A Double-Blind Study of Trazodone and Mianserin in the Treatment of Depression in General Practice

1982 ◽  
Vol 10 (3) ◽  
pp. 147-156 ◽  
Author(s):  
H H Richards ◽  
R N Midha ◽  
S Miller
Keyword(s):  
General Practice ◽  
Side Effects ◽  
Therapeutic Effect ◽  
Rating Scale ◽  
Double Blind ◽  
Global Improvement ◽  
Hamilton Depression Rating Scale ◽  
Self Rating ◽  
Visual Analogue Scales ◽  
Analogue Scales

The antidepressant and anxiolytic efficacy of trazodone (100–200 mg daily), mianserin (60–120 mg daily) and diazepam (15–30 mg daily) was evaluated in ninety-three patients suffering from mild to moderate depression, with or without anxiety, over 6 weeks in a double-blind non-crossover general practice study. Efficacy was evaluated using the Hamilton Depression Rating Scale, Patient Self-Rating Visual Analogue scales, physician global assessments and the Zung Self-Rating Anxiety Scale. All three treatments significantly reduced symptoms of depression, as measured on the Hamilton Depression Rating Scale and the physician's assessment of Global Improvement. Trazodone was significantly superior to both mianserin and diazepam. As assessed using Visual Analogue Scales, trazodone was also shown to be significantly superior to diazepam in improving the patient's ability to concentrate and in reducing daytime tiredness. Although evidence of efficacy was found, there were no differences in activity between the treatment groups using the physician's assessment of Current Severity or on assessment of Therapeutic Effect. The treatments all caused a reduction in anxiety as assessed by the Zung Self-Rating Scale. The overall incidence of side-effects was similar between groups. For those side-effects considered to be significantly interfering with the patient's function, but not outweighing the therapeutic effect, a reduction of dosage was effective. Several patients complaining of drowsiness or lethargy as an unacceptable daytime side-effect were switched successfully from twice daily to night-time dosing. Significantly more patients with side-effects (outweighing therapeutic effect or in the presence of no improvement) were withdrawn from the mianserin group than from the trazodone or diazepam groups. Overall, the therapeutic efficacy in relation to the incidence of clinically significant side-effects, favoured trazodone for the treatment of general practice patients suffering from depression, with or without anxiety.

A Comparative Trial of Opipramol and Chlordiazepoxide in the Treatment of Anxiety

1973 ◽  
Vol 1 (3) ◽  
pp. 145-150 ◽  
Author(s):  
K Jepson ◽  
G Beaumont
Keyword(s):  
Clinical Trial ◽  
General Practice ◽  
Side Effects ◽  
Rating Scale ◽  
Comparative Trial ◽  
Anxiety Score ◽  
Double Blind ◽  
Somatic Anxiety ◽  
Daily Dose ◽  
The Difference

A daily dose of 200 mg of opipramol (Insidon, Geigy) and 30 mg of chlordiazepoxide (Librium, Roche) were compared in a clinical trial in general practice. The trial was double blind and a stratified randomisation technique was employed. Twenty four patients received opipramol and twenty six chlordiazepoxide for four weeks. A total anxiety score and separate ‘psychic’ anxiety and ‘somatic’ anxiety scores were recorded, using a rating scale initially and after two and four weeks treatment. No overall difference in efficacy was found between the two drugs—opipramol producing a 76% improvement and chlordiazepoxide 64% by the end of the study. There was no difference in the relief of psychic anxiety. Although opipramol appeared to give more relief of somatic anxiety, the difference was not statistically significant. Again although opipramol relieved more individual symptoms than chlordiazepoxide, none of the differences were significant. 70% of patients on opipramol and 74% of those on chlordiazepoxide were classified ‘better’ globally by both doctor and patient by the end of the trial. The total number of side effects recorded was similar on both drugs although drowsiness occurred twice as frequently on chlordiazepoxide as it did on opipramol.

A Comparative Clinical Trial of Org GB 94 and Imipramine in the Treatment of Depression in General Practice

1975 ◽  
Vol 3 (4) ◽  
pp. 251-260 ◽  
Author(s):  
J E Murphy
Keyword(s):  
Clinical Trial ◽  
General Practice ◽  
Side Effects ◽  
Treatment Period ◽  
Therapeutic Effect ◽  
Double Blind ◽  
Comparative Clinical Trial ◽  
Two Agents ◽  
Treatment Of Depression

A double-blind controlled comparative clinical trial of Org GB 94 and imipramine was conducted in general practice. Fifty-five patients were treated with Org GB 94 (60 mg daily) and fifty-four with imipramine (150 mg daily). In the doses employed both agents were equally effective in relieving depression over a four week treatment period. Tolerance of the two agents was similar. Although no statistically significant differences emerged, with regard to both therapeutic effect and some side-effects a trend in favour of Org GB 94 was apparent.

