Efficacy of Allopurinol and Dypiridamole in Acute Mania

This study has been completed.
Sponsor:
Collaborator:
Stanley Medical Research Institute
Information provided by:
Hospital Espirita de Porto Alegre
ClinicalTrials.gov Identifier:
NCT00560079
First received: November 15, 2007
Last updated: September 19, 2008
Last verified: November 2007
  Purpose

This study aims to evaluate the potential antimanic efficacy, safety and tolorability of the purinergic agents allopurinol and dipyridamole as an add-on treatment to lithium in a sample of 180 drug-free manic patients enrolled in a double-blind, placebo-controlled design.


Condition Intervention Phase
Mania
Drug: Allopurinol
Drug: Dipyridamole
Drug: Placebo
Phase 4

Study Type: Interventional
Study Design: Allocation: Randomized
Endpoint Classification: Safety/Efficacy Study
Intervention Model: Parallel Assignment
Masking: Double Blind (Subject, Caregiver, Investigator, Outcomes Assessor)
Primary Purpose: Treatment
Official Title: A Double-Blind, Randomized, Placebo-Controlled 4-Week Study on the Efficacy and Safety of the Purinergic Agents Allopurinol and Dipyridamole in Acute Bipolar Mania.

Resource links provided by NLM:


Further study details as provided by Hospital Espirita de Porto Alegre:

Primary Outcome Measures:
  • This study aimed to evaluate the potential antimanic efficacy, safety and tolerability [ Time Frame: 28 days ]

Secondary Outcome Measures:
  • Plasma uric acid levels [ Time Frame: 28 days ]

Enrollment: 180
Study Start Date: November 2003
Study Completion Date: April 2006
Arms Assigned Interventions
Experimental: 1
Lithium 900mg/day plus allopurinol 600mg/day
Drug: Allopurinol
Allopurinol 600mg/day bid for 28 days
Active Comparator: 2 Drug: Dipyridamole
Dipyridamole 200mg/day bid for 28 days
Placebo Comparator: 3 Drug: Placebo
Placebo

Detailed Description:

Men and women ages 18 to 65 years, who were inpatients with a diagnosis of manic episode were recruited at the emergency room of Espirita Hospital of Porto Alegre (HEPA), Brazil (n=180) between September 2004 and 2006. The presence of manic episode was confirmed using SCID-I and the severity of episode was evaluated using the Young Mania Rating Scale (YMRS) and the Clinical Global Impression scale (CGI). Patients were required to present a score>22 on the YMRS at screening to be included. Subjects presenting rapid cycling, mixed episodes and comorbidities with axis I psychiatric disorders were not considered for inclusion. All subjects presented good physical health determined by physical exam, medical history, blood screening and electrocardiogram. Patients were randomly assigned to allopurinol 600 mg/day, dipyridamole 200mg or placebo as add-on medication lithium treatment for a 4-week, double-blind trial. The use of adjunctive antipsychotic agents (typical or second-generation drugs) was not allowed during the double-blind period. Adjunctive diazepam was used when necessary (maximum dose=20mg/day). Raters (psychiatrists) were trained together to establish reliability (YMRS =0.90). This study was approved by the Espirita Hospital Ethics Committee-IRB. Written informed consent was obtained from all patients and/or family member. Possible adverse events were monitored weekly during the follow-up period. Regarding primary outcome measures, we compared the percentage of responders according YMRS score decrease of at least 50% among allopurinol, dipyridamole and placebo groups, using fisher exact test. Also, the percentage of improvement from baseline to endpoint was obtained and compared among groups using analysis of variances (one-way ANOVA) with Duncan post-hoc test. Remission rates (YMRS scores < 12) were also analyzed. P values < 0.05 were considered statistically significant. Besides completers analysis, intention to treat and LOCF were employed to include data from drop-out patients who were evaluated at visit 3. Possible correlations were measured using Pearson test. Fischer exact test and X2 evaluated response and remission rates. Data are presented as mean ± standard deviation.

  Eligibility

Ages Eligible for Study:   18 Years to 65 Years
Genders Eligible for Study:   Both
Accepts Healthy Volunteers:   No
Criteria

Inclusion Criteria:

  • The presence of manic episode was confirmed using SCID-I and the severity of episode was evaluated using the Young Mania Rating Scale (YMRS) and the Clinical Global Impression scale (CGI). Patients were required to present a score>22 on the YMRS at screening to be included.All subjects presented good physical health determined by physical exam, medical history, blood screening and electrocardiogram

Exclusion Criteria:

  • Subjects presenting rapid cycling, mixed episodes and comorbidities with axis I psychiatric disorders were not considered for inclusion. .
  Contacts and Locations
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Please refer to this study by its ClinicalTrials.gov identifier: NCT00560079

Locations
Brazil
Hospital Espirita de Porto Alegre
Porto Alegre, RS, Brazil, 91720-440
Sponsors and Collaborators
Hospital Espirita de Porto Alegre
Stanley Medical Research Institute
Investigators
Principal Investigator: Rodrigo Machado-Vieira, MD, MSc, PhD Staff Member
  More Information

No publications provided by Hospital Espirita de Porto Alegre

Additional publications automatically indexed to this study by ClinicalTrials.gov Identifier (NCT Number):
ClinicalTrials.gov Identifier: NCT00560079     History of Changes
Other Study ID Numbers: 03T-356
Study First Received: November 15, 2007
Last Updated: September 19, 2008
Health Authority: Brazil: Ministry of Health

Additional relevant MeSH terms:
Bipolar Disorder
Affective Disorders, Psychotic
Mood Disorders
Mental Disorders
Allopurinol
Dipyridamole
Purinergic Agents
Enzyme Inhibitors
Molecular Mechanisms of Pharmacological Action
Pharmacologic Actions
Gout Suppressants
Antirheumatic Agents
Therapeutic Uses
Free Radical Scavengers
Antioxidants
Antimetabolites
Protective Agents
Physiological Effects of Drugs
Phosphodiesterase Inhibitors
Platelet Aggregation Inhibitors
Hematologic Agents
Vasodilator Agents
Cardiovascular Agents
Neurotransmitter Agents

ClinicalTrials.gov processed this record on July 28, 2014