scholarly journals Antidepressant study design affects patient expectancy: a pilot study

2009 ◽  
Vol 40 (5) ◽  
pp. 781-788 ◽  
Author(s):  
B. Rutherford ◽  
J. Sneed ◽  
D. Devanand ◽  
R. Eisenstadt ◽  
S. Roose

BackgroundResponse to antidepressant medication is higher in comparator versus placebo-controlled randomized controlled trials (RCTs). Patient expectancy is an important influence on clinical outcome in the treatment of depression and may explain this finding. The results are reported from a pilot RCT studying expectancy and depression outcome in placebo-controlled versus comparator treatment conditions.MethodOut-patients aged 18–65 years with major depressive disorder (MDD) were enrolled in this 8-week RCT. Subjects were randomized to placebo-controlled (escitalopram or placebo) or comparator (escitalopram or citalopram) administration of antidepressant medication. Subjects reported their expected likelihood and magnitude of depression improvement before and after randomization using questions from the Credibility and Expectancy Scale (CES). A regressed change model of post-randomization expectancy of improvement was fit to the data to determine whether subjects in the comparator group reported greater expectancies of improvement than subjects in the placebo-controlled group.ResultsTwenty subjects with mean age 56.5±11.7 years, a baseline Hamilton Depression Rating Scale (HAMD) score of 24.2±5.3, baseline Beck Depression Inventory (BDI) score of 24.9±6.4 and baseline Clinical Global Impressions (CGI) – Severity score of 4.0±0.3 were enrolled in the study. Adjusting for other factors, the effect of group assignment on expected magnitude of improvement was significant and large (effect size 1.5). No group differences in expected likelihood of improvement were found.ConclusionsRandomization to comparator versus placebo-controlled administration of antidepressant medication produced greater expectancies of how much patients would improve during the trial. This expectancy difference may explain the higher response and remission rates that are observed in comparator versus placebo-controlled trials.

Author(s):  
Sushant Aryal ◽  
Kajal Chakrabarti ◽  
Mayuri Gupta

Background: Several generations of antidepressant medication which act by distinct pharmacological mechanisms have been introduced for the treatment of depression; tricyclic antidepressants (TCAs) were first line of treatment for many years. However, over the last decade, selective serotonin reuptake inhibitors (SSRIs) have displaced TCAs, mainly because of better side effect profile. There are no references in literature on comparison of efficacy of TCAs and SSRIs in Nepalese population. This study attempted to compare the efficacy of amitriptyline, a reference standard TCA with escitalopram, a newer SSRI in Nepalese population.Methods: An open level, randomised, prospective study was conducted for one year duration. Eighty outpatients suffering from major depression who met inclusion and exclusion criteria were randomly assigned to either amitriptyline or escitalopram group for four week study. Seventy one patients (amitriptyline N: 36, escitalopram N: 35) completed the study. Hamilton Depression Rating Scale (HDRS) was used to measure the antidepressant effect. Antidepressant efficacy was evaluated on reduction of HDRS score before and after therapy (End of four weeks).Results: In amitriptyline group, mean percentage reduction in HDRS score was 58.29% (13.5 points), while in escitalopram group was 60.78% (14.03 points). Both the drugs significantly improved the HDRS score at the end of the study (p<0.05). On intergroup comparison, antidepressant efficacy of amitriptyline and escitalopram did not differ significantly from each other (p>0.05).Conclusions: This study suggests that escitalopram is effective in the treatment of depression and its efficacy appears to be comparable to amitriptyline at the end of four weeks.