Differential Dosing of Trazodone in Elderly Depressed Patients: A Study to Investigate Optimal Dosing

1986 ◽  
Vol 14 (5) ◽  
pp. 279-284 ◽  
Author(s):  
P K Mukherjee ◽  
A Davey
Keyword(s):  
Dose Group ◽  
Rating Scale ◽  
High Dose Group ◽  
High Dose ◽  
Base Line ◽  
Double Blind ◽  
Visual Analogue Scales ◽  
Initial Starting ◽  
Analogue Scales ◽  
Significant Superiority

We investigated the comparative efficacy and tolerance of two initial starting doses of trazodone in 20 elderly inpatients suffering from depressive illness. The first 2-week phase was double-blind. Patients received either 25 mg trazodone tds or 50 mg tds. After this time the study was open, the dose of trazodone being titrated from the initial starting dose to maximise efficacy and tolerance. Patients received study medication for a total of 6 weeks. Assessments for efficacy included the Hamilton Depression rating scale, Zung anxiety scale, visual analogue scales for depression, euphoria and tension, and global assesments of severity and improvement of condition. Tolerance was assessed by means of a checklist of symptoms and adverse effects. Assessments were performed at base line and at weekly or bi-weekly intervals thereafter. A total of 18 patients were included in the analysis. The Zung and visual analogue scales indicated significant superiority for the high-dose group at Week 2. The Hamilton ratings indicated significant superiority for the high-dose group at Week 6 with a strong trend in favour of the high dose group at Week 2. Measures of severity of illness and improvement indicated more rapid improvement over time in the high-dose group. The treatment was generally well tolerated and at no time did adverse events outweigh therapeutic benefit. The incidence of headache and nausea was more frequent in the high-dose group in the first 2 weeks. The group of elderly patients studied benefited from trazodone therapy initiated at a higher therapeutic dose. This dose (150 mg total daily) was well tolerated and proved effective over the course of 6 weeks' treatment.

Report on a Double-Blind Comparison of Two Different Regimens of Dothiepin (Prothiaden)

1983 ◽  
Vol 11 (1) ◽  
pp. 15-20 ◽  
Author(s):  
J Boening
Keyword(s):  
Side Effects ◽  
Therapeutic Effect ◽  
Rating Scale ◽  
Endogenous Depression ◽  
Clinical Impression ◽  
Night Time ◽  
Double Blind ◽  
Significant Difference ◽  
Single Night ◽  
Node Group

Thirty patients diagnosed as suffering from endogenous depression were entered into a 3-week double-blind trial comparing three times a day dosage of dothiepin with a single night-time dosage in a dosage range of 75 mg to 225 mg per day. The trial was conducted on in-patients and assessments were made pretrial and after 1 and 3 weeks. The patients were assessed by clinician-rated scales for psychomotor and psychic symptoms and by Zung's self-rating scale. Fifteen patients received dothiepin three times a day (day-time group) and fifteen received it as a single night-time dose (node group). There were two withdrawals in the day-time group and three in the node group. All withdrawals were due to lack of therapeutic effect. Over the 3-week trial 67% of the day-time group and 47% of the node group showed a clinical improvement. It was found that there was no statistically significant difference between the two methods of treatment. In the day-time group seven patients and in the night-time group nine patients suffered from side-effects. No particular pattern of side-effects emerged. There were no drug-related changes in the laboratory results. It was concluded that the therapeutic effect of both dosage regimes should be regarded as equivalent. Advantages, due to the specific action of dothiepin, compared with classical antidepressants for reference, could, however, not be presumed by the clinical impression.

