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PregnancyPhase 4MAGDALENANCT02185547

Effects and Consequences for Mother and Child From Treatment for Depression

A Phase 4 study testing Zoloft and ICBT in people with Pregnancy and Moderate Depression, run by Katarina Wide at 1 site in Sweden.

Terminated

Stopped early. The study ended before it was planned to and will not resume.

Official record
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Trial 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. Read more about this study

Who is it for?
Ages 18 to 55 years
Conditions the study is for
Pregnancy, Moderate Depression
What is being tested?
Zoloft and ICBT
Could I receive a placebo?
No, everyone receives an active treatment
How many people
17 participants
Where
1 siteSweden
Study dates
21 Feb 2016to 4 Nov 2019
Phase
Phase 4
Are there results?
None posted in the registry

Key requirements

Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.

  • Ages 18 to 55 years
  • All sexes
  • No healthy volunteers
  • Adult

Who may be able to join

  • Female > 18 years old
  • Pregnant, gestational week 9-21.
  • 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

Who cannot join

  • 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

Trial locations and contacts

1 site in 1 country.

Sweden1 site

  • Karolinska University Hospital

    Stockholm, 14186

Other trials in Sweden

About this study

Official title: 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.

Read the 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.

Being tested
Zoloft, ICBT
Keywords
women

What participants receive

What participants receive. In a randomised study each person is assigned to one group by chance.

  • ZoloftDrug

    Sertraline treatment 25 mg

  • ICBTBehavioural

    Internet behavioral cognitive therapy only

Study groups in NCT02185547
Study groupRoleWhat they receive
ICBT in combination with sertraline treatmentExperimentalInternet cognitive behavioral therapy in combination with sertraline treatment
Receives: Drug: Zoloft; Behavioral: ICBT
ICBTActive comparatorOnly Internet cognitive behavioral treatment, no additional depression treatment
Receives: Behavioral: ICBT

What is being measured

The primary outcome is the main question the study is designed to answer.

  1. Cognitive development

    The differences in cognitive development at 2 years evaluated by the standard Bayley Scales of Infant and Toddler Development third edition (BSID-III)®.

    Measured: 2 years

Secondary outcomes (6)

  1. measure in MADRS_S

    1. 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

    Measured: 12 weeks, 14 weeks and 30 weeks

  2. Stresshormone level

    Effects on levels of S-hCG, cytokines,

    Measured: up to 3 months postpartum

  3. Pharmacological assessment

    Plasma sertraline concentrations.

    Measured: 4, 14, 18 weeks

  4. Pharmacological assessment

    Pharmacokinetic variations in the metabolism of sertraline. Assess activity of enzymes regulating the metabolism of sertralin.

    Measured: 4, 14, 18 weeks

  5. Pharmacological assessment

    Genetic variations in the metabolism of sertraline. Assess concentration of sertralin and markers for metabolism of sertralin on specific regions of sertralin pathways.

    Measured: 4, 14, 18 weeks

  6. Pharmacological assessment

    Effects on prolactin levels. Assess prolactin.

    Measured: 4, 14, 18 weeks

Timeline

From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.

  1. First posted9 Jul 2014 (estimated)
  2. Study start21 Feb 2016
  3. Primary completion4 Nov 2019
  4. Study completion4 Nov 2019

Why it stopped: Difficulties in recruiting participants.

Resources

More details

For doctors and researchers: how the study is designed, who runs it, and its registry IDs.

Study design
Study type
Interventional
Phase
Phase 4
Primary purpose
Treatment
Allocation
Randomised
Intervention model
Parallel groups
Masking
Quadruple blind
Who is masked
Participant, Care provider, Investigator, Outcomes assessor
Enrolment
17 participants (actual)
IDs, dates and publications
ClinicalTrials.gov ID
NCT02185547
Sponsor's protocol ID
KWMP001
Acronym
MAGDALENA
Status last verified
Jan 2020
First submitted
6 Jul 2014
Last updated
18 Jan 2020
Results posted
No
Data monitoring committee
No

Publications

  • Wide K, Winbladh B, Kallen B. Major malformations in infants exposed to antiepileptic drugs in utero, with emphasis on carbamazepine and valproic acid: a nation-wide, population-based register study. Acta Paediatr. 2004 Feb;93(2):174-6. doi: 10.1080/08035250310021118.

