Depression, Postpartum
Conditions
Keywords
Postpartum, Depression, Medication Therapy, Zoloft, Sertraline, Interpersonal Psychotherapy
Brief summary
This study will evaluate the effectiveness of antidepressant medication alone and interpersonal psychotherapy alone in treating women with postpartum depression.
Detailed description
Postpartum depression (PPD) occurs in approximately 13% of postpartum women. The impact of PPD is significant, including emotional distress for the woman as well as disturbances in infant development. Common signs of depression after childbirth may include anxiety, irritability, low energy, and lack of concern for self or infant. If left untreated, PPD may last for more than 1 year, causing strain on family life and the mother's relationship with her infant. Infants of depressed mothers are also at a higher risk for developmental delays, behavioral problems, and difficulty eating and sleeping. Despite the public health significance of PPD, relatively little research has been done to determine the most effective treatments. Specifically, there is a lack of research concerning the use of antidepressant medication for treating PPD. Interpersonal psychotherapy (IPT), which focuses on interpersonal issues related to depression, has been more thoroughly studied for the treatment for PPD, but it has not been compared to the other treatment. This study will evaluate the effectiveness of antidepressant medication alone and IPT alone in treating women with PPD. Participation in this double-blind study will last 9 months. Participants will first undergo initial assessments, which include interviews about depressive symptoms, self-report forms about medical history, blood tests, and a pregnancy test. Participants will then be randomly assigned to one of three treatments: sertraline, placebo, or IPT. All three treatments will be administered over 13 weeks. Participants assigned to take sertraline or placebo will attend nine 30-minute sessions over the 13-week treatment period. During these sessions, participants will be administered the study medication and will be assisted with parenting issues and skills by a psychiatrist. Participants receiving IPT will attend weekly 50-minute sessions over the 13-week treatment period. These sessions will focus on improving relationships with others, setting goals, and increasing coping skills. All participants will also complete interviews and questionnaires about their depression once a month. Following the 13 weeks of treatment, participants will undergo follow-up assessments at Months 3 and 6 post-treatment. Follow-up assessments will repeat initial interviews and questionnaires and will include a form about the infant's nature.
Interventions
DRUGSertraline
Participants assigned to sertraline treatment will take 25 to 50 mg daily for Weeks 1 through 3, and dosage will be increased to 100 to 150 mg daily in Weeks 4 through 10. Participants will be titrated up to 200 mg daily at Week 11 for the final 2 weeks of treatment. In addition, at each week participants will receive specific mother-crafting techniques keyed to the baby's age and development. The mother-crafting component is aimed at providing relevant information to the mother about infant care.
DRUGPlacebo
Participants taking the placebo will follow the same titration schedule as those taking sertraline. In addition, the participates will receive the same specific mother-crafting techniques as those taking sertraline.
BEHAVIORALInterpersonal psychotherapy (IPT)
IPT will be administered in 13 individual 50-minute sessions over 13 weeks. These sessions will focus on improving relationships with others, setting goals, and increasing coping skills.
BEHAVIORALClinical management
Clinical management includes treatment as usual for those receiving medication for depression.
BEHAVIORALMothercrafting
Mother-crafting techniques are keyed to the baby's age and development. The mother-crafting component is aimed at providing relevant information about infant care
Sponsors
National Institute of Mental Health (NIMH)
Women and Infants Hospital of Rhode Island
Study design
Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
TREATMENT
Masking
QUADRUPLE (Subject, Caregiver, Investigator, Outcomes Assessor)
Eligibility
Sex/Gender
FEMALE
Age
18 Years to 50 Years
Healthy volunteers
No
Inclusion criteria
* Primary DSM-IV diagnosis of major depressive disorder by clinical interview * Score of greater than 12 on HAM-D * Delivery of an infant within the 12 months prior to study entry * Able to speak and read English sufficiently to complete the study procedures * Willing to use effective birth control methods throughout the study
Exclusion criteria
* Woman whose infant has died prior to study entry * Current or past diagnosis of bipolar disorder, schizophrenia or other psychotic disorder; * Diagnosis of alcohol or drug abuse or dependence (except nicotine) or anorexia in the past year; * Psychotic symptoms; * Acute suicidal or homicidal risks; * Women who have been on an antidepressant for more than 14 days prior to consent, (if less than 14 days and willing to taper off, will be eligible to continue once tapered off); * Women on daily anxiolytic medication (i.e. benzodiazepine, buspirone) or daily psychoactive herbal preparation (St. John's Wort or Fish Oil) (if willing to discontinue these substances may be eligible once they have been tapered off); * Medications taken PRN over the listed dose and frequency (women will still be eligible if they take: Lunesta/Eszopiclone 3 mg or less, up to 3 nights a week, Ambien/Zolpidem 5mg or less, Ambien CR 6.25 mg or less, up to 3 nights a week, Lorazepam or equivalent benzodiazepine dose: 0.5 mg up to 3 nights a week, Sonata/Zaleplon: 5 mg or less, up to 3 nights a week, Rozerem/Ramelteon: 8 mg or less, up to 3 nights a week); * If they take antidepressants PRN for insomnia (eg: Desyrel/Trazodone, Elavil/Amitriptyline, Remeron/Mirtazapine; * Ongoing concurrent psychotherapeutic treatment or psychotherapeutic treatment within the last month; * Psychiatric symptoms requiring specialized psychiatric treatment; * Significant medical disorder that would make sertraline treatment contra-indicated, * Previous trial of IPT therapy with a certified IPT therapist or an adequate trial of sertraline (i.e. at least 8 weeks of at least 100 mg daily of sertraline).
