CompletedNCT00602355Updated Sep 21, 2016Results posted

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

A Phase 2 interventional study of Sertraline and Placebo in Depression, Postpartum, sponsored by Women and Infants Hospital of Rhode Island. Completed at 2 sites in United States. Open to female participants aged 18 Years to 50 Years. Per ClinicalTrials.gov, last updated 2016-09-21.

Sponsored by Women and Infants Hospital of Rhode Island · Phase 2, Interventional, and Treatment

Phase: Phase 2
Study type: Interventional
Enrollment: 162
Allocation: Randomized
Ages: 18 Years to 50 Years
Sex: Female

Study summary

This study will evaluate the effectiveness of antidepressant medication alone and interpersonal psychotherapy alone in treating women with postpartum depression.

Read the detailed description

Postpartum depression (PPD) occurs in approximately 13% of postpartum women. The impact of PPD is significant, including emotional distress for the woman as well as disturbances in infant development. Common signs of depression after childbirth may include anxiety, irritability, low energy, and lack of concern for self or infant. If left untreated, PPD may last for more than 1 year, causing strain on family life and the mother's relationship with her infant. Infants of depressed mothers are also at a higher risk for developmental delays, behavioral problems, and difficulty eating and sleeping. Despite the public health significance of PPD, relatively little research has been done to determine the most effective treatments. Specifically, there is a lack of research concerning the use of antidepressant medication for treating PPD. Interpersonal psychotherapy (IPT), which focuses on interpersonal issues related to depression, has been more thoroughly studied for the treatment for PPD, but it has not been compared to the other treatment. This study will evaluate the effectiveness of antidepressant medication alone and IPT alone in treating women with PPD.

Participation in this double-blind study will last 9 months. Participants will first undergo initial assessments, which include interviews about depressive symptoms, self-report forms about medical history, blood tests, and a pregnancy test. Participants will then be randomly assigned to one of three treatments: sertraline, placebo, or IPT. All three treatments will be administered over 13 weeks. Participants assigned to take sertraline or placebo will attend nine 30-minute sessions over the 13-week treatment period. During these sessions, participants will be administered the study medication and will be assisted with parenting issues and skills by a psychiatrist. Participants receiving IPT will attend weekly 50-minute sessions over the 13-week treatment period. These sessions will focus on improving relationships with others, setting goals, and increasing coping skills. All participants will also complete interviews and questionnaires about their depression once a month. Following the 13 weeks of treatment, participants will undergo follow-up assessments at Months 3 and 6 post-treatment. Follow-up assessments will repeat initial interviews and questionnaires and will include a form about the infant's nature.

Conditions studied

Depression, Postpartum

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Keywords

Postpartum
Depression
Medication Therapy
Zoloft
Sertraline
Interpersonal Psychotherapy

In context

Depression, Postpartum

528 studies on the registry are indexed under Depression, Postpartum; 124 are open to participants now.

This study's enrollment of 162 is above the median of 105 across 425 interventional studies indexed under Depression, Postpartum.

Browse Depression, Postpartum studies →

Lead sponsor

Women and Infants Hospital of Rhode Island is the lead sponsor of 92 studies on the registry; 24 are open to participants now.

Counted across the registry records on this site, refreshed daily.

Who can participate

Ages eligible: 18 Years to 50 Years
Sexes eligible: Female
Accepts healthy volunteers: No

Inclusion criteria

Primary DSM-IV diagnosis of major depressive disorder by clinical interview
Score of greater than 12 on HAM-D
Delivery of an infant within the 12 months prior to study entry
Able to speak and read English sufficiently to complete the study procedures
Willing to use effective birth control methods throughout the study

Exclusion criteria

Exclusion Criteria:

