Randomised clinical trial comparing oral versus depot formulations of zuclopenthixol in patients with schizophrenia and previous violence

2006 ◽  
Vol 21 (1) ◽  
pp. 34-40 ◽  
Author(s):  
C. Arango ◽  
I. Bombín ◽  
T. González-Salvador ◽  
I. García-Cabeza ◽  
J. Bobes
Keyword(s):  
Clinical Trial ◽  
Treatment Adherence ◽  
Randomised Clinical Trial ◽  
Positive Symptoms ◽  
Violent Behaviour ◽  
Depot Formulation ◽  
Violent Acts ◽  
Receive Treatment ◽  
To Receive

AbstractObjectiveThe aim of this longitudinal study was to determine whether the depot formulation of an antipsychotic reduces violence in outpatients with schizophrenia as compared to oral administration of the same antipsychotic.MethodsForty-six previously violent patients with schizophrenia were randomised to receive treatment with oral or depot zuclopenthixol for 1 year. Clinicians interviewed patients at baseline and every month thereafter to assess treatment adherence. An interviewer blinded to treatment assignments interviewed an informant about any violent behaviour during the previous month.ResultsViolence during the follow-up year was inversely proportional to treatment adherence, better compliance, and greater reduction of positive symptoms. Lower frequency of violent acts was observed in the depot group. The level of insight at baseline was not significantly associated with violence recidivism. Regardless of route of administration, treatment non-adherence was the best predictor of violence.ConclusionsSome patients with schizophrenia and prior violent behaviour may benefit from the depot formulation of antipsychotic medication.

scholarly journals Physical therapy plus general practitioners’ care versus general practitioners’ care alone for sciatica: a randomised clinical trial with a 12-month follow-up

2008 ◽  
Vol 17 (4) ◽  
pp. 509-517 ◽  
Author(s):  
Pim A. J. Luijsterburg ◽  
Arianne P. Verhagen ◽  
Raymond W. J. G. Ostelo ◽  
Hans J. M. M. van den Hoogen ◽  
Wilco C. Peul ◽  
...  
Keyword(s):  
Clinical Trial ◽  
Physical Therapy ◽  
General Practitioners ◽  
Randomised Clinical Trial

Ketazolam (Solatran) an Open Study of Once-a-Day Treatment in Ambulatory Patients with Anxiety

1981 ◽  
Vol 9 (1) ◽  
pp. 69-73 ◽  
Author(s):  
R Deberdt
Keyword(s):  
Open Study ◽  
Rating Scale ◽  
Day Treatment ◽  
Night Time ◽  
Subjective Assessments ◽  
Ambulatory Patients ◽  
Hamilton Anxiety Rating Scale ◽  
Receive Treatment ◽  
To Receive

The efficacy of ketazolam (Solatran®)* in alleviating the symptoms of short-term reactive or neurotic anxiety in thirty-three patients was examined using a single 30 mg night-time dose in an open study. Patients were to receive treatment for up to 1 month and thereafter as necessary for several months. At the follow-up visits, at the end of the first, second and fourth weeks and then at the end of therapy if continued, the clinical condition was assessed by the Hamilton Anxiety Rating Scale and physician's and patients' subjective global assessments. A highly significant improvement was observed after a week's treatment in both somatic and psychic aspects of anxiety. A favourable response as measured by the two subjective assessments was observed in more than 80% of the patients by the third visit. There were two reports of morning tiredness, both dose-related, but no other adverse effects. Only four patients derived no benefit from the treatment.

scholarly journals Effect of Vitamin D Supplementation on Faecal Microbiota: A Randomised Clinical Trial

Nutrients ◽  
2019 ◽  
Vol 11 (12) ◽  
pp. 2888 ◽  
Author(s):  
Negar Naderpoor ◽  
Aya Mousa ◽  
Luisa Fernanda Gomez Arango ◽  
Helen L. Barrett ◽  
Marloes Dekker Nitert ◽  
...  
Keyword(s):  
Clinical Trial ◽  
Vitamin D ◽  
Gut Microbiota ◽  
Randomised Clinical Trial ◽  
Vitamin D Supplementation ◽  
Faecal Microbiota ◽  
Lower Abundance ◽  
Α Diversity ◽  
Significant Difference

In animal studies, vitamin D supplementation has been shown to improve gut microbiota and intestinal inflammation. However, limited evidence exists on the effect of vitamin D supplementation on the human gut microbiota. We examined the effect of vitamin D supplementation on faecal microbiota in 26 vitamin D-deficient (25-hydroxyvitamin D (25(OH)D) ≤50 nmol/L), overweight or obese (BMI ≥25 kg/m2) otherwise healthy adults. Our study was ancillary to a community based double-blind randomised clinical trial, conducted between 2014 and 2016. The participants provided stool samples at baseline and after 100,000 international units (IU) loading dose of cholecalciferol followed by 4000 IU daily or matching placebo for 16 weeks. Faecal microbiota was analysed using 16S rRNA sequencing; V6–8 region. There was no significant difference in microbiome α-diversity between vitamin D and placebo groups at baseline and follow-up (all p > 0.05). In addition, no clustering was found based on vitamin D supplementation at follow-up (p = 0.3). However, there was a significant association between community composition and vitamin D supplementation at the genus level (p = 0.04). The vitamin D group had a higher abundance of genus Lachnospira, and lower abundance of genus Blautia (linear discriminate analysis >3.0). Moreover, individuals with 25(OH)D >75 nmol/L had a higher abundance of genus Coprococcus and lower abundance of genus Ruminococcus compared to those with 25(OH)D <50 nmol/L. Our findings suggest that vitamin D supplementation has some distinct effects on faecal microbiota. Future studies need to explore whether these effects would translate into improved clinical outcomes.

