NCT02185547终止4 期
Effects and Consequences for Mother and Child From Treatment for Depression, A Prospective Randomized, Placebo- Controlled, Trial With Internet-based Cognitive Behavior Therapy and Sertraline or Placebo for Moderate Depression in Pregnancy
Katarina Wide1 个研究点 分布在 1 个国家目标入组 17 人开始时间: 2016年2月21日最近更新:
适应症
干预措施
相关药物
试验速览
- 阶段
- 4 期
- 状态
- 终止
- 发起方
- 入组人数
- 17
- 试验地点
- 1
- 主要终点
- Cognitive development
研究概览
简要总结
This study targets women with moderate depression during pregnancy. We aim to investigate the direct effect of the newborn child and the long term consequences on the cognitive developement on children who´s mother has been treated with CBT alone or in combination with antidepressants.
详细描述
The primary objective is to study the direct neonatal effects and the long-term consequences on cognitive development in children prenatal exposed to maternal sertraline treatment compared to exposure to maternal depression treated with only ICBT.
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 55 Years（Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •Female > 18 years old
- •Pregnant, gestational week 9-
- •Verified moderate depression according to SCID-I with or without concomitant anxiety disorder.
- •Signed informed consent
- •Able to understand the Swedish language orally and in written and able to use the internet for the ICBT, including having succeded in filling out online questionnaires
- •Are willing to participate to all study visits
- •Plans to give birth at the Department of Obstetrics at Karolinska University Hospital, Huddinge or at additional study site such as Norrland University Hospital (NUS), Umeå
排除标准
- •Known drug or alcohol abuse
- •Serious psychiatric disorder such as psychosis, bipolar disorder, severe personality disorder, ADHD/ADD, autism or mental retardation) and severe melancholic or psychotic depression.
- •Known idiosyncrasy to Zoloft or allergy to one of the Zoloft excipients
- •Ongoing medication with SSRI, SNRI, TCA, mood-stabilizers, antiepileptic drugs ,psychotropic drugs, tramadol, propafenon, tolbutamid, flekainid, psychostimulants and atomoxetine, insulin or steroids
- •Any severe somatic disease that necessitate regular treatment with systemic steroids, severe heart and lung disease, kidney disease, liver disease, diabetes mellitus, or epilepsy with drug treatment.
- •Women who either during screening or treatment on self-assessment forms (MADRS-S: 4 or more points on question about suicidal ideation (question 9)) report symptoms of severe suicidal thoughts or suicide plans will be contacted for structured suicide risk assessment by telephone (by experienced staff from the unit for internet psychiatry according to clinical routine). If judged necessary patients will be booked for psychiatric assessment by study nurse. If acute assessment or care is judged necessary, referral to psychiatric emergency departments will be made according to the same routine as in regular care.
- •Also women, who contact the study personal and report symptoms of suicidal thoughts or suicide plans will receive psychiatric assessment as specified above. Women who according to psychiatric assessment have a high suicidal risk will be excluded from the study. These women will be actively transferred into necessary psychiatric treatment as usual.
- •Other factors that are clinical significant and could jeopardize study results or its intention, as judged by study psychiatrist or study obstetrician
研究组 & 干预措施
ICBT in combination with sertraline treatment
Experimental
Internet cognitive behavioral therapy in combination with sertraline treatment
干预措施: Zoloft (Drug)
ICBT
Active Comparator
Only Internet cognitive behavioral treatment, no additional depression treatment
干预措施: ICBT (Behavioral)
ICBT in combination with sertraline treatment
Experimental
Internet cognitive behavioral therapy in combination with sertraline treatment
干预措施: ICBT (Behavioral)
结局指标
主要结局
Cognitive development
时间窗: 2 years
The differences in cognitive development at 2 years evaluated by the standard Bayley Scales of Infant and Toddler Development third edition (BSID-III)®.
次要结局
- measure in MADRS_S(12 weeks, 14 weeks and 30 weeks)
- Stresshormone level(up to 3 months postpartum)
- Pharmacological assessment(4, 14, 18 weeks)
研究者
Katarina Wide
M.D associated professor
Karolinska University Hospital
研究点 (1)
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