Journal Article
Pragmatic Clinical Trial
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Early Improvement Predicts Treatment Outcomes for Patients With Acute Mania: A Naturalistic Study in Taiwan.

BACKGROUND: Bipolar disorder is a serious mental disorder. This study investigated whether early improvement at week 1 or 2 could predict treatment outcomes at week 4 in clinical populations with acute mania.

METHODS: We conducted a naturalistic study, recruiting inpatients with bipolar mania for acute treatment. Symptom severity was assessed using the Young Mania Rating Scale (YMRS) at weeks 0, 1, 2, 3, and 4. Early improvement was defined as a reduction in the YMRS score of at least 20% or 25%, assessed at weeks 1 and 2. Response was defined as a reduction of 50% or more in the YMRS score, and remission was defined as an end-point YMRS score of 12 or less. Receiver operating characteristic curves were used to determine whether week 1 or week 2 had better discriminative capacity. Sensitivity, specificity, and predictive values were calculated for the different definitions of early improvement.

RESULTS: Of the 350 patients, 32.9% (n = 115) and 16.6% (n = 58) of the subjects were classified as responders and remitters at week 4, respectively. Early improvement at week 2 showed better discriminative capacity, with areas under the receiver operating characteristic curve greater than 0.8. It had high sensitivity and high negative predictive value for 2 cutoffs in predicting response and remission.

CONCLUSIONS: Relatively lower response and remission rates were observed. Response and remission could be predicted by early improvement at week 2, whereas patients without early improvement were unlikely to reach response and remission at week 4.

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