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Allopurinol Add-on Treatment for Refractory Mania

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ClinicalTrials.gov Identifier: NCT00643123
Recruitment Status : Completed
First Posted : March 26, 2008
Results First Posted : April 13, 2018
Last Update Posted : May 8, 2019
Sponsor:
Collaborator:
National Alliance for Research on Schizophrenia and Depression
Information provided by (Responsible Party):
Itai Danovitch, Cedars-Sinai Medical Center

Study Type Interventional
Study Design Allocation: Randomized;   Intervention Model: Parallel Assignment;   Masking: Double (Participant, Investigator);   Primary Purpose: Treatment
Conditions Bipolar Disorder
Mixed Mania
Treatment-Resistant Mania
Interventions Drug: Allopurinol
Other: Placebo
Enrollment 40
Recruitment Details  
Pre-assignment Details 8 subjects screen failed; 5 subjects did not qualify at Baseline. 13 total subjects were not randomized
Arm/Group Title Allopurinol Placebo
Hide Arm/Group Description Allopurinol: 300-600 mg/day over a 6 week period Placebo: Inactive substance
Period Title: Overall Study
Started 15 12
Completed 10 11
Not Completed 5 1
Reason Not Completed
Lost to Follow-up             4             0
Withdrawal by Subject             1             1
Arm/Group Title Allopurinol Placebo Total
Hide Arm/Group Description Allopurinol: 300-600 mg/day over a 6 week period Placebo: Inactive substance Total of all reporting groups
Overall Number of Baseline Participants 15 12 27
Hide Baseline Analysis Population Description
[Not Specified]
Age, Categorical  
Measure Type: Count of Participants
Unit of measure:  Participants
Number Analyzed 15 participants 12 participants 27 participants
<=18 years
0
   0.0%
0
   0.0%
0
   0.0%
Between 18 and 65 years
15
 100.0%
12
 100.0%
27
 100.0%
>=65 years
0
   0.0%
0
   0.0%
0
   0.0%
Sex: Female, Male  
Measure Type: Count of Participants
Unit of measure:  Participants
Number Analyzed 15 participants 12 participants 27 participants
Female
8
  53.3%
5
  41.7%
13
  48.1%
Male
7
  46.7%
7
  58.3%
14
  51.9%
Race/Ethnicity, Customized  
Measure Type: Count of Participants
Unit of measure:  Participants
Race or Ethnicity Number Analyzed 15 participants 12 participants 27 participants
Caucasian
9
  60.0%
8
  66.7%
17
  63.0%
African-American
3
  20.0%
4
  33.3%
7
  25.9%
Hispanic
3
  20.0%
0
   0.0%
3
  11.1%
Region of Enrollment  
Measure Type: Number
Unit of measure:  Participants
United States Number Analyzed 15 participants 12 participants 27 participants
15 12 27
Marital Status  
Measure Type: Count of Participants
Unit of measure:  Participants
Number Analyzed 15 participants 12 participants 27 participants
Never Married
8
  53.3%
6
  50.0%
14
  51.9%
Married
1
   6.7%
3
  25.0%
4
  14.8%
Divorced
4
  26.7%
3
  25.0%
7
  25.9%
Not Reported
2
  13.3%
0
   0.0%
2
   7.4%
Employment Status  
Measure Type: Count of Participants
Unit of measure:  Participants
Number Analyzed 15 participants 12 participants 27 participants
Employed
4
  26.7%
4
  33.3%
8
  29.6%
Unemployed
9
  60.0%
6
  50.0%
15
  55.6%
Disabled
1
   6.7%
2
  16.7%
3
  11.1%
Student
1
   6.7%
0
   0.0%
1
   3.7%
1.Primary Outcome
Title Young Mania Rating Scale (YMRS)
Hide Description

The YMRS is an 11-item, clinician-administered rating scale to assess the severity of manic symptoms before, during and after treatment. There are four items that are graded on a 0 to 8 scale (irritability, speech, thought content, and disruptive/aggressive behavior), while the remaining seven items are graded on a 0 to 4 scale. A score of 0 indicates the behavior is absent, whereas a score of 4 or 8 indicates the behavior is present and severe.

The change in score between Baseline and the Completion Visit will be reported. Ideally, the two time points will be Baseline and 6 Weeks after Baseline, but, if a subject terminates early, his/her last YMRS score will be carried forward to the final visit.

