Trial · NCT00602355

Effectiveness of Sertraline Alone and Interpersonal Psychotherapy Alone in Treating Women With Postpartum Depression

NCT00602355, Phase 2, Completed, Women and Infants Hospital of Rhode Island; results first posted 2016-09-21

3 sourcestrials-2026-11-12-0.5.0

Cite this record

ConductScience Library. Effectiveness of Sertraline Alone and Interpersonal Psychotherapy Alone in Treating Women With Postpartum Depression. Trials, record NCT00602355. Release trials-2026-11-12-0.5.0, 12 Nov 2026. https://conductscience.org/library/trials/NCT00602355

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Trial

As registered on ClinicalTrials.gov, in the graph's capture of the registry.

Title: Effectiveness of Sertraline Alone and Interpersonal Psychotherapy Alone in Treating Women With Postpartum Depression
NCT number: NCT00602355
Status: Completed
Phases: Phase 2
Enrollment: 162 participants, actual
Lead sponsor: Women and Infants Hospital of Rhode Island
Conditions: Depression, Postpartum
Interventions: Sertraline, Placebo, Interpersonal psychotherapy (IPT), Clinical management, Mothercrafting
First posted: 2008-01-28
Last updated: 2016-09-21
Results first posted: 2016-09-21

Source ClinicalTrials.gov

Registered outcomes5

Each outcome the trial registered, primary first, in ClinicalTrials.gov's words.

List	Outcome	Time frame	Description
Primary	Hamilton Depression Rating Scale (HAM-D)	Measured at baseline; post-treatment; and Months 3 and 6 of follow-up	Measure total ranges from 0 to 50, with lower scores indicating better outcomes.
Secondary	Depression Illness Severity Based on Beck Depression Inventory (BDI)	Measured at baseline; post-treatment; and Months 3 and 6 of follow-up	Measure total ranges from 0 to 56, with lower scores indicating better outcomes.
Secondary	Global Illness Severity Based on Clinical Global Impression (CGI) Scale	Measured at baseline; post-treatment; and Months 3 and 6 of follow-up	Measure total ranges from 1 to 7, with lower scores indicating better outcomes.
Secondary	Social Functioning Based on Postpartum Adjustment Questionnaire (PPAQ)	Measured at baseline; post-treatment; and Months 3 and 6 of follow-up	Measure total ranges from 1 to 5, with lower scores indicating better outcomes.
Secondary	Hamilton Anxiety Rating Scale (HARS)	Measured at baseline; post-treatment; and Months 3 and 6 of follow-up	Measure total ranges from 0 to 56, with lower scores indicating better outcomes.

Source ClinicalTrials.gov

Outcomes5

Each outcome the trial posted results for, in ClinicalTrials.gov's words.

Type	Outcome	Time frame	Units	Measured as
PRIMARY	Hamilton Depression Rating Scale (HAM-D)	Measured at baseline; post-treatment; and Months 3 and 6 of follow-up	units on a scale	MEAN
SECONDARY	Depression Illness Severity Based on Beck Depression Inventory (BDI)	Measured at baseline; post-treatment; and Months 3 and 6 of follow-up	units on a scale	MEAN
SECONDARY	Global Illness Severity Based on Clinical Global Impression (CGI) Scale	Measured at baseline; post-treatment; and Months 3 and 6 of follow-up	units on a scale	MEAN
SECONDARY	Social Functioning Based on Postpartum Adjustment Questionnaire (PPAQ)	Measured at baseline; post-treatment; and Months 3 and 6 of follow-up	units on a scale	MEAN
SECONDARY	Hamilton Anxiety Rating Scale (HARS)	Measured at baseline; post-treatment; and Months 3 and 6 of follow-up	units on a scale	MEAN

Source ClinicalTrials.gov

Results by group60

Each measurement the trial posted, group by group, in the words and numbers it posted.

Outcome	Group	Category	Value	Spread	Units
Hamilton Depression Rating Scale (HAM-D)	1 (Placebo)	Baseline	22.0	Standard Deviation 4.7	units on a scale
Hamilton Depression Rating Scale (HAM-D)	2 (Sertraline)	Baseline	21.8	Standard Deviation 4.7	units on a scale
Hamilton Depression Rating Scale (HAM-D)	3 (IPT)	Baseline	22.0	Standard Deviation 4.5	units on a scale
Hamilton Depression Rating Scale (HAM-D)	1 (Placebo)	Post-Treatment	8.8	Standard Deviation 6.0	units on a scale
Hamilton Depression Rating Scale (HAM-D)	2 (Sertraline)	Post-Treatment	8.1	Standard Deviation 7.1	units on a scale
Hamilton Depression Rating Scale (HAM-D)	3 (IPT)	Post-Treatment	8.2	Standard Deviation 6.8	units on a scale
Hamilton Depression Rating Scale (HAM-D)	1 (Placebo)	3-Month Follow-up	6.7	Standard Deviation 6.7	units on a scale
Hamilton Depression Rating Scale (HAM-D)	2 (Sertraline)	3-Month Follow-up	5.8	Standard Deviation 6.5	units on a scale
Hamilton Depression Rating Scale (HAM-D)	3 (IPT)	3-Month Follow-up	7.3	Standard Deviation 7.4	units on a scale
Hamilton Depression Rating Scale (HAM-D)	1 (Placebo)	6-Month Follow-up	6.5	Standard Deviation 6.8	units on a scale

1 to 10 of 60Source ClinicalTrials.gov

See all 60 results by group

Participant flow9

How many started, completed or left each group, period by period.

