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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

2014-08-27 03:15:00 | BioPortfolio

Summary

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.

Description

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.

Study Design

Allocation: Randomized, Control: Placebo Control, Endpoint Classification: Efficacy Study, Intervention Model: Parallel Assignment, Masking: Double Blind (Subject, Caregiver, Investigator), Primary Purpose: Treatment

Conditions

Mania

Intervention

Allopurinol, Placebo

Location

Beer-Yaakov Mental Health Center
Beer-Yaakov
Cluj-Napoca
Israel
70350

Status

Not yet recruiting

Source

Sheba Medical Center

Results (where available)

View Results

Links

Published on BioPortfolio: 2014-08-27T03:15:00-0400

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Allopurinol Add-on Treatment for Refractory Mania

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

Study to Evaluate sUA-Lowering Activity, Safety & PK Interaction of Oral BCX4208 & Allopurinol Admin. in Subjects w/Gout

To evaluate safety and efficacy of BCX4208 alone and in combination with allopurinol in subjects with gout.

Allopurinol Maintenance Study for Bipolar Disorder

The purpose of this study is to investigate the efficacy of allopurinol as an augmentation agent for the prevention of mania in bipolar disorder patients with currently stable mood.

Allopurinol Combination Study

To compare the proportion of subjects whose serum urate (sUA) levels are < 6.0 mg/dL following 4 weeks of continuous treatment of RDEA594 in combination with allopurinol to allopurinol alo...

Allopurinol in Schizophrenia: A Randomized Trial Administering Allopurinol vs Placebo as add-on Antipsychotics in Patients With Schizophrenia

The objective of the study is to evaluate the efficacy of allopurinol, compared to placebo, as add-on to anti-psychotics in the treatment of patients with schizophrenia.

PubMed Articles [973 Associated PubMed Articles listed on BioPortfolio]

Allopurinol augmentation in acute mania: A meta-analysis of placebo-controlled trials.

Allopurinol is a xanthine oxidase inhibitor commonly used in the treatment of gout. Recent studies have also shown its promise as an adjunctive treatment for manic episodes in bipolar 1 disorder, poss...

How to prevent allopurinol hypersensitivity reactions?

Allopurinol hypersensitivity syndrome (AHS) is a severe and sometimes life-threatening adverse drug reaction. Although AHS is rare, the number of patients with gout requiring allopurinol is high, and ...

Design and rationale for the veterans affairs "cooperative study program 594 comparative effectiveness in gout: Allopurinol vs. febuxostat" trial.

Gout patients do not routinely achieve optimal outcomes related in part to suboptimal administration of urate lowering therapy (ULT) including first-line xanthine oxidase inhibitors allopurinol or feb...

Association between ABCG2 rs2231142 and poor response to allopurinol: replication and meta-analysis.

ABCG2 rs2231142 (Q141K) has been reported to be associated with poor response to allopurinol, while there are conflicting data on the association between the genetically independent ABCG2 rs10011796 v...

The vasodilatory effect of allopurinol mediates its antihypertensive effect: Effects on calcium movement and cardiac hemodynamics.

Despite the reported reduction in blood pressure in hypertensive patients treated with allopurinol, the mechanism of the allopurinol hypotensive effect is still unclear. In the current study, the hypo...

Medical and Biotech [MESH] Definitions

A XANTHINE OXIDASE inhibitor that decreases URIC ACID production. It also acts as an antimetabolite on some simpler organisms.

Misunderstanding among individuals, frequently research subjects, of scientific methods such as randomization and placebo controls.

A butyrophenone with general properties similar to those of HALOPERIDOL. It is used in the treatment of PSYCHOSES including MANIA and SCHIZOPHRENIA. (From Martindale, The Extra Pharmacopoeia, 30th ed, p621)

An effect usually, but not necessarily, beneficial that is attributable to an expectation that the regimen will have an effect, i.e., the effect is due to the power of suggestion.

Agents that are used to treat bipolar disorders or mania associated with other affective disorders.

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