Placebo response in antidepressant drug trials

1994 ◽  
Vol 9 (3) ◽  
pp. 115-118 ◽  
Author(s):  
M Beneke ◽  
W Rasmus ◽  
J Fritze
Keyword(s):  
Frequency Analysis ◽  
Low Dose ◽  
Antidepressant Drug ◽  
Placebo Response ◽  
Response Patterns ◽  
Relative Efficacy ◽  
Drug Trials ◽  
Double Blind ◽  
Pooled Data ◽  
Blind Trials

SummaryResponse patterns derived from dichotomized (0/1) weekly CGI ratings conducted in antidepressant drug trials (Quitkin et al, 1984) were compared with those found in the pooled data from several randomized double-blind trials comparing the relative efficacy and tolerability low-dose flupenthixol im with that of three trieyclics (amitriptyline sr, imipramine, doxepine). Using the configurational frequency analysis (Krauth and Lienert, 1973), the postulated patterns could be rediscovered in our data apart from “early onset persistent patterns” which were less frequent in Quitkin et al's (1984) drug data. However, apart from this finding no “typical” patterns in terms of drug- or placebo-dependent response patterns could be detected in either the flupenthixol or Quitkin et al's (1984) data. It is concluded that there is little empirical evidence for the assumption of placebo- or drug related change- or response patterns. Moreover, theoretical aspects do not support the usefulness of such concepts.

scholarly journals A Randomized Controlled Exploratory Evaluation of Standardized Ayurvedic Formulations in Symptomatic Osteoarthritis Knees: A Government of India NMITLI Project

2011 ◽  
Vol 2011 ◽  
pp. 1-12 ◽  
Author(s):  
Arvind Chopra ◽  
Manjit Saluja ◽  
Girish Tillu ◽  
Anuradha Venugopalan ◽  
Sanjeev Sarmukaddam ◽  
...  
Keyword(s):  
Weight Bearing ◽  
Placebo Response ◽  
Zingiber Officinale ◽  
Tinospora Cordifolia ◽  
Drug Trials ◽  
Double Blind ◽  
Efficacy Analysis ◽  
Multiple Treatment ◽  
Intention To Treat ◽  
Womac Questionnaire

The multidisciplinary “New Millennium Indian Technology Leadership Initiative” Arthritis Project was undertaken to validate Ayurvedic medicines. Herbal formulations in popular use were selected by expert consensus and standardized using modern tools. Our clinical strategy evolved from simple exploratory evaluations to better powered statistically designed drug trials. The results of the first drug trial are presented here. Five oral formulations (coded A, B, C, D and E), with a common base ofZingiber officinaleandTinospora cordifoliawith a maximum of four plant extracts, were evaluated; with placebo and glucosamine as controls. 245 patients suffering from symptomatic OA knees were randomized into seven arms (35 patients per arm) of a double blind, parallel efficacy, multicentric trial of sixteen weeks duration. The groups matched well at baseline. There were no differences for patient withdrawals (17.5%) or adverse events (AE) of mild nature. Intention-to-treat efficacy analysis, demonstrated no significant differences (P<.05) for pain (weight bearing) and WOMAC questionnaire (knee function); placebo response was high. Based on better pain relief, significant (P<.05) least analgesic consumption and improved knee status, “C” formulation was selected for further development. Controlled exploratory drug trials with multiple treatment arms may be used to economically evaluate several candidate standardized formulations.

scholarly journals Efficacy and Tolerability of Telmisartan Plus Amlodipine in Asian Patients Not Adequately Controlled on Either Monotherapy or on Low-Dose Combination Therapy

2014 ◽  
Vol 2014 ◽  
pp. 1-11 ◽  
Author(s):  
Dingliang Zhu ◽  
Pingjin Gao ◽  
Nobutaka Yagi ◽  
Helmut Schumacher
Keyword(s):  
Combination Therapy ◽  
Low Dose ◽  
Response Rate ◽  
Response Rates ◽  
Phase 3 ◽  
Double Blind ◽  
Pooled Data ◽  
Asian Patients ◽  
Single Pill ◽  
Dose Combination

Objective. To evaluate the efficacy and safety of the telmisartan plus amlodipine (T/A) single-pill combination (SPC) in Asian patients with hypertension whose blood pressure (BP) was not adequately controlled on either monotherapy or on low-dose combination therapy.Patients and Methods. Data are presented from five Boehringer Ingelheim-sponsored phase 3, double-blind, 8-week, studies: two studies in nonresponders to amlodipine (data pooled for amlodipine), two studies on nonresponders to telmisartan (pooled data), and one on nonresponders to low-dose T/A SPC.Results. After 8 weeks’ treatment, mean reductions from the reference baseline in diastolic BP (DBP; primary endpoint), systolic BP (SBP), and SBP, DBP goal, and response rates were higher with the T/A SPC than respective monotherapies. The T80/A5 SPC resulted in greater reductions in DBP and SBP, and higher DBP goal and response rate than the low-dose T40/A5 SPC. Peripheral edema incidence was low (amlodipine 0.5%, telmisartan 0.0%, and T/A SPC 0.7%).Discussion and Conclusion. In Asian patients whose BP is not adequately controlled with telmisartan or amlodipine monotherapy, T/A SPC treatment results in greater BP reduction, and higher DBP and SBP goal and response rates. The safety and tolerability of the T/A SPC are comparable to those of the respective monotherapies and consistent with those reported in previous studies.

