Moclobemide in Elderly Patients with Cognitive Decline and Depression: An International Double-blind, Placebo-controlled Trial

1996 ◽  
Vol 168 (2) ◽  
pp. 149-157 ◽  
Author(s):  
M. Roth ◽  
C. Q. Mountjoy ◽  
R. Amrein ◽  
Keyword(s):  
Cognitive Function ◽  
Major Depression ◽  
Elderly Patients ◽  
Cognitive Decline ◽  
Controlled Trial ◽  
Depression Scale ◽  
Hamilton Depression Scale ◽  
Double Blind ◽  
Treatment Groups ◽  
Diagnosis Of Dementia

BackgroundThe new reversible MAOI moclobemide was compared with placebo in the treatment of elderly patients with DSM–III diagnosis of dementia and/or of major depression.MethodSix hundred and ninety-four elderly patients with symptoms of depression and cognitive decline entered an international, multi-centre, double blind trial in which they were randomly allocated to treatment with either moclobemide 400 mg daily or placebo for 42 days. Five hundred and eleven patients met DSM–III criteria for dementia and were also depressed (DEM+D); 183 did not meet DSM–III criteria for dementia but met the criteria for DSM–III major depressive episode and also suffered from cognitive decline (MDE+CD).ResultsAnalysis of the 17 and 24-item Hamilton Depression Scale scores showed that moclobemide, compared with placebo, produced significantly greater improvement in both the demented and depressed groups (P= 0.001 both diagnostic groups). There was an improvement in cognitive function as measured by the SCAG Factor 1 in moclobemide treated patients (P= 0.005 DEM+D;P= 0.02 MDE+CD). There was no evidence of decline in cognitive function as the result of treatment Clinical global assessment of tolerance was ‘excellent’ and ‘good’ in 88% of the moclobemide and in 92% of the placebo treated patients. The proportion of patients discontinuing treatment prematurely was similar in both treatment groups. There were no significant differences in side-effects between treatment groups. There were no significant changes in vital signs, ECG or laboratory findings in either treatment group. There were no dietary restrictions and no report of any tyramine reaction.ConclusionsMoclobemide was shown to be a safe, well tolerated and effective antidepressant, which did not cause impairment of cognitive function in elderly patients with a DSM–III diagnosis of dementia and/or DSM–III major depression.

The Ham D6 is more homogenous and as sensitive as the Ham D17

2007 ◽  
Vol 22 (4) ◽  
pp. 252-255 ◽  
Author(s):  
Y. Lecrubier ◽  
P. Bech
Keyword(s):  
Effect Size ◽  
Controlled Trial ◽  
Depression Scale ◽  
Primary Outcome Measure ◽  
Antidepressant Effect ◽  
Hamilton Depression Scale ◽  
Recurrent Depression ◽  
Double Blind ◽  
Specificity And Sensitivity ◽  
Pre Treatment

AbstractObjectiveUsing the data of a positive d.b.c.t. comparing an hypericum extract (W55570) to placebo in depressed patients we explored whether the Ham D6 was unidimentional and in case of a positive answer whether the total score was as sensitive as the total score of the Ham D17.MethodsThe study was a 6 weeks double blind placebo controlled trial comparing 300 mg of hypericum t.i.d (n = 186), to placebo (n = 189), in patients with a single or recurrent depression according to DSM-IV. Superiority of hypericum versus placebo on the main outcome criterion (HDRS 17) was already published.The unidimensionality of the Hamilton depression scale 6 and 17 items were tested using a Mokken scale analysis. The effect size according to the initial severity of depression was calculated on the ITT last observation carried forward population.ResultsThe Ham D6, covering the core symptoms of depression was unidimensional, implying that improving this score reflects a true antidepressant effect. The Ham D17 was not unidimensional.Hypericum was an effective antidepressant in patients with a pre-treatment score of 12 or more (n = 208) on the Ham D6, the effect size was 0.46. No difference with placebo was observed for those with a score of less than 12 (n = 167).ConclusionsFor the evaluation of an antidepressant effect, because of its specificity and sensitivity, the Ham D6 should be used as a primary outcome measure rather than the Ham D17.

scholarly journals Efficacy and Safety of Chuanxiong Qingnao Granule in Patients with Migraine: A Randomized, Double-Blind, Placebo-Controlled Trial

2021 ◽  
Vol 2021 ◽  
pp. 1-8
Author(s):  
Yi-Fan Li ◽  
Hui-Min Hu ◽  
Bo-Ning Wang ◽  
Yi Zhang ◽  
Xing Liu ◽  
...  
Keyword(s):  
Treatment Group ◽  
Migraine Attack ◽  
Controlled Trial ◽  
Depression Scale ◽  
Control Group ◽  
Hamilton Depression Scale ◽  
Efficacy And Safety ◽  
Attack Frequency ◽  
Double Blind ◽  
Double Blind Placebo

