Clinical Trials/NCT02185547

NCT02185547

Terminated

Phase 4

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 site in 1 country17 target enrollmentFebruary 21, 2016

ConditionsPregnancy Moderate Depression

InterventionsZoloft ICBT

DrugsZoloft

Overview

Phase: Phase 4
Intervention: Zoloft
Conditions: Pregnancy
Sponsor: Katarina Wide
Enrollment: 17
Locations: 1
Primary Endpoint: Cognitive development
Status: Terminated
Last Updated: 6 years ago

Overview Investigators Eligibility Criteria Arms & Interventions Outcomes Sites Similar Trials

Overview

Brief Summary

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.

Detailed Description

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.

Registry

clinicaltrials.gov

Start Date

February 21, 2016

End Date

November 4, 2019

Last Updated

6 years ago

Study Type

Interventional

Study Design

Parallel

Sex

All

Investigators

Sponsor

Katarina Wide

Responsible Party

Sponsor Investigator

Principal Investigator

Katarina Wide

M.D associated professor

Karolinska University Hospital

Eligibility Criteria

Inclusion Criteria

•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

Exclusion Criteria

•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

Arms & Interventions

ICBT in combination with sertraline treatment

Internet cognitive behavioral therapy in combination with sertraline treatment

Intervention: Zoloft

ICBT

Only Internet cognitive behavioral treatment, no additional depression treatment

Intervention: ICBT

ICBT in combination with sertraline treatment

Internet cognitive behavioral therapy in combination with sertraline treatment

Intervention: ICBT

Outcomes

Primary Outcomes

Cognitive development

Time Frame: 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)®.