BL-1020, a New γ-Aminobutyric Acid-Enhanced Antipsychotic: Results of 6-Week, Randomized, Double-Blind, Controlled, Efficacy and Safety Study

Objective: BL-1020 is a γ-aminobutyric acid (GABA)-enhanced antipsychotic that combines dopamine antagonism with GABA agonist activity. On the basis of animal models, we tested the hypotheses that BL-1020 would be effective in ameliorating both psychotic symptoms and cognitive impairments, with a favorable safety profile in acutely ill schizophrenia patients.

Method: 363 hospital-based psychiatric patients in India, Romania, and United States aged 18 to 65 years and meeting criteria for DSM-IV-TR diagnosis of chronic schizophrenia were randomized double-blind to receive BL-1020 10 mg/d, BL-1020 20-30 mg/d, placebo, or risperidone (2-8 mg/d) for 6 weeks. The main outcome measures were the Positive and Negative Syndrome Scale (PANSS), Brief Assessment of Cognition in Schizophrenia, Readiness for Discharge Questionnaire, Clinical Global Impressions Scale (CGI) , and Extrapyramidal Symptom Rating Scale. The study ran from July 2008 to June 2009.

Results: BL-1020 20-30 mg was significantly better than placebo on PANSS (P=.02) and CGI (P<.001) measurements, with no significant differences noted between BL-1020 20-30 mg and risperidone. There were no significant differences in the maximum change on Extrapyramidal Symptom Rating Scale between risperidone and BL-1020 20-30 mg, and both were significantly worse (P<.001) than placebo. BL-1020 20-30 mg was associated with significantly greater improvements on cognitive functioning as measured by the Brief Assessment of Cognition in Schizophrenia composite score when compared to placebo (effect size=0.50, P=.009), risperidone (effect size=0.43, P=.019), and BL-1020 10 mg (effect size=0.42, P=.013) after 6 weeks.

Conclusions: BL-1020 appears to be an effective antipsychotic with possible procognitive effects that will need to be further tested for short- and long-term effects. A further randomized controlled trial using the US Food and Drug Administration-recommended Measurement and Treatment Research to Improve Cognition in Schizophrenia cognitive battery is ongoing.

Trial Registration: ClinicalTrials.gov identifier: NCT00567710

J Clin Psychiatry 2012;73(9):e1168-e1174

© Copyright 2012 Physicians Postgraduate Press, Inc.

Submitted: January 9, 2012; accepted: May 1, 2012 (doi:10.4088/JCP.12m07642).

Corresponding author: Yona Geffen, PhD, Avraham Pharmaceuticals, 42 Hayarkon St, Industrial Zone, Yavneh, 81227, Israel ([email protected]).