Double-Blind Comparison of Half-Dose and Standard-Dose Flupenthixol Decanoate in the Maintenance Treatment of Stabilised Out-Patients with Schizophrenia

1987 ◽  
Vol 151 (5) ◽  
pp. 634-638 ◽  
Author(s):  
D. A. W. Johnson ◽  
J. M. Ludlow ◽  
K. Street ◽  
R. D. W. Taylor
Keyword(s):  
Dose Reduction ◽  
Dose Group ◽  
Maintenance Treatment ◽  
Low Dose ◽  
Standard Dose ◽  
Controlled Trial ◽  
Social Function ◽  
Double Blind ◽  
Blind Comparison ◽  
Flupenthixol Decanoate

A double-blind controlled trial of 50% dose reduction in maintenance treatment in stable out-patients with low BPRS scores and good social function shows a significantly higher relapse rate in the low-dose group at 12 months (P < 0.05). After an interval of 24–36 months from dose reduction, 56–76% had experienced a relapse and 76–79% had resumed their former dosage. No clear advantage was shown for the lower dose in either a reduction of side-effects or improved social function, but a reduced prevalence or lower rate of symptom emergence for tardive dyskinesia was suggested.

Low-Dose (0.05 Unit/kg/hour) vs Standard-Dose (0.1 Unit/kg/hour) Insulin in the Management of Pediatric Diabetic Ketoacidosis: A Randomized Double-Blind Controlled Trial

2021 ◽  
Vol 58 (7) ◽  
pp. 617-623
Author(s):  
Ramachandran Rameshkumar ◽  
Ponnarmeni Satheesh ◽  
Puneet Jain ◽  
Jagadeesh Anbazhagan ◽  
Shilpa Abraham ◽  
...  
Keyword(s):  
Diabetic Ketoacidosis ◽  
Low Dose ◽  
Standard Dose ◽  
Controlled Trial ◽  
Double Blind

scholarly journals P125: Low dose intravenous ketorolac in renal colic, a pilot randomized controlled trial

CJEM ◽  
2020 ◽  
Vol 22 (S1) ◽  
pp. S109-S110
Author(s):  
J. Chao ◽  
P. Brasher ◽  
K. Cheung ◽  
R. Sharma ◽  
K. Badke ◽  
...  
Keyword(s):  
Dose Group ◽  
Low Dose ◽  
Renal Colic ◽  
Standard Dose ◽  
Controlled Trial ◽  
Pain Reduction ◽  
Primary Objective ◽  
Recruitment Rate ◽  
Convenience Sample ◽  
Increased Risk

Introduction: Non-steroidal anti-inflammatory drugs (NSAIDs) are first-line analgesics for emergency department (ED) patients with renal colic. Lower doses of intravenous (IV) ketorolac may provide similar pain relief to standard dosing in patients with acute pain. Patients with renal colic may be at increased risk of acute kidney injury; exposing them to lower doses of NSAIDs may put them at lower risk while providing equally effective analgesia. We conducted a pilot study to determine the feasibility of a randomized trial comparing the effectiveness and safety of low with standard ketorolac dosing in ED patients with suspected renal colic. The primary objective was to demonstrate the ability to achieve an enrolment target of 2 patients per week. Methods: We enrolled a convenience sample of adults presenting to an academic urban ED with unilateral flank pain suspected to be renal colic. We randomized patients to 10 mg (low dose, intervention) or 30 mg (standard dose, control). Participants, treating physicians and nurses, and researchers were blinded to treatment allocation. Our main feasibility outcome was the recruitment rate. Secondary outcomes were changes in pain scores (0-10) at 30 and 120 minutes post-ketorolac administration, vital signs, adverse events and ED length of stay. Results: We approached 82 patients, of whom 47 (57.3%) were eligible. Of these, 36 consented to participating and 30 were randomized. The proportion of screened patients who were enrolled was 36.6% (30/82). We completed enrolment over a 21-week period, with an average recruitment rate of 1.5 patients/week (range 0-4). The average baseline pain score for all participants was 6.9 (SD = 2.1). At 30 minutes post-ketorolac administration, the low dose group had a mean pain reduction of 2.0 points compared to a pain reduction of 1.7 in standard dose group (difference = 0.3, 90% CI: -0.7 to 1.4). Conclusion: These preliminary results support the possibility that low dose ketorolac may be efficacious in this patient population. We did not meet our target recruitment of 2 patients per week as this was primarily due to restricted recruitment hours. To successfully conduct a larger trial, we would need to expand both recruitment hours and the number of sites.

scholarly journals Double-Blind, Randomized, Three-Armed, Placebo-Controlled, Clinical Investigation to Evaluate the Benefit and Tolerability of Two Dosages of IQP-AE-103 in Reducing Body Weight in Overweight and Moderately Obese Subjects

