Mortality and use of psychotropic medication in patients with stroke:a population-wide, register-based study

OBJECTIVES: The study sought to describe whether psychotropic medication may have long-term side effects in patients with stroke compared with controls. SETTING: Use of national register data from healthcare services were identified from the Danish National Patient Registry in Denmark. Information about psychotropic medication use was obtained from the Danish Register of Medicinal Product Statistics. OBJECTIVES: We aimed to evaluate all-cause mortality in relation to the use of benzodiazepines, antidepressants and antipsychotics in patients with stroke and matched controls. PARTICIPANTS: Patients with a diagnosis of stroke and either no drug use or preindex use of psychotropic medication (n=49 968) and compared with control subjects (n=86 100) matched on age, gender, marital status and community location. PRIMARY OUTCOME MEASURE: All-cause mortality. RESULTS: All-cause mortality was higher in patients with previous stroke compared with control subjects. Mortality HRs were increased for participants prescribed serotonergic antidepressant drugs (HR=1.699 (SD=0.030), p=0.001 in patients; HR=1.908 (0.022), p<0.001 in controls, respectively), tricyclic antidepressants (HR=1.365 (0.045), p<0.001; HR=1.733 (0.022), p<0.001), benzodiazepines (HR=1.643 (0.040), p<0.001; HR=1.776 (0.053), p<0.001), benzodiazepine-like drugs (HR=1.776 (0.021), p<0.001; HR=1.547 (0.025), p<0.001), first-generation antipsychotics (HR=2.001 (0.076), p<0.001; HR=3.361 (0.159), p<0.001) and second-generation antipsychotics (HR=1.645 (0.070), p<0.001; HR=2.555 (0.086), p<0.001), compared with no drug use. Interaction analysis suggested statistically significantly higher mortality HRs for most classes of psychotropic drugs in controls compared with patients with stroke. CONCLUSIONS: All-cause mortality was higher in patients with stroke and controls treated with benzodiazepines, antidepressants and antipsychotics than in their untreated counterparts. Our findings suggest that care should be taken in the use and prescription of such drugs, and that they should be used in conjunction with adequate clinical controls

The Danish schizophrenia registry

AIM OF DATABASE: To systematically monitor and improve the quality of treatment and care of patients with schizophrenia in Denmark. In addition, the database is accessible as a resource for research. STUDY POPULATION: Patients diagnosed with schizophrenia and receiving mental health care in psychiatric hospitals or outpatient clinics. During the first year after the diagnosis, patients are classified as incident patients, and after this period as prevalent patients. MAIN VARIABLES: The registry currently contains 21 clinical quality measures in relation to the following domains: diagnostic evaluation, antipsychotic treatment including adverse reactions, cardiovascular risk factors including laboratory values, family intervention, psychoeducation, postdischarge mental health care, assessment of suicide risk in relation to discharge, and assessment of global functioning. DESCRIPTIVE DATA: The recorded data are available electronically for the reporting clinicians and responsible administrative personnel, and they are updated monthly. The registry publishes the national and regional results of all included quality measures in the annual audit reports. External researchers may obtain access to the data for use in specific research projects by applying to the steering committee. CONCLUSION: The Danish Schizophrenia Registry represents a valuable source of informative data to monitor and improve the quality of care of patients with schizophrenia in Denmark. However, continuous resources and time devoted is necessary to maintain the integrity of the registry and the validity of the data

Prolonged-release melatonin versus placebo for benzodiazepine discontinuation in patients with schizophrenia: a randomized clinical trial - the SMART trial protocol

<p>Abstract</p> <p>Background</p> <p>Treatment of schizophrenia frequently includes prolonged benzodiazepine administration despite a lack of evidence of its use. It is often difficult to discontinue benzodiazepines because of the development of dependence. We aim to assess if melatonin can facilitate the withdrawal of prolonged benzodiazepine administration in patients with schizophrenia. Furthermore, we aim to investigate the association of benzodiazepine dose reduction with the following clinically important variables: sleep, psychophysiology, cognition, social function, and quality of life.</p> <p>Methods/Design</p> <p>Randomized, blinded, two-armed, parallel superiority trial. We plan to include 80 consenting outpatients diagnosed with schizophrenia or schizoaffective disorder, 18-55 years of age, treated with antipsychotic drug(s) and at least one benzodiazepine derivative for the last three months before inclusion. Exclusion criteria: currently under treatment for alcohol or drug abuse, aggressive or violent behavior, known mental retardation, pervasive developmental disorder, dementia, epilepsy, terminal illness, severe co morbidity, inability to understand Danish, allergy to melatonin, lactose, starch, gelatin, or talc, hepatic impairment, pregnancy or nursing, or lack of informed consent. After being randomized to prolonged-release melatonin (Circadin^®) 2 mg daily or matching placebo, participants are required to slowly taper off their benzodiazepine dose. The primary outcome measure is benzodiazepine dose at 6 months follow-up. Secondary outcome measures include sleep, psychophysiological, and neurocognitive measures. Data are collected at baseline and at 6 months follow-up regarding medical treatment, cognition, psychophysiology, sleep, laboratory tests, adverse events, psychopathology, social function, and quality of life. Data on medical treatment, cognition, psychophysiology, adverse events, social function, and quality of life are also collected at 2 and 4 months follow-up.</p> <p>Discussion</p> <p>The results from this trial will examine whether melatonin has a role in withdrawing long-term benzodiazepine administration in schizophrenia patients. This group of patients is difficult to treat and therefore often subject to polypharmacy which may play a role in the reduced life expectancy of patients compared to the background population. The results will also provide new information on the association of chronic benzodiazepine treatment with sleep, psychophysiology, cognition, social function, and quality of life. Knowledge of these important clinical aspects is lacking in this group of patients.</p> <p>Trial Registration</p> <p>ClinicalTrials <a href="http://www.clinicaltrials.gov/ct2/show/NCT01431092">NCT01431092</a></p

The role of depression in the prediction of a "late" remission in first-episode psychosis:An analysis of the OPTiMiSE study

Objective: The identification of predictors of psychosis remission could guide early clinical decision-making for treatment of first-episode schizophrenia (FES). Methods: We analyzed two non-independent subsamples of patients with FES ages 18-40 years from the OPTiMiSE study dataset to investigate the demographic and clinical factors that might help to differentiate "late" re-mitters (i.e., not in remission at week 2 or 4, but achieving remission within a 10-week follow-up period) from non-remitters within the same period. Results: Subsample 1 included 216 individuals (55 females, mean age 25.9 years) treated with amisulpride in an open-label design who were not in remission at week 2. Early symptomatic response between baseline and week 2 (odds ratio (OR)- 4.186, 95% confidence interval (CI)- 2.082-8.416, p < 0.001) and older age (OR- 1.081, 95% = CI 1.026-1.138, p- 0.003) were the only variables significantly associated with a higher probability of psychosis remission at week 4. Subsample 2 was composed of the 72 participants (19 females, mean age 25.1 years) who were not in remission at week 4 and completed a 6-week double-blind randomized trial comparing continuation of amisulpride with switch to olanzapine. Depression at baseline (as measured with the Calgary Depression Scale for Schizophrenia) was significantly associated with a nearly 3-fold lower likelihood of psychosis remission during the 10-week follow-up (hazard ratio = 2.865, 95% CI = 1.187-6.916, p = 0.019). Conclusion: Our results reinforce the importance of assessing depressive symptoms in people with FES and support the relevance of an early response (as early as 2 weeks) as a predictor of clinical outcome in this population. (C) 2021 Elsevier B.V. All rights reserved