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 Antidepressa

Objective: Conventional antidepressant treatments result in symptom remission in 30% of those treated for major depressive disorder, raising the need for effective adjunctive therapies. Inflammation has an established role in the pathophysiology of major depressive disorder, and minocycline has been shown to modify the immune-inflammatory processes and also reduce oxidative stress and promote neuronal growth. This double-blind, randomised, placebo-controlled trial examined adjunctive minocycline (200 mg/day, in addition to treatment as usual) for major depressive disorder. This double-blind, randomised, placebo-controlled trial investigated 200 mg/day adjunctive minocycline (in addition to treatment as usual) for major depressive disorder. Methods: A total of 71 adults with major depressive disorder ( Diagnostic and Statistical Manual of Mental Disorders–Fourth Edition) were randomised to this 12-week trial. Outcome measures included the Montgomery–Asberg Depression Rating Scale (primary outcome), Clinical Global Impression–Improvement and Clinical Global Impression–Severity, Hamilton Anxiety Rating Scale, Quality of Life Enjoyment and Satisfaction Questionnaire, Social and Occupational Functioning Scale and the Range of Impaired Functioning Tool. The study was registered on the Australian and New Zealand Clinical Trials Register: www.anzctr.org.au , #ACTRN12612000283875. Results: Based on mixed-methods repeated measures analysis of variance at week 12, there was no significant difference in Montgomery–Asberg Depression Rating Scale scores between groups. However, there were significant differences, favouring the minocycline group at week 12 for Clinical Global Impression–Improvement score – effect size (95% confidence interval) = −0.62 [−1.8, −0.3], p = 0.02; Quality of Life Enjoyment and Satisfaction Questionnaire score – effect size (confidence interval) = −0.12 [0.0, 0.2], p < 0.001; and Social and Occupational Functioning Scale and the Range of Impaired Functioning Tool score – 0.79 [−4.5, −1.4], p < 0.001. These effects remained at follow-up (week 16), and Patient Global Impression also became significant, effect size (confidence interval) = 0.57 [−1.7, −0.4], p = 0.017. Conclusion: While the primary outcome was not significant, the improvements in other comprehensive clinical measures suggest that minocycline may be a useful adjunct to improve global experience, functioning and quality of life in people with major depressive disorder. Further studies are warranted to confirm the potential of this accessible agent to optimise treatment outcomes.

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Modafinil Augmentation of SSRI Therapy in Patients with Major Depressive Disorder and Excessive Sleepiness and Fatigue: A 12-Week, Open-label, Extension Study

CNS Spectrums ◽

10.1017/s1092852900010622 ◽

2006 ◽

Vol 11 (2) ◽

pp. 93-102 ◽

Cited By ~ 38

Author(s):

Michael E. Thase ◽

Maurizio Fava ◽

Charles DeBattista ◽

Sanjay Arora ◽

Rod J. Hughes

Keyword(s):

Major Depressive Disorder ◽

Depressive Disorder ◽

Clinical Global Impression ◽

Rating Scale ◽

Extension Study ◽

Dose Titration ◽

Open Label ◽

Major Depressive ◽

Residual Symptoms ◽

Excessive Sleepiness

AbstractIntroduction:Many patients with major depressive disorder (MDD) treated with selective serotonin reuptake inhibitors have residual symptoms (eg, persistent fatigue, excessive sleepiness) despite an overall antidepressant response. Placebo-controlled studies indicate that modafinil, a wake-promoting agent, may relieve residual symptoms.Methods:This 12-week, open-label, dose titration, extension study followed an 8-week placebo-controlled study of modafinil augmentation in patients with MDD. The dose was 100–400 mg/day. The median stable dose was 300 mg/day. Assessments were the Epworth Sleepiness Scale, Brief Fatigue Inventory, Clinical Global Impression of Improvement scale, 17-item Hamilton Rating Scale for Depression, and Montgomery-Åsberg Depression Rating Scale.Results:Of the 245 patients treated, 194 completed the study; 70% reported Clinical Global Impression of Improvement scale responses of “much improved” or “very much improved” between open-label baseline and final visit (previous randomized modafinil group: 74%; placebo group: 66%). When data were analyzed for four subsets of patients (former modafinil responders, placebo responders, modafinil nonresponders, and placebo nonresponders), improvements in scores on all outcome measures were at least twice as great among former modafinil and placebo nonresponders compared with responders. Most common adverse events were headache (18%), nausea (9%), and dizziness (7%); all were generally mild to moderate in severity.Conclusion:Twelve weeks of modafinil augmentation relieved excessive sleepiness, reduced fatigue, and improved patients' overall clinical condition, including mood.

