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Effectiveness of adding allopurinol to the treatment of manic patients

Effectiveness of adding Allopurinol to Sodium valproate in bipolar manic patients: A double-blind, randomized, placebo-controlled trial

Status
Active, not recruiting
Phases
Phase 3
Study type
Interventional
Source
IRCT
Registry ID
IRCT201202229111N1
Enrollment
70
Registered
2012-05-23
Start date
2012-05-21
Completion date
Unknown
Last updated
2018-02-22

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

Mania. Manic episode

Interventions

Intervention 1: Both groups of patients will receive similar sodium valproate. placebo with similar appearance, dosage, and from same pharmaceutical company in control group. Intervention 2: Both grou
Placebo
Treatment - Drugs
Both groups of patients will receive similar sodium valproate. placebo with similar appearance, dosage, and from same pharmaceutical company in control group.
Both groups of patients will receive similar sodium valproate. Allopurinol 600 mg daily (300 mg twice daily) in intervention group.

Sponsors

Research Center for Behavioral Disorders And Substance Abuse
Lead Sponsor

Eligibility

Sex/Gender
All

Inclusion criteria

Inclusion criteria: Inclusion criteria: All patients who are admitted to psychiatric wards of Farshchian Psychiatry Hospital, Hamedan, Iran, for acute phase of mania according to DSM IV-TR. Exclusion criteria: 1) General health priority; 2) Having other psychiatric diagnostics such as schizophrenia, anxiety disorders and etc; 3) Consumption of substance or dependence on alcohol during the past month; 4) Existence of prominent problem in their laboratory tests; 5) History of serious cardiac, respiratory, nervous, endocrine, kidney disease, and uncontrolled diabetes; 6) Pregnancy and breastfeeding; 7) Consumption of drugs such as Azathioprine, Mercaptopurine, Apalcillin, Amoxicillin, Ampicillin, Warfarin and Theophylline; 8) Sensitivity to Allopurinol; 9) The need for ECT during the treatment; 10) Having YMRS < 17.

Exclusion criteria

Exclusion criteria:

Design outcomes

Primary

MeasureTime frame
Mania. Timepoint: 1, 7, 14, 21, 28 days or at the end of treatment. Method of measurement: YMRS and CGI.

Secondary

MeasureTime frame
Uric acid. Timepoint: 1, 28 days or at the end of treatment. Method of measurement: Serum level.

Countries

Iran (Islamic Republic of)

Contacts

Public ContactDr.Mohamad Haghighi

Hamadan University of Medical Sciences

Haghighi@umsha.ac.ir+98 81 1827 4185

Outcome results

None listed

Source: IRCT (via WHO ICTRP) · Data processed: Feb 4, 2026