Comparison of Efficacy of Amoxapine and Imipramine in a Multi-Clinic Double-Blind Study Using the WHO Schedule for a Standard Assessment of Patients with Depressive Disorders

A multi-clinic double-blind controlled study on amoxapine in comparison with imipramine, using the WHO Schedule for a Standard Assessment of Patients with Depressive Disorders, was performed and the data were analyzed with 111 patients. The assessment of severity of illness and overall improvement indicated clearly the superiority of the antidepressive effect of amoxapine to that of imipramine. The onset of antidepressive effect of amoxapine was clearly more rapid than that of imipramine, and in more than half of the patients in the amoxapine group the improvement was seen within four days following the drug administration, Amoxapine was superior to imipramine in terms of safety and usefulness. The side-effects due to amoxapine appeared less frequently and were less serious than with imipramine. The difference between amoxapine and imipramine was especially remarkable for hypotensive effect. The antidepressive effect of amoxapine was superior to that of imipramine for almost all symptoms and signs. Amoxapine displayed an especially remarkable effect on psychomotor retardation, depressive feeling, anxiety and tension, somatic complaints and sleep disturbance.

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Hypotensive Effect of Oxprenolol in Mild Hypertension: A Co-Operative Controlled Study

Clinical Science ◽

10.1042/cs045163s ◽

1973 ◽

Vol 45 (s1) ◽

pp. 163s-166s ◽

Cited By ~ 1

Author(s):

G. Muiesan ◽

M. Motolese ◽

A. Colombi

Keyword(s):

Experimental Design ◽

Moderate Hypertension ◽

Mild Hypertension ◽

Diastolic Pressure ◽

Hypotensive Effect ◽

Standing Position ◽

Controlled Study ◽

Double Blind Study ◽

Factorial Experimental Design ◽

Double Blind

1. In a multicentre double-blind study, oxprenolol (OX) hypotensive effect was investigated in 329 patients with mild to moderate hypertension. 2. A factorial experimental design with three factors was chosen: OX mg/day 0, 20, 40, 60, 80; dihydrazinophthalazine (DHZ) mg/day 0, 30; and hydrochlorothiazide (HCH) mg/day 0, 30. Each treatment was carried out for a period of 4 weeks after an adequate placebo period. 3. Independently of the association with DHZ and/or HCH, OX yielded a hypotensive effect linearly related to dose (P < 0.05) for systolic and diastolic pressure in the standing position, but only for diastolic pressure in the supine position. 4. The addition of DHZ and/or HCH to OX at 80 mg/day caused a significant increase in the final hypotensive effect.

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Children With Influenza A Infection: Treatment With Rimantadine

PEDIATRICS ◽

10.1542/peds.80.2.275 ◽

1987 ◽

Vol 80 (2) ◽

pp. 275-282

Author(s):

Caroline Breese Hall ◽

Raphael Dolin ◽

Christine L. Gala ◽

David M. Markovitz ◽

Yu Qin Zhang ◽

...

Keyword(s):

Influenza A ◽

Clinical Signs ◽

Severity Of Illness ◽

Signs And Symptoms ◽

Clinical Isolates ◽

Double Blind Study ◽

Double Blind ◽

Viral Shedding ◽

Development Of Resistance ◽

Clinical Signs And Symptoms

Treatment with rimantadine of influenza in children and the potential development of resistance in clinical isolates associated with therapy have not been previously studied. We compared rimantadine to acetaminophen therapy in a controlled, double-blind study of 91 children with influenza-like illness. Of 69 children with proven influenza A/H3N2 infection, 37 received rimantadine and 32 received acetaminophen for five days. Children receiving rimantadine showed significantly greater reduction in fever and improvement in daily scores for symptoms and severity of illness during the first three days. Viral shedding also diminished significantly during the first two days but subsequently increased such that by days 6 and 7 the proportion of children shedding virus, as well as the quantity of virus shed, was significantly greater in the rimantadine group. During the seven-day study, of the 22 children in the rimantadine group with serial isolates tested, ten (45.5%) had resistant isolates compared with two (12.5%) of those with serial isolates in the acetaminophen group (P < .03). Thus, of the total 37 children in the rimantadine group, 27% were found to have resistant isolated compared with 6% in the total group receiving acetaminophen (P < .04). Furthermore, the mean inhibitory concentration of rimantadine increased with time in the rimantadine group (r = .4, P = .002) but not in the acetaminophen group. Rimantadine therapy, thus, appears to be significantly more effective than acetaminophen in ameliorating the clinical signs and symptoms of influenza in children. Treatment with rimantadine was also associated with increased viral shedding after the medication was discontinued and with the development of resistance in the clinical isolates, the significance of which is unknown.