2019 ◽  
Vol 2019 ◽  
pp. 1-12 ◽  
Author(s):  
Ralf Uebelhack ◽  
Udo Bongartz ◽  
Stephanie Seibt ◽  
Gordana Bothe ◽  
Pee Win Chong ◽  
...  
Keyword(s):  
Weight Loss ◽  
Body Weight ◽  
Placebo Group ◽  
Body Fat ◽  
Dose Group ◽  
Low Dose ◽  
Clinical Investigation ◽  
Controlled Trial ◽  
High Dose ◽  
Double Blind

Objective. This study was performed to determine the efficacy and tolerability/safety of IQP-AE-103 on body weight reduction in overweight to moderately obese adults. Methods. A double-blind, randomized, placebo-controlled trial involved one hundred and eight subjects (BMI between 25 and 35 kg/m2) that were randomly assigned to either the low-dose or the high-dose IQP-AE-103 group, or the placebo group. Following a 2-week run-in period, subjects received two capsules of investigational product after three daily main meals for 12 weeks. Subjects were instructed to maintain a nutritionally balanced hypocaloric diet according to the individual’s energy requirement. Body weight, body fat, and waist and hip circumference were measured at baseline, and after 2, 4, 8, and 12 weeks. Subjects also rated their feelings of hunger and fullness using visual analogue scales, and food craving on a 5-point scale at the same time intervals. Blood samplings for safety laboratory parameters were taken before and at the end of the study. Results. After 12 weeks of intake, the high-dose IQP-AE-103 group had a significantly greater weight loss compared with the placebo (5.03 ± 2.50 kg vs. 0.98 ± 2.06 kg, respectively; p<0.001) and the low-dose group (3.01 ± 2.19 kg; p=0.001). The high-dose group experienced a decrease in body fat of 3.15 ± 2.41 kg compared with a decrease of 0.23 ± 2.74 kg for the placebo group (p<0.001). High-dose IQP-AE-103 also decreased the feeling of hunger in 66% subjects. A beneficial effect of IQP-AE-103 on the lipid metabolism was also demonstrated in the subgroup of subjects with baseline total cholesterol levels above 6.2 mmol/L. No side effects related to the intake of IQP-AE-103 were reported. Conclusions. These findings indicate that IQP-AE-103 could be an effective and safe weight loss intervention. This trial is registered with NCT03058367.

A randomized controlled trial comparing standard- and low-dose strategies for transfusion of platelets (SToP) to patients with thrombocytopenia

Blood ◽  
2009 ◽  
Vol 113 (7) ◽  
pp. 1564-1573 ◽  
Author(s):  
Nancy M. Heddle ◽  
Richard J. Cook ◽  
Alan Tinmouth ◽  
C. Tom Kouroukis ◽  
Tor Hervig ◽  
...  
Keyword(s):  
Randomized Controlled Trial ◽  
Low Dose ◽  
Standard Dose ◽  
Controlled Trial ◽  
Data Safety Monitoring Board ◽  
World Health ◽  
Double Blind ◽  
Who Grade ◽  
Randomized Controlled ◽  
Platelet Transfusions

Abstract A noninferiority study was performed comparing low-dose and standard-dose prophylactic platelet transfusions. A double-blind randomized controlled trial (RCT) was performed in 6 sites in 3 countries. Thrombocytopenic adults requiring prophylactic platelet transfusion were randomly allocated to standard-dose (300-600 × 109 platelets/product) or low-dose (150- < 300 × 109 platelets/product) platelets. The primary outcome (World Health Organization [WHO] bleeding ≥ grade 2) was assessed daily through clinical examination, patient interview, and chart review. A WHO grade was assigned through adjudication. The Data Safety Monitoring Board stopped the study because the difference in the grade 4 bleeding reached the prespecified threshold of 5%. At this time, 129 patients had been randomized and 119 patients were included in the analysis (58 low dose; 61 standard dose). Three patients in the low-dose arm (5.2%) had grade 4 bleeds compared with none in the standard-dose arm. WHO bleeding grade 2 or higher was 49.2% (30/61) in the standard-dose arm and 51.7% (30/58) in the low-dose group (relative risk [RR], 1.052; 95% confidence interval [CI], 0.737-1.502). A higher rate of grade 4 bleeding in patients receiving low-dose prophylactic platelet transfusions resulted in this RCT being stopped. Whether this finding was due to chance or represents a real difference requires further investigation. These clinical studies are registered on http://www.clinicaltrials.gov as NCT00420914.

Risks of Alternate-Day Prednisone in Patients With Cystic Fibrosis

PEDIATRICS ◽  
1991 ◽  
Vol 87 (2) ◽  
pp. 245-246
Author(s):  
Beryl J. Rosenstein ◽  
Howard Eigen
Keyword(s):  
Cystic Fibrosis ◽  
Placebo Group ◽  
Interim Analysis ◽  
Inflammatory Process ◽  
Dose Group ◽  
Low Dose ◽  
Controlled Trial ◽  
The United States ◽  
High Dose ◽  
Double Blind

