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Randomised controlled trial.
Follow up period:
79 centres in 15 countries; 1997 to 2001.
463 adults with bipolar I disorder (mean age range 42 to 44 years), who were stabilised with lamotrigine during an 8–16 week open label phase (n = 966). Main inclusion criteria: current or recent (past 60 days) DSM-IV major depressive episode; ⩾1 manic or hypomanic episodes, and ⩾1 depressive episodes within 3 years of enrolment. Exclusions: >6 DSM-IV mood episodes in the past year; significant psychiatric or medical comorbidity; …
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