse, while providing targeted treatment options for improving cognitive functions such as attention. AKL-T01 (EndeavorRx®) is the first and only FDA-cleared nonpharmacological prescription digital therapeutic delivered through a video game interface for the treatment of ADHD.

The objective is to summarize the data from a clinical trial in support of FDA clearance using AKL-T01 adjunctively in children currently taking stimulant medication for ADHD.

The STARS-Adjunct Trial was a multicenter, 12-week, open-label study of AKL-T01 in 206 children aged 8 to 14 years with a confirmed diagnosis of primarily inattentive or combined-type ADHD. The study included two cohorts: (1) subjects currently treated with ADHD medication (n=130) and (2) subjects not on any ADHD medication (n=76). Subjects had an ADHD Impairment Rating Scale (IRS) score ≥3 at baseline, and both cohorts used AKL-T01 for approximately 25 minutes per day, 5 days per week, over two 4-week treatment periods separated by a 4-week treatment pause.

AKL-T01 significantly improved (lowered) ADHD-related impairment as measured with the IRS (clinician rated) after the first 4-week treatment in both cohorts (P< 0.001). Results show that effects persist during a 4-week treatment pause and further improve with a second 4-week treatment period. A majority of parents and children indicated a perceived improvement in ability to pay attention after the trial. Most common device-related adverse events were decreased frustration tolerance, headache, and irritability which ranged from mild to moderate. No serious adverse events were reported.

This study adds to and extends the clinical evidence base for AKL-T01, a video game-based treatment for improving attentional functioning in 8–12-year-old children with ADHD. Continued evaluation of the effects of AKL-T01 on other important aspects of functioning, like academic and social functioning, health utilization, and health outcomes, would continue to add to the evidence base that the effects observed in this and previous studies have substantial clinical and functional impact.

Akili Interactive

Priming stimulation, which involves high-frequency repetitive transcranial magnetic stimulation (rTMS) followed by low-frequency, has been shown to enhance neural response and is one of the novel paradigms found beneficial in adult patients with depression and has not been studied in late-life depression (LLD). This study aims to compare the effect of adjunctive priming vis-a-vis no priming rTMS over right dorso-lateral prefrontal cortex (DLPFC), on treatment of LLD.

This trial is registered in Clinical Trial Registry-India (CTRI) on www.ctri.nic.in. CTRI registration number: CTRI/2020/08/027230. Forty patients of LLD who are symptomatic after an adequate antidepressant trial will be randomized into 2 groups (active priming and sham priming rTMS); each receiving 10 sessions of rTMS over 2 weeks. Patients will remain blind to treatment allocation. Assessments will be done using Hamilton rating scale for depression, Geriatric Depression Scale, Hamilton rating scale for Anxiety, Somatic Symptom Severity Scale 8, Hindi Mental Status Examination, and Clinical Global Impression scale at baseline, week 1, 2, and 4. Side effect checklist will be applied after each session in both groups and at the end of 4 weeks.

Data will be analyzed using statistical software Statistical Package for Social Sciences. Both the groups (active and sham groups) will be compared at the four given timepoints. Also, the baseline characteristics will be compared with the 3 follow-up points for any change.

The findings of the study will give an insight to the possible role of priming to augment the effect of low-frequency rTMS in LLD.

Patients with a severe mental illness such as bipolar I disorder (BP-I) have a higher prevalence of obesity and related metabolic comorbidities than the general population. This study evaluated the impact of cariprazine on weight and blood pressure in patients with BP-I depression using electronic medical records (EMRs) from a nationally representative database.

Analyses were based on data from EMRs in the Symphony Health’s Integrated Dataverse® from March 2015 to October 2018. Patients ≥18 years of age with ≥2 cariprazine fills (first dispensing=index date) and clinical activity for ≥12 months pre-index (baseline) and ≥1 month post-index were included. Patients also had a diagnosis of BP-I depression at their most recent episode prior to cariprazine initiation. The on-treatment period spanned from the index date to the earliest of cariprazine discontinuation, a switch to another atypical or long-acting injectable antipsychotic, end of clinical activity, or end of data. Metabolic outcomes of interest were weight and blood pressure (systolic and diastolic). For each outcome, patients were required to have ≥1 measurement in both the baseline and on-treatment periods. Linear trajectories during those periods were estimated using mixed-effects models; 95% confidence intervals (CIs) were calculated using non-parametric bootstrap procedures.

