Background: Women who have suffered one episode of postpartum-onset major d
epression (PPMD) comprise a high-risk group for subsequent episodes. We con
ducted a double-blind, randomized clinical trial to test the efficacy of no
rtriptyline in the prevention of recurrent PPMD.
Method: Nondepressed women who had at least one past episode of PPMD (Resea
rch Diagnostic Criteria) were recruited during pregnancy. Subjects were ran
domly assigned to nortriptyline or placebo. Treatment began immediately pos
tpartum. Each subject was assessed for 20 sequential weeks with the Hamilto
n Rating Scale for Depression and Research Diagnostic Criteria for recurren
ce of major depression.
Results: No difference was found in the rate of recurrence in women treated
with nortriptyline compared with those treated with placebo. Of 26 subject
s who took nortriptyline preventively, 6 (0.23, 95% exact confidence interv
al [CI] = 0.09 to 0.44) suffered recurrences. Of 25 subjects who took place
bo, 6 (0.24, 95% exact CI = 0.09 to 0.45) suffered recurrence (Fisher exact
p = 1.00).
Conclusion: Nortriptyline did not confer additional preventive efficacy bey
ond that of placebo. The rate of recurrence of PPMD (one fourth of women) w
as unacceptably high.