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Supplementation of n-3 Polyunsaturated Fatty Acids for Major Depressive Disorder: A Randomized, Double-Blind, 12-Week, Placebo-Controlled Trial in Korea

Annals of Nutrition and Metabolism ◽

10.1159/000377640 ◽

2015 ◽

Vol 66 (2-3) ◽

pp. 141-148 ◽

Cited By ~ 14

Author(s):

Yongsoon Park ◽

Yoo-Sin Park ◽

Seok Hyeon Kim ◽

Dong Hoon Oh ◽

Yong-Chon Park

Keyword(s):

Fatty Acids ◽

Major Depressive Disorder ◽

Depressive Disorder ◽

Polyunsaturated Fatty Acids ◽

Clinical Global Impression ◽

Rating Scale ◽

Depression Scale ◽

Major Depressive ◽

Double Blind ◽

Pufa Supplementation

Background: Controversy over the efficacy of n-3 polyunsaturated fatty acids (PUFAs) in depression continues to this day. The present study investigated the hypothesis that n-3 PUFA supplementation reduces depressive symptoms in Korean patients with major depressive disorder. Methods: In a randomized, double-blind, placebo-controlled, 12-week, parallel-group trial, 35 patients with Center for Epidemiological Studies Depression Scale Korean version (CES-D-K) scores ≥25 and depression confirmed by a psychiatrist were assigned to take either 3 capsules of n-3 PUFAs (1,140 mg of EPA + 600 mg of DHA; n = 18) or placebo (olive oil + safflower oil; n = 17). Results: Supplementation with n-3 PUFAs significantly reduced Clinical Global Impression Improvement (CGI-I) scores as compared with intake of placebo using intention-to-treat analysis with last-observation-carried-forward after adjusting for energy, fat, and fish intake. However, the CES-D-K, Hamilton Depression Rating Scale-17, and Clinical Global Impression Scale scores did not significantly differ between the n-3 PUFA and placebo groups. After supplementation with n-3 PUFAs, the erythrocyte levels of n-3 PUFAs were significantly increased, but n-6 PUFA levels were decreased. Conclusions: n-3 PUFAs demonstrated an advantage over placebo that did not reach clinical significance, although CGI-I score was significantly decreased in the n-3 PUFA group as compared with the placebo group.

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The Relationship Between Depression Symptoms and Anxiety Symptoms During Acute ECT for Patients With Major Depressive Disorder

The International Journal of Neuropsychopharmacology ◽

10.1093/ijnp/pyz038 ◽

2019 ◽

Author(s):

Chun-Jen Huang ◽

Ching-Hua Lin ◽

Jyh-I Wu ◽

Wei-Cheng Yang

Keyword(s):

Major Depressive Disorder ◽

Depressive Disorder ◽

Electroconvulsive Therapy ◽

Goodness Of Fit ◽

Rating Scale ◽

Anxiety Symptoms ◽

Depression Symptoms ◽

Major Depressive ◽

Chi Square ◽

Hamilton Depression Rating Scale

AbstractBackgroundWe investigated the efficacy of electroconvulsive therapy in patients with major depressive disorder and concomitant anxiety symptoms and explored the relationships between depression symptoms and anxiety symptoms during acute electroconvulsive therapy.MethodsMajor depressive disorder inpatients (N = 130) requiring electroconvulsive therapy were recruited for a maximum of 12 treatments each. Depression symptoms, using the core factor subscale derived from the 17-item Hamilton Depression Rating Scale, and anxiety symptoms, using the anxiety/somatization subscale from the Hamilton Depression Rating Scale-17, were assessed before electroconvulsive therapy, after every 3 electroconvulsive therapy treatments, and after the final electroconvulsive therapy. Both core factor subscale and anxiety/somatization subscale scores were converted to T-score units to compare the degrees of changes between depression symptoms and anxiety symptoms after electroconvulsive therapy. The relationships between core factor subscale and anxiety/somatization subscale were analyzed using the cross-lagged longitudinal model during acute electroconvulsive therapy.ResultsA total 116 patients who completed at least the first 3 electroconvulsive therapy treatments were included in the analysis. Reduction of core factor scale T-scores was significantly greater than that of anxiety/somatization subscale T-scores. The model satisfied all indices of goodness-of-fit (chi-square = 30.204, df = 24, P = 0.178, Tucker-Lewis Index = 0.976, Comparative Fit Index = 0.989, Root Mean Square Error of Approximation = 0.047). Core factor subscale changes did not definitely predict subsequent anxiety/somatization subscale changes.ConclusionsElectroconvulsive therapy is effective in the acute treatment of major depressive disorder patients associated with anxiety symptoms. Anxiety symptoms improved less than depression symptoms during acute electroconvulsive therapy. However, earlier reduction in depression symptoms does not definitely drive subsequent relief in anxiety symptoms.

