Effectiveness and Tolerability of Carbamazepine vs. Oxcarbazepine as Mood Stabilizers

Abstract

Background.?Patients with bipolar illness or maniac-type schizoaffective disorder often present a variety of symptoms and mixed responses to treatment. Several anticonvulsants have been found effective in the treatment of mood disorders. In the early 70's, the clinical efficacy of carbamazepine in the treatment of acute mania was reported. Oxcarbazepine has been available in the United States since 2000. Both drugs display a different spectrum of properties and side effect profiles. Objective.?To compare the effectiveness and tolerability of carbamazepine and oxcarbazepine in a naturalistic setting. Methods.?A retrospective and concurrent chart review of all patients treated with carbamazepine or oxcarbazepine (n = 33) as mood stabilizers between 01 and 12 2002. The effectiveness was evaluated using the Positive And Negative Syndrome Scale (PANSS). Tolerability was assessed according to side effects recorded on charts. Patients with charts that were not complete were excluded from this study. Results.?There were no significant differences in efficacy between groups on positive (F = 3.575, P = 0.075), negative (F = 2.641, P = 0.121), or the general subscales (F = 1.111, P = 0.306) of the PANSS. Patients in both groups developed gastrointestinal upset and headache, but no significant differences in tolerability between the two therapies were found (χ² = 0.466, df = 1, P = 0.659) and (χ² = 0.195, df = 1, P = 0.367 respectively). Conclusion.?In summary, the patient charts reviewed demonstrated that carbamazepine, as well as, oxcarbazepine are equally effective and tolerable as mood stabilizers.     

Efficacy and Tolerability of Low-dose Transdermal Estrogen (Oesclim®) in the Treatment of Menopausal Symptoms

Summary

Objective:To establish the proportion of symptomatic postmenopausal women who can be satisfactorily maintained on a low HRT dose of 25?μg/day 17-β-estradiol (Oesclim® 25 transdermal patches), after 8 weeks of treatment.

Study design and patients: This was a multicenter open label non-comparative trial. Treatment was initiated with 25?μg/day dosage, which could be increased to 50?μg/day if required after 8 weeks, according to clinical evaluation. Sequential treatment with an oral progestogen was also given for >12 days/month in all non-hysterectomized women. The primary criterion for evaluation of efficacy was the proportion of patients who remained on Oesclim® 25 after 8 weeks of treatment in comparison to patients requiring Oesclim® 50.

Results: Sixty-two patients were included in the study and 60 were treated. 88.3% of treated patients [CI: 78.7–94.9] fulfilled the primary criterion, remaining with the Oesclim® 25 dosage after 8 weeks of treatment. All clinical menopausal symptoms showed a decrease from baseline to the end of the study. The mean daily number of vasomotor symptoms decreased from

8.2 (±5.6) at baseline, for the entire treated population, to 1.0 (±2.2) and 1.0 (±1.2) at the end of the study in patients remaining with Oesclim® 25 and in those requiring Oesclim® 50, respectively. At the interim visit, patients in the Oesclim® 50 group had a higher number of symptoms than those maintained on Oesclim® 25. The global efficacy of the treatment was evaluated as very effective/effective by 93% of all patients and very good/good by investigators for 91% of their patients. Overall 91% of all patients evaluated the global tolerability as very well/well, while investigators rated it very good/good for 97% of their patients. The vast majority of all patients (93%) were very satisfied/satisfied with the trial treatment, and 90% of them were willing to continue the study drug.

Conclusion: Oesclim® low dose (25?μg) hormonal transdermal therapy was efficient in management of climacteric symptoms in this 16-week study. The good acceptance of the treatment was associated with its high efficiency and tolerability.     

