Trial Outcomes & Findings for Genetic Predictors of Lithium Response in Bipolar Disorder (NCT NCT00252577)

Last Updated: 2020-01-29

Results Overview

The primary outcome measure was time to relapse in months following stabilization on lithium.

Recruitment status

COMPLETED

Target enrollment

130 participants

Primary outcome timeframe

every 2 months for 2 years

Results posted on

2020-01-29

Subjects with bipolar disorder were recruited through the San Diego VA Mood Clinic

Participant milestones
Measure	Bipolar Disorder Veterans with bipolar disorder Lithium treatment: Lithium is a standard treatment for bipolar disorder. Patients will be stabilized on lithium monotherapy over a 3 month period, observed for one month, and then followed every 2 months in maintenance phase for 2 years
Overall Study STARTED	130
Overall Study COMPLETED	110
Overall Study NOT COMPLETED	20

Reasons for withdrawal
Measure	Bipolar Disorder Veterans with bipolar disorder Lithium treatment: Lithium is a standard treatment for bipolar disorder. Patients will be stabilized on lithium monotherapy over a 3 month period, observed for one month, and then followed every 2 months in maintenance phase for 2 years
Overall Study Lost to Follow-up	20

Genetic Predictors of Lithium Response in Bipolar Disorder

Baseline characteristics by cohort
Measure	Bipolar Disorder n=130 Participants Veterans with bipolar disorder Lithium treatment: Lithium is a standard treatment for bipolar disorder. Patients will be stabilized on lithium monotherapy over a 3 month period, observed for one month, and then followed every 2 months in maintenance phase for 2 years
Age, Categorical <=18 years	0 Participants n=5 Participants
Age, Categorical Between 18 and 65 years	101 Participants n=5 Participants
Age, Categorical >=65 years	29 Participants n=5 Participants
Age, Continuous	45.9 years STANDARD_DEVIATION 11.38 • n=5 Participants
Sex: Female, Male Female	14 Participants n=5 Participants
Sex: Female, Male Male	116 Participants n=5 Participants
Race (NIH/OMB) American Indian or Alaska Native	0 Participants n=5 Participants
Race (NIH/OMB) Asian	8 Participants n=5 Participants
Race (NIH/OMB) Native Hawaiian or Other Pacific Islander	0 Participants n=5 Participants
Race (NIH/OMB) Black or African American	12 Participants n=5 Participants
Race (NIH/OMB) White	108 Participants n=5 Participants
Race (NIH/OMB) More than one race	2 Participants n=5 Participants
Race (NIH/OMB) Unknown or Not Reported	0 Participants n=5 Participants
Region of Enrollment United States	130 Participants n=5 Participants

Timeframe: every 2 months for 2 years

Population: outpatients at VA San Diego Healthcare System

The primary outcome measure was time to relapse in months following stabilization on lithium.

Outcome measures
Measure	Bipolar Disorder n=130 Participants Veterans with bipolar disorder Lithium treatment: Lithium is a standard treatment for bipolar disorder. Patients will be stabilized on lithium monotherapy over a 3 month period, observed for one month, and then followed every 2 months in maintenance phase for 2 years
Time to Relapse	24.6 months Interval 19.5 to 29.7

Serious events: 0 serious events

Other events: 16 other events

Deaths: 0 deaths

Adverse event data not reported

Other adverse events
Measure	Bipolar Disorder n=130 participants at risk Subjects with Bipolar Disorder who are treated with lithium
Metabolism and nutrition disorders weight gain	12.3% 16/130 • Number of events 16 • 10 years The study is ended.

VA San Diego Healthcare System

Phone: 858-552-8585