Single-Dose Synthetic Psilocybin With Psychotherapy for Treatment-Resistant Bipolar Type II Major Depressive Episodes: A Nonrandomized Controlled Trial.

Importance: Bipolar II disorder (BDII) is a debilitating condition frequently associated with difficult-to-treat depressive episodes. Psilocybin has evidence for rapid-acting antidepressant effects but has not been investigated in bipolar depression. Objective: To establish the safety and efficacy of psilocybin in patients with BDII in a current depressive episode. Design, Setting, and Participants: This was a 12-week, open-label nonrandomized controlled trial conducted at Sheppard Pratt Hospital. Participants aged 18 to 65 years with BDII, a current depressive episode longer than 3 months, and documented insufficient benefit with at least 2 pharmacologic treatments during the current episode were invited to participate. Of 70 approached, 19 met inclusion criteria and were enrolled. The trial was conducted between April 14, 2021, and January 5, 2023. Interventions: A single dose of synthetic psilocybin, 25 mg, was administered. Psychotropic medications were discontinued at least 2 weeks prior to dosing. Therapists met with patients for 3 sessions during pretreatment, during the 8-hour dosing day, and for 3 integration sessions posttreatment. Main Outcomes and Measures: The primary outcome measure was change in Montgomery-Åsberg Depression Rating scale (MADRS) at 3 weeks posttreatment. Secondary measures included MADRS scores 12 weeks posttreatment, the self-rated Quick Inventory of Depression Symptoms-Self Rating (QIDS-SR), and the self-rated Quality of Life Enjoyment and Satisfaction Questionnaire-Short Form (Q-LES-Q-SF), each completed at baseline and all subsequent visits. Safety measures included the Columbia Suicide Severity Rating Scale (CSSRS) and the Young Mania Rating Scale (YMRS) completed at each visit. Results: Of the 15 participants in this study (6 male and 9 female; mean [SD] age, 37.8 [11.6] years), all had lower scores at week 3, with a mean (SD) change of -24.00 (9.23) points on the MADRS, (Cohen d = 4.08; 95% CI, -29.11 to -18.89; P < .001). Repeat measures analysis of variance showed lower MADRS scores at all tested posttreatment time points, including the end point (Cohen d = 3.39; 95% CI, -33.19 to -16.95; adjusted P < .001). At week 3, 12 participants met the response criterion (50% decrease in MADRS), and 11 met remission criterion (MADRS score ≤10). At the study end point, 12 patients met both response and remission criteria. QIDS-SR scores and Q-LES-Q-SF scores demonstrated similar improvements. YMRS and CSSRS scores did not change significantly at posttreatment compared to baseline. Conclusions and Relevance: The findings in this open-label nonrandomized controlled trial suggest efficacy and safety of psilocybin with psychotherapy in BDII depression and supports further study of psychedelics in this population.

The mental health impact of contact with COVID-19 patients on healthcare workers in the United States.

This study assessed the relationship between contact with COVID-19 patients and the mental health of healthcare workers (HCWs) in the United States (US). In a convenience sample of 957 HCWs who completed an anonymous online survey between April-May 2020, HCWs who provided direct care to confirmed or suspected COVID-19 patients reported increased depressive and posttraumatic symptoms compared to HCWs with no COVID-19 patient contact. Additionally, more frequent contact was associated with higher distress. More data drawn from diverse samples that better represent US HCWs are needed to fully assess the scope of this association.

Lateral canthoplasty using the Mitek anchor system.

BACKGROUND: Lower-eyelid shape and position have important aesthetic and functional implications. While primary canthoplasty is generally a straightforward procedure, secondary canthoplasty can be considerably challenging. This is especially true in the setting of poor periorbital tissues and the resultant lack of a stable platform from which to suspend the canthus. We report the first use of the Mitek device in secondary lateral canthal procedures to remedy this common problem. METHODS: Twelve patients underwent a total of 19 revision lateral canthoplasties using the mini Mitek suture anchor system. All of the patients had had prior cosmetic and/or reconstructive surgery in the lateral canthal area with resultant canthal malpositioning. To correct this, suture anchors were placed into a 2-mm area of intact bone on the lateral orbital wall, and the lateral canthal tendon was resuspended into proper position. RESULTS: In this series, there were no postoperative infections or patient reports of persistent discomfort at the anchor sites. All suture anchors remained in proper position postoperatively, and patients reported satisfaction with eyelid shape and function. Most of the patients reported resolution of their preoperative symptoms. Mean follow-up time was 24.2 months. CONCLUSION: The Mitek suture anchor is an excellent tool for lateral canthoplasty in patients with significant periorbital scarring or suboptimal canthal positioning after multiple cosmetic surgery procedures. It is also a good option for patients with significant soft tissue damage owing to prior surgery, radiation, or trauma in the periorbital field. This technique can be performed quickly through small incisions and requires only a small amount of stable bone for tendon fixation. Results are excellent and the procedure has proven to be safe and effective in our series of patients.