2003 ◽  
Vol 183 (2) ◽  
pp. 102-104 ◽  
Author(s):  
Gordon Parker ◽  
Ian M. Anderson ◽  
Peter Haddad

A recent alert from the UK Committee on Safety of Medicines stated that the dangers of treatment of depression with paroxetine outweigh the benefits in those under 18. Such a warning should focus our minds on the evidence on which clinical practice is based. Antidepressant treatment of depression in the under-18s has been thought to be justified because clinical trials show that it works so well in over-18s. But is that a reasonable assessment of the evidence? Kirsch et al (2002) use the analogy of ‘The Emperor's New Clothes' to describe the findings from their meta-analysis of randomised placebo-controlled trials of antidepressants. They conclude that antidepressant medication appears to have only a small effect on outcome over and above placebo. In this analogy psychiatry is the emperor, drug trials are the fraudsters and the deception is being revealed by a growing body of critical opinion proposing that, once methodological problems with clinical trials are taken into account, antidepressants either do not work at all or have an effect that is so small as to be clinically unimportant (Andrews, 2001; Moncrieff, 2002). A large number of randomised placebo-controlled trials of antidepressants have been carried out over the past decades, mostly funded by the pharmaceutical industry, and it is now recognised that about 50% of negative trials go unpublished (Thase, 1999). Meanwhile, unipolar depression has jumped into the top five of the world's total burden of disease, and there is an imperative need for effective and safe treatments. Do we need more randomised controlled trials (RCTs) of antidepressant medications, or has that research paradigm outlived its usefulness? In this month's debate, Professor Gordon Parker, University of New South Wales and Black Dog Institute, Australia, and Drs Ian Anderson and Peter Haddad from the University of Manchester discuss whether clinical trials for antidepressant medication produce meaningless results.


Author(s):  
Charles B. Nemeroff ◽  
Alan F. Schatzberg

The treatment of unipolar major depression with antidepressant medication is well established on the basis of scores of randomized placebo-controlled trials involving thousands of patients. Tricyclic antidepressants (TCAs) were the first to be studied extensively; meta-analyses of placebo-controlled trials show them to be consistently and significantly more efficacious than a placebo. Because of a narrow safety margin and significant drug-induced adverse side effect problems, TCAs have now largely been replaced as the first-line treatment of depression by selective serotonin reuptake inhibitors (SSRIs)—fluoxetine, sertraline, paroxetine, citalopram, and escitalopram; serotonin norepinephrine reuptake inhibitors (SNRIs)—venlafaxine and duloxetine; as well as other compounds, including, for example, bupropion and mirtazapine. Each of these agents has been shown to be superior to a placebo and as effective as comparator TCAs or SSRIs in controlled trials. Clinical trials consistently show them to be better tolerated than TCAs, and they clearly have a wider margin of safety. However, there is a controversy concerning whether TCAs are more effective than SSRIs for the treatment of the most severely ill depressed patients. Monoamine oxidase inhibitors (MAOIs), while also more effective than placebo, have generally been reserved for treatment-refractory patients; however, a recently released transdermally delivered selegiline may be used in less refractory patients. It is now generally recognized that patients with recurrent major depression benefit from continued antidepressant treatment, and there is evidence that TCAs, SSRIs, SNRIs, and so forth are all effective for the long-term management of recurrent major depression. An important issue in evaluating the antidepressant literature is to distinguish between response rated as a reduction in the level of symptoms on a rating scale and response rated as true remission from illness.


2015 ◽  
Vol 12 (S1) ◽  
pp. S-3-S-6
Author(s):  
P. Majumder ◽  
I. Sharma ◽  
P. Vostanis ◽  
C. Bone

We investigated the efficacy of aerobic exercise alongside antidepressant medication as an adjuvant maintenance treatment for depression. Fifty patients in remission were randomly assigned to either medication only or medication plus exercise. Assessment of psychopathology was made at 6-weekly intervals (for 24 weeks) using the Hamilton Rating Scale for Depression. The medication-plus-exercise group showed significantly more improvement at 12 and 24 weeks than the medication-only group. This study adds to a growing evidence base that suggests aerobic exercise is worthy of further development in the treatment of depressive disorders.


2001 ◽  
Vol 9 (1) ◽  
pp. 43-57 ◽  
Author(s):  
Parinda Khatri ◽  
James A. Blumenthal ◽  
Michael A. Babyak ◽  
W. Edward Craighead ◽  
Steve Herman ◽  
...  