A naturalistic study on the criteria of choice of second-generation antidepressants: A comparison of venlafaxine and SSRIs in depressed inpatients

INTRODUCTION: The objective of this study was to compare, in a naturalistic setting, the efficacy and tolerability of selective serotonin reuptake inhibitors (paroxetine, sertraline, citalopram) and venlafaxine, in 120 depressed inpatients. This paper attempts to review which variables may influence a physician's choice of a specific antidepressant for a specific patient. METHOD: Patients were assessed using the Hamilton Psychiatric Rating Scale for Depression (HAM-D), the Montgomery-Åsberg Depression Rating Scale (MADRS), the Clinical Global Impression (CGI) and the Symptoms Check List (SCL-90). The two groups under assessment were comparable in all socio-demographic characteristics. We used logistic regression analyses to identify variables that differentiate the two groups at baseline. This, in turn, would represent those variables with the potential to influence a physician's selection of an antidepressant. RESULTS: Venlafaxine patients reported significantly worse scores on MADRS at baseline, but any difference was no longer present at discharge. We found no significant variation in the efficacy of the antidepressants under study and there were no differences in the incidence and profiles of adverse events between the groups of patients. CONCLUSION: The degree of severity of the actual depressive picture appears to influence choice in favour of venlafaxine. However, it appears that the choice of SSRIs is more closely linked to patients who present a previous history of non-mood psychiatric symptoms.     

Efficacy and tolerability of two home bleaching systems having different peroxide delivery

The aim of this study was to investigate tooth whitening efficacy and oral side effects during bleaching with Whitestrips (WS) (6% hydrogen peroxide H(2)O(2) gel) and Vivadent Vivastyle (VS) (10% carbamide peroxide gel). Forty-seven subjects were included in this single blind, randomized, parallel group study. Application of WS was performed twice a day for 30 min. Trays filled with VS were worn for 60 min once a day. Tooth color was evaluated by measuring L*a*b* values before the study and after completion of the bleaching. Treatment tolerability was monitored throughout bleaching with an 8-week follow-up after completion of therapy. After 2 weeks both treatment groups demonstrated significant improvements in tooth color compared to baseline. A shift toward less yellow (-Deltab) and brighter (+DeltaL) tooth color was observed. Deltab amounted to -1.69 +/- 0.38 for WS and -1.20 +/- 0.34 for VS (mean value +/- SE). DeltaL was +1.55 +/- 0.41 for WS and +1.20 +/- 0.37 for VS. There was no significant difference between the two systems. No significant differences between the two bleaching systems were recorded for clinically observed signs or reported symptoms. Gingival irritation was observed in 13%, reported tooth hypersensitivities in 22% and reported gum irritation in 20% of the total study population. At an 8-week follow-up visit no adverse effects were observed. Both WS and VS demonstrated significant and comparable levels of tooth color improvement after 2 weeks. Each treatment caused similar levels of transient oral side effects.     

Tolerability and feasibility of at-home remotely supervised transcranial direct current stimulation (RS-tDCS): Single-center evidence from 6,779 sessions

IntroductionThe ability to deploy transcranial direct current stimulation (tDCS) at home is a key usability advantage to support scaling for pivotal clinical trials. We have established a home-based tDCS protocol for use in clinical trials termed remotely supervised (RS)-tDCS.ObjectiveTo report the tolerability and feasibility of tDCS sessions completed to date using RS-tDCS in clinical trials.MethodsWe analyzed tolerability (i.e., adverse events, AEs) reported in six Class I/II/III trials using RS-tDCS to study symptom outcomes over 10 to 60 daily applications. Across the six clinical trials, 308 participants (18–78 years old) completed an average of 23 sessions for a total of 6779 RS-tDCS administrations. The majority of participants were diagnosed with multiple sclerosis, and open-label trials included those diagnosed with a range of other conditions (e.g., Parkinson's disease, post-stroke aphasia, traumatic brain injury, cerebellar ataxia), with minimum-to-severe neurologic disability. Clinical trial feasibility (i.e., treatment fidelity and blinding integrity) was examined using two Class I randomized controlled trials (RCTs).ResultsNo serious AEs occurred. Across administrations, three sessions (0.04%) were aborted due to discomfort, but no participant discontinued due to tolerability. The AEs most commonly reported by participants were tingling (68%), itching (41%) and warmth sensation (42%) at the electrode site, and these were equally reported in active and sham tDCS conditions. The two Class I RCTs resulted in rapid enrollment, high fidelity to treatment completion, and blinding integrity.ConclusionsAt-home RS-tDCS is tolerable, including when used over extended periods of time. Home-based RS-tDCS is feasible and can enable Class I tDCS clinical trial designs.