In total, 1702 patients who met study eligibility criteria had ≥1 weight measurement recorded in the baseline and on-treatment periods; of these patients, 178 had bipolar I depression as their most recent episode. Patients gained an average of 2.43 kg/year during the baseline period and 0.60 (95% CI: -1.97, 3.70) kg/year during the on-treatment period. Analyses of blood pressure change (n=179) showed that cariprazine had neutral effects over the on-treatment period. Patients’ systolic blood pressure increased at 1.12 mmHg/year during baseline and decreased at -0.63 (95% CI: -3.59, 2.25) mmHg/year during the on-treatment period. For diastolic blood pressure, increases of 0.25 mmHg/year during baseline and 0.44 (95% CI: -1.65, 2.16) mmHg/year during the on-treatment period were observed.

Although patient weight was increasing prior to cariprazine initiation, a neutral weight trajectory was seen with long-term cariprazine treatment among those with a most recent BP-I depression episode. Cariprazine also had minimal impact on systolic or diastolic blood pressure. Overall, these findings are consistent with prior short- and long-term studies showing that cariprazine has a neutral weight and metabolic profile.

AbbVie

Although English Chinese translators receive high salaries, their mental abilities are overwhelmed during long-term cross-cultural translation. In addition, the requirements for translation submission time and quality make them face long-term pressure, and over time, they develop anxiety disorders, mainly manifested as sleep disorders. To address this issue, research has added psychological intervention therapy to traditional drug therapy and used a combination of treatment strategies to treat anxiety disorders.

100 English Chinese translators with anxiety disorders were randomly divided into two groups: Group C and Group D. Group C received drug therapy, while Group D received psychological intervention in addition to drug therapy. The experiment lasted for 3 months and their psyche was evaluated by Hamilton Anxiety Scale and data treatment was analyzed using SPSS 21.0. Metrics were indicated in the shape of average ± criterion variation and t-test was used.

The Hamilton scale score of Group D was 25.52 ± 1.15 before the intervention, and 7.06 ± 0.88 after the intervention; Before the intervention, the score of Group C was 25.47 ± 1.06, and after the intervention, it was 14.03 ± 1.55. Overall, the combination of drug therapy and psychological intervention has a better therapeutic effect.

English Chinese translators often exhibit anxiety disorders such as neurotic tension and sleep disorders in cross-cultural translation, and the combination of psychological intervention strategies in drug therapy is effective in treating their anxiety disorders.

Major depressive disorder (MDD) is a common neuropsychiatry disorder with high prevalence and recurrence rate, but the misdiagnosis rate is inevitable due to the shortage of objective laboratory-based diagnostic criteria. This study is focused on the disturbance of lipid metabolism, providing potential biomarkers for diagnosing.

Lipid metabolism-related molecules in plasma of 42 drug-naïve MDD patients and 49 healthy people were measured by liquid chromatography-mass spectrometry. Further to evaluate the diagnostic values of changed metabolites, these molecules were evaluated by the receiver operating characteristic curve. Based on the significant role of phosphatidylcholine (PC) disturbance in depression, oxidization of PCs, oxidation of 1-palmitoyl-2-arachidonoyl-sn-glycero-3-phosphocholine (OxPAPC), IL-8 and caspase-3 in hippocampus, and serum of chronic lipopolysaccharide (cLPS) depression mice were detected by ELISA.

Compared with healthy control, MDD patients expressed higher 1,2-dipalmitoyl-sn-glycero-3-phosphocholine (16:0-16:0 PC, DPPC), 1-palmitoyl-2-arachidonoyl-sn-glycero-3-phosphocholine (16:0-20:4 PC, PAPC), 1-palmitoyl-2-stearoyl-sn-glycero-3-phosphocholine (16:0-18:0 PC), glycocholic acid, taurocholic acid, glycoursodeoxycholic acid, and chenodeoxycholic acid glycine conjugate, and lower 1-heptadecanoyl-2-hydroxy-sn-glycero-3-phosphocholine (LPC 20:0). The 16:0-20:4 PC showed the great diagnostic value for MDD with an area under the curve (AUC) of 0.9519, and combination of 16:0 PC, 16:0-18:0 PC, and 16:0-20:4 PC exhibited the highest diagnostic value with AUC of 0.9602. OxPAPC was certified increase in hippocampus and serum of cLPS depression mice, which further supported PCs disorder participated in depression.

This research offers 16:0-20:4 PC as the latent diagnostic indicator for MDD and hints the important role of PCs in depression.

With the increasing academic pressure on students, students have become a large group of anxiety patients. Some studies have shown that Huayu Changshen Formula can relieve the stagnation of liver qi in patients, and has high application value in the clinical treatment of anxiety disorders. In order to improve its treatment effect on students with anxiety disorder, the study proposed a combined treatment method of Huayu Changshen Formula and ideological and political psychological intervention to improve the diagnosis and treatment level of students with anxiety disorder.