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| Hamilton Depression Rating Scale (HAM-D) | Measured at baseline; post-treatment; and Months 3 and 6 of follow-up | Measure total ranges from 0 to 50, with lower scores indicating better outcomes. |
Secondary
| Measure | Time frame | Description |
|---|---|---|
| Depression Illness Severity Based on Beck Depression Inventory (BDI) | Measured at baseline; post-treatment; and Months 3 and 6 of follow-up | Measure total ranges from 0 to 56, with lower scores indicating better outcomes. |
| Global Illness Severity Based on Clinical Global Impression (CGI) Scale | Measured at baseline; post-treatment; and Months 3 and 6 of follow-up | Measure total ranges from 1 to 7, with lower scores indicating better outcomes. |
| Social Functioning Based on Postpartum Adjustment Questionnaire (PPAQ) | Measured at baseline; post-treatment; and Months 3 and 6 of follow-up | Measure total ranges from 1 to 5, with lower scores indicating better outcomes. |
| Hamilton Anxiety Rating Scale (HARS) | Measured at baseline; post-treatment; and Months 3 and 6 of follow-up | Measure total ranges from 0 to 56, with lower scores indicating better outcomes. |
Countries
United States
Participant flow
Participants by arm
| Arm | Count |
|---|---|
| 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 | 53 |
| 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 | 56 |
| 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. | 53 |
| Total | 162 |
Baseline characteristics
| Characteristic | 1 (Placebo) | 2 (Sertraline) | 3 (IPT) | Total |
|---|---|---|---|---|
| Age, Categorical <=18 years | 0 Participants | 0 Participants | 0 Participants | 0 Participants |
| Age, Categorical >=65 years | 0 Participants | 0 Participants | 0 Participants | 0 Participants |
| Age, Categorical Between 18 and 65 years | 53 Participants | 56 Participants | 53 Participants | 162 Participants |
| Age, Continuous | 27.28 years STANDARD_DEVIATION 5.11 | 28.16 years STANDARD_DEVIATION 5.63 | 26.26 years STANDARD_DEVIATION 6.15 | 27.25 years STANDARD_DEVIATION 5.67 |
| Ethnicity (NIH/OMB) Hispanic or Latino | 17 Participants | 14 Participants | 13 Participants | 44 Participants |
| Ethnicity (NIH/OMB) Not Hispanic or Latino | 36 Participants | 41 Participants | 40 Participants | 117 Participants |
| Ethnicity (NIH/OMB) Unknown or Not Reported | 0 Participants | 1 Participants | 0 Participants | 1 Participants |
| Race (NIH/OMB) American Indian or Alaska Native | 0 Participants | 0 Participants | 0 Participants | 0 Participants |
| Race (NIH/OMB) Asian | 1 Participants | 0 Participants | 1 Participants | 2 Participants |
| Race (NIH/OMB) Black or African American | 7 Participants | 7 Participants | 10 Participants | 24 Participants |
| Race (NIH/OMB) More than one race | 0 Participants | 0 Participants | 0 Participants | 0 Participants |
| Race (NIH/OMB) Native Hawaiian or Other Pacific Islander | 0 Participants | 0 Participants | 0 Participants | 0 Participants |
| Race (NIH/OMB) Unknown or Not Reported | 14 Participants | 13 Participants | 10 Participants | 37 Participants |
| Race (NIH/OMB) White | 31 Participants | 36 Participants | 32 Participants | 99 Participants |
| Region of Enrollment United States | 53 participants | 56 participants | 53 participants | 162 participants |
| Sex: Female, Male Female | 53 Participants | 56 Participants | 53 Participants | 162 Participants |
| Sex: Female, Male Male | 0 Participants | 0 Participants | 0 Participants | 0 Participants |
Adverse events
| Event type | EG000 affected / at risk | EG001 affected / at risk | EG002 affected / at risk |
|---|---|---|---|
| deaths Total, all-cause mortality | — / — | — / — | — / — |
| other Total, other adverse events | 20 / 53 | 19 / 56 | 16 / 53 |
| serious Total, serious adverse events | 7 / 53 | 8 / 56 | 8 / 53 |
Outcome results
Primary
Hamilton Depression Rating Scale (HAM-D)
Measure total ranges from 0 to 50, with lower scores indicating better outcomes.