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A double-blind randomized placebo-controlled study of low dose mirtazapine once daily in patients of major depressive disorders on escitalopram

International Journal of Basic & Clinical Pharmacology ◽

10.18203/2319-2003.ijbcp20191602 ◽

2019 ◽

Vol 8 (5) ◽

pp. 1067

Author(s):

Mallikarjuna Rao I. ◽

Usha Kiran Prayaga ◽

Dharma Rao Uppada ◽

Ramachandra Rao E. ◽

B. L. Kudagi

Keyword(s):

Depressive Disorders ◽

Low Dose ◽

Rating Scale ◽

Controlled Study ◽

P Value ◽

Chi Square ◽

Double Blind ◽

Increased Risk ◽

Significant Difference ◽

Chi Square Test

Background: The SSRIs being used as 1st line therapy in treatment of depression have delayed therapeutic effect which makes the patient vulnerable to an increased risk of suicide and decreased adherence to the treatment and will prematurely discontinue the therapy. The present study was conducted to evaluate if low dose mirtazapine-escitalopram combination therapy has any add on benefit over monotherapy with escitalopram.Methods: In a single-centered, comparative study involving patients with depression attending the out-patient after screening and exclusion, 60 eligible patients were randomly assigned to receive tablet mirtazapine 7.5 mg plus tablet escitalopram 10 mg intervention or tablet escitalopram 10 mg plus placebo intervention in a double-blind 6-week treatment phase. The primary outcome measure was the change in the 17-item Hamilton Depression Rating Scale (HDRS) and Montgomery-Asberg Depression Rating Scale (MADRS) score from baseline. Participants were evaluated at baseline, 1st, 2nd,4th and 6th week. Results were analyzed using Chi-Square test for adverse effects and independent t-test analysis for efficacy parameter.Results: In the analysis of results at 6th week the numbers of patients achieved remission in mirtazapine group are more with a p-value of 0.018 which is significant and the numbers of responders in mirtazapine group are also more which is statistically significant on chi-square test. There is no significant difference was observed between the two groups with reference to occurrence of adverse effect.Conclusions: Adding low dose mirtazapine has an added benefit in terms of efficacy and getting remission early with more number of responders in the treatment of major depression.

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Efficacy of ethyl-eicosapentaenoic acid in bipolar depression: Randomised double-blind placebo-controlled study

The British Journal of Psychiatry ◽

10.1192/bjp.188.1.46 ◽

2006 ◽

Vol 188 (1) ◽

pp. 46-50 ◽

Cited By ~ 191

Author(s):

Sophia Frangou ◽

Michael Lewis ◽

Paul McCrone

Keyword(s):

Eicosapentaenoic Acid ◽

Rating Scale ◽

Bipolar Depression ◽

Unipolar Depression ◽

Adjunctive Treatment ◽

Secondary Outcome ◽

Controlled Study ◽

Double Blind Study ◽

Young Mania ◽

Double Blind

BackgroundEpidemiological and clinical studies suggest that increased intake of eicosapentaenoic acid (EPA) alleviates unipolar depression.AimsTo examine the efficacy of EPA in treating depression in bipolar disorder.MethodIn a 12-week, double-blind study individuals with bipolar depression were randomly assigned to adjunctive treatment with placebo (n=26) or with 1g/day (n=24) or 2 g/day (n=25) of ethyl-EPA. Primary efficacy was assessed by the Hamilton Rating Scale for Depression (HRSD), with changes in the Young Mania Rating Scale and Clinical Global Impression Scale (CGI) as secondary outcome measures.ResultsThere was no apparent benefit of 2g over 1g ethyl-EPA daily. Significant improvement was noted with ethyl-EPA treatment compared with placebo in the HRSD (P=0.04) and the CGI (P=0.004) scores. Both doses were well tolerated.ConclusionsAdjunctive ethyl-EPA is an effective and well-tolerated intervention in bipolar depression.

