A Novel Approach to Monitoring Cognitive Adverse Events for Interventional Studies Involving Advanced Dementia Patients: Insights From the Electroconvulsive Therapy for Agitation in Dementia Study.

OBJECTIVE: To develop an individualized method for detecting cognitive adverse events (CAEs) in the context of an ongoing trial of electroconvulsive therapy for refractory agitation and aggression for advanced dementia (ECT-AD study). METHODS: Literature search aimed at identifying (a) cognitive measures appropriate for patients with advanced dementia, (b) functional scales to use as a proxy for cognitive status in patients with floor effects on baseline cognitive testing, and (c) statistical approaches for defining a CAE, to develop CAEs monitoring plan specifically for the ECT-AD study. RESULTS: Using the Severe Impairment Battery-8 (SIB-8), baseline floor effects are defined as a score of ≤5/16. For patients without floor effects, a decline of ≥6 points is considered a CAE. For patients with floor effects, a decline of ≥30 points from baseline on the Barthel Index is considered a CAE. These values were derived using the standard deviation index (SDI) approach to measuring reliable change. CONCLUSIONS: The proposed plan accounts for practical and statistical challenges in detecting CAEs in patients with advanced dementia. While this protocol was developed in the context of the ECT-AD study, the general approach can potentially be applied to other interventional neuropsychiatric studies that carry the risk of CAEs in patients with advanced dementia.

Electroconvulsive Therapy in Heart Transplant Patients: To Avoid or Embrace?

ABSTRACT: Patients with heart disease are at an increased risk of depression. Electroconvulsive therapy (ECT) is a highly effective treatment for severe depressive episodes. However, ECT may increase the risk for adverse outcomes in certain patients because of changes in blood pressure and heart rate secondary to an initial parasympathetic surge followed by a sympathetic surge and peripheral catecholamine release. In post-cardiac transplant patients, these acute hemodynamic changes on a denervated heart may bring clinical challenges. The available data on ECT in heart transplant patients are limited. The authors of this article present a summary of the available literature relating to ECT in heart transplant patients.The authors performed a literature search of 6 online databases yielding 6 English-language case reports of ECT in cardiac transplant patients. All patients experienced changes in hemodynamic variables during and immediately after ECT, ranging from moderate decrease in blood pressure to extreme hypertension. The cases did not report any serious cardiac complications during the course of ECT. In the 5 patients whose psychiatric responses to treatment were detailed, all had improvement in their depressive symptoms. Electroconvulsive therapy may be considered for severe cases of depression in patients with a history of cardiac transplant, but the potential benefit of ECT needs to be weighed against risks. In the limited number of cases reported in the literature, ECT seems to have been relatively safe and effective.

Differences in clinical presentations of patients seeking care for treatment-resistant depression across sexual orientations and gender identities.

BACKGROUND: Sexual and/or gender minority (SGM) individuals experience higher rates and greater severity of depressive disorders than non-SGM persons. SGM individuals are more likely than non-SGM individuals to seek mental health treatment and to present to treatment with unique characteristics that should be accounted for when considering treatment recommendations. Patients seeking care for treatment-resistant depression (TRD) are offered a variety of evidence-based interventions ranging in modality and invasiveness (eg, psychotherapy and neuromodulation). METHODS: The current study used data from a TRD clinical research program to examine whether SGM (N = 52) and non-SGM (N = 202) patients differed in their clinical presentations and the treatment recommendations offered to them. RESULTS: We found that SGM patients were younger, had a more severe history of childhood trauma, and reported greater current suicidality than non-SGM patients. There were no significant differences in treatment recommendations between groups. CONCLUSIONS: This study adds to nascent literature investigating clinical characteristics of SGM populations seeking mental health care and provides foundational evidence for the unique treatment considerations necessary for SGM individuals seeking treatment for TRD. Research into whether treatment outcomes differ for SGM and non-SGM individuals with TRD is encouraged, given clinical differences in trauma history and suicidality.

Acute and Prophylactic Management of Postictal Agitation in Electroconvulsive Therapy.

