A Three-Month Double-Blind Study of Clobazam versus Diazepam in Out-Patients Suffering from Neurotic Disturbances

1979 ◽  
Vol 7 (5) ◽  
pp. 404-410 ◽  
Author(s):  
H P Schjønsby ◽  
A E Gordon ◽  
D Koeppen
Keyword(s):  
Global Assessment ◽  
Anxiety Scale ◽  
Double Blind Study ◽  
Efficacy And Safety ◽  
Double Blind ◽  
Significant Difference ◽  
Hamilton Anxiety Scale ◽  
Period Data ◽  
The Individual ◽  
Hamilton Anxiety

Efficacy and safety of the 1,5 benzodiazepine, clobazam, in comparison to the 1,4 benzodiazepine, diazepam, were controlled in sixty psychiatric out-patients over a period of three months. In the course of this long treatment period data were obtained confirming findings of shorter-lasting studies. Global assessment of the therapeutic efficacy and the total scores of the Hamilton Anxiety Scale revealed no significant difference between the compounds. Both groups showed a significant (p < 0.01) improvement in the total scores of the Hamilton Anxiety Scale after two weeks of treatment. Scores of the individual items indicated distinct spectra of action: Clobazam was more effective in diminishing anxious mood, whereas diazepam was better able to influence muscular symptoms of anxiety. The relevance of the findings for a more individualized therapy is pointed out.

Valproate (depakine-chrono) in the acute treatment of outpatients with generalized anxiety disorder without psychiatric comorbidity: Randomized, double-blind placebo-controlled study

2008 ◽  
Vol 23 (2) ◽  
pp. 109-114 ◽  
Author(s):  
Nadir A. Aliyev ◽  
Zafar N. Aliyev
Keyword(s):  
Anxiety Disorder ◽  
Anxiety Disorders ◽  
Generalized Anxiety Disorder ◽  
Anxiety Scale ◽  
Generalized Anxiety ◽  
Study Group ◽  
Double Blind ◽  
Double Blind Placebo ◽  
Hamilton Anxiety Scale ◽  
Hamilton Anxiety

AbstractObjectiveAnxiety disorders are highly prevalent in population of European countries. However, the effect of Valproate (depakine-chrono) on generalized anxiety disorder (GAD) has not been studied in a double-blind placebo-controlled design.MethodEighty patients (all men) were washout from the all medications. Each patient was randomized to receive either depakine-chrono (40 patients) for 6 weeks or matched placebo (40 patients) in a double-blind manner. Eligible participants, in addition to meeting the DSM-IV criteria for GAD and having a minimum score of 25 and more on the Hamilton Anxiety Scale, were required to be between 18 and 65 years. Response was defined as a 50% reduction in the Hamilton anxiety scale score. Response and side effects with depakine-chrono and placebo were compared by using analysis of variance (ANOVA) and chi-square tests. Six patients did not return for at least one subsequent assessment, leaving 74 patients (36 taking depakine-chrono and 38 taking placebo) in the valuables study group.ResultsTwenty six of the 36 depakine-chrono-treated participants responded by 6 weeks, versus six of the 38 placebo-treated participants (p < 0.001). The most common and problematic side effect in the depakine-chrono group was dizziness and nausea.ConclusionsThe authors believe this to be the first double-blind placebo-controlled randomization study to test the efficacy of a depakine-chrono in the management of anxiety disorders. They need to be replicated in a larger study group.

Oxypertine and Medazepam in Patients Suffering from Anxiety Neurosis. Report of a Double Blind Study

1977 ◽  
Vol 5 (6) ◽  
pp. 130-135
Author(s):  
J F Donald ◽  
W P McMillin
Keyword(s):  
Anxiety Scale ◽  
Blind Study ◽  
Double Blind Study ◽  
Anxiety Neurosis ◽  
Double Blind ◽  
Phobic Anxiety ◽  
Two Agents ◽  
Middlesex Hospital ◽  
Hamilton Anxiety Scale ◽  
Blind Comparison

In two centres a total of 50 patients with anxiety neurosis was studied in a randomised, between patient, double blind comparison of the therapeutic efficacies of two new anxiolytic agents, oxypertine ( Integrin) and medazepam ( Nobrium). Treatment was continued for four weeks. Assessments were made using the Middlesex Hospital Questionnaire ( MHQ), the Hamilton Anxiety Scale and the Graphic Scale. On all three ratings both agents produced a significant improvement in the patients' condition. Significant differences between the two agents were recorded by the MHQ sub tests and total score. Phobic anxiety responded significantly better to medazepam ( p < 0·03). Depression responded significantly better to oxypertine ( p < 0·02) which was also associated with a greater improvement in three of the remaining four sub tests and a significantly greater reduction in score for overall neuroticism ( p < 0·05).

