Trial Outcomes & Findings for Allopurinol Maintenance Study for Bipolar Disorder (NCT NCT00732251)

Last Updated: 2019-10-02

Results Overview

Young Mania Rating Scale is an 11-item, clinician-administered scale to assess severity of manic symptoms before, during and after treatment. Four items are graded on a min. 0 to max. 8 scale (irritability, speech, thought content and disruptive/aggressive behavior) while the remaining 7 items are graded on a min. 0 to max. 4 scale. A score of 0 indicates behavior is absent and 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, the last Young Mania Rating Scale score will be used. The scores from each question are added for a total score ranging from min. 0 to max 60; higher scores indicate 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 manic episode, and over 20 indicates a manic state.

Recruitment status

TERMINATED

Study phase

PHASE4

Target enrollment

15 participants

Primary outcome timeframe

2 Years

Results posted on

2019-10-02

Participant Flow

7 subjects screen failed.

Participant milestones

Participant milestones
Measure	Allopurinol Allopurinol: Allopurinol: 300-600 mg/day over a 24 month period
Overall Study STARTED	8
Overall Study COMPLETED	1
Overall Study NOT COMPLETED	7

Reasons for withdrawal

Reasons for withdrawal
Measure	Allopurinol Allopurinol: Allopurinol: 300-600 mg/day over a 24 month period
Overall Study Lost to Follow-up	3
Overall Study Withdrawal by Subject	3
Overall Study Early Term due to Site Closure	1

Baseline Characteristics

Allopurinol Maintenance Study for Bipolar Disorder

Baseline characteristics by cohort

Baseline characteristics by cohort
Measure	Allopurinol n=8 Participants Allopurinol: Allopurinol: 300-600 mg/day over a 24 month period
Age, Categorical <=18 years	0 Participants n=93 Participants
Age, Categorical Between 18 and 65 years	8 Participants n=93 Participants
Age, Categorical >=65 years	0 Participants n=93 Participants
Sex: Female, Male Female	3 Participants n=93 Participants
Sex: Female, Male Male	5 Participants n=93 Participants
Ethnicity (NIH/OMB) Hispanic or Latino	1 Participants n=93 Participants
Ethnicity (NIH/OMB) Not Hispanic or Latino	0 Participants n=93 Participants
Ethnicity (NIH/OMB) Unknown or Not Reported	7 Participants n=93 Participants
Race (NIH/OMB) American Indian or Alaska Native	0 Participants n=93 Participants
Race (NIH/OMB) Asian	1 Participants n=93 Participants
Race (NIH/OMB) Native Hawaiian or Other Pacific Islander	0 Participants n=93 Participants
Race (NIH/OMB) Black or African American	1 Participants n=93 Participants
Race (NIH/OMB) White	2 Participants n=93 Participants
Race (NIH/OMB) More than one race	0 Participants n=93 Participants
Race (NIH/OMB) Unknown or Not Reported	4 Participants n=93 Participants
Region of Enrollment United States	8 Participants n=93 Participants

PRIMARY outcome

Timeframe: 2 Years

Population: The outcome measure will be the total number of patient visits at which the Young Mania Rating Scale was administered per the number of patient visits at which a manic episode (according to the Young Mania Rating Scale) was recorded. The number of manic episodes prior to study start were not collected.

Outcome measures

Outcome measures
Measure	Allopurinol n=81 patient visits Allopurinol: Allopurinol: 300-600 mg/day over a 24 month period
Number of Manic Episodes According to the Young Mania Rating Scale	3 patient visits

SECONDARY outcome

Timeframe: 2 years

Population: Total number of patient visits at which the Hamilton Depression Scale was administered per the number of patient visits at which a depressive episode (according to the Hamilton Depression Scale) was recorded. The number of depressive episodes prior to the study were not collected.

The Hamilton Depression Rating Scale is a tool used to determine a patient's level of depression before, during, and after treatment. The Hamilton Depression Scale form lists 21 items, but the scoring is based on the first 17 questions. Eight items are scored on a 5-point scale, ranging from 0 (min) = not present to 4 (max) = severe. Nine are scored from 0 (min) to 2 (max). The sum of the scores from the first 17 questions is: 0 (min) to 7 (max) = normal, 8 (min) to 13 (max) = mild depression, 14 (min) to 18 (max) = moderate depression, 19 (min) to 22 (max) = severe depression and ≥ 23=very severe depression. A score of 11 or more indicates a depressive episode in terms of this outcome measure.

Outcome measures

Outcome measures
Measure	Allopurinol n=86 patient visits Allopurinol: Allopurinol: 300-600 mg/day over a 24 month period
Number of Depressive Episodes Per Patient Visit According to the Hamilton Depression Scale	7 patient visits

SECONDARY outcome

Timeframe: 2 years

Population: Data on the number of hospitalizations was not collected before or during the study

The number of psychiatric hospitalizations that occur during the study will be compared to the number of hospitalizations that occurred prior to the study.

Outcome measures

Outcome data not reported

Adverse Events

Allopurinol

Serious events: 0 serious events

Other events: 1 other events

Deaths: 0 deaths

Serious adverse events

Adverse event data not reported

Other adverse events

Other adverse events
Measure	Allopurinol n=8 participants at risk Allopurinol: Allopurinol: 300-600 mg/day over a 24 month period
Psychiatric disorders Hospitalization	12.5% 1/8 • Number of events 2 • 2 years

Additional Information

Felicia Mayes

Cedars Sinai Medical Center

Phone: 310-423-0825

Email: [email protected]

Results disclosure agreements

Principal investigator is a sponsor employee
Publication restrictions are in place