A Double-Blind Comparison of Three Times Daily and Single Night Dosage of the Tricyclic Anti-Depressant Dothiepin

1974 ◽  
Vol 2 (1) ◽  
pp. 12-19 ◽  
Author(s):  
J B Pearce ◽  
W Linford Rees
Keyword(s):  
Single Dose ◽  
Dosage Regimen ◽  
Trial Design ◽  
Double Blind Trial ◽  
Double Blind ◽  
Matching Placebo ◽  
Symptoms Of Depression ◽  
Daily Dosage Regimen ◽  
Single Night ◽  
Blind Comparison

The study here presented was designed to evaluate the advantages of a once a day dosage of tricyclic anti-depressants as against a thrice daily dosage regimen using dothiepin (Prothiaden) and matching placebo capsules in a group comparative double-blind trial design. A total of sixty-two patients were admitted to the trial and were randomly allocated to one or other of the dosage regimes. Patients were assessed weekly for five weeks. More favourable results were achieved with patients taking the single dose nocturnally which was well tolerated in addition to being effective in relieving symptoms of depression. A number of possible advantages of this method of administration are discussed.

Mental handicap and double-blind trial design

1987 ◽  
Vol 151 (5) ◽  
pp. 706-707
Author(s):  
M. Craft ◽  
I.A. Ismail ◽  
D. Krishnamurti ◽  
J. Mathews ◽  
A. Regan ◽  
...  
Keyword(s):  
Trial Design ◽  
Double Blind Trial ◽  
Double Blind ◽  
Blind Trial ◽  
Mental Handicap

scholarly journals Mental handicap and double-blind trial design

1987 ◽  
Vol 151 (5) ◽  
pp. 705-706
Author(s):  
Ruth Dark ◽  
Edward Rogers
Keyword(s):  
Trial Design ◽  
Double Blind Trial ◽  
Double Blind ◽  
Blind Trial ◽  
Mental Handicap

scholarly journals Randomised double blind trial of single dose doxycycline for treating cholera in adults.

BMJ ◽  
1990 ◽  
Vol 300 (6740) ◽  
pp. 1619-1621 ◽  
Author(s):  
A N Alam ◽  
N H Alam ◽  
T Ahmed ◽  
D A Sack
Keyword(s):  
Single Dose ◽  
Double Blind Trial ◽  
Double Blind ◽  
Blind Trial

Learning and Memory Impairment with Benzhexol

1987 ◽  
Vol 21 (4) ◽  
pp. 612-614 ◽  
Author(s):  
Cherrie A. Galletly ◽  
Colin D. Field
Keyword(s):  
Single Dose ◽  
Motor Skills ◽  
Memory Impairment ◽  
Short Term Memory ◽  
Double Blind Trial ◽  
Short Term ◽  
Double Blind ◽  
Term Memory ◽  
New Learning ◽  
Significant Impairment

A double-blind trial to determine the effects of a single dose of 2 mg benzhexol on cognitive functioning was undertaken using normal volunteers. Ninety minutes after the drug or placebo was taken, subjects completed a battery of psychological tests designed to measure learning, memory and motor skills. Benzhexol ingestion was associated with significant impairment of short-term memory and slowing of the rate of new learning.

A Controlled Study of Trancopal in the Treatment of Sleep Disturbances Due to Anxiety

1978 ◽  
Vol 6 (2) ◽  
pp. 115-120 ◽  
Author(s):  
J M T Warnock
Keyword(s):  
Placebo Group ◽  
Side Effects ◽  
Sleep Disturbances ◽  
Controlled Study ◽  
Night Time ◽  
Double Blind ◽  
Matching Placebo ◽  
Daily Record ◽  
Single Night

Sixty-eight patients presenting with sleep disturbances due to mild neurotic anxiety were treated for two weeks with a single night-time dose of 400 mg Trancopal or matching placebo under double-blind conditions. Patients kept a daily record of the quality of their sleep and the observer carried out a weekly rating of anxiety using a modified Hamilton scale. By Day 7 patients receiving Trancopal had a significantly better rating for sleep and mean Hamilton scores for day-time anxiety than the placebo group. Side-effects were minimal. It was concluded that for patients with sleep disturbances due to neurotic anxiety Trancopal is a well tolerated and effective alternative to the hypnotics.