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One (effect) size does not fit at all: Interpreting clinical significance and effect sizes in depression treatment trials

Journal of Psychopharmacology ◽

10.1177/0269881120922950 ◽

2020 ◽

Vol 34 (10) ◽

pp. 1074-1078 ◽

Cited By ~ 1

Author(s):

Fredrik Hieronymus ◽

Sameer Jauhar ◽

Søren Dinesen Østergaard ◽

Allan H Young

Keyword(s):

Major Depressive Disorder ◽

Depressive Disorder ◽

Clinical Significance ◽

Rating Scale ◽

Clinical Importance ◽

Scientific Basis ◽

Mean Difference ◽

Major Depressive ◽

Hamilton Depression Rating Scale ◽

Sum Score

The efficacy of antidepressants in major depressive disorder has been continually questioned, mainly on the basis of studies using the sum-score of the Hamilton Depression Rating Scale as a primary outcome parameter. On this measure antidepressants show a standardised mean difference of around 0.3, which some authors suggested is below the cut-off for clinical significance. Prompted by a recent review that, using this argument, concluded antidepressants should not be used for adults with major depressive disorder, we (a) review the evidence in support of the cut-off for clinical significance espoused in that article (a Hamilton Depression Rating Scale standardised mean difference of 0.875); (b) discuss the limitations of average Hamilton Depression Rating Scale sum-score differences between groups as measure of clinical significance; (c) explore alternative measures of clinical importance; and (d) suggest future directions to help overcome disagreements on how to define clinical significance. We conclude that (a) the proposed Hamilton Depression Rating Scale cut-off of 0.875 has no scientific basis and is likely misleading; (b) there is no agreed upon way of delineating clinically significant from clinically insignificant; (c) evidence suggests the Hamilton Depression Rating Scale sum-score underestimates antidepressant efficacy; and (d) future clinical trials should consider including measures directly reflective of functioning and wellbeing, in addition to measures focused on depression psychopathology.

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Latent structure of the hamilton depression rating scale in major depressive disorder

Biological Psychiatry ◽

10.1016/0006-3223(96)84032-7 ◽

1996 ◽

Vol 39 (7) ◽

pp. 523-524

Author(s):

J. Cai ◽

I. Galynker

Keyword(s):

Major Depressive Disorder ◽

Depressive Disorder ◽

Rating Scale ◽

Latent Structure ◽

Major Depressive ◽

Hamilton Depression Rating Scale

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Efficacy and safety of selegiline transdermal system (STS) for the atypical subtype of major depressive disorder: pooled analysis of 5 short-term, placebo-controlled trials

CNS Spectrums ◽

10.1017/s1092852913000655 ◽

2013 ◽

Vol 19 (4) ◽

pp. 324-329 ◽

Cited By ~ 5

Author(s):

Chi-Un Pae ◽

Ashwin A. Patkar ◽

Saeheon Jang ◽

Kimberly B. Portland ◽

Sungwon Jung ◽

...

Keyword(s):

Major Depressive Disorder ◽

Depressive Disorder ◽

Rating Scale ◽

Remission Rate ◽

Pooled Analysis ◽

Comparable Efficacy ◽

Efficacy And Safety ◽

Short Term ◽

Major Depressive ◽

Definition Of

ObjectiveThe objective of the present study is to investigate the efficacy and safety of the selegiline transdermal system (STS) in major depressive disorder (MDD) with atypical features.MethodsThis was a post-hoc analysis of 5 short-term trials. The atypical subtype was defined as the presence of at least 1 item with a score of 2 or greater from items 22–26 on the 28-item Hamilton Depression Rating Scale (HAMD-28), and a maximum score of 1 point for items 6 (insomnia late), 12 (somatic symptoms, gastrointestinal), and 16 (loss of weight) to exclude vegetative features of melancholic depression. The mean changes of HAMD-28 total score from baseline to the endpoint (response rate defined as ≥50% reduction in HAMD-28 scores and remission rate defined as ≤10 HAMD-28 total score at the treatment endpoint) were compared between atypical and nonatypical groups.ResultsIn this analysis, 352 subjects (STS = 168 vs placebo = 184) met the definition of atypical subtype at baseline. STS (n = 641) significantly decreased HAMD-28 total score compared with placebo (n = 648) from beginning to end of treatment (–10.7 ± 9.3 vs –9.4 ± 9.3; p = 0.014). STS showed comparable efficacy in patients with the atypical subtype compared with the nonatypical subtype for placebo-subtracted mean change in HAMD-28 total score (–2.11 ± 1.01 vs. –1.0 ± 0.60; p = 0.34), odds ratio (OR) for response (1.41 vs 1.23, p = 0.62), and OR for remission (1.77 vs 1.18, p = 0.22).ConclusionSTS appears to be comparably efficacious and tolerable in atypical and nonatypical subtypes of MDD. Adequately powered, controlled, clinical trials are necessary to confirm our findings.

