Beck Depression Inventory

Randomized controlled trial of trigeminal nerve stimulation for drug-resistant epilepsy..

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To explore the safety and efficacy of external trigeminal nerve stimulation (eTNS) in patients with drug-resistant epilepsy (DRE) using a double-blind randomized controlled trial design, and to test the suitability of treatment and control parameters in preparation for a phase III multicenter clinical trial.

METHODS: This is a double-blind randomized active-control trial in DRE. Fifty subjects with 2 or more partial onset seizures per month (complex partial or tonic-clonic) entered a 6-week baseline period, and then were evaluated at 6, 12, and 18 weeks during the acute treatment period. Subjects were randomized to treatment (eTNS 120 Hz) or control (eTNS 2 Hz) parameters.
RESULTS: At entry, subjects were highly drug-resistant, averaging 8.7 seizures per month (treatment group) and 4.8 seizures per month (active controls). On average, subjects failed 3.35 antiepileptic drugs prior to enrollment, with an average duration of epilepsy of 21.5 years (treatment group) and 23.7 years (active control group), respectively. eTNS was well-tolerated. Side effects included anxiety (4%), headache (4%), and skin irritation (14%). The responder rate, defined as >50% reduction in seizure frequency, was 30.2% for the treatment group vs 21.1% for the active control group for the 18-week treatment period (not significant, p = 0.31, generalized estimating equation [GEE] model). The treatment group experienced a significant within-group improvement in responder rate over the 18-week treatment period (from 17.8% at 6 weeks to 40.5% at 18 weeks, p = 0.01, GEE). Subjects in the treatment group were more likely to respond than patients randomized to control (odds ratio 1.73, confidence interval 0.59-0.51). eTNS was associated with reductions in seizure frequency as measured by the response ratio (p = 0.04, analysis of variance [ANOVA]), and improvements in mood on the Beck Depression Inventory (p = 0.02, ANOVA).
CONCLUSIONS: This study provides preliminary evidence that eTNS is safe and may be effective in subjects with DRE. Side effects were primarily limited to anxiety, headache, and skin irritation. These results will serve as a basis to inform and power a larger multicenter phase III clinical trial. CLASSIFICATION OF EVIDENCE: This phase II study provides Class II evidence that trigeminal nerve stimulation may be safe and effective in reducing seizures in people with DRE.

Source: Neurology

Cognitive-Behavioral Therapy for Patients with Treatment-Resistant Depression.

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CBT added to antidepressant drugs was beneficial in primary care practices.

Primary care physicians (PCPs) often prescribe antidepressant medications, but only about a third of patients will respond fully to initial pharmacotherapy. When initial pharmacotherapy fails, options include dose escalation, changing agents, or psychotherapy. Brief cognitive-behavioral therapy (CBT) is effective for patients with previously untreated depression, but its role as second-line therapy, added to antidepressant medications, has not been studied well.

Researchers in the U.K. identified 469 depressed adults who had failed to respond to a minimum of 6 weeks of antidepressant therapy. Patients continued to receive usual care by their PCPs (including antidepressants) and were randomized to receive or to not receive 12 to 18 sessions of CBT delivered in or near their PCPs’ offices. Usual-care participants could be referred for counseling, CBT, or secondary care, when such treatment was deemed to be clinically appropriate.

After 6 months, significantly more patients in the CBT group than in the usual care–alone group (46% vs. 22%) reached the primary endpoint of 50% decline in depressive symptoms, as measured by the 63-point Beck Depression Inventory (BDI). Patients who received CBT also had significantly higher rates of remission (BDI <10) after 6 months. Differences in these outcomes remained significant after 12 months of follow-up.

Comment: This study will support the growing interest in integrating behavioral health services into primary care practices, where psychiatric and somatic morbidities commonly coexist and interact. New clinical and financial models will be required, but the payoff for patients’ health and productivity could be substantial.

Source:Journal Watch General Medicine