Woman whose infant has died prior to study entry
Current or past diagnosis of bipolar disorder, schizophrenia or other psychotic disorder;
Diagnosis of alcohol or drug abuse or dependence (except nicotine) or anorexia in the past year;
Psychotic symptoms;
Acute suicidal or homicidal risks;
Women who have been on an antidepressant for more than 14 days prior to consent, (if less than 14 days and willing to taper off, will be eligible to continue once tapered off);
Women on daily anxiolytic medication (i.e. benzodiazepine, buspirone) or daily psychoactive herbal preparation (St. John's Wort or Fish Oil) (if willing to discontinue these substances may be eligible once they have been tapered off);
Medications taken PRN over the listed dose and frequency (women will still be eligible if they take: Lunesta/Eszopiclone 3 mg or less, up to 3 nights a week, Ambien/Zolpidem 5mg or less, Ambien CR 6.25 mg or less, up to 3 nights a week, Lorazepam or equivalent benzodiazepine dose: 0.5 mg up to 3 nights a week, Sonata/Zaleplon: 5 mg or less, up to 3 nights a week, Rozerem/Ramelteon: 8 mg or less, up to 3 nights a week);
If they take antidepressants PRN for insomnia (eg: Desyrel/Trazodone, Elavil/Amitriptyline, Remeron/Mirtazapine;
Ongoing concurrent psychotherapeutic treatment or psychotherapeutic treatment within the last month;
Psychiatric symptoms requiring specialized psychiatric treatment;
Significant medical disorder that would make sertraline treatment contra-indicated,
Previous trial of IPT therapy with a certified IPT therapist or an adequate trial of sertraline (i.e. at least 8 weeks of at least 100 mg daily of sertraline).

Study design

Phase: Phase 2
Primary purpose: Treatment
Allocation: Randomized
Intervention model: Parallel assignment
Masking: Quadruple (Participant, Care provider, Investigator, Outcomes assessor)
Enrollment: 162 participants (actual)

Study arms

Placebo comparator
1 (Placebo)
Participants receiving placebo pill with clinical management plus mothercrafting
Drug: Placebo · Behavioral: Clinical management · Behavioral: Mothercrafting
Active comparator
2 (Sertraline)
Participants receiving active medication sertraline with clinical management plus mothercrafting
Drug: Sertraline · Behavioral: Clinical management · Behavioral: Mothercrafting
Active comparator
3 (IPT)
Participants receiving interpersonal psychotherapy (IPT) alone
Behavioral: Interpersonal psychotherapy (IPT)

Interventions

DrugSertraline
Participants assigned to sertraline treatment will take 25 to 50 mg daily for Weeks 1 through 3, and dosage will be increased to 100 to 150 mg daily in Weeks 4 through 10. Participants will be titrated up to 200 mg daily at Week 11 for the final 2 weeks of treatment. In addition, at each week participants will receive specific "mother-crafting" techniques keyed to the baby's age and development. The mother-crafting component is aimed at providing relevant information to the mother about infant care.
Also known as: Zoloft
DrugPlacebo
Participants taking the placebo will follow the same titration schedule as those taking sertraline. In addition, the participates will receive the same specific "mother-crafting" techniques as those taking sertraline.
BehavioralInterpersonal psychotherapy (IPT)
IPT will be administered in 13 individual 50-minute sessions over 13 weeks. These sessions will focus on improving relationships with others, setting goals, and increasing coping skills.
BehavioralClinical management
Clinical management includes treatment as usual for those receiving medication for depression.
BehavioralMothercrafting
Mother-crafting techniques are keyed to the baby's age and development. The mother-crafting component is aimed at providing relevant information about infant care

What researchers measure

Primary outcomes

Hamilton Depression Rating Scale (HAM-D)
Measure total ranges from 0 to 50, with lower scores indicating better outcomes.
Time frame: Measured at baseline; post-treatment; and Months 3 and 6 of follow-up

Secondary outcomes

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

Results

Posted Sep 21, 2016

Participant flow

Participant flow — Overall Study
Milestone	1 (Placebo)	2 (Sertraline)	3 (IPT)
Started	53	56	53
Completed	44	38	43
Not completed	9	18	10

Outcome measures

PrimaryHamilton Depression Rating Scale (HAM-D)

Measure total ranges from 0 to 50, with lower scores indicating better outcomes.

Time frame:: Measured at baseline; post-treatment; and Months 3 and 6 of follow-up
Reported as:: Mean · units on a scale

Hamilton Depression Rating Scale (HAM-D)
units on a scale	1 (Placebo)	2 (Sertraline)	3 (IPT)
Baseline	22.0 ± 4.7	21.8 ± 4.7	22.0 ± 4.5
Post-Treatment	8.8 ± 6.0	8.1 ± 7.1	8.2 ± 6.8
3-Month Follow-up	6.7 ± 6.7	5.8 ± 6.5	7.3 ± 7.4
6-Month Follow-up	6.5 ± 6.8	4.9 ± 5.7	6.1 ± 6.5

SecondaryDepression Illness Severity Based on Beck Depression Inventory (BDI)

Measure total ranges from 0 to 56, with lower scores indicating better outcomes.

