NCT00560079

Brief Summary

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.

Trial Health

87
On Track

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
180

participants targeted

Target at P50-P75 for phase_4

Timeline
Completed

Started Nov 2003

Typical duration for phase_4

Geographic Reach
1 country

1 active site

Status
completed

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

Study Start

First participant enrolled

November 1, 2003

Completed
1.4 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

April 1, 2005

Completed
1 year until next milestone

Study Completion

Last participant's last visit for all outcomes

April 1, 2006

Completed
1.6 years until next milestone

First Submitted

Initial submission to the registry

November 15, 2007

Completed
4 days until next milestone

First Posted

Study publicly available on registry

November 19, 2007

Completed
Last Updated

August 16, 2016

Status Verified

August 1, 2016

Enrollment Period

1.4 years

First QC Date

November 15, 2007

Last Update Submit

August 15, 2016

Conditions

Mania

Outcome Measures

Primary Outcomes (1)

  • This study aimed to evaluate the potential antimanic efficacy, safety and tolerability

    28 days

Secondary Outcomes (1)

  • Plasma uric acid levels

    28 days

Study Arms (3)

1

EXPERIMENTAL

Lithium 900mg/day plus allopurinol 600mg/day

Drug: Allopurinol

2

ACTIVE COMPARATOR
Drug: Dipyridamole

3

PLACEBO COMPARATOR
Drug: Placebo

Interventions

AllopurinolDRUG

Allopurinol 600mg/day bid for 28 days

1
DipyridamoleDRUG

Dipyridamole 200mg/day bid for 28 days

2
PlaceboDRUG

Placebo

3

Eligibility Criteria

Age18 Years - 65 Years
Sexall
Healthy VolunteersNo
Age GroupsAdult (18-64), Older Adult (65+)

You may qualify if:

  • 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

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

Hospital Espirita de Porto Alegre

Porto Alegre, Rio Grande do Sul, 91720-440, Brazil

Location

Related Publications (1)

  • Machado-Vieira R, Soares JC, Lara DR, Luckenbaugh DA, Busnello JV, Marca G, Cunha A, Souza DO, Zarate CA Jr, Kapczinski F. A double-blind, randomized, placebo-controlled 4-week study on the efficacy and safety of the purinergic agents allopurinol and dipyridamole adjunctive to lithium in acute bipolar mania. J Clin Psychiatry. 2008 Aug;69(8):1237-45. doi: 10.4088/jcp.v69n0806.

    PMID: 18681754DERIVED

MeSH Terms

Conditions

Mania

Interventions

AllopurinolDipyridamole

Condition Hierarchy (Ancestors)

Neurobehavioral ManifestationsNeurologic ManifestationsNervous System DiseasesSigns and SymptomsPathological Conditions, Signs and Symptoms

Intervention Hierarchy (Ancestors)

PurinesHeterocyclic Compounds, 2-RingHeterocyclic Compounds, Fused-RingHeterocyclic CompoundsPyrimidinesHeterocyclic Compounds, 1-Ring

Study Officials

  • Rodrigo Machado-Vieira, MD, MSc, PhD

    Staff Member

    PRINCIPAL INVESTIGATOR

Study Design

Study Type
interventional
Phase
phase 4
Allocation
RANDOMIZED
Masking
QUADRUPLE
Who Masked
PARTICIPANT, CARE PROVIDER, INVESTIGATOR, OUTCOMES ASSESSOR
Purpose
TREATMENT
Intervention Model
PARALLEL
Sponsor Type
OTHER
Responsible Party
SPONSOR

Study Record Dates

First Submitted

November 15, 2007

First Posted

November 19, 2007

Study Start

November 1, 2003

Primary Completion

April 1, 2005

Study Completion

April 1, 2006

Last Updated

August 16, 2016

Record last verified: 2016-08

Locations

BR(1)