A total of 86 students with anxiety disorders from February 2020 to November 2020 were retrospectively analyzed. All patients were randomly divided into the experimental group and the control group. The patients in the experimental group were treated with the combination of Huayu Changshen Formula and ideological and political psychological intervention, and the patients in the control group were treated with paroxetine. The treatment lasted for 10 weeks. Before and after the treatment, Hamilton Anxiety Scale (HAHA) was used for scoring to understand the anxiety level of patients. The symptom scale of liver qi stagnation syndrome was used to score the patient’s condition. All data were analyzed by SPSS24.0 software.

Before treatment, there was no significant difference in HAHA score and Traditional Chinese Medica (TCM) symptom score between the two groups; After treatment, the HAHA scores of the patients in the experimental group and the control group decreased to about 7.88 and 12.39 respectively, and the TCM symptom scores of the patients in the experimental group decreased by about 4.86 points compared with the control group. The difference between the two groups of patients was statistically significant (P < 0.05). The observation of the overall efficacy of the two groups of patients showed that the recovery rate of the experimental group patients reached 28.78%, which was 24% higher than that of the control group. The overall efficacy difference between the two groups was statistically significant (P < 0.05).

The combined treatment of Huayu Changshen Formula and ideological and political psychological intervention has improved the overall treatment level of anxiety disorder, and its therapeutic effect is far better than that of paroxetine, which can significantly improve students’ anxiety disorder, and can be popularized in the clinical treatment of anxiety disorder.Table 1.

Changes in patients’ HAHA score and TCM symptom score before and after the treatment

The research is supported by: Jiangsu Postgraduate Research and Practice Innovation Program: Marx’s Thought of Civil Society and Its Contemporary Value (No. KYCX22_1694).

Tardive dyskinesia (TD) is a persistent and potentially disabling movement disorder associated with exposure to antipsychotics and other dopamine receptor blocking agents. Effective and comprehensive treatment of TD requires reducing patients’ abnormal involuntary movements without disrupting their psychiatric stability. This can be especially challenging when patients have complex psychiatric conditions (e.g., >1 psychiatric diagnosis) and are taking multiple medications. Valbenazine, a highly potent and selective vesicular monoamine transporter 2 (VMAT2) inhibitor, is approved for the once-daily treatment of TD. This post hoc analysis of two long-term studies (KINECT 3, KINECT 4) was conducted to evaluate changes in psychiatric status and clinician- and patient-reported treatment success in study participants who received valbenazine (40 or 80 mg) for 48 weeks.

Data from KINECT 3 and KINECT 4 were pooled and analyzed in participants categorized by their primary psychiatric diagnosis: schizophrenia/schizoaffective disorder (“SCHZ”) or mood disorder (“MD”). Concomitant medications needed for managing these and other psychiatric or medical conditions were allowed. Treatment success was defined as achieving a rating of “much improved” or “very much improved” at Week 48, as assessed using the Clinical Global Impression of Change-Tardive Dyskinesia (CGI-TD) and Patient Global Impression of Change (PGIC). Psychiatric stability was monitored using the following scales: Positive and Negative Syndrome Scale (PANSS) and Calgary Depression Scale for Schizophrenia (CDSS) in the SCHZ subgroup; Young Mania Rating Scale (YMRS) and Montgomery-Åsberg Depression Rating Scale (MADRS) in the MD subgroup. Suicidal ideation/behavior was monitored using the Columbia-Suicide Severity Rating Scale.

More than 75% of study participants in the SCHZ subgroup achieved treatment success with valbenazine, based on clinician assessment (CGI-TD, 79.7%) and patient self-report (PGIC, 78.0%). Mean changes from baseline to Week 48 for PANSS scores (positive symptoms [-0.7], negative symptoms [‑0.6], general psychopathology [-1.9], total [-3.2]) and CDSS total score (-0.5) indicated maintenance of psychiatric stability in the SCHZ subgroup. Similar treatment success rates were found in the MD subgroup for both CGI-TD (77.6%) and PGIC (84.5%), with mean changes from baseline in YMRS total score (-1.0) and MADRS total score (+0.3) indicating psychiatric stability was maintained. No emergence of suicidal ideation/behavior was observed during the studies.

Pooled analyses from two 48-week studies indicate that long-term treatment of TD with once-daily valbenazine resulted in substantial clinician- and patient-reported global improvements in TD, while psychiatric stability was maintained regardless of primary psychiatric condition.

Neurocrine Biosciences, Inc.

Depression is a common psychiatric disease, which has become one of the main causes of the loss of healthy life years. According to the survey, up to 50% of the patients with depression are school students. Depression mainly depends on drug therapy, psychological intervention and physical therapy. In recent years, exercise therapy has become an economical and environment-friendly intervention mode for depression due to its advantages of high compliance and few side effects. The teaching of theoretical mechanics can mobilize students’ enthusiasm for learning, promote their deep thinking and arouse their curiosity to explore the unknown, and have a certain role in relieving students’ mental pressure. Therefore, based on theoretical mechanics teaching, the study used exercise therapy to intervene in students’ depression, aiming to explore effective methods to improve students’ depression, and explore the changes in neurobiological mechanism of exercise intervention combined with theoretical mechanics teaching in the treatment of depression.

