Abstract | INTRODUCTION: METHODS: A randomized, double-blind, placebo-controlled, parallel-group 12-week study was conducted at 23 centers in the United States. Clinically stable subjects with schizophrenia were randomized in an equal ratio to ABT-288 10 mg, ABT-288 25 mg, or placebo once daily while continuing their antipsychotic regimen. The primary efficacy measure was the change from baseline to day 84 evaluation on the Measurement and Treatment Research to Improve Cognition in Schizophrenia Consensus Cognitive Battery (MCCB) composite score vs placebo. Secondary measures included cognitive functioning and psychiatric scales. Safety assessments and sparse pharmacokinetic sampling were also conducted. RESULTS: A total of 214 subjects were randomized. The mean baseline MCCB composite score was 28.4. Approximately 80% of subjects completed the study. The MCCB composite score mean change from baseline to day 84 was numerically worse for both the 10 mg (1.90, P = .618) and 25 mg (0.64, P = .946) doses of ABT-288 vs placebo (2.19). Results from the secondary measures were consistent with the primary analysis. Subjects' schizophrenia symptoms remained stable throughout the study as evidenced by stable Positive and Negative Syndrome Scale scores. Overall, study medication was tolerated; however, an increased incidence of psychosis-related and sleep-related adverse events was associated with ABT-288. DISCUSSION: Neither dose of ABT-288 resulted in cognitive improvement in clinically stable adults with schizophrenia.
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Authors | George M Haig, Earle Bain, Weining Robieson, Ahmed A Othman, Jeffrey Baker, Robert A Lenz |
Journal | Schizophrenia bulletin
(Schizophr Bull)
Vol. 40
Issue 6
Pg. 1433-42
(Nov 2014)
ISSN: 1745-1701 [Electronic] United States |
PMID | 24516190
(Publication Type: Clinical Trial, Phase II, Journal Article, Multicenter Study, Randomized Controlled Trial, Research Support, Non-U.S. Gov't)
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Copyright | © The Author 2014. Published by Oxford University Press on behalf of the Maryland Psychiatric Research Center. All rights reserved. For permissions, please email: [email protected]. |
Chemical References |
- 2-(4'-(5-methylhexahydropyrrolo(3,4-b)pyrrol-1-yl)biphenyl-4-yl)-2H-pyridazin-3-one
- Histamine H3 Antagonists
- Pyridazines
- Pyrroles
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Topics |
- Adult
- Cognition Disorders
(drug therapy, etiology)
- Double-Blind Method
- Female
- Histamine H3 Antagonists
(administration & dosage, adverse effects, pharmacology)
- Humans
- Male
- Middle Aged
- Pyridazines
(administration & dosage, adverse effects, pharmacology)
- Pyrroles
(administration & dosage, adverse effects, pharmacology)
- Schizophrenia
(complications, drug therapy)
- Treatment Failure
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