Period	Milestone	Group	Participants
Overall Study	STARTED	1 (Placebo)	53
Overall Study	STARTED	2 (Sertraline)	56
Overall Study	STARTED	3 (IPT)	53
Overall Study	COMPLETED	1 (Placebo)	44
Overall Study	COMPLETED	2 (Sertraline)	38
Overall Study	COMPLETED	3 (IPT)	43
Overall Study	NOT COMPLETED	1 (Placebo)	9
Overall Study	NOT COMPLETED	2 (Sertraline)	18
Overall Study	NOT COMPLETED	3 (IPT)	10

Source ClinicalTrials.gov

Adverse events171

Each adverse event the trial posted, group by group: the participants affected out of those at risk.

Type	Event	Organ system	Group	Affected	At risk
other	Participant reported experiencing headaches	General disorders	1 (Placebo)	7	53
other	Participant reported experiencing headaches	General disorders	2 (Sertraline)	4	56
other	Participant reported experiencing headaches	General disorders	3 (IPT)	3	53
other	Participant reported experiencing insomnia	General disorders	1 (Placebo)	2	53
other	Participant reported experiencing insomnia	General disorders	2 (Sertraline)	5	56
other	Participant reported experiencing insomnia	General disorders	3 (IPT)	3	53
other	Participant reported experiencing decreased libido	General disorders	1 (Placebo)	7	53
other	Participant reported experiencing decreased libido	General disorders	2 (Sertraline)	2	56
other	Participant reported experiencing decreased libido	General disorders	3 (IPT)	0	53
other	Patient reported experiencing severe fatigue/sleepiness	General disorders	1 (Placebo)	3	53

1 to 10 of 171Source ClinicalTrials.gov

See all 171 adverse events

Adverse event totals9

The totals the trial posted for each group.

Total	Group	Affected	At risk
Total, all-cause mortality	1 (Placebo)
Total, all-cause mortality	2 (Sertraline)
Total, all-cause mortality	3 (IPT)
Total, other adverse events	1 (Placebo)	20	53
Total, other adverse events	2 (Sertraline)	19	56
Total, other adverse events	3 (IPT)	16	53
Total, serious adverse events	1 (Placebo)	7	53
Total, serious adverse events	2 (Sertraline)	8	56
Total, serious adverse events	3 (IPT)	8	53

Source ClinicalTrials.gov

Papers1

The papers the trial lists on ClinicalTrials.gov.

PMID	Listed as
30447565	DERIVED

Source PubMed

Grants2

The grants NIH RePORTER links to the trial, newest funded first: NIH's, and some of AHRQ's, CDC's, FDA's and VA's. Each shows its title, principal investigators, organization and funder in its newest year.

Project	Title	Principal investigators	Organization	Funder	Fiscal years	Source
R01MH074636	Placebo Controlled Trial of Sertraline and IPT for Postpartum Depression	STUART, SCOTT P	UNIVERSITY OF IOWA	NATIONAL INSTITUTE OF MENTAL HEALTH	2007 to 2012	NIH RePORTER
R01MH074919	Placebo Controlled Trial of Sertaline and IPT for Postpartum Depression	ZLOTNICK, CARON	WOMEN AND INFANTS HOSPITAL-RHODE ISLAND	NATIONAL INSTITUTE OF MENTAL HEALTH	2007 to 2012	NIH RePORTER

Trial comparisons0

Comparisons of the trial's two groups, calculated by ConductScience from the counts it posted.

None in this release.

Tests0

The ConductCognition tests this trial's registered outcomes name, as ScienceGraph matched them in trial-tests-2026-11-12-0.2.1.

None in this release.

Data dates

The day each source was copied for this release.

ClinicalTrials.gov: 2026-11-12; ClinicalTrials.gov
Results, from AACT: 2026-03-23; AACT
NIH grant links: 2026-11-13; NIH RePORTER

Sources 3

ClinicalTrials.gov's posted results, through CTTI's AACTFreely available. Acknowledgement requested
ClinicalTrials.govNo license stated
NIH RePORTER's clinical studies and project filesPublic domain

Each source's terms

ClinicalTrials.gov's posted results, through CTTI's AACTClinicalTrials.gov data via Aggregate Analysis of ClinicalTrials.gov (AACT), CTTI. CTTI makes its materials freely available and requests acknowledgement. https://aact.ctti-clinicaltrials.org/documentation/299
ClinicalTrials.govnone stated
NIH RePORTER's clinical studies and project filesPublic domain (NIH RePORTER)

ClinicalTrials.gov's data carry an international copyright outside the United States: https://clinicaltrials.gov/about-site/terms-conditions.

For software

Read this trial from software.

The record and each of its lists are JSON, twenty rows a page. No key.

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