CHMP recommends approval of generic memantine product (Memantine ratiopharm)
Source: European Medicines Agency
Area: News
The Committee for Medicinal Products for Human Use (CHMP) of the European Medicines Agency (EMA) has recommended the granting of a marketing authorisation for Memantine ratiopharm for the treatment of patients with moderate to severe Alzheimer's disease.
Memantine ratiopharm is a generic of Ebixa® (authorised in the EU in May 2002), and has been shown to be bioequivalent to this reference product
Detailed recommendations for the use of this product will be described in the summary of product characteristics (SmPC), which will be published in the Europe...
Source: NeLM - Mental Health - March 25, 2013 Category: Psychiatry Source Type: news
Validity of medication adherence self-reports in adults with Type 2 diabetes
Source: Diabetes Care
Area: Evidence > Medicines Management > References
Objective: To assess the validity of self-report measures of diabetes medication adherence and evaluate the effect of depression on the validity of these reports.
Research Design and Methods: Adults with type 2 diabetes, treated with oral medications in the USA, completed a set of medication adherence self-reports that varied response scales and time frames, were administered structured clinical interviews for depression, and provided blood samples for HbA1c as part of a screening for an intervention study. A subsample of partici...
Source: NeLM - Mental Health - March 25, 2013 Category: Psychiatry Source Type: news
NICE Bites - March 2013; No 50: Psychosis and schizophrenia in young adults
Source: North West Medicines Information Centre
Area: Health In Focus
NICE Bites is a monthly bulletin which summarises key prescribing points from NICE guidance. This edition includes one topic; Psychosis and schizophrenia in children and young adults. (Source: NeLM - Mental Health)
Source: NeLM - Mental Health - March 22, 2013 Category: Psychiatry Source Type: news
Trends in on-label and off-label modafinil use in USA
Source: JAMA
Area: News
JAMA Internal Medicine has featured a research letter describing the "off-label" use of modafinil in the US. Using the National Ambulatory Medical Care Survey, a nationally representative sample of ambulatory visits were evaluated ( January 1, 2002, to December 31, 2009) to determine the extent of modafinil use, and to categorise patients by whether or not they had an on-label indication for modafinil, defining off-label use as the absence of an on-label diagnosis. Additionally, the association between modafinil use and other centrally acting medications that might interact with modafinil such as a...
Source: NeLM - Mental Health - March 20, 2013 Category: Psychiatry Source Type: news
Vanda Pharmaceuticals Ltd withdraws its marketing authorisation application for Fanaptum (iloperidone)
Source: No information given
Area: News
The European Medicines Agency has been formally notified by Vanda Pharmaceuticals Ltd of its decision to withdraw its application for a centralised marketing authorisation for the medicine Fanaptum® (iloperidone) intended to be used for the treatment of schizophrenia.
In its official letter, the company stated that it is withdrawing the application because the CHMP identified missing data which will not be available in a timeframe acceptable in the centralised procedure. (Source: NeLM - Mental Health)
Source: NeLM - Mental Health - March 15, 2013 Category: Psychiatry Source Type: news
MHRA launches learning package on benzodiazepines
Source: MHRA
Area: News
The MHRA has developed a CPD-approved learning module on benzodiazepines for clinical practitioners. The self-directed learning package outlines the key risks of these drugs including:
. the main features of the adverse effect
. factors that increase the risk
. how the risk can be reduced
. specific treatment for the adverse effect (Source: NeLM - Mental Health)
Source: NeLM - Mental Health - March 14, 2013 Category: Psychiatry Source Type: news
Meta-Analysis: Adjunctive atypical antipsychotic treatment for major depressive disorder
Source: PLoS Medicine
Area: News
Atypical antipsychotic medications are widely prescribed for the adjunctive treatment of depression, yet little is known about their total risk-benefit profile. This meta-analysis reviewed the efficacy and safety profiles of aripiprazole, olanzapine/fluoxetine combination (OFC), quetiapine, and risperidone used for the adjunctive treatment of depression.
The study which included 14 randomised controlled trials found that:
. All four drugs had significant effects on remission, as follows: aripiprazole (odds ratio [OR], 2.01; 95% CI, 1.48-2.73), OFC (OR, 1.42; 95% ...
Source: NeLM - Mental Health - March 13, 2013 Category: Psychiatry Source Type: news
Centralized, stepped, patient preference-based treatment for patients with post-acute coronary syndrome depression: CODIACS Vanguard randomized controlled trial
Source: JAMA Internal Medicine
Area: Evidence > Medicines Management > References
Importance: Controversy remains about whether depression can be successfully managed after acute coronary syndrome (ACS) and the costs and benefits of doing so.
