Effectiveness of Sertraline Alone and Interpersonal Psychotherapy Alone in Treating Women With Postpartum Depression
Condition: Depression, Postpartum
MeSH terms: Depression, Postpartum; Depression; Depressive Disorder
Intervention: Sertraline; Placebo; Interpersonal psychotherapy (IPT); Clinical management; Mothercrafting
Intervention description: 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.; 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.; 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.; Clinical management includes treatment as usual for those receiving medication for depression.; 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
Intervention MeSH terms: Sertraline
Phase: Phase 2
Study type: Interventional
Primary purpose: Treatment
Allocation: Randomized
Intervention model: Parallel Assignment
Masking: Quadruple (Participant, Care Provider, Investigator, Outcomes Assessor)
Enrollment: 162.0
Sex: Female
Minimum age: 18 Years
Maximum age: 50 Years
Healthy volunteers: No
Keywords: Postpartum; Depression; Medication Therapy; Zoloft; Sertraline; Interpersonal Psychotherapy

Summary:

      This study will evaluate the effectiveness of antidepressant medication alone and
      interpersonal psychotherapy alone in treating women with postpartum depression.
    

Eligibility criteria:

        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).