ABSTRACT: Postictal agitation (PIA) is a common adverse effect of electroconvulsive therapy (ECT), a treatment used for a variety of psychiatric disorders. Because of risk of harm to patients and health providers when patients develop PIA, its acute management and prophylaxis are of vital importance for ECT practitioners. This article describes PIA risk factors, as well as practical steps to manage this ECT complication. Nonpharmacologic patient safety interventions are critical components of PIA management. Benzodiazepines, antipsychotics, and additional anesthetic doses are discussed as acute treatment interventions. Prophylactic pharmacologic choices described include antipsychotics, postseizure anesthetics, and dexmedetomidine. Exploratory choices such as melatonin and intranasal formulations of sedatives are also discussed. This review suggests that common medication like olanzapine and propofol are cost-effective considerations to decrease PIA incidence and/or severity after ECT. In addition, dexmedetomidine presents a management alternative for treatment-resistant PIA. This literature review outlines treatment choices while suggesting future directions for considering effective treatments of postictal agitation in clinical settings.

Psychometric Properties of the Chinese Version of the ElectroConvulsive Therapy Cognitive Assessment: An Electroconvulsive Therapy-Specific Cognitive Screening Tool.

OBJECTIVES: Electroconvulsive therapy (ECT) is an effective somatic treatment, but it may be limited by cognitive adverse effects. The existing cognitive screening instruments often lack specificity to ECT-associated cognitive deficits. The ElectroConvulsive Therapy Cognitive Assessment was developed and validated in a clinical setting, but the reliability and validity of the Chinese version of ElectroConvulsive Therapy Cognitive Assessment (ECCA-C) have not been studied in a large clinical sample. METHODS: The ECCA-C and the Montreal Cognitive Assessment (MoCA) were administered to patients with major depressive disorder (MDD) undergoing ECT at 3 time points: pretreatment (baseline), before the fifth treatment, and 1 week posttreatment. The instruments were also administered to a sample of healthy subjects. RESULTS: Sixty-five patients with MDD and 50 age- and sex-matched healthy controls were recruited in this study. Overall, the patient group had statistically significantly lower MoCA and ECCA-C scores than the control group (both P values <0.001). The Cronbach α of the ECCA-C was 0.88 at baseline. Statistically significant decreases over time were observed in ECCA-C: pre-ECT (23.9 ± 4.0) > mid-ECT (21.3 ± 3.4) > post-ECT (18.7 ± 4.8) (all P values <0.001), whereas no statistically significant changes in MoCA scores were found at these 3 time points (F = 1.86, P = 0.165). A cutoff score of 26.5 on the ECCA-C was found to best differentiate between MDD patients and healthy controls. CONCLUSIONS: The ECCA-C showed satisfactory psychometric properties and may be a more sensitive instrument than the MoCA to assess cognitive impairment associated with ECT.

The Use of ECT in the Elderly-Looking Beyond Depression.

PURPOSE OF REVIEW: We reviewed recent evidence on the use of electroconvulsive therapy (ECT) in the geriatric population. This review looked at the literature on depression, for which there is a breadth of data, as well as other conditions that have historically not been as well studied, as well as attempting to provide practical recommendations for ECT practitioners. This review also examined the impact of the COVID-19 pandemic on ECT in the elderly. RECENT FINDINGS: ECT shows robust efficacy across many psychiatric diseases, from depression and bipolar disorder to psychosis and catatonia. It has also shown positive results at improving behavioral symptoms of dementia, as well as improving motor symptoms seen in Parkinson's disease. It is routinely found to be a safe treatment as well, generally with only minimal transient side effects. ECT should not be considered a "last-resort" treatment for geriatric patients suffering from psychiatric disorders. It has historical and recent literature supporting its use in many psychiatric disorders and has been shown to be safe with minimal side effects when appropriate considerations are taken for the elderly population.

The Cardiovascular Side Effects of Electroconvulsive Therapy and Their Management.