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Daflon 500 mg: Symptoms and Edema

Angiology ◽

10.1177/00033197050560i105 ◽

2005 ◽

Vol 56 (6_suppl) ◽

pp. S25-S32 ◽

Cited By ~ 11

Author(s):

Albert-Adrien Ramelet

Keyword(s):

Quality Of Life ◽

Controlled Study ◽

Venous Disease ◽

Double Blind Study ◽

Life Questionnaire ◽

Double Blind ◽

Randomized Controlled ◽

Randomized Controlled Studies ◽

Significant Difference

Patients suffering from any class of the Clinical, Etiological, Anatomical, Pathophysiological (CEAP) classification of chronic venous disease (CVD) may be symptomatic (C0s-C6s). Leg heaviness, discomfort, itching, cramps, pain, paresthesia, and edema (C3) are the most frequent manifestations of CVD and a major reason for medical consultation. Daflon 500 mg (micronized purified flavonoid fraction [MPFF]) is an effective treatment for symptoms and edema in CVD as demonstrated in several randomized controlled studies. A 2-month, double-blind study in 40 patients established the superiority of Daflon 500 mg over placebo with regard to symptoms and objective signs. This was confirmed in another double-blind, placebo-controlled trial (2 months’ treatment, 160 patients), and in the Reflux assEssment and quaLity of lIfe improvEment with micronized Flavonoids (RELIEF) study. The latter included 5,052 patients in 23 countries, using a visual analog scale for evaluating pain, leg heaviness, cramps, and a sensation of swelling. All symptoms showed significant and progressive improvement. The quality-of-life results (scores on the ChronIc Venous Insufficiency quality of life Questionnaire [CIVIQ]) paralleled those of symptoms. The decrease in the ankle and calf circumferences was significantly greater (p<0.001) in the group of patients treated with Daflon 500 mg in two studies, and correlated well with the improvement in the sensation of swelling (p<0.001). This was confirmed with more sophisticated measurement techniques as in the RELIEF study or in a trial assessing edema with an optoelectronic volumeter in 20 patients. A further double-blind, randomized, controlled study established a statistically significant difference in favor of Daflon 500 mg in comparison with diosmin, both on symptoms and edema. The therapeutic efficacy of Daflon 500 mg on CVD symptoms and edema has been demonstrated in double-blind, randomized, controlled studies. Further studies using a new approach may define the most precise and validated methodology for application in future research in phlebology.

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Comparison of the efficacy of moclobemide and fluvoxamine in elderly patients with a severe depressive episode

European Psychiatry ◽

10.1017/s0924933800000705 ◽

1993 ◽

Vol 8 (6) ◽

pp. 319-324 ◽

Cited By ~ 8

Author(s):

JP Bocksberger ◽

JP Gachoud ◽

J Richard ◽

Ρ Dick

Keyword(s):

Side Effects ◽

Elderly Patients ◽

Psychomotor Retardation ◽

Antidepressant Effect ◽

Reversible Inhibitor ◽

Double Blind Study ◽

Double Blind ◽

New Class ◽

Low Incidence ◽

To Receive

SummaryIn a double-blind study carried out on elderly patients (older than 65 years) the efficacy and tolerability of the new antidepressant moclobemide was compared. Moclobemide belongs to a new class of substances called RIMA (Reversible inhibitor of the monoamine oxidase type A). Fluvoxamine, a selective reuptake-inhibitor of 5-HT, belongs to a class of antidepressants known for their better tolerability compared to tricyclic especially with elderly patients. Forty elderly patients (mean age 75 years) with major depression (according to DSM III) were randomized to receive either moclobemide (300 mg) or fluvoxamine (100 mg) twice daily. Dosages were increased when necessary on day 8, to a maximum of 450 mg moclobemide or 200 mg fluvoxamine and in most cases were maintained at these levels for the remainder of the study period (four weeks). Moclobemide was more effective than fluvoxamine showing a marked antidepressant effect and an earlier effect on psychomotor retardation. The two drugs were well tolerated showing a low incidence of side effects.

