Comparative Efficacy and Safety of Sertraline Versus Nortriptyline in Major Depression in Patients 70 and Older

1999 ◽  
Vol 11 (1) ◽  
pp. 85-99 ◽  
Author(s):  
Sanford I. Finkel ◽  
Ellen M. Richter ◽  
Cathryn M. Clary
Keyword(s):  
Major Depression ◽  
Rating Scale ◽  
Antidepressant Treatment ◽  
Change Score ◽  
Attrition Rate ◽  
Double Blind ◽  
Almost All ◽  
Positive Effect ◽  
Population Segment

Background. Few randomized, double-blind studies that examine antidepressant treatment in patients 70 years and older are available. To provide additional data on the safety and efficacy of antidepressants in this rapidly growing population segment, a subgroup analysis of a larger sertraline vs. nortriptyline elderly depression treatment study was performed. Methods. Outpatients (N = 76) who met DSM-III-R criteria for major depression with a minimum Hamilton Depression Rating Scale (HAM-D) severity score of 18 were randomized to 12 weeks of flexible dose treatment with sertraline (50–150 mg) or nortriptyline (25–100 mg). Results. Both treatments significantly improved depression as measured by the HAM-D and Clinical Global Impression scales. At Weeks 10, 12, and endpoint, sertraline demonstrated a significantly greater reduction in depression severity compared to nortriptyline as measured by improvement on the 24-item HAM-D (mean adjusted change score of 14.8 vs. 7.6, respectively, at Week 12; p = .001). Sixty-five percent of sertraline-treated patients were responders by Week 12 (50% or greater reduction from baseline in 24-item HAM-D score) compared to 26% of nortriptyline-treated patients (p < .05). Sertraline treatment had a significantly more positive effect, when compared to nortriptyline, across almost all associated measures of cognitive function, energy, anxiety, and quality of life and was better tolerated than nortriptyline, with a lower attrition rate/side effect burden. Conclusion. The efficacy advantage of sertraline appeared to be even greater in this subgroup of older patients drawn from a larger treatment study of depression that included elderly individuals over the age of 60.

scholarly journals Responsiveness of the Scripps Neurologic Rating Scale During a Multiple Sclerosis Clinical Trial

1999 ◽  
Vol 26 (4) ◽  
pp. 283-289 ◽  
Author(s):  
James A. Koziol ◽  
Adriana Lucero ◽  
Jack C. Sipe ◽  
John S. Romine ◽  
Ernest Beutler
Keyword(s):  
Multiple Sclerosis ◽  
Clinical Trial ◽  
Rating Scale ◽  
Effect Sizes ◽  
Active Therapy ◽  
Double Blind ◽  
Treatment Groups ◽  
Negative Effect ◽  
The Individual ◽  
Positive Effect

Objective:The Scripps neurologic rating scale (SNRS) is a summary measure of individual components comprising a neurological examination, designed for use in multiple sclerosis (MS). Our objective is to evaluate the responsiveness of the SNRS, within the context of a 2-year, randomized, double-blind crossover study of the efficacy of cladribine for treatment of secondary progressive MS.Methods:Effect sizes were determined for the SNRS and its components, separately for each treatment group (initial placebo, and initial cladribine) over both years of the clinical trial, using a standard random effects model.Results:Individual components tended to show positive effect sizes (improvement) during periods of active therapy in both treatment groups, and negative effect sizes (deterioration) during periods of no active therapy. Summation indices derived from the individual components of the SNRS seemed somewhat more stable than the individual components. The two components mentation and mood, and bladder, bowel, or sexual dysfunction, were rather unresponsive in our clinical trial.Conclusion:Changes in the components of the SNRS over the course of our clinical trial were consistent between the two treatment groups. Most components were moderately responsive; and, the summary SNRS score appropriately summarized the moderate magnitudes of change evinced in the individual components.

scholarly journals Quality of life, diagnosis, and treatment of patients with major depression: a prospective cohort study in primary care

2011 ◽  
Vol 33 (3) ◽  
pp. 245-251 ◽  
Author(s):  
Ana Flávia Barros da Silva Lima ◽  
Marcelo Pio de Almeida Fleck
Keyword(s):  
Quality Of Life ◽  
Primary Care ◽  
Cohort Study ◽  
Major Depression ◽  
Antidepressant Treatment ◽  
Epidemiologic Studies ◽  
World Health ◽  
World Health Organization Quality

