Evaluation of cariprazine in the treatment of bipolar I and II depression: a randomized, double-blind, placebo-controlled, phase 2 trial

This double-blind placebo-controlled, fixed/flexible-dose phase 2 trial assessed the efficacy, safety, and tolerability of cariprazine vs. placebo for depressive episodes associated with bipolar I or II disorder. Primary endpoint was change in Montgomery–Åsberg Depression Rating Scale (MADRS) total scores (baseline to week 8), and secondary endpoint was mean Clinical Global Impressions-Improvement score (week 8). Patients were randomized (N = 233) 1:1:1 to placebo, ‘low-dose’ 0.25–0.5 mg/day or ‘high-dose’ 1.5–3.0 mg/day cariprazine. Adverse events, laboratory results, vital signs, extrapyramidal symptoms, and suicide risk were monitored. Neither cariprazine group significantly separated from placebo in primary (mixed-effect model repeated measures MADRS least-squares mean differences: low-dose = −0.7, P = 0.7408; high-dose = 0.0, P = 0.9961) or secondary efficacy measures. No new safety signals with cariprazine were observed and common treatment-emergent adverse events (≥5% of cariprazine patients and twice the rate of placebo) included insomnia, akathisia, dry mouth, nausea, weight increased, diarrhea, restlessness, vomiting, musculoskeletal stiffness, migraine, and cough. Metabolic and weight changes were generally similar for cariprazine and placebo. Factors that may have affected the outcome of the trial were identified, which helpe...
Source: International Clinical Psychopharmacology - Category: Psychiatry Tags: Original Articles Source Type: research

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Authors: Hallgren RC, Rowan JJ Abstract Context: Osteopathic physicians often target the rectus capitis posterior minor (RCPm) and rectus capitis posterior major (RCPM) muscles when using muscle energy or soft tissue cervical techniques to treat patients with head and neck pain. The RCPm and RCPM muscles are located deep within the posterior occipitoatlantal and atlantoaxial interspaces, respectively. Objective: To characterize the functional role of RCPm and RCPM muscles by comparing electromyographic (EMG) activation patterns of these muscles with EMG activation patterns of specific flexor and extensor muscle...
Source: Journal of the American Osteopathic Association - Category: Complementary Medicine Tags: J Am Osteopath Assoc Source Type: research
Conclusions: Syndrome of the trephined occurs more frequently than previously described in posttraumatic patients with large cranial vault defects. Cranial vault reconstruction leads to significant, quantifiable functional improvement in a large number of patients. CLINICAL QUESTION/LEVEL OF EVIDENCE: Therapeutic, IV.
Source: Plastic and Reconstructive Surgery - Category: Cosmetic Surgery Tags: Pediatric/Craniofacial: Original Articles Source Type: research
ConclusionsLess than half of the total number of patients maintained a medium level of overall HRQoL after diagnosis and treatment of breast cancer, and nearly 60% continued to have lower overall HRQoL even after the treatment was complete. Older participants with more severe economic burden and higher depression experienced lower and more persistent overall HRQoL; thus, these patients should be monitored and provided supportive care as a part of survivorship care.
Source: Supportive Care in Cancer - Category: Cancer & Oncology Source Type: research
AbstractOncology outpatient care centers generally subjugate patients ’ psychosocial needs to their physical care requirements. Consequently, the patients’ self-management (SM) ability and utilization of social resources are essential in regulating their psychological distress (anxiety and depression). The study aims were (1) to examine the prevalence and severity of psychological distress in female cancer patients in outpatient settings in Taiwan and (2) to identify the major factors of psychological distress. Female cancer patients were recruited from oncology outpatient settings in Taiwan. Patients completed...
Source: Supportive Care in Cancer - Category: Cancer & Oncology Source Type: research
The calcitonin gene-related peptide monoclonal antibody compared favorably to placebo for reducing the number of average monthly migraine days in a study of people with treatment-resistant migraine.Medscape Medical News
Source: Medscape Pharmacist Headlines - Category: Drugs & Pharmacology Tags: Neurology & Neurosurgery News Source Type: news
Purpose of review In recent years there has been interest in the use of machine learning in suicide research in reaction to the failure of traditional statistical methods to produce clinically useful models of future suicide. The current review summarizes recent prediction studies in the suicide literature including those using machine learning approaches to understand what value these novel approaches add. Recent findings Studies using machine learning to predict suicide deaths report area under the curve that are only modestly greater than, and sensitivities that are equal to, those reported in studies using more co...
Source: Current Opinion in Psychiatry - Category: Psychiatry Tags: PROVISION OF SERVICES TO PEOPLE WITH MENTAL ILLNESSES: Edited by Giovanni de Girolamo and Thomas Becker Source Type: research
Purpose of review Schools are increasingly at the forefront of mental healthcare for young people internationally. This review aims to describe recent developments in school-based mental health activities to respond to mental health needs in adolescents, with a focus on empirical studies aimed at preventing, ameliorating or treating mental disorders. Recent findings The field is characterized by substantial heterogeneity in program design and research methods. Evidence for effectiveness of single-faceted school-based mental health programs is equivocal. Recent systematic reviews and meta-analyses have reported mixed f...
Source: Current Opinion in Psychiatry - Category: Psychiatry Tags: PROVISION OF SERVICES TO PEOPLE WITH MENTAL ILLNESSES: Edited by Giovanni de Girolamo and Thomas Becker Source Type: research
This study investigated the effects of mental illness and mental distress on family members' employment and sleep time. Employed men and women family members and unemployed women family members who wanted to work were included in the study. METHODS: Japanese survey data from the 2013 Comprehensive Survey of Living Conditions were analyzed to identify the above-mentioned effects. A propensity score matching method was used to create a valid comparison group for family members of patients with mental illness and distress. RESULTS: For depression, family member average weekly work hours decreased by a range of 1.06 (p%lt;0.01) to 1.18 (p
Source: Journal of Mental Health Policy and Economics - Category: Psychiatry Tags: J Ment Health Policy Econ Source Type: research
Conclusion: Insomnia was associated with disability in men, whereas aging and pain severity were associated with disability in women. Catastrophic thinking was not associated with disability in both sexes. PMID: 32454923 [PubMed - in process]
Source: Pain Research and Management - Category: Anesthesiology Authors: Tags: Pain Res Manag Source Type: research
Conclusion. The results of our own research clearly indicate that the use of the radiofrequency waves brings pain relief and improvement of clinical parameters to a greater extent than in sonophoresis. It can be a very important new method in supportive treatment of TMD. Research needs to be continued. PMID: 32454921 [PubMed - in process]
Source: Pain Research and Management - Category: Anesthesiology Authors: Tags: Pain Res Manag Source Type: research
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