ABSTRACT: Electroconvulsive therapy (ECT) remains stigmatized in the broader medical community because of misunderstandings about treatment procedures, mortality rates, and cardiovascular complications. Electroconvulsive therapy causes periprocedural hemodynamic variability because of the surges in parasympathetic and sympathetic nervous systems after the administration of the electrical charge. Patients experience an increase in cardiac workload, which is potentially dangerous for patients with preexisting heart disease. Several findings suggest that cardiac complications occur most frequently in patients with underlying cardiovascular disease. We describe the cardiovascular complications that may result from ECT treatment and offer insight on how to mitigate these concerns if they occur. PubMed was queried using terms "electroconvulsive therapy" and "cardiovascular adverse effects." A table is provided with the common cardiovascular side effects of ECT and the most recent evidence-based treatment strategies to manage them. Generally, ECT is a safe procedure in which complications are minor and manageable. Most major complications caused by ECT are related to the cardiovascular system; however, with an appropriate pre-ECT evaluation and a comprehensive multidisciplinary team approach, the cardiovascular complications can be well managed and minimized. Providing proper cardiac clearance can prevent cardiac complications and provide timely care to treatment-resistant populations who are at risk for excessive morbidity and suicide.

Ultrabrief Right Unilateral Electroconvulsive Therapy for the Treatment of the Neuropsychiatric Symptoms of Dementia with Lewy Bodies.

OBJECTIVES: Dementia with Lewy bodies (DLB) is a debilitating disorder associated with a number of distressing neuropsychiatric symptoms. There is currently limited guidance regarding the most effective strategies of managing these symptoms, and both pharmacologic and nonpharmacologic strategies are often used. Electroconvulsive therapy (ECT) has been reported as a potential nonpharmacologic method to alleviate some of these debilitating neuropsychiatric symptoms. However, there remains a paucity of evidence in current literature. This report aims to add to existing literature regarding ECT in DLB by highlighting successful treatment in seven cases. METHODS: Our study is a retrospective case series of 7 patients with DLB who received treatment with ultrabrief (UB) right unilateral (RUL) ECT for the treatment of agitation and depressive symptoms. Participants included patients with a diagnosis of DLB who were admitted to Emory University Hospital at Wesley Woods from 2011 to 2020 presenting with agitation and/or depressive symptoms after failing pharmacologic intervention. Patients underwent UB RUL ECT administered by a board-certified psychiatrist. After treatment, Pittsburg Agitation Scale and Clinical Global Impression-Improvement scales were recorded as measures of agitation and clinical improvement, respectively. RESULTS: All 7 patients responded to UB RUL ECT with marked improvement in their presenting symptoms of agitation and/or depression without significant adverse effects from treatment. CONCLUSIONS: Ultrabrief RUL ECT seems to be a safe and effective treatment of the agitative and depressive features of DLB.

Simulated Electroconvulsive Therapy: A Novel Approach to a Control Group in Clinical Trials.

OBJECTIVES: Agitation is the most common behavioral symptom of Alzheimer disease (AD) affecting approximately 40% to 60% of the AD population, yet there are no Food and Drug Administration-approved therapies for the myriad of behavioral or psychological symptoms of dementia. There is growing evidence from naturalistic studies that electroconvulsive therapy (ECT) is a safe and effective treatment for agitation in AD patients who are refractory to pharmacotherapy and behavioral interventions. Despite the existing evidence, ECT remains underused because of stigma, lack of education, and concerns regarding adverse cognitive effects. Randomized controlled clinical trials of ECT are an opportunity to provide high-quality evidence of ECT as a safe and efficacious treatment for agitation in the AD population. We describe the methods for the Electroconvulsive Therapy in Alzheimer's Dementia study, which uses a novel, simulated ECT (S-ECT) control group to conduct a single-blind efficacy study of ECT for the treatment of agitation and aggression in individuals with moderate to severe AD. METHODS: We discuss the rationale, study design, methodology, ethical and practical challenges, and management strategies in using an S-ECT group as the comparator arm in this randomized controlled trial of ECT in AD-related treatment refractory agitation and aggression. CONCLUSIONS: Validation of the safety and efficacy of ECT in patients with advanced AD with refractory agitation and aggression is necessary. This can be accomplished through creative formulation of S-ECT groups that effectively maintain the blind while providing scientific integrity.

