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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

This study has been completed.
Sponsor:
ClinicalTrials.gov Identifier:
NCT01092221
First Posted: March 24, 2010
Last Update Posted: May 8, 2012
The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details.
Information provided by (Responsible Party):
Sheba Medical Center
March 17, 2010
March 24, 2010
May 8, 2012
May 2010
April 2011   (Final data collection date for primary outcome measure)
  • 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 ]
Same as current
Complete list of historical versions of study NCT01092221 on ClinicalTrials.gov Archive Site
  • 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) ]
Same as current
Not Provided
Not Provided
 
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
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.

Interventional
Phase 3
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Triple (Participant, Care Provider, Investigator)
Primary Purpose: Treatment
Mania
  • Drug: Allopurinol
    Allopurinol 1 capsule 300 mg, BID
    Other Name: Alloril, Zylol, Zyloric
  • Drug: Placebo
    Placebo 1 capsule, 300 mg, BID
  • Experimental: Allopurinol
    Intervention: Drug: Allopurinol
  • Placebo Comparator: Placebo
    Intervention: Drug: Placebo
Not Provided

*   Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline.
 
Completed
180
April 2011
April 2011   (Final data collection date for primary outcome measure)

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.
Sexes Eligible for Study: All
18 Years to 65 Years   (Adult)
No
Contact information is only displayed when the study is recruiting subjects
Israel,   Romania
 
 
NCT01092221
SHEBA-10-7724-MW-CTIL
No
Not Provided
Not Provided
Sheba Medical Center
Sheba Medical Center
Not Provided
Principal Investigator: Mark Weiser Sheba Medical Center
Sheba Medical Center
May 2012

ICMJE     Data element required by the International Committee of Medical Journal Editors and the World Health Organization ICTRP