Randomized clinical trial of bedtime sublingual cyclobenzaprine (TNX-102 SL) in military-related PTSD and the role of sleep quality in treatment response.

Effective posttraumatic stress disorder (PTSD) pharmacotherapy is needed. This 12-week randomized multicenter trial evaluated efficacy and safety of TNX-102 SL, a bedtime sublingual formulation of cyclobenzaprine, in patients with military-related PTSD randomized to TNX-102 SL 2.8 mg or 5.6 mg, or placebo. Primary analysis comparing change from baseline in Clinician-Administered PTSD Scale-5 score between 2.8 mg (n=90) and placebo (n=92) was not significant. Secondary analysis of 5.6 mg (n=49) vs placebo demonstrated a mean difference of -4.5 units, p=.05, or, accounting for missing data by multiple imputation, -5.0 units, p=.03. Clinician Global Impression - Improvement responder rate was greater in 5.6 mg than placebo (p=0.04), as was mean functional improvement in Sheehan Disability Scale social domain (p=.03) and trended in work domain (p=.05). Post-hoc analyses showed early sleep improvement predicted improvement in PTSD after 12 weeks for TNX-102 SL (p<.01), not for placebo. Most common administration site reaction in TNX-102 SL groups was oral hypoaesthesia (5.6 mg, 36%; 2.8 mg, 39%; placebo, 2%), while most common systemic adverse event was somnolence (5.6 mg, 16%; 2.8 mg, 12%; placebo, 6%). This provides preliminary evidence that TNX-102 SL 5.6 mg reduces PTSD symptoms, improves sleep and psychosocial function, and is well tolerated. Clinicaltrials.gov Identifier: NCT02277704.

Impact of fruits and vegetables vouchers on food insecurity in disadvantaged families from a Paris suburb.

BACKGROUND: Social inequalities in nutrition lead a high number of families to struggle with food insecurity, even in developed countries. We aimed to assess the impact of fruits and vegetables vouchers on food security among disadvantaged households from a Paris suburb. METHODS: We used a pre-post assessment design. Families answered face-to-face questionnaires on food consumption and food security status before and after a randomly assigned intervention. Households in the intervention group received vouchers to buy exclusively fruits and vegetables over one year. Both intervention and control groups benefitted from nutritional education through workshops performed by dieticians during the study period. The Household Food Security Module (HFSM) was used to assess food security status of households at inclusion. Food Insufficiency Indicator (FSI) was used to assess food security at inclusion and follow-up. Evolution of FSI on both groups was evaluated using McNemar test. RESULTS: Among the 91 families included between May 2015 and May 2016, 64 completed the post assessment questionnaire. At inclusion, 68.3% of families were experiencing food insecurity and 78.1% were experiencing food insufficiency. No association was found between food consumptions and food security status. After one-year follow-up, the prevalence of food insufficiency was significantly decreased in the intervention group (61.8%, with p value = 0.03), and unchanged in the control group. CONCLUSION: In this pilot study, food insufficiency was significantly decreased in families receiving vouchers for fruits and vegetables over a one-year period. TRIAL REGISTRATION: NCT02461238, registered 3 June 2015 - Retrospectively registered, https://clinicaltrials.gov/ct2/show/NCT02461238.

Recruitment of precarious families in an interventional study: Lessons from the French "Fruits and vegetables at home" (FLAM) trial.