60 students suffering from depression were randomly selected and divided into three groups, 20 students in each group. In group A, exercise combined with theoretical mechanics teaching was used for the intervention treatment of students with depression. In group B, only theoretical mechanics teaching was used for intervention treatment, while in group C, no intervention treatment was used. The three groups of experiments were performed with the same exercise intensity, exercise frequency, and exercise volume. Then record and sort out the main neurobiological mechanisms such as nerve cells and neurotransmitters that have changed during the treatment of depression. The experiment lasted for 12 weeks. In addition, the experiment used literature, observation and other experimental methods to collate and analyze data information.

The study found that exercise combined with theoretical mechanics teaching has the best performance effect in treating students’ depression. The intervention intensity is usually 50% - 85% of the maximum heart rate, and the recommended exercise frequency is 3-5 times/week. The neurobiological mechanism of exercise intervention on students’ depression based on theoretical mechanics teaching is shown in Figure 1 below.Figure 1.

Neurobiological mechanism of exercise intervention on students’ depression based on theoretical mechanics teaching

As shown by the arrow in Figure 1, it has a promoting effect. According to research, the neurobiological mechanism of exercise combined with theoretical mechanics teaching in the treatment of depression is mainly manifested in regulating cytokine production, mediating microRNA expression, increasing neurotransmitter release, maintaining mitochondrial function, and reducing apoptosis of hippocampal neurons.

This study verified that exercise intervention combined with theoretical mechanical therapy has a certain relieving effect on students’ depression. At the same time, it was found in this treatment process that the neurobiological mechanism of exercise combined with theoretical mechanics in the intervention of depression was mainly to regulate the expression of cytokines and mediating microRNA, release of neurotransmitters, inhibit the inflammatory pathway, maintain the mitochondrial function, and reduce the apoptosis of hippocampal neurons.

The research is supported by: “Science and Technology Project of China Railway Corporation, China (Grant No. 1341324011)”.

Graduate students, as highly intelligent individuals, are more likely to experience mania during their studies than the general population. They are affected by learning pressure, environmental factors, and other factors and manifested as high spirits and irritability. Art therapy, as a relatively effective treatment method, is often used for psychological intervention and treatment. Therefore, this study innovatively constructs music courses from the perspective of ideological and political education to alleviate graduate students’ mania.

Fifty graduate students with mania from a certain university were selected as the research subjects and randomly divided into Group A and Group B. Group A used traditional treatment methods, while Group B added innovative music courses to the traditional treatment methods for combined treatment. After the experiment, the data were processed and analyzed using SPSS 20.0.

After the combination of results and intervention treatment, the overall compliance rate of student patients reached 98%, significantly higher than 60% in Group A; In the quality of life score, the social function score of Group B was 65.95 ± 4.20, the mental health score was 64.54 ± 4.89, and the psychological function score was 67.39 ± 5.14, all of which were higher than those of Group A.

From the perspective of ideological and political education in the curriculum, the innovative construction of music courses has an effective alleviating effect on graduate students’ mania.

Guangxi academic degree and postgraduate education reform project (No. JGY2021162).

Mania is a common psychological disease, which is often treated with drugs in clinical practice, but the effect of conventional nursing intervention is not significant. Therefore, this study tries to intervene manic students through predictive nursing and psychological education.

From March 2020 to March 2021, 116 manic students who entered our hospital for treatment were selected as research subjects. They were randomly divided into a routine intervention group and a joint intervention group, each containing 58 manic students. The routine intervention group was given routine nursing care in the psychiatric department of our hospital. The joint intervention group was intervened through predictive nursing and psychological education. The intervention effect was evaluated by the Bech Rafaelsdn Mania Rating Scale (BRMS) and the Global Assessment Scale (GAS).

Before the intervention, there was no significant difference in BRMS and GAS scores between the two groups (P > 0.01). After the intervention, the BRMS score of the joint intervention group was significantly lower than that of the control group, and the GAS score was significantly higher than that of the control group, and the difference was statistically significant (P < 0.01). Table 1 shows the comparison of BRMS and GAS scores between the two groups of manic students before and after the intervention.Table 1.

Comparison of BRMS and GAS scores before and after intervention

This study proved that the intervention effect of predictive nursing combined with psychological education on manic students was significant. This therapy can effectively reduce the onset of mania and improve the treatment compliance of patients by changing students’ psychological cognition. This study is of great significance to the psychological intervention of manic students.