Allopurinol Add-on Treatment for Refractory Mania
Condition: Bipolar Disorder; Mixed Mania; Treatment-Resistant Mania
MeSH terms: Mania; Bipolar Disorder
Study type: Interventional
Phase: Phase 4

Summary: 
      The purpose of this study is to investigate the efficacy of allopurinol as an augmentation
      agent for treatment resistant mania and mixed mania.
    

Detailed description: 
      Bipolar disorder is a severe mental disorder with episodes of mania and depression. Current
      medications for mania can have significant side effects, high costs and the need for blood
      monitoring. The purpose of this research study is to study the effectiveness of allopurinol,
      in combination with lithium or valproic acid or carbamazepine, for treatment-resistant
      bipolar mania and mixed mania. This research study is designed to test the safety and/or
      effectiveness of allopurinol that has been approved by the U.S. Food and Drug Administration
      (FDA) for recurrent calcium renal calculus, gout, hyperuricemia (cancer and tumor lysis
      syndrome), but it is not approved for use in treatment-resistant bipolar mania or mixed
      mania.

      Participants in this double-blind study will be randomly assigned to one of two study groups.
      The first group will receive the study medication of allopurinol while the second group will
      receive a placebo. These will be taken in conjunction with current medications and doses. The
      study will last for 7 weeks (an initial screening, a baseline visit and 4 follow-up visits at
      weeks 1,2,4, and 6). The initial screening visit will be used to determine whether or not the
      subject is able to participate in the study. The following will be conducted during the
      screening visit: Review of medical and psychiatric history along with standard psychiatric
      assessment exams; Physical examination, including review of prior and current medications and
      adverse drug effects; An electrocardiogram (ECG) - a painless test which is done by attaching
      straps or pads to your limbs and chest and recording the electrical pattern of your heart,
      will be done to record your heart rhythm; About 5 tablespoons of blood will be drawn to
      assess basic laboratory values that show if you are healthy enough to participate in the
      study; Blood levels of lithium, valproic acid, and/or carbamazepine will be measured; A urine
      sample will be collected to test for the presence of illegal drugs and for pregnancy test (if
      you are a female of child-bearing potential); Collection of demographic data (e.g., age,
      gender, marital status, social and vocational status) and other information including health
      beliefs, and knowledge of illness. At the baseline visit the participant will be given
      questionnaires related to mood, quality of life, disability, medications, and side effects.
      The participant's vitals (temperature, weight, heart rate, and blood pressure) will be
      measured. The participant will be randomized to treatment (300 mg of allopurinol/day) or
      placebo. After week one at the Week 1 visit, those that have tolerated the dosage of
      allopurinol will get an increased dosage. The participant will also complete a set of
      questionnaires. Vitals will be taken. The remaining follow-up visits will be similar to visit
      one except that there will be no more increases in dosage; Week 2 will include a blood draw
      to measure levels of lithium, valproic acid, and/or carbamazepine in the participant's blood,
      and the final visit at Week 6 will in addition include a blood draw, and exit physical exam,
      and a urine sample will be collected.
    

Intervention name(s): Allopurinol; Placebo
Intervention type(s): Drug; Other
Intervention description(s): 300-600 mg/day over a 6 week period; Inactive substance
Other intervention name(s): Zyloprim
Intervention MeSH terms: Allopurinol
Allocation: Randomized
Intervention model: Parallel Assignment
Masking: Double (Participant, Investigator)
Primary purpose: Treatment
Keywords: Bipolar Disorder; Mania; Mixed mania; Allopurinol; Treatment-Resistant mania