Time frame:: Measured at baseline; post-treatment; and Months 3 and 6 of follow-up
Reported as:: Mean · units on a scale

Depression Illness Severity Based on Beck Depression Inventory (BDI)
units on a scale	1 (Placebo)	2 (Sertraline)	3 (IPT)
Baseline	26.2 ± 7.7	27.0 ± 8.0	25.9 ± 8.3
Post-Treatment	10.8 ± 11.5	10.0 ± 10.2	10.5 ± 10.2
3-Month Follow-up	8.5 ± 8.7	7.3 ± 9.1	10.7 ± 11.0
6-Month Follow-up	9.2 ± 10.0	5.1 ± 7.0	7.8 ± 8.8

SecondaryGlobal Illness Severity Based on Clinical Global Impression (CGI) Scale

Measure total ranges from 1 to 7, with lower scores indicating better outcomes.

Time frame:: Measured at baseline; post-treatment; and Months 3 and 6 of follow-up
Reported as:: Mean · units on a scale

Global Illness Severity Based on Clinical Global Impression (CGI) Scale
units on a scale	1 (Placebo)	2 (Sertraline)	3 (IPT)
Baseline	4.1 ± 0.7	4.0 ± 0.6	3.9 ± 0.8
Post-treatment	2.1 ± 1.1	2.0 ± 1.2	2.0 ± 1.3
3-Month Follow-up	1.9 ± 1.0	1.8 ± 1.2	2.0 ± 1.3
6-Month Follow-up	1.7 ± 1.0	1.7 ± 1.1	1.8 ± 1.2

SecondarySocial Functioning Based on Postpartum Adjustment Questionnaire (PPAQ)

Measure total ranges from 1 to 5, with lower scores indicating better outcomes.

Time frame:: Measured at baseline; post-treatment; and Months 3 and 6 of follow-up
Reported as:: Mean · units on a scale

Social Functioning Based on Postpartum Adjustment Questionnaire (PPAQ)
units on a scale	1 (Placebo)	2 (Sertraline)	3 (IPT)
Baseline	2.7 ± 0.4	2.7 ± 0.4	2.6 ± 0.4
Post-Treatment	2.4 ± 0.5	2.2 ± 0.4	2.3 ± 0.4
3-Month Follow-up	2.3 ± 0.4	2.1 ± 0.4	2.3 ± 0.4
6-Month Follow-up	2.3 ± 0.4	2.1 ± 0.4	2.2 ± 0.4

SecondaryHamilton Anxiety Rating Scale (HARS)

Measure total ranges from 0 to 56, with lower scores indicating better outcomes.

Time frame:: Measured at baseline; post-treatment; and Months 3 and 6 of follow-up
Reported as:: Mean · units on a scale

Hamilton Anxiety Rating Scale (HARS)
units on a scale	1 (Placebo)	2 (Sertraline)	3 (IPT)
Baseline	20.9 ± 6.6	20.3 ± 6.1	19.4 ± 6.2
Post-Treatment	9.9 ± 8.0	9.4 ± 7.9	8.3 ± 9.0
3-Month Follow-up	7.4 ± 7.8	6.6 ± 7.1	7.0 ± 7.5
6-Month Follow-up	7.5 ± 8.4	6.2 ± 6.4	7.3 ± 8.3

Adverse events

Non-serious events are listed at a 0% frequency threshold.

Adverse event summary by group
Group	Deaths	Serious	Other
1 (Placebo)	—	7/53 (13.2%)	20/53 (37.7%)
2 (Sertraline)	—	8/56 (14.3%)	19/56 (33.9%)
3 (IPT)	—	8/53 (15.1%)	16/53 (30.2%)

Most frequent serious events

Showing 10 of 20

Most frequent serious events
Event	1 (Placebo)	2 (Sertraline)	3 (IPT)
Infant hospitalized - bronchiolitisRespiratory, thoracic and mediastinal disorders	0/53	0/56	2/53
Suicidal ideations or thoughts of self-harmPsychiatric disorders	1/53	2/56	0/53
Participant hospitalized - gall bladder removalSurgical and medical procedures	0/53	2/56	0/53
Infant hospitalized - bronchitisRespiratory, thoracic and mediastinal disorders	1/53	1/56	0/53
Participant hospitalized - kidney infectionInfections and infestations	0/53	0/56	1/53
Participant hospitalized - bronchitisRespiratory, thoracic and mediastinal disorders	0/53	0/56	1/53
Worsening of neurovegetative symptomsPsychiatric disorders	1/53	0/56	0/53
Participant hospitalized - hernia surgerySurgical and medical procedures	0/53	0/56	1/53
Participant hospitalized - chest painGeneral disorders	1/53	0/56	0/53
Infant hospitalized - croup coughRespiratory, thoracic and mediastinal disorders	1/53	0/56	0/53