Emotional Resilience of Older Adults during COVID-19: A Systematic Review of Studies of Stress and Well-Being.

OBJECTIVES: To examine post-traumatic stress, depression, anxiety, and well-being in older adults under quarantine. METHODS: A systematic review of CINAHL, Ovid EBM Reviews, Ovid Embase, Ovid Medline, Ovid PsycINFO, Scopus, and Web of Science from 2000 to 2020 was conducted. Keywords included coronavirus, epidemic, quarantine, stress, mental health, and similar terms. Included studies enrolled participants under quarantine, quantitatively measured mental health or well-being, and characterized outcomes by age. RESULTS: Of 894 initial results, 20 studies met the criteria and were included. Studies comprise 106,553 participants from eight countries, ages 6-100, two epidemics (COVID-19, SARS), and 27 assessment tools. One study found greater distress in older adults relative to younger adults, one found no significant differences, and 18 found lower negative outcomes in older participants in at least one metric. CONCLUSIONS: Older adults in this review generally have lower stress and less negative emotions under quarantine than younger adults. It is unknown how this compares to pre-pandemic measures. More representative and longitudinal studies are needed to measure the impact of quarantine on the mental health of older adults. CLINICAL IMPLICATIONS: As existing scales may not capture the full extent of pandemic psychological effects on older adults, clinicians must vigilantly monitor older adults' mental health.

Exploring Nonmotor Neuropsychiatric Manifestations of Parkinson Disease in a Comprehensive Care Setting.

Parkinson disease (PD) is a debilitating neurological condition that includes both motor symptoms and nonmotor symptoms (NMS). Psychiatric complaints comprise NMS and are collectively referred to as neuropsychiatric manifestations. Common findings include atypical depressive symptoms, anxiety, psychosis, impulse control disorder, deterioration of cognition, and sleep disturbances. Quality of life (QoL) of patients suffering from NMS is greatly impacted and many times can be more debilitating than motor symptoms of PD. We expand on knowledge gained from treatment models within a comprehensive care model that incorporates multidisciplinary specialists working alongside psychiatrists to treat PD. Insight into background, clinical presentations, and treatment options for patients suffering from neuropsychiatric manifestations of PD are discussed. Identifying symptoms early can help improve QoL, provide early symptom relief, and can assist tailoring treatment plans that limit neuropsychiatric manifestations.

Efficacy and Safety of ECT for Behavioral and Psychological Symptoms of Dementia (BPSD): A Retrospective Chart Review.

OBJECTIVE: Much of the functional disturbance in patients with dementia reflects the presence of noncognitive behavioral and psychological symptoms of dementia (BPSD). Agitation is among the most distressing symptoms for patients, clinicians, and caregivers. Currently no pharmacotherapy has clearly been shown to be of value for this condition. This study used a chart review method to examine the safety and efficacy of electroconvulsive therapy (ECT) for patients with dementia receiving ECT for agitation. METHODS: A retrospective chart review was conducted of patients with dementia presenting with symptoms of aggression or agitation and who received ECT treatments. Aggression and agitation were measured by pre- and post-ECT Pittsburg Agitation Scale (PAS) scores. Detailed history of the use of psychotropic medications as well as other clinically relevant variables was analyzed. FINDINGS: Sixty elderly patients (45 women and 15 men, 75% female, mean age 77.5 ± 8.0 years) were included in the analysis. Most patients were treatment resistant to multiple psychotropic medications prior to ECT (mean number 6.1±1.5). The baseline PAS total was 9.3 ± 3.7 and it decreased significantly after three (2.5±2.8) and six (1.5±2.3) ECT treatments. No significant ECT-related medical complications were observed except transient confusion. A decrease in the number of psychotropics prescribed along with an increase in the GAF score was observed after the ECT treatment course. CONCLUSION: ECT was safe in this sample of patients who had co-morbid medical conditions. ECT was associated with the following observations: 1) a reduction in agitation; 2) a reduction in psychotropic polypharmacy; and 3) an improvement in global functioning level. Further research evaluating the effects of ECT in the setting of dementia is warranted.

