Placebo Controlled Trial of Sertraline and Interpersonal Psycho-Therapy for Postpartum Depression
试验速览
- 阶段
- 2 期
- 状态
- 已完成
- 发起方
- 入组人数
- 162
- 试验地点
- 2
- 主要终点
- Hamilton Depression Rating Scale (HAM-D)
研究概览
简要总结
This study will evaluate the effectiveness of antidepressant medication alone and interpersonal psychotherapy alone in treating women with postpartum depression.
详细描述
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.
研究设计
- 研究类型
- Interventional
- 分配方式
- Randomized
- 干预模型
- Parallel
- 主要目的
- Treatment
- 盲法
- Quadruple (Participant, Care Provider, Investigator, Outcomes Assessor)
入排标准
- 年龄范围
- 18 Years 至 50 Years（Adult）
- 性别
- Female
- 接受健康志愿者
- 否
入选标准
- •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
排除标准
- •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).
研究组 & 干预措施
1 (Placebo)
Participants receiving placebo pill with clinical management plus mothercrafting
干预措施: Mothercrafting (Behavioral)
1 (Placebo)
Participants receiving placebo pill with clinical management plus mothercrafting
干预措施: Placebo (Drug)
1 (Placebo)
Participants receiving placebo pill with clinical management plus mothercrafting
干预措施: Clinical management (Behavioral)
2 (Sertraline)
Participants receiving active medication sertraline with clinical management plus mothercrafting
干预措施: Sertraline (Drug)
2 (Sertraline)
Participants receiving active medication sertraline with clinical management plus mothercrafting
干预措施: Clinical management (Behavioral)
2 (Sertraline)
Participants receiving active medication sertraline with clinical management plus mothercrafting
干预措施: Mothercrafting (Behavioral)
3 (IPT)
Participants receiving interpersonal psychotherapy (IPT) alone
干预措施: Interpersonal psychotherapy (IPT) (Behavioral)
结局指标
主要结局
Hamilton Depression Rating Scale (HAM-D)
时间窗: 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.
次要结局
- Depression Illness Severity Based on Beck Depression Inventory (BDI)(Measured at baseline; post-treatment; and Months 3 and 6 of follow-up)
- Global Illness Severity Based on Clinical Global Impression (CGI) Scale(Measured at baseline; post-treatment; and Months 3 and 6 of follow-up)
- Social Functioning Based on Postpartum Adjustment Questionnaire (PPAQ)(Measured at baseline; post-treatment; and Months 3 and 6 of follow-up)
- Hamilton Anxiety Rating Scale (HARS)(Measured at baseline; post-treatment; and Months 3 and 6 of follow-up)
研究者
Caron Zlotnick
Director of Behavioral Medicine Research
Women and Infants Hospital of Rhode Island