A Controlled Multi-Centre Study of Hygroton® in the Treatment of Angina Pectoris

1977 ◽  
Vol 5 (6) ◽  
pp. 87-93
Author(s):  
J Bennion-Pedley ◽  
J F Donald ◽  
D F Ingram ◽  
R Million ◽  
J Seldrup
Keyword(s):  
Attack Rate ◽  
Adrenergic Receptor ◽  
Anginal Attack ◽  
Double Blind ◽  
Multi Centre Study ◽  
Matching Placebo ◽  
Different Types ◽  
Blind Comparison ◽  
Advantageous Effect ◽  
Better Than

Following the reports of Floyd (1966) and Floyd & Domenet (1972) a study was conducted on the effect of adding 50 mg of chlorthalidone ( Hygroton®) or a matching placebo to the usual antianginal regime of 25 patients. The study was a double blind comparison between chlorthalidone 50 mg tablets and a matching placebo; each patient received both treatments. Chlorthalidone was found to be significantly better than placebo in both reducing the incidence of attacks and the consumption of glyceryl trinitrate. Chlorthalidone reduced the day-time anginal attack rate by 38% as compared with the placebo attack rate. This improvement is of the same order as that achieved by beta-adrenergic receptor blocking agents in similar types of trial. A marked variation in response was found between different types of patients. The earlier investigations with diuretics in angina are reviewed, and a possible explanation for the advantageous effect of chlorthalidone is offered.

Double-Blind Comparison of a Single Dose and a Five-Day Course of Metronidazole in the Treatment of Trichomoniasis

1980 ◽  
Vol 35 (9) ◽  
pp. 589-590
Author(s):  
R. N. Thin ◽  
M. A. E. Symonds ◽  
R. Booker ◽  
S. Cook ◽  
F. Langley
Keyword(s):  
Single Dose ◽  
Double Blind ◽  
Blind Comparison

Prevention of pterygium recurrence by postoperative single dose beta-irradiation: a prospective randomised clinical double-blind trial

2003 ◽  
Vol 57 (2) ◽  
pp. S252
Author(s):  
I.J Schulz ◽  
L.J Hartman ◽  
J.M Roesink ◽  
R.J Tersteeg ◽  
I van der Tweel ◽  
...  
Keyword(s):  
Single Dose ◽  
Double Blind Trial ◽  
Double Blind ◽  
Blind Trial

scholarly journals The Therapeutic Evaluation of Steroids in IgA Nephropathy Global (TESTING) Study: Trial Design and Baseline Characteristics

2021 ◽  
pp. 1-10
Author(s):  
Muh Geot Wong ◽  
Jicheng Lv ◽  
Michelle A. Hladunewich ◽  
Vivekanand Jha ◽  
Lai Seong Hooi ◽  
...  
Keyword(s):  
Iga Nephropathy ◽  
Kidney Failure ◽  
Trial Design ◽  
Low Dose ◽  
Treatment Algorithm ◽  
Renin Angiotensin System ◽  
Double Blind ◽  
Matching Placebo ◽  
Therapeutic Evaluation ◽  
Baseline Characteristics

<b><i>Introduction:</i></b> Despite optimal current care, up to 30% of individuals suffering from immunoglobulin A nephropathy (IgAN) will develop kidney failure requiring dialysis or kidney transplantation. The Therapeutic Evaluation of STeroids in IgA Nephropathy Global (TESTING) study was designed to assess the benefits and risks of steroids in people with IgAN. We report the trial design as well as the baseline characteristics of study participants. <b><i>Methods:</i></b> It is an investigator-initiated, multicenter, double-blind, placebo-controlled, randomized trial of individuals with kidney biopsy-confirmed IgAN, proteinuria ≥1 g/day, and an estimated GFR of 20–120 mL/min/1.73 m<sup>2</sup>, following at least 3 months of standard of care including maximum labelled (or tolerated) dose of renin-angiotensin system blockade. The original study design randomized participants 1:1 to oral methylprednisolone (0.6–0.8 mg/kg/day, maximum 48 mg/day) for 2 months, with subsequent weaning by 8 mg/day/month over 6–8 months, or matching placebo. The intervention was modified in 2016 (due to an excess of serious infection) to low-dose methylprednisolone (0.4 mg/kg/day, maximum 32 mg/day) for 2 months, followed by weaning by 4 mg/day/month over 6–9 months, or matching placebo. Participants recruited after 2016 also received prophylaxis against <i>Pneumocystis jirovecii</i> pneumonia during the first 12 weeks of treatment. <b><i>Results:</i></b> The study recruitment period extended from May 2012 to November 2019. By the time the excess of serious infections was observed, 262 participants had been randomized to the original full-dose treatment algorithm, and an interim analysis was reported in 2016. Subsequently, 241 additional participants were randomized to a revised low-dose protocol, for a total of 503 participants from China (373), India (78), Canada (24), Australia (18), and Malaysia (10). The mean age of randomized participants was 38, 39% were female, mean eGFR at randomization was 62.7 mL/min/1.73 m<sup>2</sup>, and mean 24-h urine protein 2.54 g. The primary endpoint is a composite of 40% eGFR decline from baseline or kidney failure (dialysis, transplantation, or death due to kidney disease), and participants will be followed until the primary outcome has been observed in at least 160 randomized participants. Analyses will also be made across predefined subgroups. Effects on eGFR slope and albuminuria will also be assessed overall, as well as by the steroid dosing regimen. <b><i>Conclusions:</i></b> The TESTING study (combined full and low dose) will define the benefits of corticosteroid use on major kidney outcomes, as well as the risks of therapy, and provide data on the relative effects of different doses, in individuals with high-risk IgAN.

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