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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

  Participant Flow

Recruitment Details
Key information relevant to the recruitment process for the overall study, such as dates of the recruitment period and locations
No text entered.

Pre-Assignment Details
Significant events and approaches for the overall study following participant enrollment, but prior to group assignment
No text entered.

Reporting Groups
  Description
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.


Participant Flow:   Overall Study
    1 (Placebo)   2 (Sertraline)   3 (IPT)
STARTED   53   56   53 
COMPLETED   44   38   43 
NOT COMPLETED   9   18   10 



  Baseline Characteristics

Population Description
Explanation of how the number of participants for analysis was determined. Includes whether analysis was per protocol, intention to treat, or another method. Also provides relevant details such as imputation technique, as appropriate.
No text entered.

Reporting Groups
  Description
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.

Total Total of all reporting groups

Baseline Measures
   1 (Placebo)   2 (Sertraline)   3 (IPT)   Total 
Overall Participants Analyzed 
[Units: Participants]
 53   56   53   162 
Age 
[Units: Participants]
       
<=18 years   0   0   0   0 
Between 18 and 65 years   53   56   53   162 
>=65 years   0   0   0   0 
Age 
[Units: Years]
Mean (Standard Deviation)
 27.28  (5.11)   28.16  (5.63)   26.26  (6.15)   27.25  (5.67) 
Gender 
[Units: Participants]
       
Female   53   56   53   162 
Male   0   0   0   0 
Ethnicity (NIH/OMB) 
[Units: Participants]
       
Hispanic or Latino   17   14   13   44 
Not Hispanic or Latino   36   41   40   117 
Unknown or Not Reported   0   1   0   1 
Race (NIH/OMB) 
[Units: Participants]
       
American Indian or Alaska Native   0   0   0   0 
Asian   1   0   1   2 
Native Hawaiian or Other Pacific Islander   0   0   0   0 
Black or African American   7   7   10   24 
White   31   36   32   99 
More than one race   0   0   0   0 
Unknown or Not Reported   14   13   10   37 
Region of Enrollment 
[Units: Participants]
       
United States   53   56   53   162 


  Outcome Measures

1.  Primary:   Hamilton Depression Rating Scale (HAM-D)   [ Time Frame: Measured at baseline; post-treatment; and Months 3 and 6 of follow-up ]

2.  Secondary:   Depression Illness Severity Based on Beck Depression Inventory (BDI)   [ Time Frame: Measured at baseline; post-treatment; and Months 3 and 6 of follow-up ]

3.  Secondary:   Global Illness Severity Based on Clinical Global Impression (CGI) Scale   [ Time Frame: Measured at baseline; post-treatment; and Months 3 and 6 of follow-up ]

4.  Secondary:   Social Functioning Based on Postpartum Adjustment Questionnaire (PPAQ)   [ Time Frame: Measured at baseline; post-treatment; and Months 3 and 6 of follow-up ]

5.  Secondary:   Hamilton Anxiety Rating Scale (HARS)   [ Time Frame: Measured at baseline; post-treatment; and Months 3 and 6 of follow-up ]


  Serious Adverse Events


  Other Adverse Events


  Limitations and Caveats

Limitations of the study, such as early termination leading to small numbers of participants analyzed and technical problems with measurement leading to unreliable or uninterpretable data
No text entered.


  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
e-mail: czlotnick@butler.org



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