Time frame: Measured at baseline; post-treatment; and Months 3 and 6 of follow-up
| Arm | Measure | Group | Value (MEAN) | Dispersion |
|---|---|---|---|---|
| 1 (Placebo) | Hamilton Depression Rating Scale (HAM-D) | Baseline | 22.0 units on a scale | Standard Deviation 4.7 |
| 1 (Placebo) | Hamilton Depression Rating Scale (HAM-D) | Post-Treatment | 8.8 units on a scale | Standard Deviation 6 |
| 1 (Placebo) | Hamilton Depression Rating Scale (HAM-D) | 3-Month Follow-up | 6.7 units on a scale | Standard Deviation 6.7 |
| 1 (Placebo) | Hamilton Depression Rating Scale (HAM-D) | 6-Month Follow-up | 6.5 units on a scale | Standard Deviation 6.8 |
| 2 (Sertraline) | Hamilton Depression Rating Scale (HAM-D) | 6-Month Follow-up | 4.9 units on a scale | Standard Deviation 5.7 |
| 2 (Sertraline) | Hamilton Depression Rating Scale (HAM-D) | Baseline | 21.8 units on a scale | Standard Deviation 4.7 |
| 2 (Sertraline) | Hamilton Depression Rating Scale (HAM-D) | 3-Month Follow-up | 5.8 units on a scale | Standard Deviation 6.5 |
| 2 (Sertraline) | Hamilton Depression Rating Scale (HAM-D) | Post-Treatment | 8.1 units on a scale | Standard Deviation 7.1 |
| 3 (IPT) | Hamilton Depression Rating Scale (HAM-D) | 6-Month Follow-up | 6.1 units on a scale | Standard Deviation 6.5 |
| 3 (IPT) | Hamilton Depression Rating Scale (HAM-D) | Post-Treatment | 8.2 units on a scale | Standard Deviation 6.8 |
| 3 (IPT) | Hamilton Depression Rating Scale (HAM-D) | 3-Month Follow-up | 7.3 units on a scale | Standard Deviation 7.4 |
| 3 (IPT) | Hamilton Depression Rating Scale (HAM-D) | Baseline | 22.0 units on a scale | Standard Deviation 4.5 |
Secondary
Depression Illness Severity Based on Beck Depression Inventory (BDI)
Measure total ranges from 0 to 56, with lower scores indicating better outcomes.