Objective. To evaluate the efficacy and safety of Chuanxiong Qingnao Granule (CQG) to treat migraine. Method. This study was a randomized, double-blind, placebo-controlled trial. All migraineurs were recruited and randomly assigned into a treatment group treated with CQG and a control group treated with a placebo. The whole research process included a 4-week baseline, 12-week intervention, and 12-week follow-up. The primary outcome was responder rate, defined as the percentage of migraineurs with 50% or more reduction in the frequency of migraine attack during treatment and posttreatment period compared with the baseline. The secondary outcomes were the number of migraine days, migraine attack frequency, visual analogue scale (VAS), Fatigue Severity Scale (FSS), Hamilton Depression Scale (HAMD), and Migraine Disability Assessment (MIDAS). Results. A total of 346 migraineurs completed the research and were included in the intention-treatment analyses. The response rates differed significantly between the treatment group and the control group (71.5% vs. 12.1% at week 12 and 83.1% vs. 3.4% at week 24). Attack frequency, days of headache attack, VAS, FSS, HAMD, and MIDAS decreased at week 12 in both groups with more reduction in the treatment group ( P < 0.001 ). No severe adverse events were observed in this trial. Conclusion. Chuanxiong Qingnao Granule can significantly improve headache symptoms in patients with migraine while improving disability, fatigue, and depression with a good safety profile.

Effectiveness and Tolerance of the Hypericum Extract LI 160 Compared to Maprotiline: A Multicenter Double-Blind Study

1994 ◽  
Vol 7 (1_suppl) ◽  
pp. 24-28 ◽  
Author(s):  
G. Harrer ◽  
W.-D. Hübner ◽  
H. Podzuweit
Keyword(s):  
Depression Scale ◽  
Blind Study ◽  
Double Blind Study ◽  
Hamilton Depression Scale ◽  
Double Blind ◽  
Mean Values ◽  
Mouth Dryness ◽  
Treatment Groups ◽  
Icd 10 ◽  
Hypericum Extract

A randomized, double-blind study examining the effectiveness and tolerance of a standardized hypericum preparation when compared to maprotiline was performed in a group of 102 patients with depression, in accordance with ICD-10, F 32.1. The study was conducted in the offices of neurology and psychiatry specialists. The patients received, over a period of 4 weeks, either 3 x 300 mg of the hypericum extract or 3 x 25 mg maprotiline pills of identical appearance. Effectiveness was determined using the Hamilton Depression Scale (HAMD), the Depression Scale according to von Zerssen (D-S), and the Clinical Global Impression Scale (CGI). The total score of the HAMD scale dropped during the 4 weeks of therapy in both treatment groups by about 50%. The mean values of the D-S scale and the CGI scale showed similar results, and after 4 weeks of therapy, no significant differences in either treatment group were noticed. The onset of the effects occurred up to the second week of treatment, but were observed earlier with maprotiline than with the hypericum extract. On the other hand, maprotiline treatment resulted in more cases of tiredness, mouth dryness, and heart complaints.

The treatment of depression in general practice: a comparison of L-tryptophan, amitriptyline, and a combination of L-tryptophan and amitriptyline with placebo

1982 ◽  
Vol 12 (4) ◽  
pp. 741-751 ◽  
Author(s):  
Joan Thomson ◽  
H. Rankin ◽  
G. W. Ashcroft ◽  
Celia M. Yates ◽  
Judith K. McQueen ◽  
...  
Keyword(s):  
Depression Scale ◽  
Double Blind Study ◽  
Global Rating ◽  
Hamilton Depression Scale ◽  
Double Blind ◽  
Treatment Groups ◽  
Plasma Tryptophan ◽  
Treatment Of Depression ◽  
Biochemical Profiles ◽  
The Difference

SynopsisOne hundred and fifteen patients from 5 general practices participated in a 12-week, double-blind study comparing L-tryptophan, amitriptyline, L-tryptophan–amitriptyline combination and placebo in the treatment of depression. Analysis of total score on the Hamilton Depression Scale and a global rating of depression showed that all 3 active treatments were more effective than placebo. Significantly more patients were withdrawn as treatment failures in the placebo group compared with the active treatment groups. Side-effects necessitated withdrawal of more patients from the amitriptyline group than from the other active tratment groups, but this difference was not significant. Plasma amitriptyline and nortriptyline levels were similar in the difference was not significant. Plasma amitriptyline and nortriptyline and biochemical profiles did not alter significantly in any group, but mean heart rate was significantly increased in patients receiving amitriptyline. There was no change in free or total plasma tryptophan concentration with treatment or on remission of symptoms.

scholarly journals Efficacy and Safety of Cordyceps militaris as an Adjuvant to Duloxetine in the Treatment of Insomnia in Patients With Depression: A 6-Week Double- Blind, Randomized, Placebo-Controlled Trial

2021 ◽  
Vol 12 ◽  
Author(s):  
Jiaojiao Zhou ◽  
Xu Chen ◽  
Le Xiao ◽  
Jingjing Zhou ◽  
Lei Feng ◽  
...  
Keyword(s):  
Placebo Group ◽  
Controlled Trial ◽  
Depression Scale ◽  
Cordyceps Militaris ◽  
Secondary Outcome ◽  
Controlled Study ◽  
Depression Symptom ◽  
Hamilton Depression Scale ◽  
Efficacy And Safety ◽  
Double Blind

