Effectiveness of Sertraline Alone and Interpersonal Psychotherapy Alone in Treating Women With Postpartum Depression - Full Text View

Sponsor:	National Institute of Mental Health (NIMH)
Information provided by:	National Institute of Mental Health (NIMH)
ClinicalTrials.gov Identifier:	NCT00602355

Purpose

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

Condition	Intervention	Phase
Depression, Postpartum	Drug: Sertraline Drug: Placebo Behavioral: Interpersonal psychotherapy (IPT) Behavioral: Clinical management	Phase II

Study Type:	Interventional
Study Design:	Treatment, Randomized, Double Blind (Subject, Caregiver, Investigator, Outcomes Assessor), Placebo Control, Parallel Assignment, Efficacy Study
Official Title:	Placebo Controlled Trial of Sertraline and Interpersonal Psycho-Therapy for Postpartum Depression

Resource links provided by NLM:

MedlinePlus related topics: Depression Postpartum Care Postpartum Depression

Drug Information available for: Sertraline hydrochloride Sertraline

U.S. FDA Resources

Further study details as provided by National Institute of Mental Health (NIMH):

Primary Outcome Measures:

Hamilton Depression Rating Scale (HAM-D) [ Time Frame: Measured at baseline; Weeks 4, 8, and 12 of treatment; and Months 3 and 6 of follow-up ] [ Designated as safety issue: No ]

Secondary Outcome Measures:

Depression illness severity based on Beck Depression Inventory (BDI) and Edinburgh Postnatal Depression Scale (EPDS) [ Time Frame: Measured at baseline; Weeks 4, 8, and 12 of treatment; and Months 3 and 6 of follow-up ] [ Designated as safety issue: No ]
General illness severity based on Clinical Global Impression (CGI) scale [ Time Frame: Measured at baseline; Weeks 4, 8, and 12 of treatment; and Months 3 and 6 of follow-up ] [ Designated as safety issue: No ]
Social functioning based on Postpartum Adjustment Questionnaire (PPAQ) [ Time Frame: Measured at baseline; Weeks 4, 8, and 12 of treatment; and Months 3 and 6 of follow-up ] [ Designated as safety issue: No ]
Anxiety based on Beck Anxiety Inventory (BAI) [ Time Frame: Measured at baseline; Weeks 4, 8, and 12 of treatment; and Months 3 and 6 of follow-up ] [ Designated as safety issue: No ]

Estimated Enrollment:	150
Study Start Date:	February 2008
Estimated Study Completion Date:	June 2012
Estimated Primary Completion Date:	June 2012 (Final data collection date for primary outcome measure)

Arms	Assigned Interventions
1: Placebo Comparator Participants taking placebo pill plus clinical management	Drug: Placebo Participants taking the placebo will follow the same titration schedule as those taking sertraline. Behavioral: Clinical management Clinical management includes treatment as usual for those receiving medication for depression.
2: Active Comparator Participants receiving medication treatment alone with sertraline plus clinical management	Drug: Sertraline Participants assigned to sertraline treatment will take 50 to 100 mg daily for Weeks 1 through 3, and dosage will be increased to 150 to 200 mg daily in Weeks 4 through 8. However, participants who have not fully responded by Week 10 will be titrated up to 200 mg daily for the final 2 weeks of treatment. Behavioral: Clinical management Clinical management includes treatment as usual for those receiving medication for depression.
3: Active Comparator Participants receiving interpersonal psychotherapy (IPT) alone	Behavioral: Interpersonal psychotherapy (IPT) IPT will be administered in 12 individual 45-minute sessions over 12 weeks. These sessions will focus on improving relationships with others, setting goals, and increasing coping skills.

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 12 weeks. Participants assigned to take sertraline or placebo will attend eight 30-minute sessions over the 12-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 45-minute sessions over the 12-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 12 weeks of treatment, participants will undergo follow-up visits occurring at Weeks 1 or 2 and 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.

Eligibility

Ages Eligible for Study:	18 Years to 65 Years
Genders Eligible for Study:	Female
Accepts Healthy Volunteers:	No

Criteria

Inclusion Criteria:

Primary DSM-IV diagnosis of major depressive disorder by clinical interview
Score of greater than 15 on HAM-D
Delivery of an infant within the 6 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
Breastfeeding
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).

Contacts and Locations

Please refer to this study by its ClinicalTrials.gov identifier: NCT00602355

Locations

United States, Iowa
University of Iowa	Recruiting
Iowa City, Iowa, United States, 52242
Contact: Jennifer Bowman-Reif 319-335-0307 jennifer-bowman-reif@uiowa.edu
Principal Investigator: Scott Stuart, MD
United States, Rhode Island
Women and Infants Hospital	Recruiting
Providence, Rhode Island, United States, 02905
Contact: Sarah Sullivan 401-274-1122 ext 2865 sasullivan@wihri.org
Principal Investigator: Caron Zlotnick, PhD

Sponsors and Collaborators

National Institute of Mental Health (NIMH)

Investigators

Principal Investigator:	Caron Zlotnick	Women and Infants' Hospital
Principal Investigator:	Scott Stuart, MD	University of Iowa

More Information

No publications provided

Responsible Party:	Women and Infants Hospital ( Caron Zlotnick, PhD )
Study ID Numbers:	R01 MH074919, R01 MH074636, DSIR 83-ATP
Study First Received:	January 23, 2008
Last Updated:	March 13, 2009
ClinicalTrials.gov Identifier:	NCT00602355 History of Changes
Health Authority:	United States: Federal Government

Keywords provided by National Institute of Mental Health (NIMH):

Postpartum
Depression
Medication Therapy

Zoloft
Sertraline
Interpersonal Psychotherapy

Additional relevant MeSH terms:

Depression
Puerperal Disorders
Depression, Postpartum
Depressive Disorder
Neurotransmitter Agents
Neurotransmitter Uptake Inhibitors
Pregnancy Complications
Molecular Mechanisms of Pharmacological Action
Physiological Effects of Drugs
Psychotropic Drugs

Serotonin Uptake Inhibitors
Pharmacologic Actions
Behavioral Symptoms
Serotonin Agents
Mental Disorders
Therapeutic Uses
Mood Disorders
Sertraline
Central Nervous System Agents
Antidepressive Agents

ClinicalTrials.gov processed this record on February 08, 2010