Trial Outcomes & Findings for Effectiveness of Sertraline Alone and Interpersonal Psychotherapy Alone in Treating Women With Postpartum Depression (NCT NCT00602355)
NCT ID: NCT00602355
Last Updated: 2016-09-21
Results Overview
Measure total ranges from 0 to 50, with lower scores indicating better outcomes.
Recruitment status
COMPLETED
Study phase
PHASE2
Target enrollment
162 participants
Primary outcome timeframe
Measured at baseline; post-treatment; and Months 3 and 6 of follow-up
Results posted on
2016-09-21
Participant Flow
Participant milestones
| Measure |
1 (Placebo)
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
|
2 (Sertraline)
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
|
3 (IPT)
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 Study
STARTED
|
53
|
56
|
53
|
|
Overall Study
COMPLETED
|
44
|
38
|
43
|
|
Overall Study
NOT COMPLETED
|
9
|
18
|
10
|
Reasons for withdrawal
Withdrawal data not reported
Baseline Characteristics
Effectiveness of Sertraline Alone and Interpersonal Psychotherapy Alone in Treating Women With Postpartum Depression
Baseline characteristics by cohort
| Measure |
1 (Placebo)
n=53 Participants
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
|
2 (Sertraline)
n=56 Participants
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
|
3 (IPT)
n=53 Participants
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
n=162 Participants
Total of all reporting groups
|
|---|---|---|---|---|
|
Age, Categorical
<=18 years
|
0 Participants
n=93 Participants
|
0 Participants
n=4 Participants
|
0 Participants
n=27 Participants
|
0 Participants
n=483 Participants
|
|
Age, Categorical
Between 18 and 65 years
|
53 Participants
n=93 Participants
|
56 Participants
n=4 Participants
|
53 Participants
n=27 Participants
|
162 Participants
n=483 Participants
|
|
Age, Categorical
>=65 years
|
0 Participants
n=93 Participants
|
0 Participants
n=4 Participants
|
0 Participants
n=27 Participants
|
0 Participants
n=483 Participants
|
|
Age, Continuous
|
27.28 years
STANDARD_DEVIATION 5.11 • n=93 Participants
|
28.16 years
STANDARD_DEVIATION 5.63 • n=4 Participants
|
26.26 years
STANDARD_DEVIATION 6.15 • n=27 Participants
|
27.25 years
STANDARD_DEVIATION 5.67 • n=483 Participants
|
|
Sex: Female, Male
Female
|
53 Participants
n=93 Participants
|
56 Participants
n=4 Participants
|
53 Participants
n=27 Participants
|
162 Participants
n=483 Participants
|
|
Sex: Female, Male
Male
|
0 Participants
n=93 Participants
|
0 Participants
n=4 Participants
|
0 Participants
n=27 Participants
|
0 Participants
n=483 Participants
|
|
Ethnicity (NIH/OMB)
Hispanic or Latino
|
17 Participants
n=93 Participants
|
14 Participants
n=4 Participants
|
13 Participants
n=27 Participants
|
44 Participants
n=483 Participants
|
|
Ethnicity (NIH/OMB)
Not Hispanic or Latino
|
36 Participants
n=93 Participants
|
41 Participants
n=4 Participants
|
40 Participants
n=27 Participants
|
117 Participants
n=483 Participants
|
|
Ethnicity (NIH/OMB)
Unknown or Not Reported
|
0 Participants
n=93 Participants
|
1 Participants
n=4 Participants
|
0 Participants
n=27 Participants
|
1 Participants
n=483 Participants
|
|
Race (NIH/OMB)
American Indian or Alaska Native
|
0 Participants
n=93 Participants
|
0 Participants
n=4 Participants
|
0 Participants
n=27 Participants
|
0 Participants
n=483 Participants
|
|
Race (NIH/OMB)
Asian
|
1 Participants
n=93 Participants
|
0 Participants
n=4 Participants
|
1 Participants
n=27 Participants
|
2 Participants
n=483 Participants
|
|
Race (NIH/OMB)
Native Hawaiian or Other Pacific Islander
|
0 Participants
n=93 Participants
|
0 Participants
n=4 Participants
|
0 Participants
n=27 Participants
|
0 Participants
n=483 Participants
|
|
Race (NIH/OMB)
Black or African American
|
7 Participants
n=93 Participants
|
7 Participants
n=4 Participants
|
10 Participants
n=27 Participants
|
24 Participants
n=483 Participants
|
|
Race (NIH/OMB)
White
|
31 Participants
n=93 Participants
|
36 Participants
n=4 Participants
|
32 Participants
n=27 Participants
|
99 Participants
n=483 Participants
|
|
Race (NIH/OMB)
More than one race
|
0 Participants
n=93 Participants
|
0 Participants
n=4 Participants
|
0 Participants
n=27 Participants
|
0 Participants
n=483 Participants
|
|
Race (NIH/OMB)
Unknown or Not Reported
|
14 Participants
n=93 Participants
|
13 Participants
n=4 Participants
|
10 Participants
n=27 Participants
|
37 Participants
n=483 Participants
|
|
Region of Enrollment
United States
|
53 participants
n=93 Participants
|
56 participants
n=4 Participants
|
53 participants
n=27 Participants
|
162 participants
n=483 Participants
|
PRIMARY outcome
Timeframe: Measured at baseline; post-treatment; and Months 3 and 6 of follow-upMeasure total ranges from 0 to 50, with lower scores indicating better outcomes.