Time frame: Measured at baseline; post-treatment; and Months 3 and 6 of follow-up
| Arm | Measure | Group | Value (MEAN) | Dispersion |
|---|---|---|---|---|
| 1 (Placebo) | Depression Illness Severity Based on Beck Depression Inventory (BDI) | Baseline | 26.2 units on a scale | Standard Deviation 7.7 |
| 1 (Placebo) | Depression Illness Severity Based on Beck Depression Inventory (BDI) | Post-Treatment | 10.8 units on a scale | Standard Deviation 11.5 |
| 1 (Placebo) | Depression Illness Severity Based on Beck Depression Inventory (BDI) | 3-Month Follow-up | 8.5 units on a scale | Standard Deviation 8.7 |
| 1 (Placebo) | Depression Illness Severity Based on Beck Depression Inventory (BDI) | 6-Month Follow-up | 9.2 units on a scale | Standard Deviation 10 |
| 2 (Sertraline) | Depression Illness Severity Based on Beck Depression Inventory (BDI) | 6-Month Follow-up | 5.1 units on a scale | Standard Deviation 7 |
| 2 (Sertraline) | Depression Illness Severity Based on Beck Depression Inventory (BDI) | Baseline | 27.0 units on a scale | Standard Deviation 8 |
| 2 (Sertraline) | Depression Illness Severity Based on Beck Depression Inventory (BDI) | 3-Month Follow-up | 7.3 units on a scale | Standard Deviation 9.1 |
| 2 (Sertraline) | Depression Illness Severity Based on Beck Depression Inventory (BDI) | Post-Treatment | 10.0 units on a scale | Standard Deviation 10.2 |
| 3 (IPT) | Depression Illness Severity Based on Beck Depression Inventory (BDI) | 6-Month Follow-up | 7.8 units on a scale | Standard Deviation 8.8 |
| 3 (IPT) | Depression Illness Severity Based on Beck Depression Inventory (BDI) | Post-Treatment | 10.5 units on a scale | Standard Deviation 10.2 |
| 3 (IPT) | Depression Illness Severity Based on Beck Depression Inventory (BDI) | 3-Month Follow-up | 10.7 units on a scale | Standard Deviation 11 |
| 3 (IPT) | Depression Illness Severity Based on Beck Depression Inventory (BDI) | Baseline | 25.9 units on a scale | Standard Deviation 8.3 |
Secondary
Global Illness Severity Based on Clinical Global Impression (CGI) Scale
Measure total ranges from 1 to 7, with lower scores indicating better outcomes.
Time frame: Measured at baseline; post-treatment; and Months 3 and 6 of follow-up
| Arm | Measure | Group | Value (MEAN) | Dispersion |
|---|---|---|---|---|
| 1 (Placebo) | Global Illness Severity Based on Clinical Global Impression (CGI) Scale | Baseline | 4.1 units on a scale | Standard Deviation 0.7 |
| 1 (Placebo) | Global Illness Severity Based on Clinical Global Impression (CGI) Scale | Post-treatment | 2.1 units on a scale | Standard Deviation 1.1 |
| 1 (Placebo) | Global Illness Severity Based on Clinical Global Impression (CGI) Scale | 3-Month Follow-up | 1.9 units on a scale | Standard Deviation 1 |
| 1 (Placebo) | Global Illness Severity Based on Clinical Global Impression (CGI) Scale | 6-Month Follow-up | 1.7 units on a scale | Standard Deviation 1 |
| 2 (Sertraline) | Global Illness Severity Based on Clinical Global Impression (CGI) Scale | 6-Month Follow-up | 1.7 units on a scale | Standard Deviation 1.1 |
| 2 (Sertraline) | Global Illness Severity Based on Clinical Global Impression (CGI) Scale | Baseline | 4.0 units on a scale | Standard Deviation 0.6 |
| 2 (Sertraline) | Global Illness Severity Based on Clinical Global Impression (CGI) Scale | 3-Month Follow-up | 1.8 units on a scale | Standard Deviation 1.2 |
| 2 (Sertraline) | Global Illness Severity Based on Clinical Global Impression (CGI) Scale | Post-treatment | 2.0 units on a scale | Standard Deviation 1.2 |
| 3 (IPT) | Global Illness Severity Based on Clinical Global Impression (CGI) Scale | 6-Month Follow-up | 1.8 units on a scale | Standard Deviation 1.2 |
| 3 (IPT) | Global Illness Severity Based on Clinical Global Impression (CGI) Scale | Post-treatment | 2.0 units on a scale | Standard Deviation 1.3 |
| 3 (IPT) | Global Illness Severity Based on Clinical Global Impression (CGI) Scale | 3-Month Follow-up | 2.0 units on a scale | Standard Deviation 1.3 |
| 3 (IPT) | Global Illness Severity Based on Clinical Global Impression (CGI) Scale | Baseline | 3.9 units on a scale | Standard Deviation 0.8 |
Secondary
Hamilton Anxiety Rating Scale (HARS)
Measure total ranges from 0 to 56, with lower scores indicating better outcomes.
