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Trial record 2 of 17 for:    Postpartum Depression AND Interpersonal Psychotherapy | "Depression" AND "Depression"

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

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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:
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
Recruitment Details  
Pre-assignment Details  
Arm/Group Title 1 (Placebo) 2 (Sertraline) 3 (IPT)
Hide 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
Arm/Group Title 1 (Placebo) 2 (Sertraline) 3 (IPT) Total
Hide 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
Hide 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
1.Primary Outcome
Title Hamilton Depression Rating Scale (HAM-D)
Hide 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
Show Outcome Measure DataHide Outcome Measure Data
Hide Analysis Population Description
[Not Specified]
Arm/Group Title 1 (Placebo) 2 (Sertraline) 3 (IPT)
Hide 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)
Hide 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
Show Outcome Measure DataHide Outcome Measure Data
Hide Analysis Population Description
[Not Specified]
Arm/Group Title 1 (Placebo) 2 (Sertraline) 3 (IPT)
Hide 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
Hide 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
Show Outcome Measure DataHide Outcome Measure Data
Hide Analysis Population Description
[Not Specified]
Arm/Group Title 1 (Placebo) 2 (Sertraline) 3 (IPT)
Hide 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)
Hide 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
Show Outcome Measure DataHide Outcome Measure Data
Hide Analysis Population Description
[Not Specified]
Arm/Group Title 1 (Placebo) 2 (Sertraline) 3 (IPT)
Hide 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)
Hide 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
Show Outcome Measure DataHide Outcome Measure Data
Hide Analysis Population Description
[Not Specified]
Arm/Group Title 1 (Placebo) 2 (Sertraline) 3 (IPT)
Hide 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)
Time Frame [Not Specified]
Adverse Event Reporting Description [Not Specified]
 
Arm/Group Title 1 (Placebo) 2 (Sertraline) 3 (IPT)
Hide 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   --/--   --/--   --/-- 
Show Serious Adverse Events Hide 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
Show Other (Not Including Serious) Adverse Events Hide 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
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
Responsible Party: Caron Zlotnick, Women and Infants Hospital of Rhode Island
ClinicalTrials.gov Identifier: NCT00602355     History of Changes
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