Lithium Treatment Moderate-Dose Use Study (LiTMUS) for Bipolar Disorder: A Randomized Comparative Effectiveness Trial of Optimized Personalized Treatment With and Without Lithium
Abstract
Objective
Method
Results
Conclusions
Method
Study Design
Study Participants
Lithium Plus OPT (N=141) | OPT Alone (N=142) | All Randomized Participants (N=283) | ||||
---|---|---|---|---|---|---|
Characteristic | N | % | N | % | N | % |
Female | 77 | 54.6 | 83 | 58.5 | 160 | 56.5 |
Race | ||||||
White | 107 | 75.9 | 106 | 74.6 | 213 | 75.3 |
African American | 25 | 17.7 | 23 | 16.2 | 48 | 17.0 |
Asian | 5 | 3.5 | 7 | 4.9 | 12 | 4.2 |
Other | 4 | 2.8 | 6 | 4.2 | 3 | 1.1 |
Ethnicity | ||||||
Hispanic or Latino | 16 | 11.3 | 23 | 16.3 | 39 | 13.8 |
Not Hispanic or Latino | 125 | 88.7 | 118 | 83.7 | 243 | 86.2 |
Education | ||||||
< High school | 5 | 3.5 | 14 | 9.9 | 19 | 6.7 |
High school diploma/GED | 34 | 24.1 | 24 | 16.9 | 58 | 20.5 |
Some college | 41 | 29.1 | 37 | 26.1 | 78 | 27.6 |
Technical or associates degree | 13 | 9.2 | 14 | 9.9 | 27 | 9.5 |
College diploma (Bachelors Degree) | 37 | 26.2 | 28 | 19.7 | 65 | 23.0 |
Graduate or professional degree | 11 | 7.8 | 25 | 17.6 | 36 | 12.7 |
Employment Status | ||||||
Employed | 52 | 36.9 | 63 | 44.4 | 115 | 40.6 |
Unemployed | 49 | 34.8 | 44 | 31.0 | 93 | 32.9 |
Disability recipient | 22 | 15.6 | 25 | 17.6 | 47 | 16.6 |
Other | 18 | 12.7 | 10 | 7.0 | 20 | 9.9 |
Bipolar I disorder | 108 | 76.6 | 108 | 76.1 | 216 | 76.3 |
History of psychiatric hospitalizations | 59 | 43.7 | 60 | 42.9 | 119 | 43.3 |
History of suicide attempts | 57 | 40.7 | 58 | 41.4 | 115 | 41.1 |
Mean | SD | Mean | SD | Mean | SD | |
Age (years) | 38.7 | 11.7 | 39.4 | 13.0 | 39.1 | 12.3 |
MADRS score | 22.4 | 9.62 | 22.5 | 10.60 | 22.46 | 10.11 |
CGI severity score | 4.3 | 0.90 | 4.3 | 0.88 | 4.27 | 0.89 |
YMRS score | 13.0 | 8.49 | 12.0 | 7.96 | 12.49 | 8.23 |
Estimated depressive episodes in the previous yearb | 3.5 | 4.1 | 3.3 | 3.1 | 3.4 | 3.6 |
Estimated manic or hypomanic episodes in the previous yearc | 5.2 | 9.1 | 3.2 | 3.4 | 4.2 | 6.9 |
Randomization and Treatment
Outcomes
Statistical Analysis
Sample size determination.
Attrition.
Results
Discussion
Footnotes
References
Information & Authors
Information
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History
Authors
Funding Information
Metrics & Citations
Metrics
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