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.

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.

Improvement of Negative Symptoms in Schizophrenia: A Doubleblind Clinical Trial by Escitalopram in Male Patients

2020 ◽  
Vol 9 (3) ◽  
pp. 211-217
Author(s):  
Saeed S. Shafti
Keyword(s):  
Negative Symptoms ◽  
Primary Outcome ◽  
Controlled Trial ◽  
Psychiatric Rehabilitation ◽  
Depression Scale ◽  
Primary Outcome Measure ◽  
Neuronal Uptake ◽  
Hamilton Depression Scale ◽  
Male Patients ◽  
The Mean

Background: The negative symptoms of schizophrenia remain a major clinical trouble against psychiatric rehabilitation and available therapeutic treatments. Objective: Escitalopram is known as the most selective SSRI with minimal effects on norepinephrine and dopamine neuronal uptake. The aim of the present study is to assess the effect of escitalopram on negative symptoms of schizophrenia. Methods: This study was an eight-week, randomized, placebo-controlled trial of escitalopram set against placebo, as an add-on medication, in the treatment of 50 patients with a diagnosis of schizophrenia. While the Scale for Assessment of Negative Symptoms was used as the primary outcome measure, the Scale for Assessment of Positive Symptoms, the Simpson-Angus Scale and the Hamilton Depression Scale, as well, were used as a secondary measure for evaluation of positive, extrapyramidal and depressive symptoms, respectively. Results: The primary outcome of the present assessment was a significant reduction in the mean total score of the Scale for Assessment of Negative Symptoms (SANS) in the target group, compared to placebo, at the end of eight weeks. In this regard, most of the subscales of SANS, as well, demonstrated significant improvements by escitalopram. Conclusion: According to the findings, escitalopram can be helpful, as add-on medication, in amelioration of negative symptoms of schizophrenia.

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.

scholarly journals Randomised Double-Blind Trial of Combination Antibiotic Therapy in Rheumatoid Arthritis

2011 ◽  
Vol 2011 ◽  
pp. 1-6 ◽  
Author(s):  
Angela Smith ◽  
Caroline Doré ◽  
Peter Charles ◽  
Alena Vallance ◽  
Tara Potier ◽  
...  
Keyword(s):  
Rheumatoid Arthritis ◽  
Placebo Group ◽  
Active Treatment ◽  
Active Rheumatoid Arthritis ◽  
Controlled Trial ◽  
Primary Outcome Measure ◽  
Good Evidence ◽  
Double Blind ◽  
Acr20 Response ◽  
Significant Difference

Objective. A combination of intravenous clindamycin and oral tetracycline has been used for many years as a treatment for active rheumatoid arthritis (RA), despite the absence of good evidence for its efficacy. A single-blind pilot study of this therapy suggested that a double-blind placebo-controlled trial was warranted.Methods. Patients with active RA were randomised in a 2 : 1 ratio to receive active treatment or placebo for 25 weeks. The active treatment consisted of intravenous clindamycin in a reducing regime, and oral tetracycline twice daily three times a week. 50 patients were to be recruited. The primary outcome measure was the proportion of patients achieving an ACR20 response.Results. An interim statistical analysis was performed after 20 patients had completed the study. Two patients in the active group achieved an ACR20 response, with none in the placebo group (NS). There was a better ESR20 response in the placebo group (P=.02). There were no other significant differences between the groups. The results indicated that it was unlikely that a significant difference in ACR20 response would emerge if the remaining 30 patients were recruited. The trial was therefore halted.Conclusion. This antibiotic regime is unlikely to be a valuable therapy for active rheumatoid arthritis.

The Efficacy of Nebulized Budesonide in Dexamethasone-treated Outpatients With Croup

PEDIATRICS ◽  
1996 ◽  
Vol 97 (4) ◽  
pp. 463-466
Author(s):  
Terry P. Klassen ◽  
Lise K. Watters ◽  
Mark E. Feldman ◽  
Teresa Sutcliffe ◽  
Peter C. Rowe
Keyword(s):  
Controlled Trial ◽  
Tertiary Care ◽  
Airway Disease ◽  
Primary Outcome Measure ◽  
Lower Airway ◽  
Inspiratory Stridor ◽  
Double Blind ◽  
Oral Dexamethasone ◽  
Number Of Patients ◽  
Pediatric Outpatients