Electroconvulsive Therapy Practice Changes in Older Individuals Due to COVID-19: Expert Consensus Statement.

The ubiquitous coronavirus 2019 (COVID-19) pandemic has required healthcare providers across all disciplines to rapidly adapt to public health guidelines to reduce risk while maintaining quality of care. Electroconvulsive therapy (ECT), which involves an aerosol-generating procedure from manual ventilation with a bag mask valve while under anesthesia, has undergone drastic practice changes in order to minimize disruption of treatment in the midst of COVID-19. In this paper, we provide a consensus statement on the clinical practice changes in ECT specific to older adults based on expert group discussions of ECT practitioners across the country and a systematic review of the literature. There is a universal consensus that ECT is an essential treatment of severe mental illness. In addition, there is a clear consensus on what modifications are imperative to ensure continued delivery of ECT in a manner that is safe for patients and staff, while maintaining the viability of ECT services. Approaches to modifications in ECT to address infection control, altered ECT procedures, and adjusting ECT operations are almost uniform across the globe. With modified ECT procedures, it is possible to continue to meet the needs of older patients while mitigating risk of transmission to this vulnerable population.

Considerations and Current Trends in the Management of the Geriatric Patient on a Consultation-Liaison Service.

PURPOSE OF REVIEW: To provide consultation-liaison psychiatrists with an updated resource that can assist in the treatment and management of geriatric patients. RECENT FINDINGS: The current available literature has not shown any differences in efficacy between haloperidol and second-generation antipsychotics in patients with delirium. When considering relative advantages of forms of antipsychotic administration, there is no support for a superior safety profile of oral compared to intramuscular or intravenous administration. A recent meta-analysis of four randomized controlled trials concluded that when melatonin was administered to older age patients on medical wards, it significantly prevented the incidence of delirium when compared with the control group. While suvorexant administered nightly to elderly patients in acute care settings may lower the incidence of delirium, larger studies are needed to confirm this finding. Despite the black box warning of increased mortality risk in older patients with dementia, antipsychotics may be used with caution by the consultation-liaison (CL) psychiatrist to treat the neuropsychologic symptoms of dementia including hallucinations and psychosis in the hospital setting. While antidepressant studies have focused primarily on citalopram and escitalopram in the treatment of agitation in the setting of dementia, these two medications have not been adequately compared directly to other SSRIs for this condition. It is therefore not clear whether citalopram and escitalopram are more efficacious in treating agitation in the setting of dementia when compared to other SSRIs. While the evidence supporting trazodone's use is limited, it is generally well tolerated and is an option as a PRN for irritability and agitation in patients with Alzheimer's and mixed dementia. While there is some evidence to support the use of acetylcholinesterase inhibitors for treating cognitive impairments and hallucinations in Lewy body dementia, the usefulness of these agents in other forms of dementia is not well studied, and those studies did not show any benefit in the management of acute agitation. It is important to note that memantine can cause or exacerbate agitation and may be the cause of behavioral dysregulation. There is no evidence to support the routine use of benzodiazepines for behavioral improvement in patients with dementia. Escitalopram and citalopram do have a unique pharmacokinetic properties in the sense that they have been found to have 50-56% plasma protein binding, compared to sertraline, fluoxetine, and paroxetine (95% or more). Pooled analyses suggest that antidepressants are more effective than placebo in reducing the symptoms of post-stroke depression. SSRIs are considered first-line antidepressants in stroke patients, who are often elderly with underlying cardiovascular problems. Although treatment with SSRIs is recommended for post-stroke depression, there are no studies providing conclusive data on the superiority of a specific drug. Older age is associated with a better outcome from ECT, with remission rates of approximately 73% to 90% in patients over 65 years. ECT is the treatment of choice for patients with psychotic depression, and elderly patients with psychotic depression have been shown to have a higher remission rate and faster time to response than depressed patients without psychotic symptoms. With the average life expectancy increase, it is projected that 19 million people will reach the age of 85 or higher, an increase from 5.5 million in 2010. With an increasing older population, psychiatric consultation in the management of geriatric patients is becoming more necessary. Psychiatrists must be aware of the unique considerations in elderly patients. In this article, we provide evidence-based guidance to the CL psychiatrist on major issues relating to the older age patient, highlighting recent trends in treatment. First, we provide background on the evaluation of the medically hospitalized geriatric patient. As rates of medical and psychiatric illnesses increase with advancing age, elderly patients are more likely to be taking a higher number of medications as compared to younger patients, and physicians must pay special attention to polypharmacy, including side effects and drug interactions in this group. Next, we focus on the diagnosis, management, and unique needs of the geriatric patient presenting with common clinical syndromes of delirium, dementia, and depression. Delirium and dementia are among the most common causes of cognitive impairment in clinical settings yet are often either unrecognized or misdiagnosed as they may have similar signs and symptoms. In addition, depression is prevalent in older adults, especially in those with comorbid medical illness. Depression can be fatal as the rates of suicide are higher in later life than in any other age group. Consultation can improve the management of elderly patients and prevent unnecessary nursing home placement.