Rating antidepressant efficacy with naturalistic live versus structured videotaped interviews

1998 ◽  
Vol 13 (5) ◽  
pp. 225-230 ◽  
Author(s):  
E Corruble ◽  
V Sabran ◽  
C Payan ◽  
AJ Puech ◽  
J Fermanian ◽  
...  
Keyword(s):  
Rating Scale ◽  
Depressive Symptomatology ◽  
Antidepressant Treatment ◽  
Antidepressant Drug ◽  
Placebo Response ◽  
Double Blind Study ◽  
Double Blind ◽  
Novelty Effect ◽  
Antidepressant Efficacy ◽  
Specific Factors

SummaryTwo different methods were compared in the assessment of depressive symptomatology improvement: live naturalistic (N) performed by the patient's therapist, and from videotape record of structured clinical interview (VSI) assessed by an independent rater out of five psychiatrists.Sixty-one newly admitted depressed inpatients, with a Montgomery and Asberg Depression Rating Scale (MADRS) total score above 20, were assessed before antidepressant treatment (DO), after 10 days (D10) and 4 weeks of treatment (D28). Assessments were based on the MADRS and the Depression Retardation Rating Scale (DRRS) for both N and VSI methods, and on the SCL-90-R for self-rating.With the MADRS, the N method was shown to be more sensitive to symptomatology change than the VSI method, but the VSI method was more correlated to self-assessment than the N method was. However, these results were not replicated on the DRRS, for which an underscoring with the VSI method was evidenced as compared to the N method.As shown in other studies, the poorest agreement between the two methods was evidenced at DO, suggesting a “novelty effect” particularly with the VSI method. This “novelty effect” may be all the more pronounced if a personality disorder is associated to depression. Consequently, information concerning each patient before rating videotapes is needed, as well as investigations in the field of depression and personality disorders.The greater change observed in MADRS with the N method as compared to the VSI method, may be due non-specific factors related mostly to therapist expectations by comparison to neutral raters. This hypothesis should be tested in the placebo group of a double-blind study, and, if confirmed, the use of VSI methods, by minimising non-specific factors of improvement due to therapist expectations, may decrease the placebo response in antidepressant drug trials.

scholarly journals Therapeutic potential of targeting Tfr/Tfh cell balance by low-dose-IL-2 in active SLE: a post hoc analysis from a double-blind RCT study

2021 ◽  
Vol 23 (1) ◽  
Author(s):  
Miao Miao ◽  
Xian Xiao ◽  
Jiayi Tian ◽  
Yunzhi Zhufeng ◽  
Ruiling Feng ◽  
...  
Keyword(s):  
Low Dose ◽  
Activity Index ◽  
Cell Subset ◽  
Immunoglobulin M ◽  
Controlled Clinical Trial ◽  
Double Blind ◽  
Post Hoc Analysis ◽  
Immune Balance ◽  
Cell Balance ◽  
Post Hoc

Abstract Objective To investigate the regulation of T follicular regulatory (Tfr) and T follicular (Tfh) cell subtypes by low-dose IL-2 in systemic lupus erythematosus (SLE) in a randomized, double-blind, placebo-controlled clinical trial. Methods A post hoc analysis was performed in a randomized cohort of SLE patients (n=60) receiving low-dose IL-2 therapy (n=30) or placebo (n=30), along with the standard of care treatment. The primary endpoint was the attainment of SLE responder index-4 (SRI-4) at week 12 in the trial. Twenty-three healthy controls were enrolled for T cell subset detection at the same time as the trial. The t-stochastic neighbor embedding (tSNE) analysis of CD4 T subsets based on immune cells flow cytometry markers was performed to distinguish Tfh, Tfh1, Tfh2, Tfh17, and Tfr cell subsets. Results Compared with HC, the frequency of Tfr (CXCR5+PD-1low Treg and CXCR5+PD-1high Treg) cells was significantly reduced, while the pro-inflammatory Tfh cells were increased in patients with SLE. The imbalanced Tfh cell was associated with several pathogenic factors (anti-dsDNA antibodies (r=0.309, P=0.027) and serum IL-17 (r=0.328, P=0.021)) and SLE Disease Activity Index (SLEDAI) score (r=0.273, P=0.052). Decreased CXCR5+PD-1low Treg/Tfh and CXCR5+PD-1low Treg/Tfh17 were both associated with increased immunoglobulin M (IgM) (r=−0.448, P=0.002 and r=−0.336, P=0.024, respectively). Efficacy of low-dose IL-2 therapy was associated with a restored Tfr/Tfh cell balance. Conclusion These data support the hypothesis that promotion of Tfr is associated with decreased disease activities and that low-dose IL-2 therapy can recover Tfr/Tfh immune balance. Trial registration number ClinicalTrials.gov Registries (NCT02465580).

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