Allopurinol as Adjunctive Therapy in Intractable Epilepsy: A Double-blind and Placebo-controlled Trial

Safety and Efficacy of Two Pregabalin Regimens for Add-on Treatment of Partial Epilepsy Beydoun A, Uthman BM, Kugler AR, Greiner MJ, Knapp LE, Garofalo EA; Pregabalin 1008-009 Study Group Neurology 2005;64:475–480 Objective To evaluate the efficacy, tolerability, and safety of two pregabalin regimens administered as adjunctive therapy to that of placebo in patients with medically refractory partial epilepsy. Methods A multicenter, double-blind, randomized, parallel-group, placebo-controlled trial was performed. After a prospective 8-week baseline phase, patients were randomized to 12 weeks of double-blind treatment with placebo or pregabalin, 600 mg/day, administered twice daily (BID) or 3 times daily (TID). Primary efficacy was measured as change in seizure frequency from baseline of either pregabalin regimen compared with placebo. Secondary efficacy comparisons included the proportion of patients experiencing ≥50% reduction in seizure frequency (responder rate) and median percentage change from baseline in seizure frequency. Safety/tolerability assessments included adverse events (AEs), physical and neurologic examinations, and clinical laboratory evaluation. Efficacy and safety analyses were performed on the intent-to-treat (ITT) population. Results Pregabalin treatment resulted in seizure frequency reductions: 53% for pregabalin TID ( P ≤ 0.0001) and 44% for pregabalin BID ( P ≤ 0.0001) compared with a 1% increase for placebo. Responder rates were 49% for pregabalin TID and 43% for pregabalin BID compared with 9% for placebo ( P ≤ 0.001). Both pregabalin regimens were similar in efficacy and tolerability. The most common AEs were dizziness, somnolence, and ataxia. Conclusions Pregabalin administered at 600 mg/day is safe, generally well tolerated, and efficacious as adjunctive therapy for the treatment of patients with partial seizures, with or without secondary generalizations. This dose can be administered on a twice-daily or 3-times-daily schedule with similar efficacy and tolerability results.

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Dexamethasone for Morbidity After Subdural Electrode Insertion – A Randomized Controlled Trial

Canadian Journal of Neurological Sciences / Journal Canadien des Sciences Neurologiques ◽

10.1017/s031716710000305x ◽

2003 ◽

Vol 30 (4) ◽

pp. 340-348 ◽

Cited By ~ 14

Author(s):

Ramesh L. Sahjpaul ◽

Jeff Mahon ◽

Samuel Wiebe

Keyword(s):

Pain Relief ◽

Postoperative Period ◽

Controlled Trial ◽

Intractable Epilepsy ◽

Controlled Clinical Trial ◽

Antiemetic Drug ◽

Double Blind ◽

Dexamethasone Group ◽

Significant Difference ◽

Limited Duration

Background:Invasive monitoring with subdural electrodes (SDE) for investigation of medically intractable epilepsy may be associated with undesirable immediate postoperative morbidity such as headache, nausea, vomiting, fever, and meningism. We undertook to evaluate the potential beneficial role of perioperative dexamethasone in reducing these symptoms.Methods:In a double-blind placebo controlled clinical trial 30 patients undergoing SDE insertion were randomized to receive either placebo or a course of dexamethasone beginning one hour prior to surgery and tapering to discontinue over 72 hours postoperatively. Pain, pain relief, nausea, nausea relief, temperature, and meningism were assessed regularly in the postoperative period, and analgesic, antipyretic, and antiemetic drug requirements were tabulated.Results:One patient was withdrawn from the dexamethasone group due to lack of data. With regards to postoperative pain, the direction of benefit favoured dexamethasone but a significant treatment by time interaction prevented further analysis of treatment effect. The dexamethasone group did have significantly lower temperatures and higher nausea relief scores. There was no statistically significant difference between the groups with regards to pain relief, nausea, and meningism scores. The beneficial effects of dexamethasone were delayed in onset, of limited duration, and not uniform over the observation period.Conclusion:Dexamethasone appears to have a role in reducing immediate morbidity following SDE insertion but its effect is not uniform in the postoperative period; it appears to be delayed in onset, and of limited duration. Further study is necessary to determine the ideal dosing schedule.