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Predictors of Suicidal Ideation and Attempt among Patients with Major Depressive Disorder at a Tertiary Care Hospital, Puducherry

Journal of Neurosciences in Rural Practice ◽

10.1055/s-0040-1721558 ◽

2021 ◽

Vol 12 (01) ◽

pp. 122-128

Author(s):

Ralte Lalthankimi ◽

Padmavathi Nagarajan ◽

Vikas Menon ◽

Jeby Jose Olickal

Keyword(s):

Major Depressive Disorder ◽

Suicidal Ideation ◽

Depressive Disorder ◽

Rating Scale ◽

Tertiary Care ◽

Severe Depression ◽

Care Hospital ◽

Suicidal Behaviors ◽

Major Depressive ◽

Severity Of Depression

Abstract Objectives Mental disorders have a large impact on death by suicide. Hence, this study aims to determine the prevalence of suicidal behaviors among major depressive disorder (MDD) patients and the associated factors. Materials and Methods This cross-sectional analytical study was conducted among individuals aged 18 to 65 years, diagnosed with MDD in the Psychiatry Outpatient Department of a Tertiary Care Center, Puducherry during March to October 2019. Severity of depression was assessed using Hamilton Depression Rating Scale and Columbia-Suicide Severity Rating Scale was used to find the suicidal behaviors. Results For 166 participants in the study, mean (standard deviation) age was 40 (11) years and majority were females (76%). More than one-third (37%) had severe or very severe depression, and the prevalence of suicidal ideation, plan, and attempts were 83, 24, and 35%, respectively. After adjusting the covariates, the severity of depression and unemployment were significantly associated with suicidal attempts (adjusted prevalence ratios [aPR] = 11.4 and 1.9), and very severe depression was associated with suicidal ideation (aPR = 1.6). Among 140 individuals with suicidal ideation, 45 (32%) had an ideation frequency of 2 to 3 times/week, 69 (50%) had ideation for 1 hour, 36 (26%) could control ideation with little difficulty, and 12% had suicidal ideation mostly to end or stop their pain. Conclusion Suicidal ideation and attempts were significantly high in MDD patients, and the severity of depression was significantly associated with it. Early identification of high-risk suicidal behavior and implementation of effective preventive interventions are necessary to reduce death by suicide in these groups.

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Theta burst stimulation for the acute treatment of major depressive disorder: A systematic review and meta-analysis

Translational Psychiatry ◽

10.1038/s41398-021-01441-4 ◽

2021 ◽

Vol 11 (1) ◽

Author(s):

Jeffrey D. Voigt ◽

Andrew F. Leuchter ◽

Linda L. Carpenter

Keyword(s):

Major Depressive Disorder ◽

Depressive Disorder ◽

Rating Scale ◽

Repetitive Transcranial Magnetic Stimulation ◽

High Frequency Stimulation ◽

Theta Burst Stimulation ◽

Burst Stimulation ◽

Major Depressive ◽

Significant Difference ◽

Theta Burst

AbstractPatients with major depressive disorder (MDD) may be refractory to or have contraindications that preclude treatment with antidepressant pharmacotherapies. Alternative therapies such as repetitive transcranial magnetic stimulation (rTMS) continue to evolve, and include theta burst stimulation (TBS), which has advantages over conventional rTMS. The aim of this study was to identify and meta-analyze efficacy data from all randomized controlled trials (RCTs) investigating TBS as a treatment for MDD. Published reports of RCTs (January 1, 2010 to October 23, 2020) were identified via systematic searches in computerized databases, followed by review of individual reports for inclusion. Inclusion criteria included primary diagnosis of MDD ≥ 1 week duration of therapy with ≥10 sessions, and treatment with any form of TBS. The Cochrane GRADE methodology and PRISMA criteria were used for evaluation of individual trials. Data from ten RCTs were included, representing 667 patients. Of these, 8 RCTs compared TBS to sham treatment and one compared TBS to standard rTMS (i.e., high frequency stimulation over left dorsolateral prefrontal cortex [HFL]). Quality of evidence assessment yielded high confidence in the finding of TBS being superior to sham on response measured by the Hamilton Depression Rating Scale (HRSD) (RR = 2.4; 95% CI: 1.27 to 4.55; P = 0.007; I2 = 40%). Comparison of HRSD response rates for TBS versus rTMS produced no statistically significant difference (RR = 1.02; 95% CI: 0.85 to 1.23; P = 0.80; I2 = 0%). The incidence of adverse events between TBS and rTMS was not statistically different. The findings of a positive effect of TBS vs. sham, and noninferiority of TBS vs. standard HFL rTMS support the continued development of TBS to treat depression.

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