EUCTR2013-004444-31-SE进行中（未招募）1 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 - Magdalena
未提供0 个研究点目标入组 200 人开始时间: 2015年1月13日最近更新:
试验速览
- 阶段
- 1 期
- 状态
- 进行中（未招募）
- 入组人数
- 200
研究概览
简要总结
暂无简介。
研究设计
- 研究类型
- Interventional clinical trial of medicinal product
入排标准
- 性别
- Female
入选标准
- •1.Female > 18 years old
- •2.Pregnant, gestational week 11-17 .
- •3.Verified moderate depression according to SCID-I with or without concomitant anxiety disorder.
- •4.Signed informed consent
- •5.Able to understand the Swedish language orally and in written and able to use the internet for the ICBT
- •6.Are willing to participate to all study visits
- •7.Plans to give birth at the Department of Obstetrics at Karolinska University Hospital, Huddinge
- •Are the trial subjects under 18? no
- •Number of subjects for this age range:
- •F.1.2 Adults (18-64 years) yes
- •F.1.2.1 Number of subjects for this age range 200
- •F.1.3 Elderly (>=65 years) no
- •F.1.3.1 Number of subjects for this age range
排除标准
- •Any of the below mentioned:
- •1.Known drug or alcohol abuse
- •2.Serious psychiatric disorder such as psychosis, bipolar disorder, severe personality disorder, ADHD/ADD, autism or mental retardation) and severe melancholic or psychotic depression.
- •3.Known idiosyncrasy to Zoloft or allergy to one of the Zoloft excipients
- •4.Ongoing medication with SSRI, SNRI, TCA, mood-stabilizers, antiepileptic drugs ,psychotropic drugs, tramadol, propafenon, tolbutamid, flekainid, psychostimulants and atomoxetine, insulin or steroids
- •5.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.
- •6.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.
- •7.Other factors that are clinical significant and could jeopardize study results or its intention, as judged by study psychiatrist or study obstetrician.
研究者
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