This study is designed to assess the safety and impact of RG2417 on the symptoms of bipolar depression as measured by the Montgomery-Asberg Depression Rating Scale (MADRS) and the Clinical Global Impression of Change in Bipolar Depression Scale (CGI-BP-C).
Intention-to-treat (ITT) analyses were performed on the primary outcome measure, the Hamilton rating scale for anxiety, the secondary variables, the clinical global impression of change (CGI-C), the Erlangen anxiety tension and aggression scale (EAAS), the list of complaints, and the patient's global rating of change.
In addition, tacrine-treated patients exhibited improvement in the Clinical Global Impression of Change, a subjective scale completed by both doctors and family members.
Further, the secondary endpoints of sleep interference, Clinical Global Impression of Change (CGIC), a scale used by physicians for overall assessment of patient improvement, and Patient Global Impression of Change (PGIC), a scale used by patients to report their overall assessment of change, were all statistically significant for the once-daily treatment compared to placebo over the ten week study period.
Statistically significant reductions were seen in scores on the Positive and Negative Syndrome Scale-Excited Component (PANSS-EC) at 8 and 10 weeks in the group receiving 200 mg/day of quetiapine, compared with placebo, while scores on the Clinical Global Impression of Change (CGIC) were significantly better at weeks 2, 4, 8, and 10.
Several tools were used for measuring outcome, including the Clinical Global Impression of Change scale (CGIC), the Clinical Dementia Rating Scale (CDR), the Ham Depression Scale, and the Multiple Effect Adjective Checklist.
However, THA's performance faltered on the Clinical Global Impression of Change, a test commonly used to gauge the general state of psychiatric patients, including thinking skills.