Electroconvulsive therapy (ECT) for treating agitation in dementia (major neurocognitive disorder) - a promising option.

BACKGROUND: Agitation in patients with dementia increases caretaker burden, increases healthcare costs, and worsens the patient's quality of life. Antipsychotic medications, commonly used for the treatment of agitation in patients with dementia have a box warning from the FDA for elevated mortality risk. Electroconvulsive therapy (ECT) has made significant advances over the past several years, and is efficacious in treating a wide range of psychiatric conditions. We provide a systematic review of published literature regarding the efficacy of ECT for the treatment of agitation in patients with dementia (major neurocognitive disorder). METHODS: We searched PubMed, Medline, Google Scholar, UptoDate, Embase, and Cochrane for literature concerning ECT for treating agitation in dementia using the title search terms "ECT agitation dementia;" "ECT aggression dementia;" "ECT Behavior and Psychological Symptoms of Dementia;" and "ECT BPSD." The term "dementia" was also interchanged with "Major Neurocognitive Disorder." No time frame restriction was placed. We attempted to include all publications that were found to ensure a comprehensive review. We found 11 papers, with a total (N) of 216 patients. RESULTS: Limited to case reports, case series, retrospective chart review, retrospective case-control, and an open label prospective study, ECT has demonstrated promising results in decreasing agitation in patients with dementia. Patients who relapsed were found to benefit from maintenance ECT. CONCLUSIONS: Available studies are often limited by concomitant psychotropic medications, inconsistent use of objective rating scales, short follow-up, lack of a control group, small sample sizes, and publication bias. A future randomized controlled trial will pose ethical and methodological challenges. A randomized controlled trial must carefully consider the definition of usual care as a comparison group. Well-documented prospective studies and/or additional case series with explicit selection criteria, a wide range of outcome measures, and less selection bias of the study sample that may favor treatment response, is warranted. ECT may be a promising option for the treatment of aggression and agitation in patients with severe dementia who are refractory to other treatment options, but the limitations of available studies suggest that a cautious approach to future randomized controlled trials is warranted.

Assessing Residents' Confidence in the Context of Pharmacotherapy Competence.

OBJECTIVE: We aimed to determine whether residents' confidence initiating medications increased with the number of times they prescribed individual medications and to quantify the relationship between prescription frequency and gains in confidence. METHODS: From July 2011 to June 2014, PGY-3 residents completed a survey of confidence levels at their psychopharmacology clinic orientation and then again 12 months later. The Emory Healthcare electronic medical record was used to identify all medications prescribed by each resident during their 12-month rotation and the frequency of these prescriptions. RESULTS: Confidence in initiating treatment with all medicines/medication classes increased over the 12-month period. For three of the medication classes for which residents indicated they were least confident at orientation, the number of prescriptions written during the year was significantly associated with an increase in confidence. CONCLUSIONS: Measuring resident confidence is a relevant and achievable outcome and provides data for educators regarding the amount of experience needed to increase confidence.