OBJECTIVE: To describe the demographic and clinical characteristics, adequacy of antidepressant treatment, and changes in quality of life of patients with major depression receiving follow-up care from primary care centers. METHOD: A cohort study was performed in which major depression patients were followed-up over a nine-month period. Several evaluation instruments were used, including the World Health Organization Quality of Life and the Quality of Life-Depression, Centers for Epidemiologic Studies-Depression questionnaires. RESULTS: The sample comprised 179 individuals, mostly female (73%), with a mean age of 38 years and mean education of 9 years. At the end of the follow-up period, 42% of the individuals still presented with major depression, 25% had complete symptom remission, and only 9% were properly treated with antidepressants. In relation to quality of life, there were significant differences especially between baseline and after nine months in almost all measures. CONCLUSION: This study demonstrated that depressive symptoms are poorly recognized and that treatment is often inadequate for patients followed-up in primary care units in the south of Brazil. Most of the patients continued to have symptoms of depression over the nine-month period which were associated with impaired quality of life.

The Efficacy and Tolerability of Combined Antidepressant Treatment in Different Depressive Subgroups

1993 ◽  
Vol 162 (3) ◽  
pp. 363-368 ◽  
Author(s):  
Sinead O'brien ◽  
Patrick McKeon ◽  
Myra O'regan
Keyword(s):  
Treatment Group ◽  
Side Effects ◽  
Major Depression ◽  
Orthostatic Hypotension ◽  
Antidepressant Treatment ◽  
Combined Treatment ◽  
Endogenous Depression ◽  
Double Blind Study ◽  
Double Blind ◽  
Global Improvement

Eighty patients admitted to hospital with major depression were randomly allocated to six weeks of treatment with tranylcypromine, amitriptyline, or tranylcypromine and amitriptyline in combination, in a double-blind study. Scores on the HRSD improved significantly in all three groups, but there were no differences between the three groups. Patients on tranylcypromine and amitriptyline combined improved more according to their self-ratings after six weeks, and response was earlier as measured by a clinical global improvement scale. Those with endogenous depression improved more than those with neurotic depression, irrespective of treatment group. Combined treatment was less well tolerated than single treatments and gave rise to more side-effects, although there was no serious toxicity. Orthostatic hypotension was observed more frequently in patients on combined treatment. This group also experienced a significant increase in weight and prolongation of the P-R interval on ECG.

Placebo-Controlled Trial of Lithium Augmentation of Fluoxetine and Lofepramine

1995 ◽  
Vol 166 (1) ◽  
pp. 80-86 ◽  
Author(s):  
Cornelius L. E. Katona ◽  
Mohammed T. Abou-Saleh ◽  
Deborah A. Harrison ◽  
Bertrand A. Nairac ◽  
Denzil R. L. Edwards ◽  
...  
Keyword(s):  
Rating Scale ◽  
Antidepressant Treatment ◽  
Controlled Trial ◽  
Depressive Illness ◽  
Controlled Trials ◽  
Major Depressive ◽  
Double Blind ◽  
Primary Care Settings ◽  
Resistant Depression ◽  
Lithium Augmentation

BackgroundThis study was designed to establish whether (as suggested in a number of open and relatively small controlled trials) lithium augmentation is more effective than continued antidepressant alone, where response to a standard course of antidepressant treatment has been absent or partial.MethodLithium or placebo was added on a double-blind basis for six weeks to the drug regime of 62 patients with major depressive illness (in both hospital and primary care settings) who had failed to respond to a controlled trial of fluoxetine or lofepramine. Response was defined as a final Hamilton Depression Rating Scale (HDRS) score of < 10.ResultsResponse was seen more frequently in patients taking lithium (15/29) than in those remaining on antidepressant alone (8/32; P < 0.05). Rapid response to lithium augmentation (LA) was not consistently observed in this cohort. Mean HDRS scores after six weeks were significantly lower (P < 0.01) in the lithium group after excluding those who had not achieved significant exposure to lithium (arbitrarily defined as two or more lithium levels ≥ 0.4 mmol/1). No differences in the efficacy of LA were apparent between fluoxetine and lofepramine.ConclusionsOur results confirm that LA is a useful strategy in the treatment of antidepressant-resistant depression. Partial response was, however, frequently observed with continued antidepressant treatment alone, and the superiority of LA appears to depend on achieving adequate serum lithium levels.

scholarly journals A double blind, placebo-controlled pilot study of galantamine augmentation of antidepressant treatment in older adults with major depression