Objective: To determine the effects of providing post-ACS depression care on depressive symptoms and health care costs.
Design: Multicentre, randomised, controlled trial.
Setting: Patients were recruited from 2 private and 5 academic ambulatory centres across the United States.
Participants: A total of 150 patients with elevated depressive symptoms (Beck Depression In...
Source: NeLM - Mental Health - March 11, 2013 Category: Psychiatry Source Type: news
Fifth fatality in England from anthrax due to contaminated heroin
Source: Health Protection Agency
Area: News
The Health Protection Agency (HPA) has reported the death of a person who injected heroin, who was diagnosed with anthrax infection. This brings the total number affected in the UK to seven - five in England (including four fatalities), one in Scotland and one in Wales. The source is presumed to be contaminated heroin.
Health professionals across the East of England have been reminded of the possibility of cases of anthrax in people who inject heroin. Targeted information, including posters and leaflets aimed at heroin users have been sent out by the National Treatmen...
Source: NeLM - Mental Health - March 11, 2013 Category: Psychiatry Source Type: news
RCT: Folate plus vitamin B12 supplementation in schizophrenia
Source: JAMA Psychiatry
Area: News
This Phase III randomised controlled trial investigated the effect of folate and vitamin B12 supplementation on negative symptoms of schizophrenia in adult patients with chronic schizophrenia. Negative symptoms have previously been associated with reduced blood folate levels, especially among patients with low-functioning variants in genes that regulate folate metabolism, suggesting the potential utility of folate supplementation. One hundred and forty patients were randomised to 16 weeks treatment with either folic acid 2mg with 400 microgram vitamin B12 or placebo. The main outcome me...
Source: NeLM - Mental Health - March 8, 2013 Category: Psychiatry Source Type: news
NTA report: Falling drug use: the impact of treatment
Source: NTA
Area: News
Independent research published by the National Treatment Agency for Substance Misuse (NTA) has found a significant fall in use of heroin and crack cocaine among the under 25s and under 35s.
According to the new estimates:
. the number of heroin and crack users fell to 298,752 in 2010-11, from a peak of 332,090 in 2005-06.
. The number of people injecting drugs has fallen significantly, from 129,977 in 2005-06 to 93,401 in 2010-11.
. These reductions in use are mirrored by a fall in numbers entering treatment for dependency.
. The number of people s...
Source: NeLM - Mental Health - March 7, 2013 Category: Psychiatry Source Type: news
Common mental health disorders: NHS evidence update March 2013
Source: NHS Evidence
Area: News
A summary has been published of selected new evidence relevant to NICE clinical guideline 123 'Common mental health disorders: identification and pathways to care' (2011)
Evidence Updates provide a commentary on the new evidence, describing its strengths and weaknesses, and also indicate whether it may have a potential impact on current guidance. In this case, none of the key messages highlighted would result in any change in the guidance. (Source: NeLM - Mental Health)
Source: NeLM - Mental Health - March 7, 2013 Category: Psychiatry Source Type: news
HTA-SADD trial: Sertraline vs. mirtazapine vs. placebo for depression in dementia
Source: NIHR Health Technology Assessment programme
Area: News
This double-blind placebo-controlled RCT conducted at nine English old-age psychiatry units, examined the clinical effectiveness of sertraline and mirtazapine in reducing depression 13 weeks post randomisation compared with placebo. It involved 326 patients with probable or possible Alzheimer's disease (AD), depression (4+ weeks) and Cornell Scale for Depression in Dementia (CSDD) score of 8+. They were randomised to received these antidepressants (target dose 150 mg sertraline [n= 107] or 45 mg mirtazapine [n= 108] daily), or placebo (n= 111).
Ther...
Source: NeLM - Mental Health - March 7, 2013 Category: Psychiatry Source Type: news
CAS Alert: Advice on handling users of the 2CI family of drugs
Source: CAS alert
Area: News
The Department of Health has issued an alert offering advice on handling users of the 2C family of drugs (in particular 2CI and 2CE), who may present to health services for help. These drugs have both hallucinogenic and stimulant properties at varying levels of potency, with effects similar to Ecstasy and LSD. From the information available, these drugs appear to have been purchased online.
There has been a cluster of hospitalisations following the use of the 2CI and a death has been linked to the use of either 2CI or 2CE. The alert details when patients are most likely to benefit f...
Source: NeLM - Mental Health - March 5, 2013 Category: Psychiatry Source Type: news