Objective. To determine the added clinical benefit of nebulized budesonide in children with mild to moderate croup treated with 0.6 mg/kg oral dexamethasone. Design. Randomized, double-blind, placebo-controlled trial. Setting. Emergency department of a tertiary-care pediatric hospital with 47 000 visits per year. Participants. Children 3 months to 5 years of age with a syndrome consisting of hoarseness, inspiratory stridor, and barking cough and a croup score of 3 or greater after at least 15 minutes of mist therapy. Patients were excluded from the study if they had diagnoses of epiglottitis, chronic upper or lower airway disease (not including asthma), or severe croup or had received corticosteroids within the preceding 2 weeks. Intervention. All patients received 0.6 mg/kg oral dexamethasone and were randomly assigned to receive 4 mL (2 mg) of budesonide solution (n = 25) or 4 mL of 0.9% saline solution (n = 25) by updraft nebulizer with a continuous flow of oxygen at 5 to 6 L/min. Main Outcome Measures. The primary outcome measure was the proportion of patients in each group who had clinically important changes (two points) in the croup score during the 4 hours after treatment. Results. Eighty-four percent (n = 21) of the patients who received budesonide had clinically important responses, compared with 56% (n = 14) in the placebo group. The number of patients who would need to be treated with nebulized budesonide for one patient to have a clinically important response is four patients. Conclusions. Despite receiving simultaneous oral dexamethasone, pediatric outpatients with mild to moderate croup have added, clinically important improvement in respiratory symptoms after treatment with budesonide.

scholarly journals Bone Metabolism in Patients Treated for Depression

2020 ◽  
Vol 17 (13) ◽  
pp. 4756
Author(s):  
Elżbieta Skowrońska-Jóźwiak ◽  
Piotr Gałecki ◽  
Ewa Głowacka ◽  
Cezary Wojtyła ◽  
Przemysław Biliński ◽  
...  
Keyword(s):  
Bone Metabolism ◽  
Type I Collagen ◽  
Depression Scale ◽  
Type I ◽  
Hamilton Depression Scale ◽  
Recurrent Depression ◽  
Hydroxyvitamin D ◽  
Vitamin D Levels ◽  
Turnover Markers ◽  
Carboxy Terminal

Background: Depression and osteoporosis are severe public health problems. There are conflicting findings regarding the influence of depression on bone metabolism. The aim of the presented study was to compare bone turnover markers and vitamin D levels between patients treated for depression and healthy controls. Patients and Methods: We determined a concentration of osteocalcin, carboxy-terminal telopeptide of type I collagen (β-CTX), 25-hydroxyvitamin D (25OHD) and 1,25(OH)2D3 in 99 patients, aged 46.9 ± 11 years, treated for depression, as well as in 45 healthy subjects. Depressive status was determined with the Hamilton Depression Scale (HDRS). Results: In patients treated for depression, we demonstrated significantly lower osteocalcin concentrations (p < 0.03) and higher concentration of β-CTX (result on the border of significance; p = 0.08). Those relationship were stronger in women. The level of 25OHD and 1,25(OH)2D3 did not differ significantly between the examined groups. We observed a negative correlation between the 25OHD and HDRS score after treatment in all patients treated for depression and in subgroups of women and subjects with recurrent depression. Conclusions: Our results indicate that depression is related to disturbances in bone metabolism, especially in women and patients with recurrent depression, suggesting its role in context of osteoporosis development.

scholarly journals Effects of L-Theanine Administration on Stress-Related Symptoms and Cognitive Functions in Healthy Adults: A Randomized Controlled Trial

Nutrients ◽  
2019 ◽  
Vol 11 (10) ◽  
pp. 2362 ◽  
Author(s):  
Hidese ◽  
Ogawa ◽  
Ota ◽  
Ishida ◽  
Yasukawa ◽  
...  
Keyword(s):  
Cognitive Functions ◽  
Verbal Fluency ◽  
Controlled Trial ◽  
Depression Scale ◽  
Healthy Adults ◽  
Placebo Administration ◽  
Double Blind ◽  
Randomized Controlled ◽  
Median Split ◽  
The Mean

This randomized, placebo-controlled, crossover, and double-blind trial aimed to examine the possible effects of four weeks L-theanine administration on stress-related symptoms and cognitive functions in healthy adults. Participants were 30 individuals (nine men and 21 women; age: 48.3 ± 11.9 years) who had no major psychiatric illness. L-theanine (200 mg/day) or placebo tablets were randomly and blindly assigned for four-week administration. For stress-related symptoms, Self-rating Depression Scale, State-Trait Anxiety Inventory-trait, and Pittsburgh Sleep Quality Index (PSQI) scores decreased after L-theanine administration (p = 0.019, 0.006, and 0.013, respectively). The PSQI subscale scores for sleep latency, sleep disturbance, and use of sleep medication reduced after L-theanine administration, compared to the placebo administration (all p < 0.05). For cognitive functions, verbal fluency and executive function scores improved after L-theanine administration (p = 0.001 and 0.031, respectively). Stratified analyses revealed that scores for verbal fluency (p = 0.002), especially letter fluency (p = 0.002), increased after L-theanine administration, compared to the placebo administration, in individuals who were sub-grouped into the lower half by the median split based on the mean pretreatment scores. Our findings suggest that L-theanine has the potential to promote mental health in the general population with stress-related ailments and cognitive impairments.

