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

• ClinicalTrials.gov Identifier: NCT00602355
• Recruitment Status: Completed
• First Posted: January 28, 2008
• Results First Posted: September 21, 2016
• Last Update Posted: September 21, 2016
• Sponsor: Women and Infants Hospital of Rhode Island
• Collaborator: National Institute of Mental Health (NIMH)
• Information provided by (Responsible Party): Caron Zlotnick, Women and Infants Hospital of Rhode Island

• Study Type: Interventional
• Study Design: Allocation: Randomized; Intervention Model: Parallel Assignment; Masking: Quadruple (Participant, Care Provider, Investigator, Outcomes Assessor); Primary Purpose: Treatment
• Condition: Depression, Postpartum
• Interventions: Drug: Sertraline; Drug: Placebo; Behavioral: Interpersonal psychotherapy (IPT); Behavioral: Clinical management; Behavioral: Mothercrafting
• Enrollment: 162

Participant Flow

Recruitment Details
Pre-assignment Details

Arm/Group Title	1 (Placebo)	2 (Sertraline)	3 (IPT)
Arm/Group Description	Participants receiving placebo pill with clinical management plus mothercrafting Placebo: 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. Clinical management: Clinical management includes treatment as usual for those receiving medication for depression. Mothercrafting: 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	Participants receiving active medication sertraline with clinical management plus mothercrafting Sertraline: 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. Clinical management: Clinical management includes treatment as usual for those receiving medication for depression. Mothercrafting: 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	Participants receiving interpersonal psychotherapy (IPT) alone Interpersonal 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.
Period Title: Overall Study
Started	53	56	53
Completed	44	38	43
Not Completed	9	18	10

Baseline Characteristics

Arm/Group Title		1 (Placebo)	2 (Sertraline)	3 (IPT)	Total
Arm/Group Description		Participants receiving placebo pill with clinical management plus mothercrafting Placebo: 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. Clinical management: Clinical management includes treatment as usual for those receiving medication for depression. Mothercrafting: 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	Participants receiving active medication sertraline with clinical management plus mothercrafting Sertraline: 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. Clinical management: Clinical management includes treatment as usual for those receiving medication for depression. Mothercrafting: 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	Participants receiving interpersonal psychotherapy (IPT) alone Interpersonal 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.	Total of all reporting groups
Overall Number of Baseline Participants		53	56	53	162
Baseline Analysis Population Description		[Not Specified]
Age, Categorical; Measure Type: Count of Participants; Unit of measure: Participants
	Number Analyzed	53 participants	56 participants	53 participants	162 participants
	<=18 years	0 0.0%	0 0.0%	0 0.0%	0 0.0%
	Between 18 and 65 years	53 100.0%	56 100.0%	53 100.0%	162 100.0%
	>=65 years	0 0.0%	0 0.0%	0 0.0%	0 0.0%
Age, Continuous; Mean (Standard Deviation); Unit of measure: Years
	Number Analyzed	53 participants	56 participants	53 participants	162 participants
		27.28 (5.11)	28.16 (5.63)	26.26 (6.15)	27.25 (5.67)
Sex: Female, Male; Measure Type: Count of Participants; Unit of measure: Participants
	Number Analyzed	53 participants	56 participants	53 participants	162 participants
	Female	53 100.0%	56 100.0%	53 100.0%	162 100.0%
	Male	0 0.0%	0 0.0%	0 0.0%	0 0.0%
Ethnicity (NIH/OMB); Measure Type: Count of Participants; Unit of measure: Participants
	Number Analyzed	53 participants	56 participants	53 participants	162 participants
	Hispanic or Latino	17 32.1%	14 25.0%	13 24.5%	44 27.2%
	Not Hispanic or Latino	36 67.9%	41 73.2%	40 75.5%	117 72.2%
	Unknown or Not Reported	0 0.0%	1 1.8%	0 0.0%	1 0.6%
Race (NIH/OMB); Measure Type: Count of Participants; Unit of measure: Participants
	Number Analyzed	53 participants	56 participants	53 participants	162 participants
	American Indian or Alaska Native	0 0.0%	0 0.0%	0 0.0%	0 0.0%
	Asian	1 1.9%	0 0.0%	1 1.9%	2 1.2%
	Native Hawaiian or Other Pacific Islander	0 0.0%	0 0.0%	0 0.0%	0 0.0%
	Black or African American	7 13.2%	7 12.5%	10 18.9%	24 14.8%
	White	31 58.5%	36 64.3%	32 60.4%	99 61.1%
	More than one race	0 0.0%	0 0.0%	0 0.0%	0 0.0%
	Unknown or Not Reported	14 26.4%	13 23.2%	10 18.9%	37 22.8%
Region of Enrollment; Measure Type: Number; Unit of measure: Participants
United States	Number Analyzed	53 participants	56 participants	53 participants	162 participants
		53	56	53	162