Outcome measures
| Measure |
1 (Placebo)
n=44 Participants
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
|
2 (Sertraline)
n=38 Participants
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
|
3 (IPT)
n=43 Participants
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.
|
|---|---|---|---|
|
Hamilton Depression Rating Scale (HAM-D)
Baseline
|
22.0 units on a scale
Standard Deviation 4.7
|
21.8 units on a scale
Standard Deviation 4.7
|
22.0 units on a scale
Standard Deviation 4.5
|
|
Hamilton Depression Rating Scale (HAM-D)
Post-Treatment
|
8.8 units on a scale
Standard Deviation 6.0
|
8.1 units on a scale
Standard Deviation 7.1
|
8.2 units on a scale
Standard Deviation 6.8
|
|
Hamilton Depression Rating Scale (HAM-D)
3-Month Follow-up
|
6.7 units on a scale
Standard Deviation 6.7
|
5.8 units on a scale
Standard Deviation 6.5
|
7.3 units on a scale
Standard Deviation 7.4
|
|
Hamilton Depression Rating Scale (HAM-D)
6-Month Follow-up
|
6.5 units on a scale
Standard Deviation 6.8
|
4.9 units on a scale
Standard Deviation 5.7
|
6.1 units on a scale
Standard Deviation 6.5
|
SECONDARY outcome
Timeframe: Measured at baseline; post-treatment; and Months 3 and 6 of follow-upMeasure total ranges from 0 to 56, with lower scores indicating better outcomes.
Outcome measures
| Measure |
1 (Placebo)
n=44 Participants
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
|
2 (Sertraline)
n=38 Participants
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
|
3 (IPT)
n=43 Participants
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.
|
|---|---|---|---|
|
Depression Illness Severity Based on Beck Depression Inventory (BDI)
Baseline
|
26.2 units on a scale
Standard Deviation 7.7
|
27.0 units on a scale
Standard Deviation 8.0
|
25.9 units on a scale
Standard Deviation 8.3
|
|
Depression Illness Severity Based on Beck Depression Inventory (BDI)
Post-Treatment
|
10.8 units on a scale
Standard Deviation 11.5
|
10.0 units on a scale
Standard Deviation 10.2
|
10.5 units on a scale
Standard Deviation 10.2
|
|
Depression Illness Severity Based on Beck Depression Inventory (BDI)
3-Month Follow-up
|
8.5 units on a scale
Standard Deviation 8.7
|
7.3 units on a scale
Standard Deviation 9.1
|
10.7 units on a scale
Standard Deviation 11.0
|
|
Depression Illness Severity Based on Beck Depression Inventory (BDI)
6-Month Follow-up
|
9.2 units on a scale
Standard Deviation 10.0
|
5.1 units on a scale
Standard Deviation 7.0
|
7.8 units on a scale
Standard Deviation 8.8
|
SECONDARY outcome
Timeframe: Measured at baseline; post-treatment; and Months 3 and 6 of follow-upMeasure total ranges from 1 to 7, with lower scores indicating better outcomes.