The effects of a structured exercise program on the cognitive functioning of 84 clinically depressed middle-aged and older adults (mean age = 57 years) were examined. Participants were randomized to either 4 months of aerobic exercise (n = 42) or antidepressant medication (n = 42). Assessments of cognitive functioning (memory, psychomotor speed, executive functioning, and attention/concentration), depression, and physical fitness (aerobic capacity and exercise endurance) were conducted before and after the intervention. Exercise-related changes (accounting for baseline levels of cognitive functioning and depression) were observed for memory (p = .01) and executive functioning (p = .03). There were no treatment-group differences on tasks measuring either attention/concentration or psychomotor speed. Results indicate that exercise can exert influence on specific areas of cognitive functioning among depressed older adults. Further research is necessary to clarify the kinds of cognitive processes that are affected by exercise and the mechanisms by which exercise affects cognitive functioning.


2011 ◽  
Vol 26 (S2) ◽  
pp. 1142-1142
Author(s):  
M. He ◽  
Z. Gu ◽  
X. Wang ◽  
H. Shi

Background and purposeThe conventional repetitive transcranial magnetic stimulation (rTMS) has some inadequate of efficacy weak and inadequate for the treatment of depression, easy symptomatic recurrence when stop the treatment. Ours invented the device of sleep electroencephalogram-modulated rTMS (SEM-rTMS) were safe and effective by proved of the animal experiments and clinical pre-test for the treatment of depression. The purpose of this study was to examine the efficacy and safety of SEM-rTMS for the treatment of depression.MethodsAfter 7 days without psychoactive medication, 164 patients with clinically defined depression, were randomly assigned to receive SEM-rTMS (N = 57), conventional rTMS (C-rTMS (N = 55), or sham-rTMS (N = 52) for 30 minutes/time/day for 10 days. Before and after scores on the 24-item Hamilton rating scale for depression (HAMD-24) and the clinical outcome at the 10th-day of therapy for all subjects were analyzed.ResultsTwenty two cases in the SEM-rTMS group improved mood as compared to 6 in the C-rTMS group and 2 in the sham-rTMS group (c2 = 15.89, p = 0.0004). After completion of the rTMS phase of the protocol, a (51 ± 5) % reduction of HAMD-24 scores from the baseline in the SEM-rTMS group compared with a (34 ± 4)% in the C-rTMS group ((q = 26.09, p = 0.001) and a (14 ± 3)% in Sham-rTMS group (q = 57.53,p = 0.000). The 88% total efficacy ratio in the SEM-rTMS group was significant higher than 68% in the C-rTMS group and 20% in the sham-rTMS group (c2 = 12.01, p = 0.0025). No significant side effects were noted.ConclusionIt is efficient and safe to treat depression with repetitive transcranial magnetic stimulation. (The registration. No: ChiCTR-TRC-00000438).


2003 ◽  
Vol 33 (4) ◽  
pp. 589-599 ◽  
Author(s):  
C. WHITEHEAD ◽  
S. MOSS ◽  
A. CARDNO ◽  
G. LEWIS

Background. Depression is common in people with schizophrenia and is associated with substantial morbidity and an increased risk of suicide. Our aim was to review systematically all the randomized controlled trials that have investigated the clinical effectiveness of antidepressant medication in the treatment of depression in people who also suffer with schizophrenia.Method. Electronic searches of ClinPsych, the Cochrane Library, the Cochrane Schizophrenia Group's Register of Trials, EMBASE and Medline were completed. Reference lists from identified articles were hand searched.Results. Eleven small studies were identified and all randomized fewer than 30 subjects to each group. We could only perform analyses on a subset of the trials. For five trials (aggregate N=209) the proportion improved in the antidepressant group was 26% (95% CI 10% to 42%) higher than in the placebo group. In six studies (aggregate N=267) the standardized mean difference on the Hamilton Rating Scale for Depression at the end of the trial was −0·27 (95% CI −0·7 to 0·2). There was no evidence that antidepressant treatment given during the stable phase of illness led to a deterioration of psychotic symptoms in the included trials.Conclusions. The literature reviewed was, overall, of poor quality and only a small number of trials could contribute towards the meta-analysis. The results provide weak evidence for the effectiveness of antidepressants in those with schizophrenia and depression and could be explained by publication bias. We need further research to determine the best approach towards treating depression in people with schizophrenia.