Outcome Measures

1. Primary Outcome

Title	Hamilton Depression Rating Scale (HAM-D)
Description	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

Outcome Measure Data

Analysis Population Description

[Not Specified]

Arm/Group Title	1 (Placebo)	2 (Sertraline)	3 (IPT)
Arm/Group Description:	Participants receiving placebo pill with clinical management plus mothercrafting Placebo: 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. Clinical management: Clinical management includes treatment as usual for those receiving medication for depression. Mothercrafting: 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	Participants receiving active medication sertraline with clinical management plus mothercrafting Sertraline: 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. Clinical management: Clinical management includes treatment as usual for those receiving medication for depression. Mothercrafting: 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	Participants receiving interpersonal psychotherapy (IPT) alone Interpersonal 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.
Overall Number of Participants Analyzed	44	38	43
Mean (Standard Deviation); Unit of Measure: units on a scale
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)

2. Secondary Outcome

Title	Depression Illness Severity Based on Beck Depression Inventory (BDI)
Description	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

Outcome Measure Data

Analysis Population Description

[Not Specified]

Arm/Group Title	1 (Placebo)	2 (Sertraline)	3 (IPT)
Arm/Group Description:	Participants receiving placebo pill with clinical management plus mothercrafting Placebo: 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. Clinical management: Clinical management includes treatment as usual for those receiving medication for depression. Mothercrafting: 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	Participants receiving active medication sertraline with clinical management plus mothercrafting Sertraline: 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. Clinical management: Clinical management includes treatment as usual for those receiving medication for depression. Mothercrafting: 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	Participants receiving interpersonal psychotherapy (IPT) alone Interpersonal 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.
Overall Number of Participants Analyzed	44	38	43
Mean (Standard Deviation); Unit of Measure: units on a scale
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)

3. Secondary Outcome

Title	Global Illness Severity Based on Clinical Global Impression (CGI) Scale
Description	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

Outcome Measure Data

Analysis Population Description

[Not Specified]

Arm/Group Title	1 (Placebo)	2 (Sertraline)	3 (IPT)
Arm/Group Description:	Participants receiving placebo pill with clinical management plus mothercrafting Placebo: 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. Clinical management: Clinical management includes treatment as usual for those receiving medication for depression. Mothercrafting: 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	Participants receiving active medication sertraline with clinical management plus mothercrafting Sertraline: 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. Clinical management: Clinical management includes treatment as usual for those receiving medication for depression. Mothercrafting: 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	Participants receiving interpersonal psychotherapy (IPT) alone Interpersonal 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.
Overall Number of Participants Analyzed	44	38	43
Mean (Standard Deviation); Unit of Measure: units on a scale
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)

4. Secondary Outcome

Title	Social Functioning Based on Postpartum Adjustment Questionnaire (PPAQ)
Description	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

Outcome Measure Data

Analysis Population Description

[Not Specified]

