Clinical outcomes in the biomarkers of ketamine (Bio-K) study of open-label IV ketamine for refractory depression.

OBJECTIVE: We conducted an open-label clinical trial ("Bio-K") using IV ketamine for treatment-resistant depression to identify biomarkers linked to remission. Here, we report the clinical efficacy and side effect outcomes of Bio-K. METHODS: Across 4 US sites, 75 patients ages 18-65 with treatment-refractory unipolar or bipolar depression received 3 IV ketamine infusions over an 11-day period. Key exclusion criteria were psychotic symptoms, significant substance abuse, unstable medical conditions, and any use of cannabis. Pre-existing antidepressant medication was maintained. Primary outcome was remission as measured by Montgomery-Asberg Depression Rating Scale (MADRS), with secondary outcome of 50 % reduction in Beck Suicide Scale score. Safety monitoring and varying durations of infusions were also key parameters. RESULTS: Using remission as MADRS score <10, after 3 infusions 52 % achieved remission, with 67 % achieving response. Of those achieving response after a single infusion, 66 % (22 of 33) reached remission after 3 infusions, while 40 % (16 of 40) non-responders after the first infusion went on to achieve remission after 3 infusions. Only 20 % of non-responders after 2 infusions achieved remission. Most (81 %) participants had significant suicidal ideation at baseline; of these, two-thirds (67 %) experienced at least a 50 % reduction in suicidality. Side effects were minimal. Uniquely, we had three different types of infusion categories, with individuals receiving: (1) slow (100-min) infusions only or (2) regular (40-min) infusions only or (3) a mix of infusion durations. These three infusion groups showed comparable safety and efficacy. Exploration of clinical factors revealed no link between BMI, age, or gender to remission. CONCLUSIONS: The consistency of outcomes across 4 clinical sites and across multiple instruments, suggests high acute efficacy and safety of IV ketamine for serious depressive episodes. Duration of infusion did not alter outcomes. Meaningfully, 40 % of non-responders after a single infusion did reach remission subsequently, while only 20 % of non-responders after 2 infusions achieved remission, suggesting early response is suggestive for eventual remission. Our data on varying ketamine infusion duration adds novel insights into the clinical administration of this new treatment for refractory and severe patients. Our limitations included a lack of a control group, necessitating caution about conclusions of efficacy, balanced by the utility of reporting "real-world" outcomes across multiple clinical sites. We could also not separately analyze results for bipolar disorder due to small numbers. Together, the Bio-K clinical results are promising and provide significant sample sizes for forthcoming biological markers analyses.

Clinical Predictors of Engagement in Teleintegrated Care and Telereferral Care for Complex Psychiatric Disorders in Primary Care: a Randomized Trial.

BACKGROUND: Telepsychiatry Collaborative Care (TCC) and Telepsychiatry/Telepsychology Enhanced Referral (TER) expand the reach of specialty mental health services to underserved populations. OBJECTIVE: Assess clinical predictors of treatment engagement for complex psychiatric conditions in TCC-in which remote specialists consult with primary care teams via an onsite care manager who also provides brief psychotherapy-and TER, in which remote specialists provide direct telehealth treatment. DESIGN: A randomized pragmatic trial from twenty-four primary care clinics without onsite psychiatrists or psychologists. PARTICIPANTS: A total of 1,004 adult patients screened positive for posttraumatic stress disorder (PTSD)and/or bipolar disorder were randomized to receive TCC or TER for 1 year. MAIN MEASURES: Psychotherapy engagement was measured by the number of sessions completed, and pharmacotherapy engagement by the medication adherence item from the Schizophrenia Care and Assessment Program Health Questionnaire (SCAP-HQ). KEY RESULTS: Engagement in TCC psychotherapy visits was greater compared to TER. There was no association between the PTSD symptom severity and treatment engagement. The internal state scale (ISS) activation subscale, an indicator of mania, was associated with reduced odds of initiating psychotherapy (odds ratio [OR] = 0.70; 95% CI, 0.59 to 0.84) but not the number of sessions attended once psychotherapy started. The Drug Abuse Screening Test-10(DAST-10) score was associated with receipt of fewer psychotherapy sessions (incidence ratio rate [IRR] = 0.88; 95% CI, 0.81 to 0.95). The number of physical health comorbidities was associated with greater engagement in psychotherapy (IRR = 1.11, 95% CI, 1.03 to 1.19) and pharmacotherapy (OR = 1.54; 95% CI, 1.27 to 1.87). None of the findings varied by intervention group. CONCLUSIONS: Both teleintegrated and telereferral care offer an opportunity to treat patients with complex psychiatric conditions. While there was no difference in clinical characteristics predicting engagement, onsite care managers engaged patients in more psychotherapy sessions than remote therapists. TRIAL REGISTRATION: ClinicalTrials.gov Identifier: NCT02738944.