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Antiplatelet effects of citalopram in patients with ischaemic stroke: A randomized, placebo-controlled, double-blind study

Scientific Reports ◽

10.1038/s41598-019-56487-8 ◽

2019 ◽

Vol 9 (1) ◽

Author(s):

Kristian Lundsgaard Kraglund ◽

Janne Kaergaard Mortensen ◽

Søren Paaske Johnsen ◽

Grethe Andersen ◽

Erik Lerkevang Grove

Keyword(s):

Platelet Aggregation ◽

Ischaemic Stroke ◽

Acute Ischaemic Stroke ◽

Platelet Reactivity ◽

Significant Inhibition ◽

Controlled Study ◽

Double Blind Study ◽

Stroke Patients ◽

Double Blind ◽

Ssri Treatment

AbstractWe evaluated the effect of SSRI treatment on platelet aggregation in patients with ischaemic stroke and included patients from the randomized double-blind controlled study of citalopram in acute ischaemic stroke (TALOS). Patients on clopidogrel were included 6 months after acute ischaemic stroke. Platelet parameters, including P2Y12 platelet reactivity using the VerifyNow System, were measured at the last day of study treatment and repeated after a 14-day wash-out period. A total of 60 patients were included (n = 32 randomized to citalopram). Platelet aggregation levels did not differ between the citalopram group (mean 116, 95% CI 89 to 143) and the placebo group (mean 136, 95% CI 109 to 163) (On-treatment, p = 0.14). Similarly, there was no significant change in platelet aggregation in the citalopram group from on-treatment to post-treatment (mean difference 2.0; 95% CI −18 to 14). Platelet count, size and turnover were not affected by SSRI treatment. In conclusion, SSRI therapy did not lead to statistically significant inhibition of platelet aggregation in ischaemic stroke patients treated with clopidogrel.

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Phase III Randomized, Double-Blind Study Comparing Single-Dose Intravenous Peramivir with Oral Oseltamivir in Patients with Seasonal Influenza Virus Infection

Antimicrobial Agents and Chemotherapy ◽

10.1128/aac.00360-11 ◽

2011 ◽

Vol 55 (11) ◽

pp. 5267-5276 ◽

Cited By ~ 73

Author(s):

Shigeru Kohno ◽

Muh-Yong Yen ◽

Hee-Jin Cheong ◽

Nobuo Hirotsu ◽

Tadashi Ishida ◽

...

Keyword(s):

Influenza Virus ◽

Virus Infection ◽

Influenza A ◽

Seasonal Influenza ◽

Influenza Virus Infection ◽

Influenza Viruses ◽

Phase Iii ◽

Controlled Study ◽

Double Blind Study ◽

Double Blind

ABSTRACTAntiviral medications with activity against influenza viruses are important in controlling influenza. We compared intravenous peramivir, a potent neuraminidase inhibitor, with oseltamivir in patients with seasonal influenza virus infection. In a multinational, multicenter, double-blind, double-dummy randomized controlled study, patients aged ≥20 years with influenza A or B virus infection were randomly assigned to receive either a single intravenous infusion of peramivir (300 or 600 mg) or oral administration of oseltamivir (75 mg twice a day [b.i.d.] for 5 days). To demonstrate the noninferiority of peramivir in reducing the time to alleviation of influenza symptoms with hazard model analysis and a noninferiority margin of 0.170, we planned to recruit 1,050 patients in South Korea, Japan, and Taiwan. A total of 1,091 patients (364 receiving 300 mg and 362 receiving 600 mg of peramivir; 365 receiving oseltamivir) were included in the intent-to-treat infected population. The median durations of influenza symptoms were 78.0, 81.0, and 81.8 h in the groups treated with 300 mg of peramivir, 600 mg of peramivir, and oseltamivir, respectively. The hazard ratios of the 300- and 600-mg-peramivir groups compared to the oseltamivir group were 0.946 (97.5% confidence interval [CI], 0.793, 1.129) and 0.970 (97.5% CI, 0.814, 1.157), respectively. Both peramivir groups were noninferior to the oseltamivir group (97.5% CI, <1.170). The overall incidence of adverse drug reactions was significantly lower in the 300-mg-peramivir group, but the incidence of severe reactions in either peramivir group was not different from that in the oseltamivir group. Thus, a single intravenous dose of peramivir may be an alternative to a 5-day oral dose of oseltamivir for patients with seasonal influenza virus infection.