2008 ◽  
Vol 23 (6) ◽  
pp. 625-631 ◽  
Author(s):  
Paul E. Holtzheimer ◽  
Thomas W. Meeks ◽  
Mary E. Kelley ◽  
Mustafa Mufti ◽  
Raymond Young ◽  
...  
Keyword(s):  
Older Adults ◽  
Pilot Study ◽  
Major Depression ◽  
Antidepressant Treatment ◽  
Double Blind ◽  
Double Blind Placebo

scholarly journals Fermented Soy Supplementation Improves Quality of Life Indicators: A Randomized, Placebo-Controlled, Double-Blind Trial in Adults Experiencing Heartburn

2020 ◽  
Vol 4 (Supplement_2) ◽  
pp. 1124-1124
Author(s):  
Asmaa Fatani ◽  
Kadi Vaher ◽  
Karima Alabasi ◽  
Wendy Dahl
Keyword(s):  
Quality Of Life ◽  
Pilot Study ◽  
Rating Scale ◽  
Gastrointestinal Symptoms ◽  
Lactobacillus Delbrueckii ◽  
Soy Flour ◽  
Life Questionnaire ◽  
Double Blind ◽  
Symptom Intensity

Abstract Objectives The aim of this pilot study was to determine the effects of a fermented soy supplement on heartburn relief, gastrointestinal symptoms, and quality of life. Methods A 5-week, randomized, double-blind pilot study was conducted with adults (n = 51; 37F/14 M, 31 ± 12y) experiencing mild or moderate heartburn. Following a 1-week baseline, participants self-treated heartburn symptoms with up to 3, 1 g sachets of a non-GMO soy flour fermented by Lactobacillus delbrueckii ssp. delbrueckii Rosell-187 or placebo (maltodextrin) sachets per incident for 3 weeks followed by a 1-week washout. Differences from baseline between treatments were compared using the Wilcoxon Signed Rank test (alpha 0.05). Symptom intensity at 5, 15 and 30-min post administration was assessed using a Likert-like scale (1, no symptoms to 5, severe discomfort). The Gastrointestinal Symptoms Rating Scale (GSRS) (1-no discomfort to 7-very severe discomfort) and Gastro-oesophageal Reflux Disease Quality of Life Questionnaire (GERD-QOL) (4-strongly disagree to 0-strongly agree) were administered during baseline, intervention, and washout. Results No significant differences between intervention groups were seen for heartburn severity or frequency, GSRS syndromes or GERD-QOL domains. However, individual QOL items related to inconvenience of taking medications (−1.0 ± 1.3 vs −0.04 ± 1.8, P &lt; 0.05), fear of eating (−1.4 ± 1.3 vs −0.2 ± 1.7, P &lt; 0.05), inability to concentrate at work (−0.9 ± 1.6 vs −0.3 ± 1.0, P &lt; 0.05), and disturbance of after-meal activities and rest (−1.6 ± 1.5 vs −0.7 ± 1.5, P &lt; 0.05) significantly improved with fermented soy compared to control. In addition, the frequency of heartburn (0.3 ± 0.3 vs 0.1 ± 0.3, P &lt; 0.05) and the GSRS symptoms of diarrhea (0.3 ± 1.4 vs −0.3 ± 1.2, P &lt; 0.05) and bloating (0.7 ± 1.7 vs 0.1 ± 1.3, P &lt; 0.05) were significantly improved during washout vs. baseline for the fermented soy group, demonstrating a possible carryover effect over time. Conclusions Further research is suggested to test the effect of daily supplementation of fermented soy on heartburn frequency, gastrointestinal symptoms and QOL in a trial of longer duration. Funding Sources Lallemand Bio-Ingredients

A 6-months, randomised, placebo-controlled evaluation of efficacy and tolerability of a low-dose 7-day buprenorphine transdermal patch in osteoarthritis patients naïve to potent opioids

2010 ◽  
Vol 1 (3) ◽  
pp. 122-141 ◽  
Author(s):  
Harald Breivik ◽  
Tone Marte Ljosaa ◽  
Kristian Stengaard-Pedersen ◽  
Jan Persson ◽  
Hannu Aro ◽  
...  
Keyword(s):  
Side Effects ◽  
Pain Relief ◽  
Low Dose ◽  
Rating Scale ◽  
Secondary Outcome ◽  
Double Blind Study ◽  
Double Blind ◽  
Skin Reactions ◽  
Local Skin