Going Virtual During a Pandemic: An Academic Psychiatry Department's Experience with Telepsychiatry.

Background: The novel coronavirus pandemic (COVID-19) led healthcare providers, including mental health providers, across the U.S. to swiftly shift to telemedicine. Objectives: This shift gave our Department of Psychiatry a chance to better understand key challenges and opportunities vis-à-vis virtual mental healthcare. We aimed to obtain provider feedback on the use of telepsychiatry and to learn from the provider perspective about patient experiences with video visits. This information will be used to inform the telemedicine strategy at a systems level within our psychiatry department, our academic health system, as well as the field of telemedicine as a whole. Design and Sample: A 22-item online questionnaire comprising 16 quantitative and six qualitative items was distributed to providers currently using video visits to provide care. Results: A total of 89 mental health providers completed the questionnaire. Outcomes demonstrated that while providers perceive challenges associated with virtual care (e.g., fatigue, technology-related issues, and age-related concerns), they also recognize a number of benefits to themselves and their patients (e.g., convenience and increased access). Overall, provider satisfaction, comfort, and willingness to use telepsychiatry was high. Conclusions: The vast majority of providers adapted quickly to the use of virtual platforms; many endorse advantages that suggest virtual care will continue to be a modality they provide in the future, post-COVID-19. It will be important to continue to evaluate aspects of virtual care that may limit clinical assessments and to optimize use to improve access, convenience, and cost-efficiency of mental healthcare delivery.

Correction: Factors Influencing Patients' Initial Decisions Regarding Telepsychiatry Participation During the COVID-19 Pandemic: Telephone-Based Survey.

[This corrects the article DOI: 10.2196/25469.].

Factors Influencing Patients' Initial Decisions Regarding Telepsychiatry Participation During the COVID-19 Pandemic: Telephone-Based Survey.

BACKGROUND: Telepsychiatry enables patients to establish or maintain psychiatric care during the COVID-19 pandemic. Little is known about the factors influencing patients' initial decisions to participate in telepsychiatry in the midst of a public health crisis. OBJECTIVE: This paper seeks to examine factors influencing patients' initial decisions to accept or decline telepsychiatry immediately after the stay-at-home order in Michigan, their initial choice of virtual care modality (video or telephone), and their anticipated participation in telepsychiatry once clinics reopen for in-person visits. METHODS: Between June and August 2020, we conducted a telephone-based survey using a questionnaire comprising 14 quantitative and two qualitative items as part of a quality improvement initiative. We targeted patients who had an in-person appointment date that fell in the first few weeks following the Michigan governor's stay-at-home order, necessitating conversion to virtual visits or deferment of in-person care. We used descriptive statistics to report individual survey responses and assess the association between chosen visit type and patient characteristics and future participation in telepsychiatry using multivariable logistic regression. RESULTS: A total of 244 patients whose original in-person appointments were scheduled within the first 3 weeks of the stay-at-home order in Michigan completed the telephone survey. The majority of the 244 respondents (n=202, 82.8%) initially chose to receive psychiatric care through video visits, while 13.5% (n=33) chose telephone visits and 1.2% (n=3) decided to postpone care until in-person visit availability. Patient age correlated with chosen visit type (P<.001; 95% CI 0.02-0.06). Patients aged ≥44 years were more likely than patients aged 0-44 years to opt for telephone visits (relative risk reduction [RRR] 1.2; 95% CI 1.06-1.35). Patient sex (P=.99), race (P=.06), type of insurance (P=.08), and number of previous visits to the clinic (P=.63) were not statistically relevant. Half of the respondents (132/244, 54.1%) stated they were likely to continue with telepsychiatry even after in-person visits were made available. Telephone visit users were less likely than video visit users to anticipate future participation in telepsychiatry (RRR 1.08; 95% CI 0.97-1.2). Overall, virtual visits met or exceeded expectations for the majority of users. CONCLUSIONS: In this cohort, patient age correlates with the choice of virtual visit type, with older adults more likely to choose telephone visits over video visits. Understanding challenges to patient-facing technologies can help advance health equity and guide best practices for engaging patients and families through telehealth.

Consequences of Recurrence of Major Depressive Disorder: Is Stopping Effective Antidepressant Medications Ever Safe?