BACKGROUND: The FLAM study was set up in order to assess the effectiveness of FV vouchers allowed to low-income households, on their FV consumption. The aim of the present study was to investigate issues associated with conducting interventional trials in disadvantaged populations using the FLAM study as an example of reaching target populations and recruitment difficulties. METHODS: Families were recruited in Saint-Denis city (North Paris suburb), via social and municipal structures. Main interest variables in the study (food consumptions) were collected using face-to-face food interviews, either at home or municipal facilities. A qualitative analysis was performed among people who refused to participate in order to understand the barriers to participation. RESULTS: A total of 95 parents-child pairs were included from May 2015 to May 2016. The families were mostly in precarious situation (63.3%), and most of parents were unemployed (71.3%). Almost the two third of children and 79.4% of parents were small consumers of FV (less than 3.5 servings per day). Several reasons for non-participation were reported including time constraints, understanding and mistrust issues. CONCLUSIONS: Though using facilitating strategies, we recruited fewer participants than expected. The population finally included was mainly made of precarious families with a low consumption of FV. These results highlight the importance of identifying effective facilitating strategies to improve recruitment in disadvantaged populations. TRIAL REGISTRATION: ClinicalTrial.gov no. NCT02461238, on June 3, 2015, retrospectively registered.

Fruits and vegetables at home (FLAM): a randomized controlled trial of the impact of fruits and vegetables vouchers in children from low-income families in an urban district of France.

BACKGROUND: Fruits and Vegetables (FV) consumption is considered a marker of social inequalities in health since it is considerably decreased in disadvantaged populations. The main objective of this trial was to evaluate the impact of vouchers for FV purchase on the consumption of FV among children living in disadvantaged families in a French urban district. METHODS: The FLAM study was a controlled randomized intervention trial, performed in Saint-Denis (North suburbs of Paris). The study group (intervention or control) was randomly attributed to parent-child pairs at inclusion. The intervention group received vouchers exchangeable for FV over a 1 year period. Nutritional education through workshops was available for both groups. FV consumption was assessed through face-to-face food frequency questionnaires. Participants who reported eating less than 3.5 FV per day were considered low FV consumers. RESULTS: A total of 92 parent-child pairs were included, in which 45 were allocated to the intervention group and 47 to the control group. Amongst them, 64 completed the final follow-up questionnaire (30% lost to follow-up). After one year, the proportion of low FV consumers in children was significantly lower in the intervention group (29.4%) compared to the control group (66.7%, p = 0.005). Overall, 82% of the vouchers were used by the families. CONCLUSIONS: This study found a decreased proportion of small consumers in children after 1 year of distribution of FV vouchers compared to the control group. FV vouchers could be an effective lever to increase FV consumption among children from disadvantaged households. TRIAL REGISTRATION: ClinicalTrials.gov identifier no. NCT02461238 .

[Issues surrounding the treatment of psychological disorders in the elderly]. / La problématique de la prise en charge des troubles psychiques des personnes âgées.

The treatment of psychological disorders in the elderly is very specific, requiring multi-disciplinary skills. A partnership between professionals from different fields working with elderly people is therefore essential. A survey was carried out in order to find out psychiatrists' point of view with regard to this specific care.

Understanding the fibromyalgia syndrome.

The fibromyalgia syndrome (FMS) is the most frequent cause of chronic, widespread pain. This review, which is targeted at the psychiatry and psychopharmacology communities, summarizes the state-of-the-art as it relates to both the pathophysiology and treatment of FMS. Toward this end, the anatomy and physiology of pain pathways are summarized, followed by a review of the altered biology of pain processing, neurotransmitter function, and neuroendocrine systems in FMS. The categories of current drugs employed to treat the disorder are detailed, along with a critical review of the literature supporting such use.

The psychopharmacology of fibromyalgia: a drug development perspective.

The fibromyalgia syndrome (FMS) is the most frequent cause of chronic widespread pain. In this review, we summarize the state of the art on the syndrome and its pathophysiology, with an emphasis on identifying bases for the development of novel therapies. Toward this end, the anatomy and physiology of pain pathways are summarized, followed by a review of the altered biology of pain processing, neurotransmitter function, and neuroendocrine systems in FMS. The categories of drugs currently employed to treat the disorder are detailed, along with a critical review of the literature supporting such use. Throughout the article, FMS is compared with and related to both major depressive disorder and neuropathic pain, conditions that may share some common biological processes with FMS but for which new drug discovery efforts are significantly more active due to the more established nature of these diagnoses.