Exploring Esketamine's Therapeutic Outcomes as an FDA-Designated Breakthrough for Treatment-Resistant Depression and Major Depressive Disorder With Suicidal Intent: A Narrative Review.

The expansive spectrum of major depressive disorder (MDD) continues to pose challenges for psychiatrists to treat effectively. Oral antidepressant (OAD) medications that alter monoamine neurotransmitters, mainly selective serotonin reuptake inhibitors (SSRIs) and selective norepinephrine reuptake inhibitors (SNRIs), have been the mainstay of therapy for decades. Although these drugs have been largely beneficial, a considerable subset of patients do not respond adequately to multiple conventional therapies administered for an appropriate length of time, leading to a diagnosis of treatment-resistant depression (TRD). Ketamine, a non-monoaminergic drug, has long been known for its beneficial effects on TRD when given intravenously (IV). Between 2019 and 2020, an intranasal formulation of the S (+) enantiomer of racemic ketamine, esketamine (ESK), was granted "breakthrough designation" by the FDA and approved for the indications of TRD and MDD patients exhibiting acute suicidal intent. The objective of this narrative review was to review the academic literature and collect clinical evidence that may corroborate intranasal ESK's effectiveness for its approved indications while addressing its safety and tolerability profile, adverse effects, and impact on cognition. An overview of the drug's origins, pharmacology, and standard treatment regimen are provided. The outcomes from double-blinded randomized control trials (DB-RCTs) of ESK are outlined to demonstrate the efficacy and safety data leading to its FDA approval, along with its long-term post-market safety outcomes. Comparative trials between ESK and ketamine are then evaluated to highlight ESK's consideration as a more practical alternative to ketamine in common clinical practice. The authors further discuss currently approved and developing therapies for TRD, propose future research directions, and identify the inherent limitations of the review and further research. To conduct the research required, three digital databases (PubMed, Medline, and ClinicalTrials.gov) were queried to search for key terms, including ketamine, esketamine, treatment-resistant depression, and biomarkers, using automation tools along with selective search engine results. After streamlining the results by title and abstract and removing duplicates, a total of 37 results were chosen, of which 18 are clinical trials. A reduction in the Montgomery-Asberg Depression Rating Scale (MADRS) score was the primary efficacy endpoint for most of these clinical trials. In conclusion, intranasal ESK, when used as an adjunct to market OADs, shows greater efficacy in treating TRD and MDD with suicidal intent compared to OADs and placebo alone and provides a more suitable alternative to IV ketamine. It is important to note that further research is required to fully understand the novel mechanism of action of ESK, as well as the establishment of a consensus definition of TRD, which may facilitate better detection and treatment protocols. More focused quantitative and qualitative ESK studies are needed, as well as those pertaining to its use in patients with co-existing mental illnesses.

Provider perceived barriers and facilitators to integrating routine outcome monitoring into practice in an urban community psychiatry clinic: A mixed-methods quality improvement project.

BACKGROUND AND AIMS: Although mental health clinics are under increasing pressure to demonstrate value and routine outcome monitoring (ROM) has become a mandated component of care, providers have been slow to adopt ROM into practice, with some estimating that less than 20% of mental health clinicians use it consistently in the United States. This article explores perceived barriers and facilitators to integrating ROM into practice among clinicians and administrators in a large urban US community psychiatry clinic. METHOD: One hundred and thirty-eight clinical and administrative staff were administered an anonymous web-based survey to elicit attitudes towards ROM. Responses were summarized descriptively and qualitatively synthesized into a conceptual model using inductive thematic analysis. RESULTS: Common barriers to integration included insufficient time to collect and/or use measures, not knowing what measures to use, measures being difficult to access, and insufficient training. Facilitators included increased access/ease of use, training and support, measure relevance/validity, and accountability. CONCLUSIONS: In order for psychiatry clinics to successfully implement ROM into practice, they must diagnose organization-side barriers and translate this knowledge into actionable quality improvement initiatives ranging from the infrastructural to the cultural.

Sociodemographic and clinical correlates of the frequently hospitalized African American patients with severe and persistent mental illness.

BACKGROUND: Many researchers and clinicians are becoming increasingly concerned about the phenomenon of frequent psychiatric inpatient hospitalization in those with severe and persistent mental illness. This study aims to shed light on this occurrence in the African American psychiatric inpatient population by examining their sociodemographic and clinical correlates. METHODS: We retrospectively reviewed the medical charts of 39 African American patients who have had ≥3 inpatient psychiatric admissions in a year at Howard University Hospital, an urban, academically-affiliated hospital serving a predominantly African American population in Washington, DC. RESULTS: Most frequently readmitted African American inpatients were male (62%), unmarried (95%), homeless (62%), intoxicated at admission (90%), unemployed (97%), and age ≥35 (87%); expressed suicidal ideations (85%); had a DSM-5 diagnosis of a psychotic spectrum disorder (59%) and less than fair insight into their illness (56%); and stayed in the hospital for ≤4 days (82%). CONCLUSIONS: Many lessons can be learned from this study on African American psychiatric inpatient treatment recidivists, despite the work's limitations. Among these lessons are the need for strong case management, creative aftercare planning, and well-orchestrated, multifaceted services focused on these sociodemographic and clinical correlates- especially homelessness, unemployment, substance use, mood dysregulation, and psychosis-to successfully meet this patient populations' clinical needs.

