drugset

drugset / Trial / NCT00643123

Allopurinol Add-on Treatment for Refractory Mania

NCT00643123 ↗

Phase 4 Completed 40 enrolled Cedars-Sinai Medical Center National Alliance for Research on Schizophrenia and Depression · collab

RandomizedParallel-groupDouble-blindTreatment

Summary

The purpose of this study is to investigate the efficacy of allopurinol as an augmentation agent for treatment resistant mania and mixed mania.

Timeline

Start: 2007-09
Primary completion: 2010-06
Completion: 2010-06

Outcome

Missed primary endpoint

registry analysis (other test); Allopurinol vs Placebo; p = .45; Mean Difference (Final Values) 2.9; t-test, 2 sided NCT00643123 ↗

paper allopurinol augmentation did not show a statistically significant improvement over placebo in attenuating manic symptoms. PMID 22420596 ↗

Publications

Fan A, Berg A, Bresee C, Glassman LH, Rapaport MH. Allopurinol augmentation in the outpatient treatment of bipolar mania: a pilot study. Bipolar Disord. 2012 Mar;14(2):206-10. doi: 10.1111/j.1399-5618.2012.01001.x.

Drugs

Evaluation	Drug	Modality	Dose	Route
Subject	Allopurinol	Small molecule	600 mg	—

Indications