An investigation of the application of laser-assisted indocyanine green fluorescent dye angiography in pedicle transverse rectus abdominus myocutaneous breast reconstruction.

BACKGROUND: Pedicle transverse rectus abdominus myocutaneous (pTRAM) flaps remain the most common method of autologous tissue breast reconstruction. Using pTRAM flaps, complications often arise postoperatively, secondary to inadequate circulation. Tissues from distant angiosomes are associated with poorer perfusion, but this differs among patients. Many modalities have been used to reduce the risk of complications, but none have achieved widespread application. The authors believe that laser-assisted indocyanine green fluorescent dye angiography (LA-ICGA) can potentially reduce the risk of complications. METHODS: In two routine, single-pedicle, ipsilateral pTRAM flaps, LA-ICGA imaging was performed following the division of the distal rectus muscle and deep inferior epigastric pedicle. The resulting images were used to guide design of the flap and debridement. RESULTS: In case 1, good perfusion was observed in zone 1 and part of zone 2. In case 2, good perfusion was observed in zone 1 and 50% of zone 3, with little perfusion in zone 2. In both cases, tissues with poor perfusion were debrided before transfer and inset. In both patients, there were no issues with wound healing, tissue necrosis or fat necrosis. CONCLUSIONS: The variability of perfusion of the pTRAM flap among individuals is well appreciated. LA-ICGA helped to determine the limits of good perfusion and, therefore, the limits of tissue to be preserved for transfer and inset. This helped to avoid harvesting poorly perfused tissue that would have almost certainly experienced necrosis and, ultimately, would have reduced the risk of postoperative complications.

The true incidence of near-term postoperative complications in prosthetic breast reconstruction utilizing human acellular dermal matrices: a meta-analysis.

BACKGROUND: The use of human acellular dermal matrix (HADM) materials in prosthetic-based breast reconstruction has gained popularity in recent years. Questions remain, however, regarding the nature and incidence of postoperative complications associated with this technique. The results reported in the available literature vary widely. This meta-analysis examines this question further with a broad review of the available literature in an effort to better define the true nature and incidence of near-term complications associated with the use of HADM in prosthetic-based breast reconstruction. It does not aim to compare this method of reconstruction to others. METHODS: A review of the available literature was performed in July 2009. The goal was to identify all previous works describing the placement of HADM at prosthetic-based breast reconstruction. Included were studies that documented the use of HADM for coverage of tissue expanders or permanent implants following therapeutic or prophylactic mastectomy. Excluded were studies that reported on the use of HADM in cosmetic breast surgery or studies that included the use of xenografts. Data collected included demographics as well as the nature and incidence of complications, with separate categories assigned for seroma, infection, flap necrosis, and "other." Data were analyzed using Comprehensive Meta-Analysis(®) software (Biostat, Englewood, NJ). Raw proportions, fixed-effect models, and random-effect models were used to assess the complication rates across studies. RESULTS: Eleven published articles and one abstract that was later published as an article were identified. Within these 12 studies, a total of 789 breasts were identified that had undergone reconstruction with HADM. The mean follow-up was 13.7 months. Under the random-effects model, the total complication rate was 12.0%. The most common complications were flap necrosis (3.3%), seroma (3.3%), and infection (5.6%). All complications not included in these categories were set apart in a separate category, "Other," and totaled 3.0% CONCLUSION: The true incidence of postoperative complications in the near term utilizing HADM in prosthetic-based breast reconstruction appears to be approximately 12%. The incidence of long-term complications such as capsular contracture remains unknown. However, as surgical experience with HADM grows, operative techniques designed at reducing risks will mature, strategies for managing complications will advance, and more advanced products designed to reduce the incidence of complications are likely to become available.

Activated, type I collagen (CellerateRx) and its effectiveness in healing recalcitrant diabetic wounds: a case presentation.

OBJECTIVE: To review the authors' experience with activated type I collagen in the treatment of recalcitrant wounds in the diabetic population resulting from minor trauma and/or venous stasis disease. With regard to activated collagen, CellerateRx's patented activated collagen fragments are a fraction of the size of the native collagen molecules and particles found in other products, delivering the benefits of collagen to the body immediately. DESIGN: A 2-case presentation wherein patients were treated with CellerateRx (activated, fragmented, and nonintact type I collagen) in a gel and powder form. SUBJECTS: Two middle-aged diabetic male patients with lower extremity wounds refractory to conservative wound care. RESULTS: Complete resolution of recalcitrant wounds in 6 to 7 weeks. CONCLUSIONS: Wound resolution was evident when using the authors' practice protocol, which includes the application of activated collagen. The inherent properties of type I collagen may contribute to a more rapid healing process.