Most frequent other events

Showing 10 of 37

Most frequent other events
Event	1 (Placebo)	2 (Sertraline)	3 (IPT)
Participant reported experiencing headachesGeneral disorders	7/53	4/56	3/53
Participant reported experiencing decreased libidoGeneral disorders	7/53	2/56	0/53
Worsening of symptomsPsychiatric disorders	5/53	3/56	4/53
Participant reported experiencing insomniaGeneral disorders	2/53	5/56	3/53
Patient reported experiencing severe fatigue/sleepinessGeneral disorders	3/53	3/56	2/53
Participant reported experiencing severe agitationGeneral disorders	2/53	1/56	3/53
Participant experienced rashSkin and subcutaneous tissue disorders	2/53	0/56	0/53
Participant reported experiencing dizziness/vertigoGeneral disorders	0/53	2/56	0/53
Participant reported increased conflict with spouse or partnerSocial circumstances	1/53	0/56	1/53
Patient reported experiencing delayed orgasmReproductive system and breast disorders	1/53	1/56	0/53

Baseline characteristics

Age, Categorical
Age, Categorical(Participants)	1 (Placebo)	2 (Sertraline)	3 (IPT)	Total
<=18 years	0	0	0	0
Between 18 and 65 years	53	56	53	162
>=65 years	0	0	0	0

Age, Continuous
Age, Continuous(years)	1 (Placebo)	2 (Sertraline)	3 (IPT)	Total
Mean	27.28 ± 5.11	28.16 ± 5.63	26.26 ± 6.15	27.25 ± 5.67

Sex: Female, Male
Sex: Female, Male(Participants)	1 (Placebo)	2 (Sertraline)	3 (IPT)	Total
Female	53	56	53	162
Male	0	0	0	0

Ethnicity (NIH/OMB)
Ethnicity (NIH/OMB)(Participants)	1 (Placebo)	2 (Sertraline)	3 (IPT)	Total
Hispanic or Latino	17	14	13	44
Not Hispanic or Latino	36	41	40	117
Unknown or Not Reported	0	1	0	1

Race (NIH/OMB)
Race (NIH/OMB)(Participants)	1 (Placebo)	2 (Sertraline)	3 (IPT)	Total
American Indian or Alaska Native	0	0	0	0
Asian	1	0	1	2
Native Hawaiian or Other Pacific Islander	0	0	0	0
Black or African American	7	7	10	24
White	31	36	32	99
More than one race	0	0	0	0
Unknown or Not Reported	14	13	10	37

Region of Enrollment
Region of Enrollment(participants)	1 (Placebo)	2 (Sertraline)	3 (IPT)	Total
United States	53	56	53	162

Study locations

2 sites

University of Iowa
Iowa City, Iowa 52242, United States
Women and Infants Hospital
Providence, Rhode Island 02905, United States

References and documents

Publications

O'Hara MW, Pearlstein T, Stuart S, Long JD, Mills JA, Zlotnick C. A placebo controlled treatment trial of sertraline and interpersonal psychotherapy for postpartum depression. J Affect Disord. 2019 Feb 15;245:524-532. doi: 10.1016/j.jad.2018.10.361. Epub 2018 Oct 31. PubMed 30447565 ↗

Updates

Tracking since Sep 25, 2026

No changes since tracking began. The registry record was last updated on Sep 21, 2016, before this site started recording changes on Sep 25, 2026. Its history is on ClinicalTrials.gov ↗

Registry details

Key details

Study ID: NCT00602355
Lead sponsor: Women and Infants Hospital of Rhode Island
Collaborators: National Institute of Mental Health (NIMH)
Responsible party: Caron Zlotnick (Director of Behavioral Medicine Research, Women and Infants Hospital of Rhode Island) — Principal investigator
First posted: Jan 28, 2008
Start date: Feb 2008
Primary completion: Jul 2014
Completion: Jul 2014
Results posted: Sep 21, 2016
Last update: Sep 21, 2016

Study contacts

Caron Zlotnick

principal investigator · Women and Infants Hospital

Scott Stuart, MD

principal investigator · University of Iowa

Oversight

Data monitoring committee: Yes

View the source record on ClinicalTrials.gov ↗

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