Arm/Group Title	1 (Placebo)	2 (Sertraline)	3 (IPT)
Arm/Group Description:	Participants receiving placebo pill with clinical management plus mothercrafting Placebo: 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. Clinical management: Clinical management includes treatment as usual for those receiving medication for depression. Mothercrafting: 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	Participants receiving active medication sertraline with clinical management plus mothercrafting Sertraline: 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. Clinical management: Clinical management includes treatment as usual for those receiving medication for depression. Mothercrafting: 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	Participants receiving interpersonal psychotherapy (IPT) alone Interpersonal 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.
Overall Number of Participants Analyzed	44	38	43
Mean (Standard Deviation); Unit of Measure: units on a scale
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)

5. Secondary Outcome

Title	Hamilton Anxiety Rating Scale (HARS)
Description	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

Outcome Measure Data

Analysis Population Description

[Not Specified]

Arm/Group Title	1 (Placebo)	2 (Sertraline)	3 (IPT)
Arm/Group Description:	Participants receiving placebo pill with clinical management plus mothercrafting Placebo: 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. Clinical management: Clinical management includes treatment as usual for those receiving medication for depression. Mothercrafting: 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	Participants receiving active medication sertraline with clinical management plus mothercrafting Sertraline: 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. Clinical management: Clinical management includes treatment as usual for those receiving medication for depression. Mothercrafting: 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	Participants receiving interpersonal psychotherapy (IPT) alone Interpersonal 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.
Overall Number of Participants Analyzed	44	38	43
Mean (Standard Deviation); Unit of Measure: units on a scale
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