According to the World Health Organization, major depressive disorder is the world's leading cause of disability. If clinical remission is not attained and sustained, episodes tend to recur with greater severity and with lessening responsivity to conventional treatments. Reasonably well-established clues and guidelines are presented about the high risk and profound consequences of recurrence of major depressive disorder if successful antidepressant treatments are discontinued. The authors describe actions required to achieve a "lifetime wellness" focus for treatment. Current approaches would need to be transformed from attainment of clinical remission to attainment and maintenance of lifetime wellness, with the knowledge that some individuals may need continuous treatment. Risk factors would need to be assessed and used to formulate clinical treatment guidelines for risk of recurrence. Clinical trials would need to be greatly lengthened. Measurement-based care and precision medicine would be the foundation for informing clinical decisions. The authors provide guidance in determining how to discontinue antidepressants if that decision is made despite risks.

A validation study of the Zanmi Lasante Depression Symptom Inventory (ZLDSI) in a school-based study population of transitional age youth in Haiti.

BACKGROUND: The Zanmi Lasante Depression Symptom Inventory (ZLDSI) is a screening tool for major depression used in 12 primary care clinics in Haiti's Central Plateau. Although previously validated in a clinic-based sample, the present study is the first to evaluate the validity and clinical utility of the ZLDSI for depression screening in a school-based population in central Haiti. METHODS: We assessed depressive symptoms in a school-based sample of transitional age youth (18-22 years; n = 120) with the ZLDSI. Other mental health-related assessments included a modified Structured Clinical Interview for DSM-IV-TR Axis I Disorders (SCID) for current Major Depressive Episode, the Center for Epidemiologic Studies Depression Scale, and selected items adapted from the Global School-Based Health Survey mental health module. Diagnostic assignments of major depressive episode (MDE) were based on modified SCID interviews. RESULTS: The ZLDSI demonstrated good overall accuracy in identifying current MDE (Area under the Curve = .92, 95% CI = .86, .98, p < .001). We ascertained ≥12 as the optimal cut-off point to screen for depression with a sensitivity of 100% and a specificity of 73.9%. In addition, the ZLDSI was associated with other measures of depressive symptoms, suggesting that it demonstrates construct validity. CONCLUSIONS: Study findings support that the ZLDSI has clinical utility for screening for depression among school-going transitional age youth.

Prevalence of stressful life events and their association with post-traumatic stress disorder among youth attending secondary school in Haiti.

The association between earthquakes and youth post-traumatic stress disorder (PTSD) has been well described, but little is known about the relationship between other stressful life events (SLEs) and PTSD among earthquake-affected youth. This study examines a variety of SLEs, including earthquake, and their association with PTSD among school-going Haitian youth following a major earthquake in 2010. In 2013, we assessed 120 students ages 18-22 for PTSD and other SLEs using a modified Structured Clinical Interview for DSM-IV (SCID)-based interview and the Stressful Life Events Checklist (SLE Checklist). Only 51.7% of participants on the SLE Checklist and 31.7% in the interview endorsed being affected by the earthquake or another disaster. Sexual assault showed the strongest association with PTSD in multivariable logistic regression. Contrary to our hypothesis, exposure to earthquake or another disaster was not significantly associated with current PTSD. In this population, exposure to interpersonal violence may have had a greater impact on PTSD risk than exposure to natural disaster. These data underscore the need to examine and reduce both acute and chronic stressors among disaster-affected youth.

A mobile clinic approach to the delivery of community-based mental health services in rural Haiti.

This study evaluates the use of a mental health mobile clinic to overcome two major challenges to the provision of mental healthcare in resource-limited settings: the shortage of trained specialists; and the need to improve access to safe, effective, and culturally sound care in community settings. Employing task-shifting and supervision, mental healthcare was largely delivered by trained, non-specialist health workers instead of specialists. A retrospective chart review of 318 unduplicated patients assessed and treated during the mobile clinic's first two years (January 2012 to November 2013) was conducted to explore outcomes. These data were supplemented by a quality improvement questionnaire, illustrative case reports, and a qualitative interview with the mobile clinic's lead community health worker. The team evaluated an average of 42 patients per clinic session. The most common mental, neurological, or substance abuse (MNS) disorders were depression and epilepsy. Higher follow-up rates were seen among those with diagnoses of bipolar disorder and neurological conditions, while those with depression or anxiety had lower follow-up rates. Persons with mood disorders who were evaluated on at least two separate occasions using a locally developed depression screening tool experienced a significant reduction in depressive symptoms. The mental health mobile clinic successfully treated a wide range of MNS disorders in rural Haiti and provided care to individuals who previously had no consistent access to mental healthcare. Efforts to address these common barriers to the provision of mental healthcare in resource-limited settings should consider supplementing clinic-based with mobile services.