The scores from each question are added together to form a total score ranging from 0 to 60, with higher scores indicating a greater severity of symptoms. A score of 0-12 indicates the absence of mania or a very mild manic state, a score of 13-20 or higher indicates a mild man

Time Frame 7 weeks (Baseline and 6 weeks (or last visit date) after baseline
Hide Outcome Measure Data
Hide Analysis Population Description
27 subjects were randomized but 4 (3 from the Treatment group and 1 from the Control group) withdrew from the study immediately following the baseline visit. Therefore, a second time point was unavailable for these subjects.
Arm/Group Title Allopurinol Placebo
Hide Arm/Group Description:
Allopurinol: 300-600 mg/day over a 6 week period
Placebo: Inactive substance
Overall Number of Participants Analyzed 12 11
Mean (Standard Error)
Unit of Measure: units on a scale
-12.3  (1.9) -9.6  (2.7)
Show Statistical Analysis 1 Hide Statistical Analysis 1
Statistical Analysis Overview Comparison Group Selection Allopurinol, Placebo
Comments [Not Specified]
Type of Statistical Test Other
Comments [Not Specified]
Statistical Test of Hypothesis P-Value .45
Comments [Not Specified]
Method t-test, 2 sided
Comments [Not Specified]
Method of Estimation Estimation Parameter Mean Difference (Final Values)
Estimated Value 2.9
Parameter Dispersion
Type: Standard Error of the Mean
Value: 2.3
Estimation Comments [Not Specified]
2.Secondary Outcome
Title Hamilton Depression Scale (HAM-D)
Hide Description

The Hamilton Depression Rating Scale (HAM-D) is a clinician-administered tool used to determine a patient’s level of depression before, during, and after treatment. A 28-item HAM-D form was used but only the first 17 questions are used in the assessment for depression. Of the first 17 questions, eight items are scored on a 5-point scale, ranging from 0 = not present to 4 = severe. Nine are scored from 0-2. The sum of the scores from the first 17 questions is: 0-7 = normal, 8-13 = mild depression, 14-18 = moderate depression, 19-22=severe depression and ≥ 23=very severe depression.

Questions 18-28 are scored similarly and assess sleep disorders, paranoid behavior, motor dysfunction, psychosis, and weight gain, etc.

Time Frame 7 weeks
Hide Outcome Measure Data
Hide Analysis Population Description
No data displayed because no data was collected prior to closing of the research unit.
Arm/Group Title Allopurinol Placebo
Hide Arm/Group Description:
Allopurinol: 300-600 mg/day over a 6 week period
Placebo: Inactive substance
Overall Number of Participants Analyzed 0 0
No data displayed because Outcome Measure has zero total analyzed.
Time Frame 5 months
Adverse Event Reporting Description [Not Specified]
 
Arm/Group Title Placebo Allopurinol
Hide Arm/Group Description Placebo: Inactive substance Allopurinol: 300-600 mg/day over a 6 week period
All-Cause Mortality
Placebo Allopurinol
Affected / at Risk (%) Affected / at Risk (%)
Total   0/12 (0.00%)      0/15 (0.00%)    
Show Serious Adverse Events Hide Serious Adverse Events
Placebo Allopurinol
Affected / at Risk (%) # Events Affected / at Risk (%) # Events
Total   0/12 (0.00%)      0/15 (0.00%)    
Show Other (Not Including Serious) Adverse Events Hide Other (Not Including Serious) Adverse Events
Frequency Threshold for Reporting Other Adverse Events 0%
Placebo Allopurinol
Affected / at Risk (%) # Events Affected / at Risk (%) # Events
Total   1/12 (8.33%)      2/15 (13.33%)    
Psychiatric disorders     
Suicidal thoughts and plan   0/12 (0.00%)  0 1/15 (6.67%)  1
Medication non-compliance   0/12 (0.00%)  0 1/15 (6.67%)  1
Reproductive system and breast disorders     
Inflamed prostate  [1]  1/12 (8.33%)  1 0/15 (0.00%)  0
Indicates events were collected by systematic assessment
[1]
Subject complained about enlarged prostate
Certain Agreements
All Principal Investigators ARE employed by the organization sponsoring the study.
Results Point of Contact
Layout table for Results Point of Contact information
Name/Title: Felicia Mayes
Organization: Cedars Sinai Medical Center
Phone: 310-423-0825
EMail: mayesf@cshs.org
Layout table for additonal information
Responsible Party: Itai Danovitch, Cedars-Sinai Medical Center
ClinicalTrials.gov Identifier: NCT00643123     History of Changes
Other Study ID Numbers: IRB8981
First Submitted: March 20, 2008
First Posted: March 26, 2008
Results First Submitted: January 24, 2018
Results First Posted: April 13, 2018
Last Update Posted: May 8, 2019