Intra-articular hyaluronan is without clinical effect in knee osteoarthritis: a multicentre, randomised, placebo-controlled, double-blind study of 337 patients followed for 1 year

2010 ◽  
Vol 69 (6) ◽  
pp. 1097.2-1102 ◽  
Author(s):  
Anette Jørgensen ◽  
Kristian Stengaard-Pedersen ◽  
Ole Simonsen ◽  
Mogens Pfeiffer-Jensen ◽  
Christian Eriksen ◽  
...  
Keyword(s):  
Knee Osteoarthritis ◽  
Treatment Effect ◽  
Global Assessment ◽  
Blind Study ◽  
Double Blind Study ◽  
Double Blind ◽  
Time To Recurrence ◽  
Acr Criteria ◽  
Significant Difference ◽  
Efficacy Parameters

ObjectiveTo examine the long-term efficacy and safety of five intra-articular injections with hyaluronan in knee osteoarthritis.MethodsA multicentre, randomised, placebo-controlled double-blind study of 337 patients fulfilling the American College of Rheumatology (ACR) criteria for knee osteoarthritis (clinical and laboratory) and with a Lequesne algofunctional index score (LFI) of 10 or greater. Patients received a hyaluronan product (sodium hyaluronate; Hyalgan) (n=167) or saline (n=170) intra-articularly weekly for 5 weeks and were followed up to 1 year. Time to recurrence was the primary efficacy parameter. LFI, pain on walking 50 m based on visual analogue scale (VAS pain 50 m), paracetamol consumption, patients' global assessment, Nottingham health profile, joint effusion and number of responders were secondary efficacy parameters. The efficacy parameters were analysed by intention to treat (ITT) and per protocol (PP). All adverse events (AE) were recorded as safety parameters.ResultsTime to recurrence showed no significant treatment effect (ITT analysis, p=0.26). Change from baseline in LFI and VAS pain 50 m for the ITT population showed no treatment effect. Paracetamol consumption, patients' global assessment, responder rates and AE displayed no significant difference between treatment groups, analysed by both ITT and PP. Treatment compliance was 95% in the hyaluronan group and 99% in the placebo group. No safety problems were registered.ConclusionIn patients fulfilling the ACR criteria for osteoarthritis of the knee with moderate to severe disease activity (LFI ≥10), five intra-articular injections of hyaluronan did not improve pain, function, paracetamol consumption or other efficacy parameters 3, 6, 9 and 12 months after the treatment.

Placebo-Controlled, Randomized, Double-Blind Study of Intravenous Enalaprilat Efficacy and Safety in Acute Cardiogenic Pulmonary Edema

Circulation ◽  
1996 ◽  
Vol 94 (6) ◽  
pp. 1316-1324 ◽  
Author(s):  
Djillali Annane ◽  
Eric Bellissant ◽  
Eric Pussard ◽  
Roland Asmar ◽  
Florence Lacombe ◽  
...  
Keyword(s):  
Pulmonary Edema ◽  
Blind Study ◽  
Cardiogenic Pulmonary Edema ◽  
Double Blind Study ◽  
Efficacy And Safety ◽  
Double Blind ◽  
Acute Cardiogenic Pulmonary Edema

The validity of the Melancholia Scale (MES) in predicting outcome of antidepressants in chronic idiopathic pain disorders

1991 ◽  
Vol 6 (3) ◽  
pp. 119-125 ◽  
Author(s):  
D Loldrup ◽  
M Langemark ◽  
HJ Hansen ◽  
M Kastrup ◽  
K Jeppesen ◽  
...  
Keyword(s):  
Construct Validity ◽  
Scale Score ◽  
Anxiety Scale ◽  
Full Recovery ◽  
Hamilton Depression Scale ◽  
Depressed Patients ◽  
Idiopathic Pain ◽  
Hamilton Anxiety Scale ◽  
Structure Evaluation ◽  
Hamilton Anxiety