A case of lithium-induced parkinsonism presenting with typical motor symptoms of Parkinson's disease in a bipolar patient.

Lithium is a mood stabilizer rarely associated with drug-induced parkinsonism (DIP). We present a case of an elderly woman with bipolar disorder who developed parkinsonian symptoms after chronic lithium administration despite therapeutic serum levels. Upon evaluation, classic parkinsonian signs of muscle rigidity, tremor, bradykinesia, freezing of gait, and cognitive decline were observed. Initially, she was diagnosed with Parkinson's disease (PD); however, DaTscan SPECT imaging clarified the diagnosis as DIP. As the daily lithium dosage was reduced, the patient's motor symptoms improved. This report emphasizes close monitoring of lithium levels in geriatric populations and the need to consider lithium-induced parkinsonism when PD symptoms appear in chronic lithium users.

Electroconvulsive therapy for the acute management of severe agitation in dementia (ECT-AD): A modified study protocol.

OBJECTIVE: This study began as a single-blind randomized controlled trial (RCT) to investigate the efficacy and safety of electroconvulsive therapy (ECT) for severe treatment-refractory agitation in advanced dementia. The aims are to assess agitation reduction using the Cohen-Mansfield Agitation Inventory (CMAI), evaluate tolerability and safety outcomes, and explore the long-term stability of agitation reduction and global functioning. Due to challenges encountered during implementation, including recruitment obstacles and operational difficulties, the study design was modified to an open-label format and other protocol amendments were implemented. METHODS: Initially, the RCT randomized participants 1:1 to either ECT plus usual care or simulated ECT plus usual care (S-ECT) groups. As patients were enrolled, data were collected from both ECT and simulated ECT (S-ECT) patients. The study now continues in an open-label study design where all patients receive actual ECT, reducing the targeted sample size from 200 to 50 participants. RESULTS: Study is ongoing and open to enrollment. CONCLUSION: The transition of the ECT-AD study design from an RCT to open-label design exemplifies adaptive research methodologies in response to real-world challenges. Data from both the RCT and open-label phases of the study will provide a unique perspective on the role of ECT in managing severe treatment-refractory agitation in dementia, potentially influencing future clinical practices and research approaches.

The impact of adverse childhood experiences on adult depression severity and treatment outcomes.

BACKGROUND: Past research has established that adverse childhood experiences (ACE) are correlated with depression severity. The purpose of the present study was to examine how the number and nature of ACE exposure is associated with symptomatology and treatment outcomes in adult patients with treatment resistant depression (TRD). METHODS: Participants include 454 patients with a diagnosis of major depression or persistent depressive disorder. A one-way analysis of variance (ANOVA) was used to assess whether number of ACEs was associated with certain outcomes. Linear regression analyses were performed to model the associations between the five ACE subtypes (e.g., sexual abuse, physical violence, injury/illness, childhood grief, and parental upheaval) and symptom severity. Logistic regression analyses were then used to model the association between ACE subtypes and history of lifetime suicide attempt(s) and inpatient admission(s). RESULTS: Greater ACE exposure was associated with more severe symptomatology and treatment outcomes, but these differences were only seen between patients reporting no ACEs versus 3+ ACEs. Only the subtypes of violence and illness/injury were significant predictors of more severe symptomatology. The ACE subtypes of sexual trauma and violence uniquely predicted a lifetime suicide attempt(s), and only the subtype of sexual trauma predicted lifetime inpatient admission(s). LIMITATIONS: Limitations of the present study include retrospective adult assessments of childhood trauma, lack of data on ACE severity and timing, and the cross-sectional reporting of multiple study measures. CONCLUSIONS: Exposure to multiple ACE subtypes, particularly sexual and physical trauma, is associated with depression symptom severity, and history of suicidality, and inpatient admission(s).