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

NCT01092221 | Completed Phase 3

• 1 other identifier: SHEBA-10-7724-MW-CTIL
• Study Type: interventional
• Target: 180
• Locations: 2 countries
• Sites: 24

Brief 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.

Conditions

Mania

Keywords

mania, allopurinol, add-on treatment

Outcome Measures

Primary Outcomes (2)

• 1) Change from baseline to day 42 in the YMRS

  from baseline to day 42

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

  from baseline to day 42

Secondary Outcomes (4)

• 1) Change from baseline to day 14 in the YMRS

  from baseline to day 14

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

  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).

  from baseline to day 42

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

  during the study period (42 days)

Study Arms (2)

Allopurinol

EXPERIMENTAL

Drug: Allopurinol

Placebo

PLACEBO COMPARATOR

Drug: Placebo

Interventions

Allopurinol DRUG

Allopurinol 1 capsule 300 mg, BID

Also known as: Alloril, Zylol, Zyloric

Allopurinol

Placebo DRUG

Placebo 1 capsule, 300 mg, BID

Placebo

Eligibility Criteria

• Age: 18 Years - 65 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• Male or female, 18-65 years of age, inclusive
• 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.
• Willing and able to provide informed consent, after the nature of the study has been fully explained
• 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.
• YMRS\> 17
• Patients receiving one or multiple mood stabilizers, and/or one or more anti-psychotics.
• Inpatients or outpatients.

You may not qualify if:

• Unwilling or unable, in the opinion of the Investigator, to comply with study instructions
• Pregnant or breast-feeding
• Unstable medical disease (malignancy, poorly controlled diabetes, active ischemic cardiac disease, or cardiomyopathy, serious pulmonary disease, kidney disease, impaired liver functioning).
• Currently taking any of the following medications: warfarin, amoxicilline, ampicilline, theophylline, or mycophenolate mofetil.
• Likely allergy or sensitivity to Allopurinol
• At significant risk of committing suicide, or in the opinion of the Investigator, currently is at imminent risk of suicide or harming others.
• 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.
• Concurrent delirium, mental retardation, drug-induced psychosis, or history of brain trauma.

Sponsors & Collaborators

• Sheba Medical Center: lead

Study Sites (24)

Beer-Yaakov Mental Health Center

Beer-Yaakov, 70350, Israel

Location

Sheba Medical Center

Ramat Gan, 52621, Israel

Location

Lev Hasharon Mental Health Center

Tsur Moshe, Israel

Location

Spitalul de Psihiatrie, si Neurologie, Brasov

Brasov, Brașov County, 500123, Romania

Location

Spitalul Clinic de Psihiatrie "Prof.Al. Obregia" Sectia 12

Bucharest, Bucharest, 041902, Romania

Location

Spitalul Clinic de Psihiatrie "Prof.Al. Obregia" Sectia 1

Bucharest, Bucharest, 041902, Romania

Location

Spitalul Clinic de Psihiatrie "Prof.Al. Obregia" Sectia 3

Bucharest, Bucharest, Romania

Location

Spitalul Clinic Judetean, de Urgenta,

Cluj-Napoca, Cluj-Napoca, 400012, Romania

Location

Sp. Judetean

Focşani, Focsani, Romania

Location

Sp de Psihiatrie Galati

Galati, Galați County, Romania

Location

Spitalul Clinic de Psihiatrie, "Socola",

Iași, Iaşi, 700282, Romania

Location

Spitalul Clinic de Psihiatrie, Socola

Iași, Iaşi, 700282, Romania

Location

Jebel

Timuș, Jebel Timis, Romania

Location

Spitalul Clinic de Psihiatrie, "Ghe. Preda" Sibiu

Sibiu, Sibiu County, 550245, Romania

Location

Spitalul Clinic de Urgenta Clinica "E. Pamfil"

Timișoara, Timisoara, 300182, Romania

Location

Spitalul Clinic de Psihiatrie, sectia 14

Berceni St., 10-12, Bucharest, 041902, Romania

Location

Spitalul Clinic de Psihiatrie, sectia 10

Berceni St., 10-12, Sector 4, Bucharest, 041902, Romania

Location

Spitalul Clinic, sectia 8

Berceni St., Sector 4 Bucharest, 041902, Romania

Location

Spitalul de Psihiatrie, Titan

Bld Nicolae Grigorescu, No. 41, Sector 3,, Romania

Location

Spitalul Clinic de Psihiatrie "Prof.Al. Obregia" Sectia 11

Bucharest, 041902, Romania

Location

Spitalul Clinic Judetean De Urgenta, Clinica Psihiatrie

Octavian Goga St, 17, Arad, 310022, Romania

Location

Spitalul de Psihiatrie Botosani

Str. I.C.Bratianu Nr. 116, Botosani, Romania

Location

Spitalul Clinic Judetean, Sectia Clinica Psihiatrie

Str. Victor Babes, Nr. 43, Cluj Napoca, 400012, Romania

Location

Spitalul de Psihiatrie si Neurologie

Str.Mihai Eminescu, Nr.18, Brasov, 500079, Romania

Location

MeSH Terms

Conditions

Mania

Interventions

Allopurinol

Condition Hierarchy (Ancestors)

Neurobehavioral Manifestations; Neurologic Manifestations; Nervous System Diseases; Signs and Symptoms; Pathological Conditions, Signs and Symptoms

Intervention Hierarchy (Ancestors)

Purines; Heterocyclic Compounds, 2-Ring; Heterocyclic Compounds, Fused-Ring; Heterocyclic Compounds

Study Officials

• Mark Weiser

  Sheba Medical Center

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: interventional
• Phase: phase 3
• Allocation: RANDOMIZED
• Masking: TRIPLE
• Who Masked: PARTICIPANT, CARE PROVIDER, INVESTIGATOR
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: OTHER GOV
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: March 17, 2010
• First Posted: March 24, 2010
• Study Start: May 1, 2010
• Primary Completion: April 1, 2011
• Study Completion: April 1, 2011
• Last Updated: May 8, 2012

Record last verified: 2012-05

Locations

RO (21); IL (3)