A Phase 3 interventional study of Allopurinol and Placebo in Mania, sponsored by Sheba Medical Center. Completed at 24 sites in 2 countries. Open to participants aged 18 Years to 65 Years. Per ClinicalTrials.gov, last updated 2012-05-08.
Sponsored by Sheba Medical Center · Phase 3, Interventional, and Treatment
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.
97 studies on the registry are indexed under Mania; 10 are open to participants now.
This study's enrollment of 180 is above the median of 86 across 86 interventional studies indexed under Mania.
Browse Mania studies →Sheba Medical Center is the lead sponsor of 660 studies on the registry; 63 are open to participants now.
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Exclusion Criteria:
Drug: Allopurinol
Drug: Placebo
Allopurinol 1 capsule 300 mg, BID
Also known as: Alloril, Zylol, Zyloric
Placebo 1 capsule, 300 mg, BID
1) Change from baseline to day 42 in the YMRS
Time frame: from baseline to day 42
2) Change from baseline to day 42 in the CGI-BP scale.
Time frame: from baseline to day 42
1) Change from baseline to day 14 in the YMRS
Time frame: from baseline to day 14
2) Change from baseline to day 14 in the CGI-BP scale.
Time frame: from baseline to day 14
3) Change in the PANSS activation subscale score (total score of 6 PANSS items: Hostility, poor impulse control, excitement, uncooperativeness, poor rapport, and tension) from baseline to final assessment (Day 42).
Time frame: from baseline to day 42
4) Rates of discontinuation in the allopurinol group compared to the placebo group
Time frame: during the study period (42 days)
This study is completed, as verified in May 2012. You cannot join it, but the record below documents what was studied.
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Sheba Medical Center