Outcome measures
| Measure |
1 (Placebo)
n=44 Participants
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
|
2 (Sertraline)
n=38 Participants
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
|
3 (IPT)
n=43 Participants
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.
|
|---|---|---|---|
|
Global Illness Severity Based on Clinical Global Impression (CGI) Scale
Baseline
|
4.1 units on a scale
Standard Deviation 0.7
|
4.0 units on a scale
Standard Deviation 0.6
|
3.9 units on a scale
Standard Deviation 0.8
|
|
Global Illness Severity Based on Clinical Global Impression (CGI) Scale
Post-treatment
|
2.1 units on a scale
Standard Deviation 1.1
|
2.0 units on a scale
Standard Deviation 1.2
|
2.0 units on a scale
Standard Deviation 1.3
|
|
Global Illness Severity Based on Clinical Global Impression (CGI) Scale
3-Month Follow-up
|
1.9 units on a scale
Standard Deviation 1.0
|
1.8 units on a scale
Standard Deviation 1.2
|
2.0 units on a scale
Standard Deviation 1.3
|
|
Global Illness Severity Based on Clinical Global Impression (CGI) Scale
6-Month Follow-up
|
1.7 units on a scale
Standard Deviation 1.0
|
1.7 units on a scale
Standard Deviation 1.1
|
1.8 units on a scale
Standard Deviation 1.2
|
SECONDARY outcome
Timeframe: Measured at baseline; post-treatment; and Months 3 and 6 of follow-upMeasure total ranges from 1 to 5, with lower scores indicating better outcomes.
Outcome measures
| Measure |
1 (Placebo)
n=44 Participants
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
|
2 (Sertraline)
n=38 Participants
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
|
3 (IPT)
n=43 Participants
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.
|
|---|---|---|---|
|
Social Functioning Based on Postpartum Adjustment Questionnaire (PPAQ)
Baseline
|
2.7 units on a scale
Standard Deviation 0.4
|
2.7 units on a scale
Standard Deviation 0.4
|
2.6 units on a scale
Standard Deviation 0.4
|
|
Social Functioning Based on Postpartum Adjustment Questionnaire (PPAQ)
Post-Treatment
|
2.4 units on a scale
Standard Deviation 0.5
|
2.2 units on a scale
Standard Deviation 0.4
|
2.3 units on a scale
Standard Deviation 0.4
|
|
Social Functioning Based on Postpartum Adjustment Questionnaire (PPAQ)
3-Month Follow-up
|
2.3 units on a scale
Standard Deviation 0.4
|
2.1 units on a scale
Standard Deviation 0.4
|
2.3 units on a scale
Standard Deviation 0.4
|
|
Social Functioning Based on Postpartum Adjustment Questionnaire (PPAQ)
6-Month Follow-up
|
2.3 units on a scale
Standard Deviation 0.4
|
2.1 units on a scale
Standard Deviation 0.4
|
2.2 units on a scale
Standard Deviation 0.4
|
SECONDARY outcome
Timeframe: Measured at baseline; post-treatment; and Months 3 and 6 of follow-upMeasure total ranges from 0 to 56, with lower scores indicating better outcomes.
Outcome measures
| Measure |
1 (Placebo)
n=44 Participants
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
|
2 (Sertraline)
n=38 Participants
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
|
3 (IPT)
n=43 Participants
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.
|
|---|---|---|---|
|
Hamilton Anxiety Rating Scale (HARS)
Baseline
|
20.9 units on a scale
Standard Deviation 6.6
|
20.3 units on a scale
Standard Deviation 6.1
|
19.4 units on a scale
Standard Deviation 6.2
|
|
Hamilton Anxiety Rating Scale (HARS)
Post-Treatment
|
9.9 units on a scale
Standard Deviation 8.0
|
9.4 units on a scale
Standard Deviation 7.9
|
8.3 units on a scale
Standard Deviation 9.0
|
|
Hamilton Anxiety Rating Scale (HARS)
3-Month Follow-up
|
7.4 units on a scale
Standard Deviation 7.8
|
6.6 units on a scale
Standard Deviation 7.1
|
7.0 units on a scale
Standard Deviation 7.5
|
|
Hamilton Anxiety Rating Scale (HARS)
6-Month Follow-up
|
7.5 units on a scale
Standard Deviation 8.4
|
6.2 units on a scale
Standard Deviation 6.4
|
7.3 units on a scale
Standard Deviation 8.3
|
Adverse Events
1 (Placebo)
Serious events: 7 serious events
Other events: 20 other events
Deaths: 0 deaths
2 (Sertraline)
Serious events: 8 serious events
Other events: 19 other events
Deaths: 0 deaths
3 (IPT)
Serious events: 8 serious events
Other events: 16 other events
Deaths: 0 deaths
Serious adverse events
| Measure |
1 (Placebo)
n=53 participants at risk
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
|
2 (Sertraline)
n=56 participants at risk
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
|
3 (IPT)
n=53 participants at risk
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.
