Mania Clinical Trial
Official title:
Allopurinol for Mania: A Randomized Trial Administering Allopurinol vs. Placebo as add-on to Mood Stabilizers and/or Antipsychotics in Patients in a Bipolar Manic Episode.
The objective of the study is to evaluate the efficacy of allopurinol, compared to placebo, as add-on to mood stabilizers and/or antipsychotic in the treatment of patients with bipolar disorder, in a manic episode.
An emerging body of evidence supports a role for dysfunctional purinergic related
neurotransmission in mood disorders [1, 2]. Adenosine agonists have been shown to have
properties similar to those of dopamine antagonists and there is a well characterized
antagonistic interaction between adenosine and dopamine receptors in the ventral striatum.
Increased adenosynergic transmission has been demonstrated to reduce the affinity of
dopamine agonists for dopamine receptors. It has been theorized that adenosine may exert
some of its antipsychotic effects through modulation of glutamatergic transmission.
Two double-blind, randomized, add-on, placebo-controlled trials comparing allopurinol and
placebo in acute mania have showed statistically significant greater improvements in YMRS
scores in the allopurinol vs. placebo groups. These empiric data, together with the
theoretical and basic science background cited, provide the impetus for this proposed study.
;
Allocation: Randomized, Endpoint Classification: Efficacy Study, Intervention Model: Parallel Assignment, Masking: Double Blind (Subject, Caregiver, Investigator), Primary Purpose: Treatment
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