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Lack of Association Between Serum Brain-Derived Neurotrophic Factor Levels and Improvement of Schizophrenia Symptoms in a Double-Blind, Randomized, Placebo-Controlled Trial of Memantine as Adjunctive Therapy to Clozapine

The Journal of Clinical Psychiatry ◽

10.4088/jcp.09l05388 ◽

2010 ◽

Vol 71 (01) ◽

pp. 91-92 ◽

Cited By ~ 8

Author(s):

David de Lucena ◽

Brisa Simões Fernandes ◽

Mauricio Kunz ◽

Gabriel Rodrigo Fries ◽

Laura Stertz ◽

...

Keyword(s):

Neurotrophic Factor ◽

Adjunctive Therapy ◽

Controlled Trial ◽

Brain Derived Neurotrophic Factor ◽

Double Blind

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Effect of vitamin D supplementation as adjunctive therapy to methylphenidate on ADHD symptoms: A randomized, double blind, placebo-controlled trial

Nutritional Neuroscience ◽

10.1080/1028415x.2016.1262097 ◽

2016 ◽

Vol 21 (3) ◽

pp. 202-209 ◽

Cited By ~ 17

Author(s):

Nakisa Mohammadpour ◽

Shima Jazayeri ◽

Mehdi Tehrani-Doost ◽

Mahmoud Djalali ◽

Mostafa Hosseini ◽

...

Keyword(s):

Vitamin D ◽

Adjunctive Therapy ◽

Controlled Trial ◽

Vitamin D Supplementation ◽

Adhd Symptoms ◽

Double Blind ◽

Double Blind Placebo

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A Randomized, Double-Blind Placebo-Controlled Trial on Effectiveness and Safety of Celecoxib Adjunctive Therapy in Adolescents with Acute Bipolar Mania

Journal of Child and Adolescent Psychopharmacology ◽

10.1089/cap.2016.0207 ◽

2017 ◽

Vol 27 (6) ◽

pp. 494-500 ◽

Cited By ~ 20

Author(s):

Seyed Yaser Mousavi ◽

Rasoul Khezri ◽

Mohammad-Ali Karkhaneh-Yousefi ◽

Payam Mohammadinejad ◽

Faezeh Gholamian ◽

...

Keyword(s):

Adjunctive Therapy ◽

Controlled Trial ◽

Double Blind ◽

Double Blind Placebo ◽

Bipolar Mania

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Raloxifene adjunctive therapy for postmenopausal women suffering from chronic schizophrenia: a randomized double-blind and placebo controlled trial

DARU Journal of Pharmaceutical Sciences ◽

10.1186/2008-2231-22-55 ◽

2014 ◽

Vol 22 (1) ◽

Cited By ~ 27

Author(s):

Gilda Kianimehr ◽

Farzad Fatehi ◽

Sara Hashempoor ◽

Mohammad-Reza Khodaei-Ardakani ◽

Farzin Rezaei ◽

...

Keyword(s):

Postmenopausal Women ◽

Adjunctive Therapy ◽

Controlled Trial ◽

Chronic Schizophrenia ◽

Double Blind

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Agomelatine or placebo as adjunctive therapy to a mood stabiliser in bipolar I depression: Randomised double-blind placebo-controlled trial

The British Journal of Psychiatry ◽

10.1192/bjp.bp.114.147587 ◽

2016 ◽

Vol 208 (1) ◽

pp. 78-86 ◽

Cited By ~ 37

Author(s):

Lakshmi N. Yatham ◽

Eduard Vieta ◽

Guy M. Goodwin ◽

Michel Bourin ◽

Christian de Bodinat ◽

...

Keyword(s):

Adjunctive Therapy ◽

Rating Scale ◽

Bipolar Depression ◽

Controlled Trial ◽

Acute Therapy ◽

Double Blind ◽

Continuation Therapy ◽

Primary Efficacy Measure ◽

Scale Scores ◽

Efficacy Measure

BackgroundAdjunctive antidepressant therapy is commonly used to treat acute bipolar depression but few studies have examined this strategy.AimsTo examine the efficacy of agomelatine v. placebo as adjuncts to lithium or valproate in bipolar depression.MethodPatients who were currently depressed despite taking lithium or valproate for at least 6 weeks were randomised to treatment with agomelatine (n = 172) or placebo (n = 172) for 8 weeks of acute therapy and 44 weeks of continuation therapy (trial registration: ISRCTN28588282).ResultsNo significant differences in improvement of depressive symptoms were observed between the two groups either at 8 weeks or 52 weeks on the primary efficacy measure of change in Montgomery–Åsberg Depression Rating Scale scores from baseline to end-point. Adverse events including switches into mania/hypomania were low and similar in both groups.ConclusionsAgomelatine adjunctive therapy was not superior to placebo adjunctive therapy for acute bipolar depression.

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