|
|---|---|---|---|
|
Psychiatric disorders
Suicidal ideations or thoughts of self-harm
|
1.9%
1/53
|
3.6%
2/56
|
0.00%
0/53
|
|
Psychiatric disorders
Attempted suicide
|
0.00%
0/53
|
1.8%
1/56
|
0.00%
0/53
|
|
Respiratory, thoracic and mediastinal disorders
Infant hospitalized - bronchitis
|
1.9%
1/53
|
1.8%
1/56
|
0.00%
0/53
|
|
Respiratory, thoracic and mediastinal disorders
Infant hospitalized - bronchiolitis
|
0.00%
0/53
|
0.00%
0/56
|
3.8%
2/53
|
|
Surgical and medical procedures
Participant hospitalized - gall bladder removal
|
0.00%
0/53
|
3.6%
2/56
|
0.00%
0/53
|
|
Infections and infestations
Participant hospitalized - kidney infection
|
0.00%
0/53
|
0.00%
0/56
|
1.9%
1/53
|
|
Respiratory, thoracic and mediastinal disorders
Participant hospitalized - bronchitis
|
0.00%
0/53
|
0.00%
0/56
|
1.9%
1/53
|
|
Psychiatric disorders
Worsening of neurovegetative symptoms
|
1.9%
1/53
|
0.00%
0/56
|
0.00%
0/53
|
|
Infections and infestations
Infant hospitalized - dehydration, fever, vomiting (viral infection)
|
0.00%
0/53
|
1.8%
1/56
|
0.00%
0/53
|
|
Surgical and medical procedures
Participant hospitalized - hernia surgery
|
0.00%
0/53
|
0.00%
0/56
|
1.9%
1/53
|
|
Respiratory, thoracic and mediastinal disorders
Infant hospitalized - RSV
|
0.00%
0/53
|
1.8%
1/56
|
0.00%
0/53
|
|
General disorders
Participant hospitalized - chest pain
|
1.9%
1/53
|
0.00%
0/56
|
0.00%
0/53
|
|
Surgical and medical procedures
Participant hospitalized - kidney stone removal
|
0.00%
0/53
|
1.8%
1/56
|
0.00%
0/53
|
|
Respiratory, thoracic and mediastinal disorders
Infant hospitalized - croup cough
|
1.9%
1/53
|
0.00%
0/56
|
0.00%
0/53
|
|
Pregnancy, puerperium and perinatal conditions
Participant hospitalized - dehydration from excessive vomiting
|
0.00%
0/53
|
0.00%
0/56
|
1.9%
1/53
|
|
Pregnancy, puerperium and perinatal conditions
Participant hospitalized - hyperemesis gravidarum
|
0.00%
0/53
|
0.00%
0/56
|
1.9%
1/53
|
|
Infections and infestations
Infant hospitalized - urinary infection and hand, foot, and mouth infection
|
1.9%
1/53
|
0.00%
0/56
|
0.00%
0/53
|
|
General disorders
Infant hospitalized - high fever
|
1.9%
1/53
|
0.00%
0/56
|
0.00%
0/53
|
|
General disorders
Infant hospitalized - reaction to Enfamil
|
0.00%
0/53
|
0.00%
0/56
|
1.9%
1/53
|
|
Surgical and medical procedures
Infant hospitalized - scheduled surgery for hydrocephalus
|
0.00%
0/53
|
1.8%
1/56
|
0.00%
0/53
|
Other adverse events
| Measure |
1 (Placebo)
n=53 participants at risk
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
|
2 (Sertraline)
n=56 participants at risk
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
|
3 (IPT)
n=53 participants at risk
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.