Anxiolytic Efficacy of Alprazolam Compared to Diazepam and Placebo

1980 ◽  
Vol 8 (2) ◽  
pp. 139-143 ◽  
Author(s):  
Barry M Maletzky
Keyword(s):  
Side Effects ◽  
Rating Scale ◽  
Blind Study ◽  
Double Blind Study ◽  
Symptom Scale ◽  
Double Blind ◽  
Self Rating ◽  
Hamilton Anxiety Rating Scale ◽  
Hamilton Anxiety

The anxiolytic effects of alpraxolam (0.5–3.0 mg), diazepam (5–60 mg) and placebo were evaluated in eighty-six out-patients suffering from moderate to severe psychoneurotic anxiety in this 28-day, double-blind study. Efficacy was evaluated using five rating instruments, three rated by the physician (Hamilton Anxiety Rating Scale, Physician's Global Impressions and Target Symptoms) and two by the patients (Self-Rating Symptom Scale and Patient's Global Impressions). Alprazolam was more effective than placebo on all five measures of efficacy and, on several parameters, more effective than diazepam as well. The incidence of side-effects was lowest in the alprazolam group and decreased steadily over the course of the study, whereas the incidence in the diazepam and placebo groups remained relatively unchanged.

A Multicentre Hospital Study to Compare the Hypnotic Efficacy of Loprazolam and Nitrazepam

1984 ◽  
Vol 12 (4) ◽  
pp. 229-237 ◽  
Author(s):  
C Joan McAlpine ◽  
S I Ankier ◽  
Catherine S C Elliott
Keyword(s):  
Side Effects ◽  
Subjective Evaluation ◽  
Double Blind ◽  
Visual Analogue Scales ◽  
Parallel Group ◽  
Significant Difference ◽  
Hypnotic Efficacy ◽  
Hospital Study ◽  
Analogue Scales ◽  
Single Blind

A multicentre, parallel group hospital study was carried out in 190 subjects with insomnia to compare the efficacy, incidence of hangover and the side-effects of loprazolam and nitrazepam. Following 2 nights single-blind phase on placebo, loprazolam (1·0 mg), nitrazepam (5·0 mg) or placebo was administered double-blind for 7 consecutive nights. Visual analogue scales and questions were used to rate efficacy. There was no statistically significant difference between loprazolam and nitrazepam for ‘ease of getting to sleep’, ‘restfulness of sleep’ and ‘depth of sleep’. Like nitrazepam, loprazolam diminished the number of periods of wakefulness and made it ‘easier to get to sleep again’. Subjective evaluation showed that hangover was not a feature of loprazolam. It did not affect morning alertness and patients thought they had improved balance and co-ordination while on this drug. These findings are in keeping with the evidence of other workers who have shown only minimal psychomotor impairment, if any, with loprazolam (1·0 mg). There was no statistically significant difference between treatments with respect to frequency or incidence of side-effects.

scholarly journals A Double-Blind Placebo-Controlled Trial of levetiracetam for Global Severity in Child Autism Spectrum Disorders

2018 ◽  
Vol 3 (10) ◽  
Author(s):  
N. A. Aliyev ◽  
Z. N. Aliyev
Keyword(s):  
Autism Spectrum Disorders ◽  
Placebo Group ◽  
Side Effects ◽  
Rating Scale ◽  
Autism Spectrum ◽  
Repetitive Behaviors ◽  
Double Blind ◽  
Global Improvement ◽  
Double Blind Placebo ◽  
Spectrum Disorders

Objectives: The effects of levetiracetam and placebo on global severity were compared in Child Autism Spectrum Disorders (ASD). Materials and methods: Childs with ASDs were enrolled in a 12-week double-blind placebo-controlled levetiracetamtrial. Fifty were randomly assigned to levetiracetam (n=50) or placebo (n=50).The mean maximum dosage for levetiracetamwas 950.50±279.19 mg/day Repetitive behaviors were measured with the Clinical Global Impression (CGI) improvement scale. Results: There was a significant treatment-by-time interaction indicating a significantly greater reduction in repetitive behaviors across time for levetiracetamthan for placebo. With overall response defined as a CGI global improvement score of 2 or less, there were significantly more responders at week 12 in the levetiracetamgroup than in the placebo group. The risk ratio was 1.5 for CGI global improvement (responders: levetiracetam, 50%; placebo, 10%). Side effects were not observed. Conclusions: levetiracetamtreatment, compared to placebo, resulted in significantly greater improvement in global severity behaviors, according to CGI rating scale. levetiracetamappeared to be well tolerated movement score of 2 or less, there were significantly more responders at week 12 in the levetiracetamgroup than in the placebo group. Side effects were not observed.