2020 ◽  
pp. 1-6
Author(s):  
Paul Park ◽  
Victor Chang ◽  
Hsueh-Han Yeh ◽  
Jason M. Schwalb ◽  
David R. Nerenz ◽  
...  

OBJECTIVEIn 2017, Michigan passed new legislation designed to reduce opioid abuse. This study evaluated the impact of these new restrictive laws on preoperative narcotic use, short-term outcomes, and readmission rates after spinal surgery.METHODSPatient data from 1 year before and 1 year after initiation of the new opioid laws (beginning July 1, 2018) were queried from the Michigan Spine Surgery Improvement Collaborative database. Before and after implementation of the major elements of the new laws, 12,325 and 11,988 patients, respectively, were treated.RESULTSPatients before and after passage of the opioid laws had generally similar demographic and surgical characteristics. Notably, after passage of the opioid laws, the number of patients taking daily narcotics preoperatively decreased from 3783 (48.7%) to 2698 (39.7%; p < 0.0001). Three months postoperatively, there were no differences in minimum clinically important difference (56.0% vs 58.0%, p = 0.1068), numeric rating scale (NRS) score of back pain (3.5 vs 3.4, p = 0.1156), NRS score of leg pain (2.7 vs 2.7, p = 0.3595), satisfaction (84.4% vs 84.7%, p = 0.6852), or 90-day readmission rate (5.8% vs 6.2%, p = 0.3202) between groups. Although there was no difference in readmission rates, pain as a reason for readmission was marginally more common (0.86% vs 1.22%, p = 0.0323).CONCLUSIONSThere was a meaningful decrease in preoperative narcotic use, but notably there was no apparent negative impact on postoperative recovery, patient satisfaction, or short-term outcomes after spinal surgery despite more restrictive opioid prescribing. Although the readmission rate did not significantly increase, pain as a reason for readmission was marginally more frequently observed.


2021 ◽  
Author(s):  
Angela Sanna ◽  
Paolo Follesa ◽  
Paolo Tacconi ◽  
Mariangela Serra ◽  
Maria Giuseppina Pisu ◽  
...  

AbstractSpinocerebellar ataxia 38 (SCA 38) is an autosomal dominant disorder caused by conventional mutations in the ELOVL5 gene which encodes an enzyme involved in the synthesis of very long fatty acids, with a specific expression in cerebellar Purkinje cells. Three Italian families carrying the mutation, one of which is of Sardinian descent, have been identified and characterized. One session of cerebellar intermittent theta burst stimulation (iTBS) was applied to 6 affected members of the Sardinian family to probe motor cortex excitability measured by motor-evoked potentials (MEPs). Afterwards, patients were exposed to ten sessions of cerebellar real and sham iTBS in a cross-over study and clinical symptoms were evaluated before and after treatment by Modified International Cooperative Ataxia Rating Scale (MICARS). Moreover, serum BDNF levels were evaluated before and after real and sham cerebellar iTBS and the role of BDNF Val66Met polymorphism in influencing iTBS effect was explored. Present data show that one session of cerebellar iTBS was able to increase MEPs in all tested patients, suggesting an enhancement of the cerebello-thalamo-cortical pathway in SCA 38. MICARS scores were reduced after ten sessions of real cerebellar iTBS showing an improvement in clinical symptoms. Finally, although serum BDNF levels were not affected by cerebellar iTBS when considering all samples, segregating for genotype a difference was found between Val66Val and Val66Met carriers. These preliminary data suggest a potential therapeutic use of cerebellar iTBS in improving motor symptoms of SCA38.


Sign in / Sign up

Export Citation Format

Share Document