|
|---|---|---|---|
|
General disorders
Participant reported experiencing headaches
|
13.2%
7/53
|
7.1%
4/56
|
5.7%
3/53
|
|
General disorders
Participant reported experiencing insomnia
|
3.8%
2/53
|
8.9%
5/56
|
5.7%
3/53
|
|
General disorders
Participant reported experiencing decreased libido
|
13.2%
7/53
|
3.6%
2/56
|
0.00%
0/53
|
|
General disorders
Patient reported experiencing severe fatigue/sleepiness
|
5.7%
3/53
|
5.4%
3/56
|
3.8%
2/53
|
|
Psychiatric disorders
Worsening of symptoms
|
9.4%
5/53
|
5.4%
3/56
|
7.5%
4/53
|
|
General disorders
Participant reported experiencing severe agitation
|
3.8%
2/53
|
1.8%
1/56
|
5.7%
3/53
|
|
Social circumstances
Participant reported increased conflict with spouse or partner
|
1.9%
1/53
|
0.00%
0/56
|
1.9%
1/53
|
|
Reproductive system and breast disorders
Patient reported experiencing delayed orgasm
|
1.9%
1/53
|
1.8%
1/56
|
0.00%
0/53
|
|
General disorders
Patient reported hair loss
|
0.00%
0/53
|
1.8%
1/56
|
0.00%
0/53
|
|
General disorders
Patient reported mild loss of appetite
|
1.9%
1/53
|
0.00%
0/56
|
0.00%
0/53
|
|
Injury, poisoning and procedural complications
Participant ER visit - sprained ankle
|
1.9%
1/53
|
0.00%
0/56
|
0.00%
0/53
|
|
Infections and infestations
Participant reported ear infection
|
1.9%
1/53
|
0.00%
0/56
|
0.00%
0/53
|
|
General disorders
Participant reported experiencing toothaches
|
1.9%
1/53
|
0.00%
0/56
|
0.00%
0/53
|
|
Surgical and medical procedures
Participant had 3 wisdom teeth removed
|
1.9%
1/53
|
0.00%
0/56
|
0.00%
0/53
|
|
General disorders
Infant experiencing "mild" excessive drowsiness
|
1.9%
1/53
|
0.00%
0/56
|
0.00%
0/53
|
|
General disorders
Participant reported that infant did not sleep (due to congestion) and is irritable
|
1.9%
1/53
|
0.00%
0/56
|
0.00%
0/53
|
|
Infections and infestations
Participant contracted ringworm from daughter
|
0.00%
0/53
|
1.8%
1/56
|
0.00%
0/53
|
|
Pregnancy, puerperium and perinatal conditions
Participant screened positive on pregnancy test
|
0.00%
0/53
|
1.8%
1/56
|
0.00%
0/53
|
|
General disorders
Participant reported experiencing dizziness/vertigo
|
0.00%
0/53
|
3.6%
2/56
|
0.00%
0/53
|
|
General disorders
Participant reported fainting
|
0.00%
0/53
|
0.00%
0/56
|
1.9%
1/53
|
|
General disorders
Infant had fever and diarrhea
|
0.00%
0/53
|
0.00%
0/56
|
1.9%
1/53
|
|
Surgical and medical procedures
Participant had outpatient surgery on an existing hernia
|
0.00%
0/53
|
1.8%
1/56
|
0.00%
0/53
|
|
Eye disorders
Participant injured eye while playing paintball - consulted doctor and healing well
|
0.00%
0/53
|
0.00%
0/56
|
1.9%
1/53
|
|
General disorders
Participant ER visit - experiencing abdominal pain
|
0.00%
0/53
|
1.8%
1/56
|
0.00%
0/53
|
|
General disorders
Participant reported experiencing itching and palpitations
|
0.00%
0/53
|
1.8%
1/56
|
0.00%
0/53
|
|
General disorders
Infant increased crying/fussiness, poor sleep, eating less, less frequent stool, less muscle tone
|
0.00%
0/53
|
1.8%
1/56
|
0.00%
0/53
|
|
Skin and subcutaneous tissue disorders
Participant experienced rash
|
3.8%
2/53
|
0.00%
0/56
|
0.00%
0/53
|
|
General disorders
Participant reported severe nervousness
|
1.9%
1/53
|
0.00%
0/56
|
0.00%
0/53
|
|
Infections and infestations
Participant experienced kidney infection
|
0.00%
0/53
|
0.00%
0/56
|
1.9%
1/53
|
|
Social circumstances
Increased conflict with other family and friends
|
0.00%
0/53
|
0.00%
0/56
|
1.9%
1/53
|
|
General disorders
Infant experienced increased colic
|
0.00%
0/53
|
0.00%
0/56
|
1.9%
1/53
|
|
Social circumstances
Separation from spouse
|
0.00%
0/53
|
0.00%
0/56
|
1.9%
1/53
|
|
Infections and infestations
Participant experienced sinus infection
|
1.9%
1/53
|
0.00%
0/56
|
0.00%
0/53
|
|
General disorders
Participant experienced pain due to having an IUD placed
|
0.00%
0/53
|
1.8%
1/56
|
0.00%
0/53
|
|
Infections and infestations
Participant ER visit - sinusitis
|
0.00%
0/53
|
1.8%
1/56
|
0.00%
0/53
|
|
General disorders
Participant diagnosed with 2 bulging discs causing back and leg pain
|
0.00%
0/53
|
0.00%
0/56
|
1.9%
1/53
|
|
Psychiatric disorders
Participant ER visit - shortness of breath, deemed likely to be anxiety related
|
1.9%
1/53
|
0.00%
0/56
|
0.00%
0/53
|
Additional Information
Results disclosure agreements
- Principal investigator is a sponsor employee
- Publication restrictions are in place