In recent years an immune-mediated inflammatory process has been implicated in the genesis of the pulmonary damage seen in patients with cystic fibrosis.1,2 A 4-year double-blind, placebo-controlled trial of alternate-day prednisone (2 mg/kg) was conducted in 45 cystic fibrosis patients with mild-to-moderate pulmonary disease to assess the effect of this drug on the pulmonary inflammatory process.3 The patients in the prednisone group showed better growth and pulmonary function and less morbidity compared with those in the placebo group. No complications were reported among the prednisone-treated patients. To extend these observations, the United States Cystic Fibrosis Foundation sponsored a multicenter double-blind, placebo-controlled trial of alternate-day prednisone. Since March 1986, 283 patients with cystic fibrosis, followed up at 15 centers in the United States and Canada, have been enrolled in this trial. Patients 5 through 14 years of age with mild-to-moderate pulmonary disease were randomly assigned to receive prednisone 2 mg/kg (high-dose) every other day, prednisone 1 mg/kg (low-dose) every other day, or placebo. On entry into the study, patients in the three groups were closely matched by a variety of clinical and laboratory parameters (Table 1). Patients are closely monitored at 3-month intervals for both efficacy and side effects. An interim analysis is carried out every 6 months and the results are reviewed by an unblinded study ombudsman. Initially, 95 patients were randomly assigned to the high-dose group, 94 to the low-dose group, and 94 to the placebo group. At the time of the most recent interim analysis, mean duration in the study was 33.9 months for the high-dose group, 35.3 months for the low-dose group, and 36.8 months for the placebo group.

Reducing Dosage in Maintenance Treatment of Schizophrenia

1993 ◽  
Vol 163 (S22) ◽  
pp. 58-65 ◽  
Author(s):  
Nina R. Schooler
Keyword(s):  
Dose Reduction ◽  
Maintenance Treatment ◽  
Low Dose ◽  
Dosage Reduction ◽  
Standard Dose ◽  
Treatment Strategies ◽  
Patient Characteristics ◽  
Targeted Treatment ◽  
Family Treatment ◽  
Dose Treatment

This paper reviews the assumptions and efficacy of two strategies for dose reduction during maintenance treatment in schizophrenia: low dose and targeted medication. Studies of low-dose treatment suggest that it can be used for relatively short periods of time or if the dosage reduction is moderate. Studies of targeted treatment suggest that relapse risk increases significantly compared with standard-dose treatment and that there are few offsetting advantages. The paper also reports initial findings from the NIMH Treatment Strategies in Schizophrenia Study, which compares low dose, targeted treatment and a standard dose in the context of two forms of family treatment. Early stabilisation of patients is lower than expected, but patient characteristics are useful in predicting likelihood of stabilisation.

scholarly journals Intermediate vs Standard-dose Prophylactic Anticoagulation in Patients with COVID-19 Admitted to ICU: Ninety-day Results from the INSPIRATION Trial

2021 ◽  
Author(s):  
Behnood Bikdeli ◽  
Azita H Talasaz ◽  
Farid Rashidi ◽  
Hooman Bakhshandeh ◽  
Farnaz Rafiee ◽  
...  
Keyword(s):  
Hospital Discharge ◽  
Major Bleeding ◽  
Arterial Thrombosis ◽  
Dose Group ◽  
Standard Dose ◽  
Controlled Trial ◽  
Bleeding Events ◽  
Major Bleeding Events ◽  
Prophylactic Anticoagulation ◽  
Intermediate Dose

Background: Thrombotic complications are considered among the main extrapulmonary manifestations of COVID-19. The optimal type and duration of prophylactic antithrombotic therapy in these patients remain unknown. Methods: This manuscript reports the final (90-day) results of the Intermediate versus Standard-dose Prophylactic anticoagulation In cRitically-ill pATIents with COVID-19: An opeN label randomized controlled trial (INSPIRATION) study. Patients with COVID-19 admitted to intensive care were randomized to intermediate-dose versus standard-dose prophylactic anticoagulation for 30 days, irrespective of hospital discharge status. The primary efficacy outcome was a composite of adjudicated venous or arterial thrombosis, treatment with extracorporeal membrane oxygenation (ECMO), or all-cause death. The main safety outcome was major bleeding. Results: Of 600 randomized patients, 562 entered the modified intention-to-treat analysis (median age [Q1, Q3]; 62 (50, 71) years; 237 (42.2%) women), of whom 336 (59.8%) survived to hospital discharge. The primary outcome occurred in 132 (47.8%) of patients assigned to intermediate-dose and 130 (45.4%) patients assigned to standard-dose prophylactic anticoagulation (hazard ratio [HR]: 1.21, 95% confidence interval [CI]: 0.95-1.55, P=0.11). No significant differences were observed between the two groups for other efficacy outcomes, or in the landmark analysis from days 31-90. Overall, there were 7 (2.5%) major bleeding events in the intermediate-dose group (including 3 fatal events) and 4 (1.4%) major bleeding events in the standard-dose group (none fatal) (HR: 1.82, 95% CI: 0.53-6.24, P=0.33). Conclusion: Intermediate-dose compared with standard-dose prophylactic anticoagulation did not reduce a composite of death, treatment with ECMO, or venous or arterial thrombosis at 90-day follow-up.

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