Minimum clinically important differences identified for commonly used depression rating scales

Masson, Sarah; Tejani, Aaron M

doi:10.1016/j.jclinepi.2013.01.010

Cited by 65 publications

(39 citation statements)

References 8 publications

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“…For average HAMD total score change over time, treatment group mean value differences of three or four points-margins that were clearly exceeded in our meta-analysis-have been considered clinically important [81,82]. The analyses also show that the treatment effect of WS 5570 in elderly patients was comparably pronounced as in those under the age of 60 years.…”

Section: Resultsmentioning

confidence: 58%

Phytopharmaceutical treatment of anxiety, depression, and dementia in the elderly: evidence from randomized, controlled clinical trials

Kasper

2015

Wien Med Wochenschr

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Based on subgroup analyses of randomized, controlled clinical trials, we review the efficacy of three phytopharmaceutical drugs, respectively of the corresponding active substances silexan® (WS® 1265, lavender oil) in anxiety disorders, WS® 5570 (Hypericum extract) in major depression, and EGb 761® (Ginkgo biloba extract) in Alzheimer, vascular, or mixed type dementia, in elderly patients aged ≥ 60 years. Four trials were eligible in each indication. Meta-analyses and analyses based on pooled raw data showed that the three drugs were significantly superior to placebo in the elderly subset, and that their treatment effects reflected in the main outcome measures (Hamilton Anxiety scale, Hamilton Depression scale, Neuropsychiatric Inventory) were comparable with those observed in the original trials without age restrictions. The results confirm the efficacy of the three herbal active substances in elderly patients of ≥ 60 years of age. In anxiety, depression, and dementia, they thus represent efficacious and well-tolerated alternatives to synthetic drugs.

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Section: Resultsmentioning

confidence: 58%

Phytopharmaceutical treatment of anxiety, depression, and dementia in the elderly: evidence from randomized, controlled clinical trials

Kasper

2015

Wien Med Wochenschr

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“…The actual effect size for cariprazine 1.5 mg/day was 0.28 in both the previous and current trials (both positive), but the effect size of 0.20 for cariprazine 3.0 mg/day in the current study was lower than the effect size of 0.34 in the previous positive trial . Although the Cohen's ‘d’ effect size of 0.28 is in the range generally considered small to medium, the treatment group difference in MADRS was −2.5 points and a between‐group MADRS difference of more than 1.6 to 1.9 is considered clinically significant in studies of MDD …”

Section: Discussionmentioning

confidence: 99%

Efficacy and safety of cariprazine in bipolar I depression: A double‐blind, placebo‐controlled phase 3 study

et al. 2019

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Objective: To assess the efficacy, safety, and tolerability of cariprazine in the treatment of the depressed phase of bipolar I disorder in adults (NCT02670538). Methods:In this phase 3 double-blind placebo-controlled study, adult patients with bipolar I disorder according to the Diagnostic and Statistical Manual -5th Edition criteria and a current depressive episode were randomized to placebo (n = 167), cariprazine 1.5 mg/day (n = 168) or cariprazine 3.0 mg/day (n = 158). Efficacy parameters were changes in the Montgomery-Åsberg Depression Rating Scale (MADRS) total scores (primary) and Clinical Global Impressions -Severity (CGI-S) scores (secondary) from baseline to Week 6 compared to placebo. A mixed-model for repeated measures was used to estimate the least-squares mean differences (LSMD); P-values were adjusted for multiplicity. Adverse events (AEs), laboratory results, vital signs, and suicide risk were monitored.Results: Cariprazine 1.5 mg/day significantly reduced depressive symptoms on the primary (MADRS LSMD = −2.5; adjusted P = .0417) and secondary (CGI-S LSMD = −0.3; adjusted P = .0417) efficacy parameters vs placebo; differences were not statistically significant for cariprazine 3.0 mg/day. Common treatment-emergent AEs (≥5% in either cariprazine group and at least twice the incidence of placebo) were akathisia, restlessness, nausea, and fatigue. Mean metabolic parameter changes were low and generally comparable among groups; mean weight increases were ≤0.5 kg for all groups.Conclusions: Cariprazine 1.5 mg/day significantly reduced depressive symptoms in adults with bipolar I depression compared to placebo, but differences were not significant for cariprazine 3.0 mg/day. The safety and tolerability profiles were similar to previous studies of cariprazine. K E Y W O R D S atypical antipsychotic, bipolar depression, bipolar I disorder, cariprazine, randomized controlled trialThis is an open access article under the terms of the Creative Commons Attribution-NonCommercial-NoDerivs License, which permits use and distribution in any medium, provided the original work is properly cited, the use is non-commercial and no modifications or adaptations are made.

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“…Changes in continuous measures of depressive symptoms, such as the HDRS‐17, have been used as primary outcome measures in clinical antidepressant trials for decades, but this approach has been criticized for lacking clear and empirically validated thresholds for clinically significant change in patients' symptoms or functioning (Bech, ; Kriston and von Wolff, ; Masson and Tejani, ). Using data from a large, 8‐week, single‐site clinical trial of citalopram or escitalopram for treating major depression in adults, we found that a CGI‐I score of 2 (much improved) equated to an absolute reduction (improvement) in HDRS‐17 scores of 11 points and a percent reduction of 50–57%, from baseline values.…”

Section: Discussionmentioning

confidence: 99%

Validation of the 17‐item Hamilton Depression Rating Scale definition of response for adults with major depressive disorder using equipercentile linking to Clinical Global Impression scale ratings: analysis of Pharmacogenomic Research Network Antidepressant Medication Pharmacogenomic Study (PGRN‐AMPS) data

Bobo

Angleró

Jenkins

et al. 2016

Human Psychopharmacology

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Objective To define thresholds of clinically significant change in 17-item Hamilton Depression Rating Scale (HDRS-17) scores using the Clinical global Impression-Improvement (CGI-I) scale as a gold standard. Methods We conducted a secondary analysis of individual patient data from the Pharmacogenomic Research Network Antidepressant Medication Pharmacogenomic Study (PGRN-AMPS), an 8-week, single-arm clinical trial of citalopram or escitalopram treatment of adults with major depression. We used equipercentile linking to identify levels of absolute and percent change in HDRS-17 scores that equated with scores on the CGI-I at 4 and 8 weeks. Additional analyses equated changes in the 7-item HDRS and Bech 6 scale scores with CGI-I scores. Results A CGI-I score of 2 (much improved) corresponded to an absolute decrease (improvement) in HDRS-17 total score of 11 points, and a percent decrease of 50%–57%, from baseline values. Similar results were observed for percent change in HDRS-7 and Bech 6 scores. Larger absolute (but not percent) decreases in HDRS-17 scores equated with CGI-I scores of 2 in persons with higher baseline depression severity. Conclusions Our results support the consensus definition of response based on HDRS-17 scores (≥50% decrease from baseline). A similar definition of response may apply to the HDRS-7 and Bech 6.

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Minimum clinically important differences identified for commonly used depression rating scales

Cited by 65 publications

References 8 publications

Phytopharmaceutical treatment of anxiety, depression, and dementia in the elderly: evidence from randomized, controlled clinical trials

Phytopharmaceutical treatment of anxiety, depression, and dementia in the elderly: evidence from randomized, controlled clinical trials

Efficacy and safety of cariprazine in bipolar I depression: A double‐blind, placebo‐controlled phase 3 study

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