The ANeED study - ambroxol in new and early dementia with Lewy bodies (DLB): protocol for a phase IIa multicentre, randomised, double-blinded and placebo-controlled trial.

Background: Currently, there are no disease-modifying pharmacological treatment options for dementia with Lewy bodies (DLB). The hallmark of DLB is pathological alpha-synuclein (aS) deposition. There are growing amounts of data suggesting that reduced aS clearance is caused by failure in endolysosomal and authophagic pathways, as well as and glucocerebrosidase (GCase) dysfunction and mutations in the GCase gene (GBA). The population's studies demonstrated that the incidence of GBA mutations is higher among Parkinson's disease (PD) patients, and carriers of such mutations have a higher risk of developing PD. The incidence of GBA mutations is even higher in DLB and a genome-wide association study (GWAS) confirmed the correlation between GBA mutations and DLB. In vivo experiments have shown that ambroxol (ABX) may increase GCase activity and GCase levels and therefore enhance aS autophagy-lysosome degradation pathways. Moreover, there is an emerging hypothesis that ABX may have an effect as a DLB modifying drug. The aims of the study "Ambroxol in new and early Dementia with Lewy Bodies (ANeED) are to investigate the tolerability, safety and effects of ABX in patients with DLB. Methods: This is a multicentre, phase IIa, double-blinded, randomised and placebo-controlled clinical trial, using a parallel arm design for 18 months' follow-up. The allocation ratio is 1:1 (treatment:placebo). Discussion: The ANeED study is an ongoing clinical drug trial with ABX. The unique, but not fully understood mechanism of ABX on the enhancement of lysosomal aS clearance may be promising as a possible modifying treatment in DLB. Trial Registration: The clinical trial is registered in the international trials register - clinicaltrials.com (NCT0458825) and nationally at the Current Research Information System in Norway (CRISTIN 2235504).

Pharmacological treatment and adherence one week prior to acute psychiatric admissions.

BACKGROUND AND AIMS: To describe use of and adherence to psychotropic medication 1 week prior to acute admission to a psychiatric inpatient department. METHODS: All acute inpatient admissions to a department serving a catchment area were included. RESULTS AND CONCLUSIONS: Of the 227 admissions, 158 were prescribed psychotropic medication and 129 of the 158 had taken at least 75% of the prescribed dose. Among 59 patients with affective disorders, 23 were not prescribed medication prior to admission and two refused medication, while the rest were adherent. CONCLUSION: The high adherence to medication 1 week prior to admission might be related to increased experience of serious symptoms. Lack of opportunity to receive pharmacological treatment is a major problem.

Substance use at admission to an acute psychiatric department.

Substance use is prevalent in patients with psychiatric disorders and may cause severe symptoms in addition to complicating the diagnosis of psychiatric disorders. The aims of the study were to find the prevalence in use of alcohol, drugs, benzodiazepines, hypnotics, opiates and stimulants, and to find the prevalence of substance use disorders at admission to an acute psychiatric department receiving all admissions from a catchment area. Patients were interviewed about use of medications and intoxicating substances during the last week before admission in 227 consecutive admissions. Urine samples were analysed with the liquid chromatography with mass spectrometry (LC-MS) method. Use of substances was determined from reported use and findings in urine samples. Diagnoses were set at discharge according to ICD-10 research criteria. In 81.9% of the admissions, the patient had used alcohol, drugs, benzodiazepines, hypnotics, opiates or stimulants prior to admission. More men used alcohol, cannabis and stimulants, whereas more women used benzodiazepines. In 31.7% of the admissions, 49.5% of men and 16.4% of women, the patients had a substance use disorder (ICD-10, F10-19). Patients with substance use disorders had a shorter stay in hospital than other patients, and patients with no psychiatric disorder other than substance use disorders had a median length of stay of 2 days. Most patients had used psychoactive substances before admission to the acute psychiatric department, and half of the men had a substance use disorder.

Substance abuse and recovery in a Psychiatric Intensive Care Unit.

OBJECTIVES: The purpose of this study is to compare the development in symptoms, behaviors, function and treatment between patients with or without a substance use (SU) diagnose in a Psychiatric Intensive Care Unit (PICU). METHODS: A total of 118 admitted patients were assessed at admittance, day 3 and discharge from the PICU. Symptoms of psychopathology, therapeutic steps taken, violent episodes and length of patient stay were recorded. RESULTS: More males than females received an SU diagnosis. Substance use patients had less psychiatric symptoms at admittance and showed a faster symptom reduction, more favorable and faster improvement of function and a shorter length of stay. Except for symptom reduction and shorter length of stay, these differences were largely due to differences in sex and diagnoses in the two groups. CONCLUSION: In a naturalistic group of patients in a PICU, SU is associated with favorable outcomes compared to patients not using substances.