scholarly journals A Randomised Clinical Trial of a Meridian-Based Intervention for Food Cravings With Six-Month Follow-Up

2011 ◽  
Vol 28 (1) ◽  
pp. 1-16 ◽  
Author(s):  
Peta Stapleton ◽  
Terri Sheldon ◽  
Brett Porter ◽  
Jennifer Whitty
Keyword(s):  
Clinical Trial ◽  
Psychological Symptoms ◽  
Randomised Clinical Trial ◽  
Repeated Measure ◽  
Delayed Effect ◽  
Obese Adults ◽  
Food Cravings ◽  
Group Data ◽  
Post Test

AbstractThis randomised, clinical trial tested whether The Emotional Freedom Technique (EFT) reduced food cravings. This study involved 96 overweight or obese adults who were allocated to the EFT treatment or 4-week waitlist condition. Degree of food craving, perceived power of food, restraint capabilities and psychological symptoms were assessed pre- and post- a 4-week treatment program (mixed method ANOVA comparative analysis), and at 6-month follow-up (repeated measure ANOVA with group data collapsed). EFT was associated with a significantly greater improvement in food cravings, the subjective power of food and craving restraint than waitlist from pre- to immediately post-test (p< .05). Across collapsed groups, an improvement in food cravings and the subjective power of food after active EFT treatment was maintained at 6 months, and a delayed effect was seen for craving restraint. Although there was a significant reduction in measures of psychological distress immediately after treatment (p< .05), there was no between-group difference. These findings are consistent with the hypothesis that EFT can have an immediate effect on reducing food cravings and can result in maintaining reduced cravings over time.

Plasma citrulline levels as a biomarker for bowel toxicity in prostate stereotactic radiotherapy with or without pelvic nodal radiation.

2019 ◽  
Vol 37 (7_suppl) ◽  
pp. 73-73
Author(s):  
Ciaran Fairmichael ◽  
Kelly M. Redmond ◽  
Ciara Lyons ◽  
Sarah R. Stevenson ◽  
Sarah O. Osman ◽  
...  
Keyword(s):  
Clinical Trial ◽  
Small Bowel ◽  
Stereotactic Radiotherapy ◽  
Summary Score ◽  
Pelvic Radiotherapy ◽  
Exact Test ◽  
Plasma Citrulline ◽  
Patient Reported ◽  
To Receive

73 Background: Plasma levels of citrulline, an amino acid, are derived mainly from small bowel enterocytes. Decreased levels occur in a range of bowel conditions and citrulline has been proposed as a biomarker of bowel toxicity in pelvic radiotherapy. In a prospective study, we identify no correlation between plasma citrulline and toxicity in men receiving prostate stereotactic radiotherapy randomized to receive either pelvic nodal irradiation or not. Furthermore, citrulline levels were not significantly different between these two groups. Methods: As part of an approved clinical trial, men with intermediate to high risk prostate cancer were randomised 1:1 to prostate only or prostate + pelvic nodal radiotherapy, delivered with a rectal spacer gel in situ. The prostate and proximal seminal vesicles received 40 Gy in 5 fractions. Those randomised to the pelvic nodal arm also received 25 Gy in 5 fractions to pelvic nodes. Citrulline was measured at 10 points during treatment – consent, before fraction 1, 1 and 24 hours following fraction 1, prior to each fraction 2 – 5 and at 6 weeks’ and 3 months’ follow up. Bowel toxicity was measured by EPIC patient reported scores. Results: 16 men with follow up of at least 3 months (median 9, maximum 18 months) were analysed. Reported toxicity was significantly higher in the prostate and pelvis arm: 5 of 9 men showed a decrease in EPIC bowel domain summary score of 10 points or more compared to 0 of 7 in the prostate-only arm (p = 0.0337, two tailed Fisher’s exact test). No significant correlation between toxicity and citrulline levels was seen, nor did citrulline vary significantly between arms or fall as treatment progressed. Data analysis for a further 8 men already recruited to the study is ongoing. Conclusions: Toxicity was more commonly reported by men randomised to receive pelvic radiotherapy, suggesting that the small bowel irradiated in pelvic fields plays a role in bowel toxicity experienced during stereotactic radiotherapy. Citrulline levels showed no significant correlation with toxicity or radiation dose to small bowel. We propose that citrulline is not a useful biomarker of small bowel toxicity in this setting. Clinical trial information: NCT03253978.

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