Table 2.
Duration and number of relapse events by treatment group
| A. Relapse duration (wks) | Mean (SD) duration (wks) | |||
|---|---|---|---|---|
| RLAI + TAU | TAU | Difference | p-value | |
| Any cause* | 20.0 (14.0) | 28.22 (2.69) | −8.22 | 0.052 |
| Acute manic episode | 1.81 (3.22) | 2.98 (4.58) | −1.17 | 0.34 |
| Acute depressive episode | 8.26 (8.94) | 13.28 (13.09) | −5.02 | 0.15 |
| Psychiatric hospitalization | 0 | 0.21 (0.85) | −0.21 | 0.28 |
| B. Number of events (no./yr. of follow up) | Mean (SD) no. events/yr. | |||
|---|---|---|---|---|
| RLAI + TAU | TAU | Difference | p-value | |
| Any cause* | 5.34 (2.35) | 6.26 (3.24) | −0.92 | 0.29 |
| Acute manic episode | 0.74 (1.03) | 1.64 (0.70) | −0.90 | 0.23 |
| Acute depressive episode | 2.71 (2.79) | 3.95 (3.19) | −1.25 | 0.018 |
| Psychiatric hospitalization | 0 | 0.21 (0.85) | −0.21 | 0.28 |
| Urgent care† | 0.05 (0.22) | 0.74 (1.57) | −0.69 | 0.038 |
| Necessary clinical adjustment (NCA)‡ | 1.64 (1.74) | 3.46 (2.57) | −1.82 | 0.01 |
Any-cause relapse was defined as one or more of the following at any study visit: (1) YMRS score > 14 or MADRS score > 15; (2) ≥ 20% increase in YMRS or MADRS scores from the previous study visit for patients with current MADRS ≥ 10 or YMRS ≥ 8; (3) urgent care visit/referral (psychiatric hospitalization, emergency room visit, or referral for respite care or intensive outpatient treatment) due to worsening mood symptoms; (4) CGI-S score ≥ 4; (5) syndromal relapse (DSM-IV-TR criteria for manic, hypomanic, major depressive or mixed episode met); (6) withdrawal from the study due to inefficacy; and/or (7) necessary clinical medication adjustments (NCAs).
Defined as psychiatric hospitalization, emergency room visit, or referral for respite care or intensive outpatient treatment due to worsening mood symptoms.
Defined as change in medication treatment intended to prevent worsening of clinical symptoms (any of the following): (1) addition of a new mood stabilizer, antipsychotic or antidepressant; (2) substitution of an existing bipolar medication with a new drug; and/or (3) a ≥ 20% change in dose of any current medication.