AbstractObjectivePatients with osteoarthritis (OA) pain often have insufficient pain relief from non-opioid analgesics. The aim of this trial was to study efficacy and tolerability of a low dose 7-day buprenorphine transdermal delivery system, added to a NSAID or coxib regimen, in opioid-naïve patients with moderate to severe OA pain.MethodsA 6 months randomised, double-blind, parallel-group study at 19 centres in Denmark, Finland, Norway, and Sweden, in which OA patients (>40 years) with at least moderate radiographic OA changes and at least moderate pain in a hip and/or knee while on a NSAID or a coxib were randomised to a 7-day buprenorphine patch (n = 100) or an identical placebo patch (n = 99). The initial patch delivered buprenorphine 5 μg/h. This was titrated to 10 or 20 μg/h, as needed. Rescue analgesic was paracetamol 0.5–4 g daily. Statistical analysis of outcome data was mainly with a general linear model, with treatment as factor, the primary joint of osteoarthritis, baseline scores, and season as covariates.ResultsMost patients had OA-radiographic grade II (moderate) or grade III (severe), only 8 in each group had very severe OA (grade IV). The median buprenorphine dose was 10 μg/h. 31 buprenorphine-treated patients and 2 placebo-treated patients withdrew because of side effects. Lack of effect caused 12 placebo-treated and 7 buprenorphine-treated patients to withdraw. The differences in effects between treatments: Daytime pain on movement, recorded every evening on a 0–10 numeric rating scale decreased significantly more (P = 0.029) in the buprenorphine group. Patients’ Global Impression of Change at the end of the double blind period was significantly improved in the buprenorphine group (P = 0.017). The chosen primary effect outcome measure, the Western Ontario and McMaster Universities (WOMAC) OA Index for Pain (P = 0.061), and secondary outcome measures, the WOMAC OA score for functional abilities (P = 0.055), and the WOMAC total score (P = 0.059) indicated more effects from buprenorphine than placebo, but these differences were not statistically significant. In a post-hoc, subgroup analysis with the 16 patients with radiographic grad IV (very severe) excluded, WOMAC OA Index for Pain was significantly (P = 0.039) reduced by buprenorphine, compared with placebo. WOMAC OA score for stiffness and the amount of rescue medication taken did not differ. Sleep disturbance, quality of sleep, and quality of life improved in both groups. Side effects: Typical opioid side effects caused withdrawal at a median of 11 days before completing the 168 days double blind trial in 1/3 of the buprenorphine group. Mostly mild local skin reactions occurred equally often (1/3) in both groups.ConclusionsAlthough the 24 hours WOMAC OsteoArthritis Index of pain was not statistically significantly superior to placebo, day-time movement-related pain and patients’ global impression of improvement at the end of the 6-months double blind treatment period were significantly better in patients treated with buprenorphine compared with placebo. Opioid side effects caused 1/3 of the buprenorphine-patients to withdraw before the end of the 6-months double blind study period.ImplicationsA low dose 7-days buprenorphine patch at 5–20 μg/h is a possible means of pain relief in about 2/3 of elderly osteoarthritis patients, in whom pain is opioid-sensitive, surgery is not possible, NSAIDs and coxibs are not recommended, and paracetamol in tolerable doses is not effective enough. Vigilant focus on and management of opioid side effects are essential.

Effectiveness of mirtazapine as add-on to paroxetine v. paroxetine or mirtazapine monotherapy in patients with major depressive disorder with early non-response to paroxetine: a two-phase, multicentre, randomized, double-blind clinical trial

2020 ◽  
pp. 1-9 ◽  
Author(s):  
Le Xiao ◽  
Xuequan Zhu ◽  
Amy Gillespie ◽  
Yuan Feng ◽  
Jingjing Zhou ◽  
...  
Keyword(s):  
Major Depressive Disorder ◽  
Depressive Disorder ◽  
Rating Scale ◽  
Antidepressant Treatment ◽  
Additional Treatment ◽  
Combination Group ◽  
Open Label ◽  
Major Depressive ◽  
Double Blind ◽  
Early Improvement

