A placebo‐controlled, random‐assignment, parallel‐group pilot study of adjunctive topiramate for patients with schizoaffective disorder, bipolar type

Abstract

This pilot study did not support clinical efficacy for adjunctive topiramate treatment in patients with SAD-BT. There were no major safety or tolerability issues in this study. Confirming the results of other studies, topiramate-treated patients did experience greater body weight loss and reduction in BMI.

Efficacy and tolerability of topiramate-augmentation therapy for schizophrenia: a systematic review and meta-analysis of randomized controlled trials

“…We excluded eight duplicate studies, 81 studies based on title or abstract review, and 20 studies after full-text reading. Five additional articles17,22,24–26 were identified by manually searching the review articles 17,39. Finally, 12 eligible studies15–26 were accepted (Figure 1).…”

“…With regard to tolerability, discontinuations due to worsening mental condition and unsatisfactory response17,23 were considered “discontinuation due to inefficacy”, and discontinuation due to low leukocyte levels23 was considered “discontinuation due to adverse events”. For estimation of missing data from individual studies, we imputed the standard deviation (SD) of BPRS-change scores from baseline to end point in Ko et al,19 from the data of Muscatello et al,20 and SD of CGI-S and BMI-change scores from baseline to end point in the study of Ko et al19 from the SD of Chengappa et al17 We converted weights from pounds to kilograms for Chengappa et al17 We assumed that the number of patients required for evaluating efficacy outcomes in Behdani et al16 was the same as the number of patients required for evaluating safety outcomes and the number of patients required for evaluating efficacy outcomes in Afshar et al15 was the same number of randomized patients for each treatment arm, because the trial used general linear model analysis. We used those estimations to increase sample size for analysis to gain as much statistical power as possible.…”

“…The median highest topiramate dose for all studies except Ko et al19 was 238 mg/day, so data from the 200 mg/day topiramate group but not the 100 mg/day topiramate group were used for meta-analysis. For individual adverse events, we considered memory disturbances23 and forgetfulness17 as “memory loss”, and sedation17,23 and drowsiness16 as “somnolence”.…”

Determination of plasma topiramate concentration using LC‐MS/MS for pharmacokinetic and bioequivalence studies in healthy Korean volunteers

“…It is currently being evaluated for its effect in various neurological and psychiatric disorders (Arnone, 2005;Barzman et al, 2005;Barzman et al, 2006;Gobbi et al, 2006;Lung et al, 2007;Roy Chengappa et al, 2007) and reducing body weight (Van Ameringen et al, 2002;Bray et al, 2003;McElroy et al, 2004;Wilding et al, 2004;Ko et al, 2005;Lin et al, 2005;Kotwal et al, 2006;Correll, 2007;Toplak et al, 2007;Tremblay et al, 2007), blood pressure (Halpern, 2005;Tonstad et al, 2005), alcohol dependence (Johnson et al, 2003) and smoking (Khazaal et al, 2006).…”

Effects of Topiramate on Smoking in Patients With Schizoaffective Disorder, Bipolar Type

“…This report is based on a secondary analysis of an eight-week placebo-controlled, randomized clinical trial examining the safety and efficacy of topiramate for patients with schizoaffective disorder, bipolar type 9 . Patients in the study were randomly assigned to topiramate (TOP, 100-400 mg/d) or placebo (PLA) using a 2:1 ratio in favor of topiramate.…”