Formative research on a teacher accompaniment model to promote youth mental health in Haiti: Relevance to mental health task-sharing in low-resource school settings.

BACKGROUND: Task-sharing with teachers to promote youth mental health is a promising but underdeveloped strategy in improving care access in low-income countries. AIMS: To assess feasibility, acceptability and utility of the teacher accompaniment phase of a school-based Teacher- Accompagnateur Pilot Study (TAPS) in Haiti. METHODS: We assigned student participants, aged 18-22 years ( n = 120), to teacher participants ( n = 22) within four Haitian schools; we instructed participants to arrange meetings with their assigned counterparts to discuss mental health treatment, academic skills, and/or well-being. We measured student and teacher perceived feasibility, acceptability and utility of meetings with self-report Likert-style questions. We examined overall program feasibility by the percentage of students with a documented meeting, acceptability by a composite measure of student satisfaction and utility by the percentage with identified mental health need who discussed treatment with a teacher. RESULTS: Favorable ratings support feasibility, acceptability and utility of teacher- accompagnateur meetings with students. The majority of students (54%) met with a teacher. Among students with an identified mental disorder, 43.2% discussed treatment during a meeting. CONCLUSION: This accompaniment approach to mental health task-sharing with teachers provided a school-based opportunity for students with mental health need to discuss treatment and has potential relevance to other low-income settings.

High burden of mental illness and low utilization of care among school-going youth in Central Haiti: A window into the youth mental health treatment gap in a low-income country.

BACKGROUND: The mental health treatment gap for youth in low- and middle-income countries (LMICs) is substantial; strategies for redress are urgently needed to mitigate the serious health and social consequences of untreated mental illness in youth. AIMS: To estimate the burden of major depressive episode (MDE) and posttraumatic stress disorder (PTSD) as well as utilization of care among Haitian youth in order to describe the mental health treatment gap in a LMIC setting. METHODS: We estimated the point prevalence of MDE, PTSD, and subthreshold variants in a school-based sample of youth ( n = 120, ages 18-22 years) using a modified Structured Clinical Interview for DSM-IV-TR Axis I Disorders (SCID)-based interview and examined treatment utilization among those receiving one of these diagnoses. We assessed additional psychopathology with self-report measures to examine validity of study diagnostic assignments. RESULTS: The combined prevalence of full-syndrome or subthreshold MDE or PTSD was high (36.7%). A large majority of affected individuals (88.6%) had accessed no mental health services in the health sector, and 36.4% had accessed no care of any kind in either the health or folk sectors in the past year. CONCLUSION: Findings demonstrate a high mental health burden among Haiti's youth and that many youth with MDE and PTSD are not accessing mental health care.

Catatonia in resource-limited settings: a case series and treatment protocol.

OBJECTIVE: The catatonic syndrome ("catatonia") is characterized by motor and motivation dysregulation and is associated with a number of neuropsychiatric and medical disorders. It is recognizable in a variety of clinical settings. We present observations from the treatment of four individuals with catatonia in Haiti and Rwanda and introduce a treatment protocol for use in resource-limited settings. METHODS: Four patients from rural Haiti and Rwanda with clinical signs of catatonia and a positive screen using the Bush-Francis Catatonia Rating Scale were treated collaboratively by general physicians and mental health clinicians with either lorazepam or diazepam. Success in treatment was clinically assessed by complete remittance of catatonia symptoms. RESULTS: The four patients in this report exhibited a range of characteristic and recognizable signs of catatonia, including immobility/stupor, stereotypic movements, echophenomena, posturing, odd mannerisms, mutism and refusal to eat or drink. All four cases presented initially to rural outpatient general health services in resource-limited settings. In some cases, diagnostic uncertainty initially led to treatment with typical antipsychotics. In each case, proper identification and treatment of catatonia with benzodiazepines led to significant clinical improvement. CONCLUSION: Catatonia can be effectively and inexpensively treated in resource-limited settings. Identification and management of catatonia are critical for the health and safety of patients with this syndrome. Familiarity with the clinical features of catatonia is essential for health professionals working in any setting. To facilitate early recognition of this treatable disorder, catatonia should feature more prominently in global mental health discourse.

The 2010 Haiti earthquake response.

This article presents an overview of the mental health response to the 2010 Haiti earthquake. Discussion includes consideration of complexities that relate to emergency response, mental health and psychosocial response in disasters, long-term planning of systems of care, and the development of safe, effective, and culturally sound mental health services in the Haitian context. This information will be of value to mental health professionals and policy specialists interested in mental health in Haiti, and in the delivery of mental health services in particularly resource-limited contexts in the setting of disasters.