Topical 2% Amitriptyline and 1% Ketamine in Neuropathic Pain Syndromes

2005 ◽  
Vol 103 (1) ◽  
pp. 140-146 ◽  
Author(s):  
Mary E. Lynch ◽  
Alexander J. Clark ◽  
Jana Sawynok ◽  
Michael J. L. Sullivan
Keyword(s):  
Neuropathic Pain ◽  
Rating Scale ◽  
Controlled Trial ◽  
Primary Outcome Measure ◽  
Systemic Absorption ◽  
Mcgill Pain Questionnaire ◽  
Double Blind ◽  
Blood Concentrations ◽  
Pain Syndromes ◽  
Pain Scores

Background A double-blind, randomized, placebo-controlled 3-week study evaluated the efficacy of topical 2% amitriptyline, 1% ketamine, and a combination of both in treating patients with neuropathic pain. Methods Ninety-two patients with diabetic neuropathy, postherpetic neuralgia, or postsurgical/posttraumatic neuropathic pain with allodynia, hyperalgesia, or pinprick hypesthesia were randomly assigned to receive one of four creams (placebo, 2% amitriptyline, 1% ketamine, or 2% amitriptyline-1% ketamine combined). The primary outcome measure was change in average daily pain intensity (baseline week vs. final week) using an 11-point numerical pain rating scale. Secondary outcomes included the McGill Pain Questionnaire, measures of allodynia and hyperalgesia, and patient satisfaction. Results A reduction in pain scores of 1.1-1.5 units was observed in all groups, and there was no difference between groups. Blood concentrations revealed no significant systemic absorption. Minimal side effects were encountered. Conclusion This randomized, placebo-controlled trial examining topical 2% amitriptyline, 1% ketamine, and a combination in the treatment of neuropathic pain revealed no difference between groups. Optimization of doses may be required, because another study has revealed that higher concentrations of these agents combined do produce significant analgesia.

scholarly journals Effects of bright light therapy for depression during pregnancy: a randomised, double-blind controlled trial

BMJ Open ◽  
2020 ◽  
Vol 10 (10) ◽  
pp. e038030
Author(s):  
Babette Bais ◽  
Astrid M Kamperman ◽  
Hilmar H Bijma ◽  
Witte JG Hoogendijk ◽  
Jan L Souman ◽  
...  
Keyword(s):  
Depressive Symptoms ◽  
Pregnant Women ◽  
Rating Scale ◽  
Controlled Trial ◽  
Depression Scale ◽  
Bright Light ◽  
Light Therapy ◽  
Secondary Outcome ◽  
Bright Light Therapy ◽  
Double Blind

ObjectivesApproximately 11%–13% of pregnant women suffer from depression. Bright light therapy (BLT) is a promising treatment, combining direct availability, sufficient efficacy, low costs and high safety for both mother and child. Here, we examined the effects of BLT on depression during pregnancy.DesignRandomised, double-blind controlled trial.SettingPrimary and secondary care in The Netherlands, from November 2016 to March 2019.Participants67 pregnant women (12–32 weeks gestational age) with a DSM-5 diagnosis of depressive disorder (Diagnostic and Statistical Manual of Mental Disorders).InterventionsParticipants were randomly allocated to treatment with either BLT (9000 lux, 5000 K) or dim red light therapy (DRLT, 100 lux, 2700 K), which is considered placebo. For 6 weeks, both groups were treated daily at home for 30 min on awakening. Follow-up took place weekly during the intervention, after 6 weeks of therapy, 3 and 10 weeks after treatment and 2 months postpartum.Primary and secondary outcome measuresDepressive symptoms were measured primarily with the Structured Interview Guide for the Hamilton Depression Scale—Seasonal Affective Disorder. Secondary measures were the Hamilton Rating Scale for Depression and the Edinburgh Postnatal Depression Scale. Changes in rating scale scores of these questionnaires over time were analysed using generalised linear mixed models.ResultsMedian depression scores decreased by 40.6%–53.1% in the BLT group and by 50.9%–66.7% in the DRLT group. We found no statistically significant difference in symptom change scores between BLT and DRLT. Sensitivity and post-hoc analyses did not change our findings.ConclusionsDepressive symptoms of pregnant women with depression improved in both treatment arms. More research is necessary to determine whether these responses represent true treatment effects, non-specific treatment responses, placebo effects or a combination hereof.Trial registration numberNTR5476.

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