Effects and Consequences for Mother and Child From Treatment for Depression (MAGDALENA)

January 13, 2020 updated by: Katarina Wide

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

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.

Study Overview

Status

Terminated

Conditions

Intervention / Treatment

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.

Study Type

Interventional

Enrollment (Actual)

17

Phase

  • Phase 4

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Locations

  • Sweden
      • Stockholm, Sweden, 14186
        • Karolinska University Hospital

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

14 years to 51 years (Adult)

Accepts Healthy Volunteers

No

Genders Eligible for Study

All

Description

Inclusion Criteria:

  1. Female > 18 years old
  2. Pregnant, gestational week 9-21.
  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, including having succeded in filling out online questionnaires
  6. Are willing to participate to all study visits
  7. 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:

  • 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 Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Primary Purpose: Treatment
  • Allocation: Randomized
  • Interventional Model: Parallel Assignment
  • Masking: Quadruple

Arms and Interventions

Participant Group / Arm
Intervention / Treatment
Experimental: ICBT in combination with sertraline treatment
Internet cognitive behavioral therapy in combination with sertraline treatment
Drug: Zoloft
Sertraline treatment 25 mg
Behavioral: ICBT
Internet behavioral cognitive therapy only
Active Comparator: ICBT
Only Internet cognitive behavioral treatment, no additional depression treatment
Behavioral: ICBT
Internet behavioral cognitive therapy only

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Measure Description
Time Frame
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)®.
2 years

Secondary Outcome Measures

Outcome Measure
Measure Description
Time Frame
measure in MADRS_S
Time Frame: 12 weeks, 14 weeks and 30 weeks
a) Add-on effect of sertraline measured in difference i) in self-report of depressive symptoms (MADRS-S),ii) in rate of remission from depression (measured by diagnostic psychiatric interview with MADRS at -12weeks, 14 weeks, and 30 weeks (= 3 months postpartum) of treatment
12 weeks, 14 weeks and 30 weeks
Stresshormone level
Time Frame: up to 3 months postpartum
Effects on levels of S-hCG, cytokines,
up to 3 months postpartum
Pharmacological assessment
Time Frame: 4, 14, 18 weeks
Plasma sertraline concentrations.
4, 14, 18 weeks
Pharmacological assessment
Time Frame: 4, 14, 18 weeks
Pharmacokinetic variations in the metabolism of sertraline. Assess activity of enzymes regulating the metabolism of sertralin.
4, 14, 18 weeks
Pharmacological assessment
Time Frame: 4, 14, 18 weeks
Genetic variations in the metabolism of sertraline. Assess concentration of sertralin and markers for metabolism of sertralin on specific regions of sertralin pathways.
4, 14, 18 weeks
Pharmacological assessment
Time Frame: 4, 14, 18 weeks
Effects on prolactin levels. Assess prolactin.
4, 14, 18 weeks

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Katarina Wide

Publications and helpful links

The person responsible for entering information about the study voluntarily provides these publications. These may be about anything related to the study.

General Publications

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start (Actual)

February 21, 2016

Primary Completion (Actual)

November 4, 2019

Study Completion (Actual)

November 4, 2019

Study Registration Dates

First Submitted

July 6, 2014

First Submitted That Met QC Criteria

July 8, 2014

First Posted (Estimate)

July 9, 2014

Study Record Updates

Last Update Posted (Actual)

January 18, 2020

Last Update Submitted That Met QC Criteria

January 13, 2020

Last Verified

January 1, 2020

More Information

Terms related to this study

Keywords

Additional Relevant MeSH Terms

Other Study ID Numbers

  • KWMP001

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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