Time frame: Measured at baseline; post-treatment; and Months 3 and 6 of follow-up
| Arm | Measure | Group | Value (MEAN) | Dispersion |
|---|---|---|---|---|
| 1 (Placebo) | Hamilton Anxiety Rating Scale (HARS) | Baseline | 20.9 units on a scale | Standard Deviation 6.6 |
| 1 (Placebo) | Hamilton Anxiety Rating Scale (HARS) | Post-Treatment | 9.9 units on a scale | Standard Deviation 8 |
| 1 (Placebo) | Hamilton Anxiety Rating Scale (HARS) | 3-Month Follow-up | 7.4 units on a scale | Standard Deviation 7.8 |
| 1 (Placebo) | Hamilton Anxiety Rating Scale (HARS) | 6-Month Follow-up | 7.5 units on a scale | Standard Deviation 8.4 |
| 2 (Sertraline) | Hamilton Anxiety Rating Scale (HARS) | 6-Month Follow-up | 6.2 units on a scale | Standard Deviation 6.4 |
| 2 (Sertraline) | Hamilton Anxiety Rating Scale (HARS) | Baseline | 20.3 units on a scale | Standard Deviation 6.1 |
| 2 (Sertraline) | Hamilton Anxiety Rating Scale (HARS) | 3-Month Follow-up | 6.6 units on a scale | Standard Deviation 7.1 |
| 2 (Sertraline) | Hamilton Anxiety Rating Scale (HARS) | Post-Treatment | 9.4 units on a scale | Standard Deviation 7.9 |
| 3 (IPT) | Hamilton Anxiety Rating Scale (HARS) | 6-Month Follow-up | 7.3 units on a scale | Standard Deviation 8.3 |
| 3 (IPT) | Hamilton Anxiety Rating Scale (HARS) | Post-Treatment | 8.3 units on a scale | Standard Deviation 9 |
| 3 (IPT) | Hamilton Anxiety Rating Scale (HARS) | 3-Month Follow-up | 7.0 units on a scale | Standard Deviation 7.5 |
| 3 (IPT) | Hamilton Anxiety Rating Scale (HARS) | Baseline | 19.4 units on a scale | Standard Deviation 6.2 |
Secondary
Social Functioning Based on Postpartum Adjustment Questionnaire (PPAQ)
Measure total ranges from 1 to 5, with lower scores indicating better outcomes.
Time frame: Measured at baseline; post-treatment; and Months 3 and 6 of follow-up
| Arm | Measure | Group | Value (MEAN) | Dispersion |
|---|---|---|---|---|
| 1 (Placebo) | Social Functioning Based on Postpartum Adjustment Questionnaire (PPAQ) | 3-Month Follow-up | 2.3 units on a scale | Standard Deviation 0.4 |
| 1 (Placebo) | Social Functioning Based on Postpartum Adjustment Questionnaire (PPAQ) | 6-Month Follow-up | 2.3 units on a scale | Standard Deviation 0.4 |
| 1 (Placebo) | Social Functioning Based on Postpartum Adjustment Questionnaire (PPAQ) | Post-Treatment | 2.4 units on a scale | Standard Deviation 0.5 |
| 1 (Placebo) | Social Functioning Based on Postpartum Adjustment Questionnaire (PPAQ) | Baseline | 2.7 units on a scale | Standard Deviation 0.4 |
| 2 (Sertraline) | Social Functioning Based on Postpartum Adjustment Questionnaire (PPAQ) | Baseline | 2.7 units on a scale | Standard Deviation 0.4 |
| 2 (Sertraline) | Social Functioning Based on Postpartum Adjustment Questionnaire (PPAQ) | Post-Treatment | 2.2 units on a scale | Standard Deviation 0.4 |
| 2 (Sertraline) | Social Functioning Based on Postpartum Adjustment Questionnaire (PPAQ) | 6-Month Follow-up | 2.1 units on a scale | Standard Deviation 0.4 |
| 2 (Sertraline) | Social Functioning Based on Postpartum Adjustment Questionnaire (PPAQ) | 3-Month Follow-up | 2.1 units on a scale | Standard Deviation 0.4 |
| 3 (IPT) | Social Functioning Based on Postpartum Adjustment Questionnaire (PPAQ) | 6-Month Follow-up | 2.2 units on a scale | Standard Deviation 0.4 |
| 3 (IPT) | Social Functioning Based on Postpartum Adjustment Questionnaire (PPAQ) | Baseline | 2.6 units on a scale | Standard Deviation 0.4 |
| 3 (IPT) | Social Functioning Based on Postpartum Adjustment Questionnaire (PPAQ) | Post-Treatment | 2.3 units on a scale | Standard Deviation 0.4 |
| 3 (IPT) | Social Functioning Based on Postpartum Adjustment Questionnaire (PPAQ) | 3-Month Follow-up | 2.3 units on a scale | Standard Deviation 0.4 |