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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

Information source: Sheba Medical Center
ClinicalTrials.gov processed this data on August 23, 2015
Link to the current ClinicalTrials.gov record.

Condition(s) targeted: Mania

Intervention: Allopurinol (Drug); Placebo (Drug)

Phase: Phase 3

Status: Completed

Sponsored by: Sheba Medical Center

Official(s) and/or principal investigator(s):
Mark Weiser, Principal Investigator, Affiliation: Sheba Medical Center

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.

Clinical Details

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.

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

Primary outcome:

1) Change from baseline to day 42 in the YMRS

2) Change from baseline to day 42 in the CGI-BP scale.

Secondary outcome:

1) Change from baseline to day 14 in the YMRS

2) Change from baseline to day 14 in the CGI-BP scale.

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).

4) Rates of discontinuation in the allopurinol group compared to the placebo group

Detailed 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.

Eligibility

Minimum age: 18 Years. Maximum age: 65 Years. Gender(s): Both.

Criteria:

Inclusion Criteria: 1. Male or female, 18-65 years of age, inclusive 2. Only females who are abstinent or practicing an established method of birth control (oral contraceptive tablets, hormonal implant device, hormone patch, injectable contraceptive, intrauterine device [IUD]) can be included in the trial. 3. Willing and able to provide informed consent, after the nature of the study has been fully explained 4. Current DSM-IV-TR diagnosis of bipolar I disorder with the current episode manic (296. 4x) or mixed (296. 6x), as confirmed by the Modified Structured Clinical Interview for DSM-IV (SCID). In order to ensure that this is an acute manic episode, we will verify that the current manic episode was preceded by a period of euthymia or depression. If inpatients, subjects will be included only up to 14 days after admission. Subjects with psychotic features will be included in the study. 5. YMRS> 17 6. Patients receiving one or multiple mood stabilizers, and/or one or more anti-psychotics. 7. Inpatients or outpatients. Exclusion Criteria: 1. Unwilling or unable, in the opinion of the Investigator, to comply with study instructions 2. Pregnant or breast-feeding 3. Unstable medical disease (malignancy, poorly controlled diabetes, active ischemic cardiac disease, or cardiomyopathy, serious pulmonary disease, kidney disease, impaired liver functioning). 4. Currently taking any of the following medications: warfarin, amoxicilline, ampicilline, theophylline, or mycophenolate mofetil. 5. Likely allergy or sensitivity to Allopurinol 6. At significant risk of committing suicide, or in the opinion of the Investigator, currently is at imminent risk of suicide or harming others. 7. Suffers from a significant Substance Dependence disorder based on DSM-IV criteria within the 3 months prior to Screening, or is deemed by the Investigator to have a high risk of substance use during the study. Patients with a history of recreational use of cannabinoids or alcohol, and/or patients who smoke cigarettes can be included. 8. Concurrent delirium, mental retardation, drug-induced psychosis, or history of brain trauma.

Locations and Contacts

Beer-Yaakov Mental Health Center, Beer-Yaakov 70350, Israel

Sheba Medical Center, Ramat-Gan 52621, Israel

Lev Hasharon Mental Health Center, Zur-Moshe, Israel

Spitalul Clinic de Psihiatrie, sectia 14, Berceni st., 10-12, Bucharest 041902, Romania

Spitalul Clinic de Psihiatrie, sectia 10, Berceni st., 10-12, sector 4, Bucharest 041902, Romania

Spitalul Clinic, sectia 8, Berceni st., sector 4 Bucharest 041902, Romania

Spitalul de Psihiatrie, Titan, Bld Nicolae Grigorescu, no. 41, Sector 3,, Romania

Spitalul de Psihiatrie, si Neurologie, Brasov, Brasov 500123, Romania

Spitalul Clinic de Psihiatrie "Prof.Al. Obregia" Sectia 1, Bucharest 041902, Romania

Spitalul Clinic de Psihiatrie "Prof.Al. Obregia" Sectia 11, Bucharest 041902, Romania

Spitalul Clinic de Psihiatrie "Prof.Al. Obregia" Sectia 12, Bucharest 041902, Romania

Spitalul Clinic de Psihiatrie "Prof.Al. Obregia" Sectia 3, Bucharest, Romania

Sp. Judetean, Focsani, Romania

Sp de Psihiatrie Galati, Galati, Romania

Spitalul Clinic de Psihiatrie, "Socola",, Iasi 700282, Romania

Spitalul Clinic de Psihiatrie, Socola, Iasi 700282, Romania

Spitalul Clinic Judetean De Urgenta, Clinica Psihiatrie, Octavian Goga st, 17, Arad 310022, Romania

Spitalul Clinic de Psihiatrie, "Ghe. Preda" Sibiu, Sibiu 550245, Romania

Spitalul de Psihiatrie Botosani, Str. I.C.Bratianu Nr. 116, Botosani, Romania

Spitalul Clinic Judetean, Sectia Clinica Psihiatrie, Str. Victor Babes, nr. 43, Cluj Napoca 400012, Romania

Spitalul de Psihiatrie si Neurologie, Str.Mihai Eminescu, Nr.18, Brasov 500079, Romania

Spitalul Clinic de Urgenta Clinica "E. Pamfil", Timisoara 300182, Romania

Spitalul Clinic Judetean, de Urgenta,, Cluj-Napoca,, Cluj-Napoca 400012, Romania

Jebel, Timis, Jebel Timis, Romania

Additional Information

Starting date: May 2010
Last updated: May 6, 2012

Page last updated: August 23, 2015

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