Background: Insomnia is a common clinical manifestation in patients with depression. Insomnia is not only a depression symptom but also an independent risk factor for recurrence. Cordyceps militaris (C. militaris) is thought to have the potential to treat insomnia. This study aimed to examine the efficacy and safety of duloxetine with C. militaris in improving sleep symptoms in patients with depression.Methods: This study was a single-center, randomized, double-blind, placebo-controlled study that recruited outpatients admitted to Beijing Anding hospital from January 2018 to January 2019. Major depressive disorder (MDD) with insomnia was diagnosed according to the Diagnostic and Statistical Manual of Mental Disorders (DSM-IV-TR) criteria and Mini-International Neuropsychiatric Interview (M.I.N.I.). Eligible subjects will be randomly assigned to two treatment groups in a 1:1 ratio, and receive treatment and follow-up of about 6 weeks of duloxetine plus Cordyceps militaris or placebo, respectively. The severity of depression and insomnia was evaluated at baseline and at 1, 2, 4, and 6 weeks using the 17-item Hamilton Depression Scale (HAMD-17) and Athens Insomnia Scale (AIS).Results: A total of 59 subjects were included in the study (31 in the placebo group and 28 in the C. militaris group). 11 (18.6%) participants withdrew during the study period, 5 (17.9%) in the C. militaris group, and 6 (19.3%) in the placebo group. Depressive and sleep symptoms in all patients reduced over time. We found that the total scores of AIS and its subscales decreased more in the placebo group compared to the C. militaris group (p &lt; 0.05). Secondary outcome revealed that there were no significant differences between the two groups in total HAMD-17 and its sleep factor scores (p &gt; 0.05) at 1, 2, 4, and 6 weeks after treatment initiation. The incidences of adverse events were not significantly different between the two groups (all p &gt; 0.05).Conclusion:C. militaris at the current dose and duration did not improve sleep symptoms in patients with depression, but it is safe with rare side effects.

Effectiveness and Tolerance of the Hypericum Extract LI 160 in Comparison with Imipramine: Randomized Double-Blind Study with 135 Outpatients

1994 ◽  
Vol 7 (1_suppl) ◽  
pp. 19-23 ◽  
Author(s):  
E.-U. Vorbach ◽  
W.-D. Hübner ◽  
K.-H. Arnoldt
Keyword(s):  
Side Effects ◽  
Depression Scale ◽  
Adjustment Disorder ◽  
Double Blind Study ◽  
Hamilton Depression Scale ◽  
Double Blind ◽  
Single Episode ◽  
Treatment Groups ◽  
Safety Parameters ◽  
Hypericum Extract

In a double-blind comparative study, 135 depressed patients were treated in 20 centers. Inclusion diagnoses were typical depressions with single episode (296.2), several episodes (296.3), depressive neurosis (300.4), and adjustment disorder with depressed mood (309.0) in accordance with DSM-III-R. The dosage was 3 x 300 mg hypericum extract LI 160 or 3 x 25 mg imipramine daily. The treatment lasted for 6 weeks. Main assessment criteria were the Hamilton Depression Scale (HAMD), the Depression Scale according to von Zerssen (D-S) and the Clinical Global Impressions (CGI). In both treatment groups, a parallel reduction of the Hamilton score from 20.2 to 8.8 (LI 160, n = 67) or from 19.4 to 10.7 (imipramine, n = 68), and the transformed D-S point values from 39.6 to 27.2 (LI 160) and 39.0 to 29.2 (imipramine) were found. The analysis of CGI revealed comparable results in both treatment groups. Clinically relevant changes of the safety parameters were not found. In the LI 160 group fewer and milder side effects were found as compared to imipramine.

Clomipramine HCL — A Double-Blind Study of a New Antidepressant Drug

1973 ◽  
Vol 18 (5) ◽  
pp. 403-408 ◽  
Author(s):  
D.J. Mcclure ◽  
G.L. Low ◽  
M. Gent
Keyword(s):  
Antidepressant Drug ◽  
Depression Scale ◽  
Blind Study ◽  
Double Blind Study ◽  
Hamilton Depression Scale ◽  
Double Blind ◽  
Treatment Groups ◽  
Treatment Of Depression ◽  
Before And After ◽  
Anxiety Index

A double-blind study was carried out comparing the antidepressant and anxiolytic properties of clomipramine HCL (a new antidepressant) and imipramine on a group of 24 subjects suffering from psychotic depression. The patients were divided into two groups of twelve by random sampling. Clinical assessments were made by two independent psychiatrists using the Hamilton Depression Scale and the Beck Depression Inventory, and also by a psychologist using the Welsh Anxiety Index of the MMPI and IPAT scales. The assessments were carried out one day prior to treatment and on the 5th, 10th, 15th, 22nd and 44th day after treatment commenced. Clomipramine HCL was found to be as effective as imipramine in the treatment of depression, and it also showed similar anxiolytic properties. There were no significant changes in the laboratory tests carried out before and after the treatment program was completed in both treatment groups.

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