Prevalence, Diagnosis, and Treatment Rates of Mood Disorders among Opioid Users under Criminal Justice Supervision.

BACKGROUND: Individuals involved in the criminal justice system have disproportionately high rates of psychiatric disorders when compared to the general U.S. POPULATION: If left untreated, the likelihood of subsequent arrest increases and risk for adverse health consequences is great, particularly among opioid users. OBJECTIVES: To explore the prevalence, characteristics, and treatment of mood disorders among justice involved opioid-dependent populations. METHODS: The current study enrolled 258 treatment-seeking opioid-dependent individuals under community-based criminal justice supervision (e.g., probation, parole) screened from the larger parent study, Project STRIDE, a seek/test/treat randomized control trial (RCT) examining HIV and opioid use treatment. During baseline, individuals were screened for depression using the Patient Health Questionnaire-9 (PHQ-9) and screened for bipolar disorder using the Mood Disorder Questionnaire (MDQ) tool. RESULTS: Overall, 78 (30%) participants screened positive for moderate to severe depression and 54 (21%) screened positive for bipolar disorder. Participants self-reported mood disorders at higher rates than they screened positive for these conditions. Participants screening positive for these conditions experienced significantly greater family, legal, and medical problems on the Addiction Severity Index-Lite (ASI-Lite) than those who did not screen positive. Incidence of a lifetime suicide attempt was found to be associated with a positive screen for both mood disorders. Prescribed psychotropic treatment utilization was similar among those who screened positive for depression or bipolar disorder with approximately 38% reporting taking medication. IMPORTANCE: Findings suggest universal mood disorder screening to improve comprehensive psychiatric care and treatment of opioid-dependent justice-involved individuals.

Illustrating and analyzing the processes of multi-institutional collaboration: Lessons learnt at Howard University Hospital.

Multi-institutional collaboration offers a promising approach to the dissemination of resources for capacity building and the improvement of the training of new investigators and residents, especially in areas of novel curricular content. Physicians should keep pace with the rapid growth of curricular content in an era of restricted resources. Such collaborations, in which educational entities work together and share resources and infrastructure, have been employed in health care to improve quality of care, capacity building, disparity reduction, and resident training. This paper examines a federally funded multi-institutional collaboration for the project STRIDE (Seek, Treat, Reach to Identify Pretrial Defendants Enhancement) between Yale University, George Mason University (GMU), and Howard University, a Historically Black University. The STRIDE study collaboration focused on mental health, opioid addiction, and infectious disease/HIV among Africans Americans involved in CJS (Criminal Justice System). We discuss some of the challenges and benefits of collaborative research projects conducted at Historically Black Colleges and University (HBCUs) and highlight the educational opportunities created by such collaborations for residents and other trainees, leading to the development of independent investigators through multi-institutional, structured collaborative research. We identify some unique challenges such as substance use, race, stigma, incarceration among participants, and the cultural and power difference between participating institutions, and thereby address these issues and how it impacted the course of the multi-institutional collaborative effort.

Physicochemical properties and characterization of chitosan synthesized from fish scales, crab and shrimp shells.

Chitosan is derived from different starting materials such as fish scales, shrimp and crab shells by the process of deacetylation of chitin, which is carried out using 40% KOH at 90°C for 6h. Prepared chitosan was characterized by Fourier transforms infrared spectroscopy, X-ray powder diffraction, Scanning electron microscope and Thermogravimetric analysis. Futher the physicochemical properties of chitosan like Fat binding capacity (FBC), water binding capacity (WBC), solubility, average molecular weight, ash content, moisture and degree of deacetylation of chitosan were also studied. Crystalline index (%) values of commercial, shrimp, crab and fish chitosan were found to be 96, 82, 88 and 84% respectively. The presence of amino group was confirmed from the FTIR spectra of chitosan synthesized. TGA results demonstrated the lower thermal stability of chitosan. Relatively smother surface and nano-fiber structures were observed from SEM analysis. The degree of deacetylation of chitosan from different sources such as shells of fish, shrimp and crab were found to be 75%, 78%, and 70% respectively. In a similar way the WBC and FBC of fish, shrimp and crab shells were found to be 492, 358 and 138% and 226, 246 and 138% respectively.