EEG Synchronized TMS for Individualized Therapy in Major Depressive Disorder

2011 ◽  
Vol 26 (S2) ◽  
pp. 1144-1144
Author(s):  
Y. Jin ◽  
J. Phillips ◽  
Yueqin Huang ◽  
Steven Heurta
Keyword(s):  
Major Depressive Disorder ◽  
Side Effects ◽  
Depressive Disorder ◽  
Active Treatment ◽  
Rating Scale ◽  
Repetitive Transcranial Magnetic Stimulation ◽  
Stimulus Frequency ◽  
List Type ◽  
Major Depressive ◽  
Double Blind

IntroductionEfficacy of conventional repetitive transcranial magnetic stimulation (rTMS) in major depressive disorder (MDD) is limited. The authors report here on an alternative treatment using low energy synchronized TMS (sTMS) at the intrinsic frequency of subjects’ alpha electroencephalogram (EEG).ObjectivesEstablish efficacy and safety profile of sTMS in MDD.Aim(1)Examine the clinical effectiveness of sTMS.(2)Identify adverse effects associated with sTMS.MethodsFifty-two MDD subjects with 17-item Hamilton Depression Rating Scale (HAMD17) scores >17 were enrolled into a randomized, sham controlled, double-blind trial. Current medication remained unchanged during the trial. Depressive symptoms were evaluated by HAMD17 administered weekly.EEGs were recorded at baseline to determine the stimulus frequency and at week 4 to evaluate the physiological effect. sTMS was delivered through three 6000-G cylindrical neodymium magnets synchronously rotating at a rate equal to the subject's intrinsic alpha frequency.ResultsForty-five subjects completed at least 1 week of treatment and were evaluable. Those who received active treatment had superior clinical response to sham (t = 2.54, P = 0.01), where 55.2% in the active treatment group were clinical responders versus 12.5% in sham (X2 = 7.82, P = 0.005). No significant side effects were reported. The clinical improvement was correlated with the degree of EEG improvement (r = .46, P = 0.009).ConclusionsA therapeutic effect in MDD subjects can be achieved through administration of sTMS at the subject's alpha EEG frequency. Because of minimal side effects, this appears to be a safe and effective treatment option.

A Double-Blind Comparative Clinical Trial of Floctafenine and Four Other Analgesics Conducted in General Practice

1976 ◽  
Vol 4 (3) ◽  
pp. 179-182 ◽  
Author(s):  
D M Lomas ◽  
J Gay ◽  
R N Midha ◽  
D L Postlethwaite
Keyword(s):  
Clinical Trial ◽  
General Practice ◽  
Side Effects ◽  
Analgesic Effect ◽  
Rank Order ◽  
Controlled Trial ◽  
The Other ◽  
Double Blind ◽  
Comparative Clinical Trial

Three hundred and twelve patients suffering from painful conditions were admitted to a multicentre, double-blind controlled trial, conducted in general practice in which five analgesics—floctafenine (Idarac), paracetamol, aspirin, dihydrocodeine and pentazocine—were compared. Overall ratings of analgesic effect placed floctafenine first in rank order. Floctafenine was statistically significantly superior in effect to pentazocine but not to the other three agents as far as doctor ratings were concerned; and superior to both pentazocine and dihydrocodeine in the opinion of patients. Fewer patients experienced side-effects on floctafenine than on the other four analgesics and this difference between floctafenine and pentazocine, and floctafenine and dihydrocodeine was statistically significant.

The Efficacy and Tolerability of Combined Antidepressant Treatment in Different Depressive Subgroups

1993 ◽  
Vol 162 (3) ◽  
pp. 363-368 ◽  
Author(s):  
Sinead O'brien ◽  
Patrick McKeon ◽  
Myra O'regan
Keyword(s):  
Treatment Group ◽  
Side Effects ◽  
Major Depression ◽  
Orthostatic Hypotension ◽  
Antidepressant Treatment ◽  
Combined Treatment ◽  
Endogenous Depression ◽  
Double Blind Study ◽  
Double Blind ◽  
Global Improvement

Eighty patients admitted to hospital with major depression were randomly allocated to six weeks of treatment with tranylcypromine, amitriptyline, or tranylcypromine and amitriptyline in combination, in a double-blind study. Scores on the HRSD improved significantly in all three groups, but there were no differences between the three groups. Patients on tranylcypromine and amitriptyline combined improved more according to their self-ratings after six weeks, and response was earlier as measured by a clinical global improvement scale. Those with endogenous depression improved more than those with neurotic depression, irrespective of treatment group. Combined treatment was less well tolerated than single treatments and gave rise to more side-effects, although there was no serious toxicity. Orthostatic hypotension was observed more frequently in patients on combined treatment. This group also experienced a significant increase in weight and prolongation of the P-R interval on ECG.

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