Bipolar I Disorder

Maintenance treatment of bipolar disorder as an adjunct to lithium or valproate 1
6-month, double-blind, placebo-controlled study
  • The time to intervention for a mood episode was significantly longer for GEODON plus lithium or valproate than with lithium or valproate alone (P=.01)
STUDY DESCRIPTION: GEODON plus lithium or valproate vs lithium or valproate alone (6-month bipolar maintenance study) 1
Results from a 6-month, placebo-controlled, double-blind, randomized trial in patients diagnosed with bipolar I disorder whose current or most recent episode was manic or mixed. This study had 2 phases: an open-label stabilization phase of up to 16 weeks and a double-blind maintenance phase of up to 6 months. In the open-label phase, patients were required to be stabilized on GEODON plus lithium or valproate for at least 8 weeks in order to be randomized. In the double-blind phase, stabilized patients were randomized and treated with GEODON combined with lithium or valproate (n=127) or placebo combined with lithium or valproate (n=112). One patient in the placebo arm did not have at least one post-randomization observation and was therefore excluded from the ITT analyses. Generally, in the maintenance phase, patients continued on the same dose on which they were initially stabilized, within the range of 80 mg/day to 160 mg/day. The primary end point was the time to recurrence of a mood episode requiring intervention during the double-blind phase. Mood episodes were classified as manic, mixed, or depressive. Recurrence of a mood episode requiring intervention (relapse) was defined as one or more of the following: investigator decided discontinuation was in the best interest of the patient; a loss of effect and/or requirement for an alteration to the treatment regimen (investigator judgment); patient was hospitalized for disease under study; MRS rating was ≥18 for 2 consecutive visits scheduled no more than 10 days apart; MADRS rating was ≥18 for 2 consecutive visits scheduled no more than 10 days apart. The key secondary end point was the time to discontinuation for any reason during the double-blind phase.