Time Frame	[Not Specified]
Adverse Event Reporting Description	[Not Specified]
Arm/Group Title	1 (Placebo)	2 (Sertraline)	3 (IPT)
Arm/Group Description	Participants receiving placebo pill with clinical management plus mothercrafting Placebo: 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. Clinical management: Clinical management includes treatment as usual for those receiving medication for depression. Mothercrafting: 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	Participants receiving active medication sertraline with clinical management plus mothercrafting Sertraline: 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. Clinical management: Clinical management includes treatment as usual for those receiving medication for depression. Mothercrafting: 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	Participants receiving interpersonal psychotherapy (IPT) alone Interpersonal 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.
All-Cause Mortality
	1 (Placebo)	2 (Sertraline)	3 (IPT)
	Affected / at Risk (%)	Affected / at Risk (%)	Affected / at Risk (%)
Total	--/--	--/--	--/--
Serious Adverse Events
	1 (Placebo)	2 (Sertraline)	3 (IPT)
	Affected / at Risk (%)	Affected / at Risk (%)	Affected / at Risk (%)
Total	7/53 (13.21%)	8/56 (14.29%)	8/53 (15.09%)
General disorders
Participant hospitalized - chest pain †	1/53 (1.89%)	0/56 (0.00%)	0/53 (0.00%)
Infant hospitalized - high fever †	1/53 (1.89%)	0/56 (0.00%)	0/53 (0.00%)
Infant hospitalized - reaction to Enfamil †	0/53 (0.00%)	0/56 (0.00%)	1/53 (1.89%)
Infections and infestations
Participant hospitalized - kidney infection †	0/53 (0.00%)	0/56 (0.00%)	1/53 (1.89%)
Infant hospitalized - dehydration, fever, vomiting (viral infection) †	0/53 (0.00%)	1/56 (1.79%)	0/53 (0.00%)
Infant hospitalized - urinary infection and hand, foot, and mouth infection †	1/53 (1.89%)	0/56 (0.00%)	0/53 (0.00%)
Pregnancy, puerperium and perinatal conditions
Participant hospitalized - dehydration from excessive vomiting †	0/53 (0.00%)	0/56 (0.00%)	1/53 (1.89%)
Participant hospitalized - hyperemesis gravidarum †	0/53 (0.00%)	0/56 (0.00%)	1/53 (1.89%)
Psychiatric disorders
Suicidal ideations or thoughts of self-harm †	1/53 (1.89%)	2/56 (3.57%)	0/53 (0.00%)
Attempted suicide †	0/53 (0.00%)	1/56 (1.79%)	0/53 (0.00%)
Worsening of neurovegetative symptoms †	1/53 (1.89%)	0/56 (0.00%)	0/53 (0.00%)
Respiratory, thoracic and mediastinal disorders
Infant hospitalized - bronchitis †	1/53 (1.89%)	1/56 (1.79%)	0/53 (0.00%)
Infant hospitalized - bronchiolitis †	0/53 (0.00%)	0/56 (0.00%)	2/53 (3.77%)
Participant hospitalized - bronchitis †	0/53 (0.00%)	0/56 (0.00%)	1/53 (1.89%)
Infant hospitalized - RSV †	0/53 (0.00%)	1/56 (1.79%)	0/53 (0.00%)
Infant hospitalized - croup cough †	1/53 (1.89%)	0/56 (0.00%)	0/53 (0.00%)
Surgical and medical procedures
Participant hospitalized - gall bladder removal †	0/53 (0.00%)	2/56 (3.57%)	0/53 (0.00%)
Participant hospitalized - hernia surgery †	0/53 (0.00%)	0/56 (0.00%)	1/53 (1.89%)
Participant hospitalized - kidney stone removal †	0/53 (0.00%)	1/56 (1.79%)	0/53 (0.00%)
Infant hospitalized - scheduled surgery for hydrocephalus †	0/53 (0.00%)	1/56 (1.79%)	0/53 (0.00%)
† Indicates events were collected by systematic assessment
Other (Not Including Serious) Adverse Events
Frequency Threshold for Reporting Other Adverse Events	0%
	1 (Placebo)	2 (Sertraline)	3 (IPT)
	Affected / at Risk (%)	Affected / at Risk (%)	Affected / at Risk (%)
Total	20/53 (37.74%)	19/56 (33.93%)	16/53 (30.19%)
Eye disorders
Participant injured eye while playing paintball - consulted doctor and healing well †	0/53 (0.00%)	0/56 (0.00%)	1/53 (1.89%)
General disorders
Participant reported experiencing headaches †	7/53 (13.21%)	4/56 (7.14%)	3/53 (5.66%)
Participant reported experiencing insomnia †	2/53 (3.77%)	5/56 (8.93%)	3/53 (5.66%)
Participant reported experiencing decreased libido †	7/53 (13.21%)	2/56 (3.57%)	0/53 (0.00%)
Patient reported experiencing severe fatigue/sleepiness †	3/53 (5.66%)	3/56 (5.36%)	2/53 (3.77%)
Participant reported experiencing severe agitation †	2/53 (3.77%)	1/56 (1.79%)	3/53 (5.66%)
Patient reported hair loss †	0/53 (0.00%)	1/56 (1.79%)	0/53 (0.00%)
Patient reported mild loss of appetite †	1/53 (1.89%)	0/56 (0.00%)	0/53 (0.00%)