SummaryIn patients with chronic idiopathic pain disorders we have analysed the construct validity of the Melancholia Scale as compared to the results with the scale in primary depression. The patients (n= 253) were treated in a placebo controlled trial with either clomipramine or mianserin independently of the Melancholia score. The construct validity of the Melancholia Scale was further analysed by the testing of the intensity model of depression versus anxiety using the Beck Depression Inventory, the Hamilton Anxiety Scale, the Spielberger State-Trait Anxiety Scale, and the Melancholia Scale. The construct validity in terms of scale homogeneity was analysed by Loevinger coefficients which can be considered as a latent structure evaluation. The Melancholia Scale showed acceptable homogeneity, while the Hamilton Anxiety Scale lacked sufficient homogeneity. In total, 33% of the patients had a score of 10 or more on the Melancholia Scale (corresponding to 13 or more on the Hamilton Depression Scale). The predictive validity of the Melancholia Scale was evaluated using active treatment versus placebo response after 6 weeks of therapy. It was shown that in patients with a Melancholia Scale score of 10 or more (corresponding to “less than major depression”) 72% had full recovery when treated with clomipramine, while 36% of the placebo treated patients obtained a full recovery (P≤0.05). The patients treated with mianserin obtained a full recovery in 52%. The group of patients with a Melancholia Scale score of 10 or more scored higher also on the anxiety scales indicating that the relation between depression and anxiety is a matter of severity. The depressed patients had significantly lower imipramine binding sites than the non-depressed patients.

scholarly journals Olokizumab, a monoclonal antibody against interleukin 6, in combination with methotrexate in patients with rheumatoid arthritis inadequately controlled by methotrexate: efficacy and safety results of a randomised controlled phase III study

2021 ◽  
pp. annrheumdis-2021-219876
Author(s):  
Evgeniy Nasonov ◽  
Saeed Fatenejad ◽  
Eugen Feist ◽  
Mariana Ivanova ◽  
Elena Korneva ◽  
...  
Keyword(s):  
Rheumatoid Arthritis ◽  
Disease Activity ◽  
Activity Index ◽  
Disease Activity Index ◽  
Phase Iii ◽  
Double Blind Study ◽  
Efficacy And Safety ◽  
Serious Adverse Events ◽  
Double Blind ◽  
Acr20 Response

ObjectiveTo evaluate the efficacy and safety of olokizumab (OKZ) in patients with active rheumatoid arthritis despite treatment with methotrexate (MTX).MethodsIn this 24-week multicentre, placebo-controlled, double-blind study, patients were randomised 1:1:1 to receive subcutaneously administered OKZ 64 mg once every 2 weeks, OKZ 64 mg once every 4 weeks, or placebo plus MTX. The primary efficacy endpoint was the proportion of patients achieving an American College of Rheumatology 20% (ACR20) response at week 12. The secondary efficacy endpoints included percentage of subjects achieving Disease Activity Score 28-joint count based on C reactive protein <3.2, Health Assessment Questionnaire Disability Index at week 12, ACR50 response and Clinical Disease Activity Index ≤2.8 at week 24. Safety and immunogenicity were assessed throughout the study.ResultsA total of 428 patients were randomised. ACR20 responses were more frequent with OKZ every 2 weeks (63.6%) and OKZ every 4 weeks (70.4%) than placebo (25.9%) (p<0.0001 for both comparisons). There were significant differences in all secondary efficacy endpoints between OKZ-treated arms and placebo. Treatment-emergent serious adverse events (TESAEs) were reported by more patients in the OKZ groups compared with placebo. Infections were the most common TESAEs. No subjects developed neutralising antidrug antibodies.ConclusionsTreatment with OKZ was associated with significant improvement in signs, symptoms and physical function of rheumatoid arthritis without discernible differences between the two regimens. Safety was as expected for this class of agents. Low immunogenicity was observed.Trial registration numberNCT02760368.

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