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A Placebo-Controlled Study Evaluating the Efficacy and Safety of Flexible-Dose Desvenlafaxine Treatment in Outpatients with Major Depressive Disorder

CNS Spectrums ◽

10.1017/s1092852900020046 ◽

2009 ◽

Vol 14 (1) ◽

pp. 41-50 ◽

Cited By ~ 28

Author(s):

Alan D. Feiger ◽

Karen A. Tourian ◽

Gregory R. Rosas ◽

S. Krishna Padmanabhan

Keyword(s):

Major Depressive Disorder ◽

Depressive Disorder ◽

Dose Range ◽

Severity Of Illness ◽

Final Evaluation ◽

Analysis Of Covariance ◽

Controlled Study ◽

Double Blind Study ◽

Efficacy And Safety ◽

Major Depressive

ABSTRACTIntroduction: This research compares the efficacy and safety of desvenlafaxine (administered as desvenlafaxine succinate) versus placebo in treating major depressive disorder.Methods: In this randomized, double-blind study, outpatients with major depressive disorder ≥18 years of age received desvenlafaxine 200–400 mg/day or placebo for 8 weeks. Efficacy endpoints included (primary) change in 17-item Hamilton Rating Scale for Depression score at the final evaluation (last observation carried forward, analysis of covariance) and (secondary) Clinical Global Impressions—Improvement and—Severity of Illness scales.Results: The difference between desvenlafaxine (n=117) and placebo (n=118) on the primary endpoint was not significant (−9.1 vs −7.5, P=.078). Week 8 observed cases (desvenlafaxine, n=80; placebo, n=94) results were significant (−10.7 vs −7.9, P=.008). Differences at the final evaluation (last observation carried forward) were significant for Clinical Global Impressions—Improvement (2.9 vs 2.5, P=.037) and Clinical Global Impressions—Severity of Illness (−1.9 vs −1.2, P=.041). Discontinuation rates due to adverse events (AEs) were 12% and 3% for desvenlafaxine and placebo, respectively (P=.008). The most frequently reported AE associated with desvenlafaxine was nausea (36% vs 9% [placebo]).Conclusion: In this study, the primary analysis did not show significant differences between desvenlafaxine and placebo; discontinuations due to AEs associated with the desvenlafaxine dose range may have contributed to the lack of statistical separation.

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Temelastine, a New H1-Receptor Antagonist

Journal of International Medical Research ◽

10.1177/030006058601400406 ◽

1986 ◽

Vol 14 (4) ◽

pp. 200-204 ◽

Cited By ~ 2

Author(s):

Fred Alexander ◽

Robert M Stote ◽

Nancy Allison ◽

Robert G Familiar ◽

Dianne Tatoian ◽

...

Keyword(s):

Receptor Antagonist ◽

Plasma Concentrations ◽

Controlled Study ◽

Blood Levels ◽

Double Blind Study ◽

Double Blind ◽

The Central Nervous System ◽

H1 Receptor Antagonist ◽

Oral Doses ◽

Wheal Size

Temelastine is a selective, competitive histamine H1-receptor antagonist which does not penetrate the central nervous system. The effect of varying doses of temelastine was compared in a randomized, double-blind, controlled study by measuring the inhibition of cutaneous histamine wheals. In twelve subjects single oral doses of 50, 100 and 200 mg of temelastine produced dose-dependent reductions in wheal areas. The inhibition of wheal size was maximal by 2 hr after dosing and was present at 8 hr. At 2 hr the 50, 100, and 200 mg doses reduced the wheal size by 53, 64, and 78%, respectively. Chlorpheniramine, 4 mg, reduced wheal size by 32% at the same period. The ability of temelastine to antagonize the histamine-induced skin reaction over 20 hr was evaluated in a second randomized, double-blind study. Eight subjects participated. Temelastine, 100 mg, produced reductions of 64, 49, 56 and 51% in histamine wheal area at 8, 12, 16 and 20 hr, respectively. Plasma concentrations at these times were 4.04, 2.77, 1.88, and 1.44 μmol/l, respectively. These data suggest that blood levels as low as 1.44 μmol/l may be sufficient to produce an antihistaminic effect, and that daily or twice daily dosing with 100 mg may be adequate to control allergic symptoms.

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