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Allopurinol Add-on Treatment for Refractory Mania

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details.
 
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)
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%)    
Hide Serious Adverse Events
Placebo Allopurinol
Affected / at Risk (%) # Events Affected / at Risk (%) # Events
Total   0/12 (0.00%)      0/15 (0.00%)    
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
[Not Specified]
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
Publications automatically indexed to this study by ClinicalTrials.gov Identifier (NCT Number):
Layout table for additonal information
Responsible Party: Itai Danovitch, Cedars-Sinai Medical Center
ClinicalTrials.gov Identifier: NCT00643123    
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