An Assessment of Five (PANSS, SAPS, SANS, NSA-16, CGI-SCH) commonly used Symptoms Rating Scales in Schizophrenia and Comparison to Newer Scales (CAINS, BNSS).

Scales measuring positive and negative symptoms in schizophrenia remain the primary mo Scales measuring positive and negative symptoms in schizophrenia remain the primary mode of assessing and diagnosing schizophrenia by clinicians and researchers. The scales are mainly used to monitor the severity of positive and negative symptoms and track treatment response in schizophrenics. Although these scales are widely used, quality as well as general utility of each scale varies. The quality is determined by the validity and reliability of the scales. The utility of the scale is determined by the time of administration and the settings for which the scales can be administered in research or clinical settings. There are relatively fewer articles on the utility of newer scales like CAINS (Clinical Assessment Interview for Negative Symptoms) and the BNSS (Brief Negative Symptom Scale) that compare them to the older scales PANSS (Positive and Negative Symptoms Scale), SAPS (Scale for the Assessment of Positive Symptoms) SANS (the Scale for the Assessment of Negative Symptoms), NSA-16 (Negative Symptom Assessment-16) and CGI-SCH (Clinical Global Impression Schizophrenia. The older scales were developed more than 30 years ago. Since then, our understanding of negative symptoms has evolved and currently there are newer rating scales evaluating the validity of negative symptoms. The older scales do not incorporate the latest research on negative symptoms. CAINS and BNSS are attractive for both their reliability and their concise accessible format, however, a scale that is simpler, accessible, user-friendly, that incorporates a multidimensional model of schizophrenia, addresses the psychosocial and cognitive component has yet to be developed.

Factors associated with non-adherence to Buprenorphine-naloxone among opioid dependent African-Americans: A retrospective chart review.

BACKGROUND AND OBJECTIVES: Opioid use disorders are common, chronic relapsing disorders. Buprenorphine (BUP) is an FDA approved medication in the treatment of opioid use disorders, but patient adherence to this medication remains a challenge. To identify risk factors for non-adherence, this chart review study examined the association between DSM-IV Axis I psychiatric disorders, substance use, demographics, and adherence to BUP-naloxone in African-American patients. METHODS: Charts were selected of patients who had ≥5 visits and completed psychometric screens (Patient Health Questionnaire, Mood Disorder Questionnaire, and a posttraumatic stress disorder questionnaire) at the time of the initial visit (N = 50). Urine drug screens (UDS) were also obtained. Treatment adherence was defined as BUP presence in UDS for ≥80% of the visits. RESULTS: A total of 48% of patients were adherent to treatment. Non-adherent patients had higher rates of use for not only opioids, but also cocaine, and alcohol. Cocaine use was associated with BUP-naloxone non-adherence even after controlling for opioid use. Attendance in cognitive behavioral group therapy sessions (CBT) was significantly associated with adherence. Patients endorsing PTSD symptoms showed higher adherence to treatment compared to those who did not endorse these symptoms. CONCLUSIONS AND SCIENTIFIC SIGNIFICANCE: Our results indicate that alcohol and illicit substance use is associated with non-adherence to BUP-naloxone treatment, and suggests that CBT and efforts to promote abstinence from non-opioid substance use may improve adherence among African-Americans. These findings contribute to growing literature on understanding adherence to BUP-naloxone, which is critical to reduce morbidity and mortality.

Safety and Quality Concerns Regarding Over-the-Counter Sexual Enhancement Products Sold in the USA Market Pose a Major Health Risk.

Safety and quality concerns regarding over the counter sexual enhancement products sold in the USA market pose a major health risk to the general public. Nevertheless, the use of herbal medicines continues to expand rapidly across world and many people perceive usage of herbal medication as a safe and reliable way to improve health outcome. The safety of herbal supplements has become a globally major concern in national and international health authorities due to increasing adverse events and adulterations associated with usage of herbal medications. These non FDA approved products with unknown ingredients are widely accessible for purchase ranging from local food, drug stores and to the internet. These Erectile Dysfunction (ED) pills may contain Sildenafil, the active ingredient of Viagra in much higher quantity then legally prescribed by a licensed physician or they may contain unknown quantities of Thiosildenafil, the active ingredient in Cialis. The types of chemicals found in these medications are making it harder for regulatory authorities to track them down. These products keep the consumer in the dark in terms of the quantity, ingredients, effectiveness and possible side effects. These sexual enhancement products are being sold as safe and natural with false hopes to resolve erectile dysfunction. Patients who are prone to impulsive hypersexual behavior such as patients with bipolar disorder, substance use, borderline personality disorder and those who may feel adamant to discuss erectile dysfunction with their physicians are more likely to become the victims of using illicit medications/ drugs with serious health risks consequences. We present a case report of an individual with bipolar disorder and hypersexual behavior who became victim to over the counter sexual enhancement products/supplements which caused serious health and life threatening consequences.