Treatment of maternal depression during pregnancy-efects for the mother and the child.

Phase 1

• Conditions: Prosepctive randomized two armed study to evaluate moderate depression during pregnancy treated with interbnetbased CBT and sertarline or placebo and longterm outcome in the children.Secondary objectives are effects on pregnancy, maternal bleeding, and epigenetic changes inthe mother and child.; Therapeutic area: Diseases [C] - Nervous System Diseases [C10]

• Registration Number: EUCTR2013-004444-31-SE

Brief Summary

Not available

Detailed Description

Not available

Study Timeline

• Results First Posted: 1900-01-01
• Study Start: 2015-01-13
• Last Update Posted: 1 February 2020

Recruitment & Eligibility

• Status: ot Recruiting
• Sex: Female
• Target Recruitment: 200

Inclusion Criteria

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

Exclusion Criteria

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.

Study & Design

• Study Type: Interventional clinical trial of medicinal product
• Study Design: Not specified