Clinical Study

The Bipolar Depression Electrical Treatment Trial (BETTER): Design, Rationale, and Objectives of a Randomized, Sham-Controlled Trial and Data from the Pilot Study Phase

Table 2

Changes in depressive symptoms throughout the study (pilot phase).

BaselineWeek 2Week 4Week 6
Mean (SD)Mean (SD)% (SD)Mean (SD)% (SD)Mean (SD)% (SD)

MADRS 32.8 (2.68) 26.8 (6.37)17.68 (21.16) 21.4 (10.35)33.67 (32.99) 22 (12.40)34.11 (35.97)
HDRS 23.2 (2.86) 19.8 (7.42)14.10 (32.42) 15.8 (4.43)30.99 (21.82) 16.8 (6.72)26.17 (30.10)
HAMA 32 (6) 24.6 (5.54)21.51 (20.14) 20.4 (9.01)37.59 (19.00) 22.8 (12.27)29.56 (30.03)
Response (%)02 (40)2 (40)
Remission (%)00 (0)1 (20)

MADRS: Montgomery-Asberg Depression Rating Scale; HDRS: Hamilton Depression Rating Scale; HAMA: Hamilton Anxiety Rating Scale; YMRS: Young Mania Rating Scale; percentage represents percentage of change, calculated as ((score at time point − score at baseline)/score at baseline) 100. Clinical response was defined as >50% HDRS-17 score improvements from the baseline and the remission was defined as HDRS-17 score <8.