Abstract Background This study aimed to examine the efficacy of combining paroxetine and mirtazapine v. switching to mirtazapine, for patients with major depressive disorder (MDD) who have had an insufficient response to SSRI monotherapy (paroxetine) after the first 2 weeks of treatment. Methods This double-blind, randomized, placebo-controlled, three-arm study recruited participants from five hospitals in China. Eligible participants were aged 18–60 years with MDD of at least moderate severity. Participants received paroxetine during a 2-week open-label phase and patients who had not achieved early improvement were randomized to paroxetine, mirtazapine or paroxetine combined with mirtazapine for 6 weeks. The primary outcome was improvement on the Hamilton Rating Scale for Depression 17-item (HAMD-17) scores 6 weeks after randomization. Results A total of 204 patients who showed early non-response to paroxetine monotherapy were randomly assigned to receive either mirtazapine and placebo (n = 68), paroxetine and placebo (n = 68) or mirtazapine and paroxetine (n = 68), with 164 patients completing the outcome assessment. At week 8, the least squares (LS) mean change of HAMD-17 scores did not significantly differ among the three groups, (12.98 points) in the mirtazapine group, (12.50 points) in the paroxetine group and (13.27 points) in the mirtazapine plus paroxetine combination group. Participants in the paroxetine monotherapy group were least likely to experience adverse effects. Conclusions After 8 weeks follow-up, paroxetine monotherapy, mirtazapine monotherapy and paroxetine/mirtazapine combination therapy were equally effective in non-improvers at 2 weeks. The results of this trial do not support a recommendation to routinely offer additional treatment or a switch in treatment strategies for MDD patients who do not show early improvement after 2 weeks of antidepressant treatment.

OscillococcinumR in patients with influenza-like syndromes: A placebo-controlled double-blind evaluation

1998 ◽  
Vol 87 (02) ◽  
pp. 69-76 ◽  
Author(s):  
Rosemarie Papp ◽  
Gert Schuback ◽  
Elmar Beck ◽  
Georg Burkard ◽  
Jürgen Bengel ◽  
...  
Keyword(s):  
Clinical Trial ◽  
Placebo Group ◽  
Rectal Temperature ◽  
Muscle Pain ◽  
Rating Scale ◽  
Controlled Clinical Trial ◽  
Double Blind ◽  
Duration Of Symptoms ◽  
Number Of Patients ◽  
Positive Effect

AbstractA controlled clinical trial was conducted to assess the effectiveness of OscillococcinumR in the treatment of patients with influenza-like syndromes. 188 patients received the test drug and 184 patients were assigned to the placebo. Data were recorded by the participating physicians at the beginning of the treatment, after 48 hours and after 7–10 days. During the first few days, the patients recorded their rectal temperature twice a day (mornings and evenings), 9 symptoms on a rating scale (cough, catarrh, sore throat, muscle pain, etc.), and use of medication. Recovery was defined as follows: ‘rectal temperature < 37.5°C and no headache or muscle pain’. Effectiveness was defined as a statistically significant greater decrease in symptoms after 48 hours in the verum group or a shorter duration of symptoms in comparison to the placebo group. After 48 hours the symptoms of the patients in the verum group were significantly milder (P=0.023) than in the placebo group. The number of patients with no symptoms was significantly higher in the verum group from the second day onwards (verum: 17.4%, placebo: 6.6%) until the end of the patients’ recording (day 5 in the evening: verum: 73.7%, placebo: 67.7%). The biggest group difference was recorded for the time between the evening of the second day (10.6% more patients with no symptoms) and the morning of the fourth day (10.2% more patients with no symptoms). The clinical trial showed that treatment of influenza-like syndromes with OscillococcinumR has a positive effect on the decline of symptoms and on the duration of the disease.

Repetitive transcranial magnetic stimulation does not potentiate antidepressant treatment

2004 ◽  
Vol 19 (6) ◽  
pp. 382-383 ◽  
Author(s):  
E. Poulet ◽  
J. Brunelin ◽  
C. Boeuve ◽  
J. Lerond ◽  
T. D’Amato ◽  
...  
Keyword(s):  
Transcranial Magnetic Stimulation ◽  
Major Depression ◽  
Magnetic Stimulation ◽  
Antidepressant Treatment ◽  
Repetitive Transcranial Magnetic Stimulation ◽  
Controlled Study ◽  
Antidepressant Effect ◽  
Double Blind ◽  
Pharmacological Medication

AbstractIn a double blind controlled study, rTMS results in a similar antidepressant effect to sham in combination with paroxetine. Both groups had the same delay in scale’s scores improvement. rTMS seems not to be efficient as an add-on treatment to pharmacological medication in non-resistant major depression.

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