Participant reported experiencing toothaches †	1/53 (1.89%)	0/56 (0.00%)	0/53 (0.00%)
Infant experiencing "mild" excessive drowsiness †	1/53 (1.89%)	0/56 (0.00%)	0/53 (0.00%)
Participant reported that infant did not sleep (due to congestion) and is irritable †	1/53 (1.89%)	0/56 (0.00%)	0/53 (0.00%)
Participant reported experiencing dizziness/vertigo †	0/53 (0.00%)	2/56 (3.57%)	0/53 (0.00%)
Participant reported fainting †	0/53 (0.00%)	0/56 (0.00%)	1/53 (1.89%)
Infant had fever and diarrhea †	0/53 (0.00%)	0/56 (0.00%)	1/53 (1.89%)
Participant ER visit - experiencing abdominal pain †	0/53 (0.00%)	1/56 (1.79%)	0/53 (0.00%)
Participant reported experiencing itching and palpitations † [1]	0/53 (0.00%)	1/56 (1.79%)	0/53 (0.00%)
Infant increased crying/fussiness, poor sleep, eating less, less frequent stool, less muscle tone † [2]	0/53 (0.00%)	1/56 (1.79%)	0/53 (0.00%)
Participant reported severe nervousness †	1/53 (1.89%)	0/56 (0.00%)	0/53 (0.00%)
Infant experienced increased colic †	0/53 (0.00%)	0/56 (0.00%)	1/53 (1.89%)
Participant experienced pain due to having an IUD placed †	0/53 (0.00%)	1/56 (1.79%)	0/53 (0.00%)
Participant diagnosed with 2 bulging discs causing back and leg pain †	0/53 (0.00%)	0/56 (0.00%)	1/53 (1.89%)
Infections and infestations
Participant reported ear infection †	1/53 (1.89%)	0/56 (0.00%)	0/53 (0.00%)
Participant contracted ringworm from daughter †	0/53 (0.00%)	1/56 (1.79%)	0/53 (0.00%)
Participant experienced kidney infection †	0/53 (0.00%)	0/56 (0.00%)	1/53 (1.89%)
Participant experienced sinus infection †	1/53 (1.89%)	0/56 (0.00%)	0/53 (0.00%)
Participant ER visit - sinusitis †	0/53 (0.00%)	1/56 (1.79%)	0/53 (0.00%)
Injury, poisoning and procedural complications
Participant ER visit - sprained ankle †	1/53 (1.89%)	0/56 (0.00%)	0/53 (0.00%)
Pregnancy, puerperium and perinatal conditions
Participant screened positive on pregnancy test †	0/53 (0.00%)	1/56 (1.79%)	0/53 (0.00%)
Psychiatric disorders
Worsening of symptoms † [3]	5/53 (9.43%)	3/56 (5.36%)	4/53 (7.55%)
Participant ER visit - shortness of breath, deemed likely to be anxiety related †	1/53 (1.89%)	0/56 (0.00%)	0/53 (0.00%)
Reproductive system and breast disorders
Patient reported experiencing delayed orgasm †	1/53 (1.89%)	1/56 (1.79%)	0/53 (0.00%)
Skin and subcutaneous tissue disorders
Participant experienced rash †	2/53 (3.77%)	0/56 (0.00%)	0/53 (0.00%)
Social circumstances
Participant reported increased conflict with spouse or partner †	1/53 (1.89%)	0/56 (0.00%)	1/53 (1.89%)
Increased conflict with other family and friends †	0/53 (0.00%)	0/56 (0.00%)	1/53 (1.89%)
Separation from spouse †	0/53 (0.00%)	0/56 (0.00%)	1/53 (1.89%)
Surgical and medical procedures
Participant had 3 wisdom teeth removed †	1/53 (1.89%)	0/56 (0.00%)	0/53 (0.00%)
Participant had outpatient surgery on an existing hernia †	0/53 (0.00%)	1/56 (1.79%)	0/53 (0.00%)
† Indicates events were collected by systematic assessment; [1] resolved 1-2 days after stopping medication; [2] resolved when mother stopped breastfeeding for a day and discontinued use of study medication; [3] Worsening of depressive or other psychiatric symptoms

Limitations and Caveats

[Not Specified]

More Information

Certain Agreements

Principal Investigators are NOT employed by the organization sponsoring the study.

There is NOT an agreement between Principal Investigators and the Sponsor (or its agents) that restricts the PI's rights to discuss or publish trial results after the trial is completed.

Results Point of Contact

• Name/Title: Caron Zlotnick
• Organization: Women and Infants Hospital
• Phone: 401-455-6529
• EMail: czlotnick@butler.org

Publications automatically indexed to this study by ClinicalTrials.gov Identifier (NCT Number):

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.

• Responsible Party: Caron Zlotnick, Women and Infants Hospital of Rhode Island
• ClinicalTrials.gov Identifier: NCT00602355
• Other Study ID Numbers: R01MH074919 ( U.S. NIH Grant/Contract ); R01MH074919 ( U.S. NIH Grant/Contract ); R01MH074636 ( U.S. NIH Grant/Contract ); DSIR 83-ATP
• First Submitted: January 23, 2008
• First Posted: January 28, 2008
• Results First Submitted: June 1, 2016
• Results First Posted: September 21, 2016
• Last Update Posted: September 21, 2016