Skip to main content
. Author manuscript; available in PMC: 2010 Nov 1.
Published in final edited form as: Expert Opin Pharmacother. 2009 Nov;10(16):2593–2607. doi: 10.1517/14656560903277202

TABLE 4.

PPD TREATMENT - RANDOMIZED CLINICAL TRIALS

Article Sample Size Depression
Baseline		 Pharmacological
Intervention		 Duration
Treatment		 Measures Main Outcome/Results
Gregoire
et al.,1996(41)		 61 (34 in E2
group, 27 in the
placebo group).

Breastfeeding
women:
Excluded		 Mean (SD)
EPDS tot. score
in the E2 group
and the
placebo group
were 21.8 (3)
and 21.3 (2.9),
respectively		 Transdermal 17β-
estradiol: dose
begun at 200
microgram/day for 6
months. After 3
months
dydrogesterone was
added (10 mg/day
for 12 days monthly)		 6 months EPDS, SAD Both groups improved over time; however, the E2
treated group improved rapidly during the first
month. Remission rate by month 3 in E2 group and
placebo group were 80% and 31%, respectively
Remission criteria: EPSD <14
Appleby
et al.,1997 (38)		 87: FLUO + 1
session of
counseling (22),
FLUO + 6
sessions of
counseling (2),
placebo + 1
session (23),
placebo + 6
sessions (2)
Breastfeeding
women: Excluded		 Mean HAM-D
total score in
the FLUO
group = 13.3
(range 12.2–
14.5). Mean
HAM-D score in
the placebo
group=14
(range 12.5–
15.7)		 Combination of
FLUO or placebo
plus either 1 or 6
sessions of
counseling		 12 weeks EPDS, HAM-D,
Revised clinical
Interview
Schedule		 After 1 week of treatment improvement in the
FLUO group was > placebo group. Patients
receiving 6 sessions of counseling improved more
than patients receiving 1 session.
Misri et
al., 2004(39)		 35 (16 in the
PARO group, 19
in the
CBT+PARO
group)
Breastfeeding
:NS		 Mean (SD)
HAM-D in the
PARO group
and CBT+PARO
group were
22.06
(3.38)and
21.16 (2.03),
respectively.
Mean (SD)
HAM-A were
20.31
(6.58)and
21.32 (8.22),
respectively		 PARO: dose begun
at 10 mg/day,
tailored up to a
maximum of 50
mg/day.

CBT+PARO:
Paroxetine plus 12
sessions of CBT		 12 weeks HAM-D, HAM-A,
EPSD, CGI, YBOCS		 Response rates at final visit in the PARO group and
in the CBT+PARO group were 87.5% and 78.9
(p=0.50), respectively.
Anxiety response rates at final visit in the PARO
group and in the CBT+PARO group were 75% and
84.2 % (p= 0.50), respectively.

Response criteria: ≥50%baseline HAM scores
Wisner
et al.,2006(37)		 109 (55 in the
SER group, 54
in the NTP
group).

Breastfeeding:
Included		 Mean (SD)
HAM-D in the
NTP group and
in the SER
group were
24.7 (7.2) and
25.8 (SD 5.9),
respectively		 NTP: starting dose
10 mg/d up to
a maximum of 150
mg/day.
SER: starting dose
25 mg/d up to a
maximum of 200
mg/day.		 8 weeks HAM-D, CGI-I Response rates and median time to remit did not
differ between NTP and SER group at week 8 and
24 : 55% and 67% at week 8;
79% and 73% at week 24, respectively (p=1).
Remission criteria: HAM-D <7
Yonkers
et al.,2008(40)		 70 (35 in the
PARO group, 35
in the placebo
group).
Breastfeeding:
Included		 Mean (SD)
HAM-D score in
the PARO
group and
placebo group
were 23.6
(4.7) and 24(5),
respectively		 PARO: dose begun
at 10 mg/day for the
first 2 weeks,
increased to 20
mg/day for the third
and forth week and
further increased to
30 or 40 mg/day
depending on
clinical status.
Mean (SD) dose at
study end point =
21.1 (10.7) mg/day		 8 weeks HAM-D, CGI
Inventory of
Depressive
Symptomatology-
Self Report		 Paroxetine was associated with higher rates of
remission at week 8 compared to placebo (37% and
14%, respectively). OR (95% interval confidence)
=3.5 (1.1–11.5) (p=.04).
Remission criteria: HAM-D ≤8

Abbreviations: FLUO: fluoxetine;E2: estradiol treated group; PARO:paroxetine monotherapy; SER: sertraline; NTP: nortriptyline; NS:not specified in the published article; PDS : Edinburgh Postnatal Depression Scale; HAM-D:Hamilton Depression Scale ; CGI:Clinical Global Impression Scale; YBOCS: Yale-Brown Obsessive Compulsive Scale; MADRS:Montgomery-Åsberg Depression Rating Scale; SAD:Schedule for Affective Disorders and Schizophrenia; CBT: cognitive behavioural therapy