    PubMed 15046269

  • Wide K, Winbladh B, Tomson T, Sars-Zimmer K, Berggren E. Psychomotor development and minor anomalies in children exposed to antiepileptic drugs in utero: a prospective population-based study. Dev Med Child Neurol. 2000 Feb;42(2):87-92. doi: 10.1017/s0012162200000177.

    PubMed 10698324

  • Pilo C, Wide K, Winbladh B. Pregnancy, delivery, and neonatal complications after treatment with antiepileptic drugs. Acta Obstet Gynecol Scand. 2006;85(6):643-6. doi: 10.1080/00016340600604625.

    PubMed 16752253

  • Wide K, Winbladh B, Tomson T, Kallen B. Body dimensions of infants exposed to antiepileptic drugs in utero: observations spanning 25 years. Epilepsia. 2000 Jul;41(7):854-61. doi: 10.1111/j.1528-1157.2000.tb00253.x.

    PubMed 10897157

  • Wide K, Henning E, Tomson T, Winbladh B. Psychomotor development in preschool children exposed to antiepileptic drugs in utero. Acta Paediatr. 2002;91(4):409-14. doi: 10.1080/080352502317371643.

    PubMed 12061356

  • Tomson T, Battino D, French J, Harden C, Holmes L, Morrow J, Robert-Gnansia E, Scheuerle A, Vajda F, Wide K, Gordon J. Antiepileptic drug exposure and major congenital malformations: the role of pregnancy registries. Epilepsy Behav. 2007 Nov;11(3):277-82. doi: 10.1016/j.yebeh.2007.08.015.

    PubMed 17996635

  • Fahnehjelm KT, Wide K, Ygge J, Hellstrom A, Tomson T, Winbladh B, Stromland K. Visual and ocular outcome in children after prenatal exposure to antiepileptic drugs. Acta Ophthalmol Scand. 1999 Oct;77(5):530-5. doi: 10.1034/j.1600-0420.1999.770509.x.

    PubMed 10551294

  • Forsberg L, Wide K, Kallen B. School performance at age 16 in children exposed to antiepileptic drugs in utero--a population-based study. Epilepsia. 2011 Feb;52(2):364-9. doi: 10.1111/j.1528-1167.2010.02778.x. Epub 2010 Nov 3.

    PubMed 21054354

  • Heinonen E, Blennow M, Blomdahl-Wetterholm M, Hovstadius M, Nasiell J, Pohanka A, Gustafsson LL, Wide K. Sertraline concentrations in pregnant women are steady and the drug transfer to their infants is low. Eur J Clin Pharmacol. 2021 Sep;77(9):1323-1331. doi: 10.1007/s00228-021-03122-z. Epub 2021 Mar 22.

    PubMed 33751155

Questions about this trial

What is this clinical trial studying?

A Phase 4 study testing Zoloft and ICBT in people with Pregnancy and Moderate Depression, run by Katarina Wide at 1 site in Sweden.

The full registered description is in the About this study section and the official record.

Who may be eligible to take part?

The sponsor lists 7 inclusion and 5 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.

Is this clinical trial currently recruiting?

The record says: stopped early, as of the sponsor's last update on 18 Jan 2020. Status can change between updates, so confirm with the study contact before making plans.

Where is the study taking place?

The record lists 1 site in Sweden. Whether a site is taking part right now should be confirmed with that site. See every site.

What are the possible benefits and risks?

They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.

What does this phase mean?

Phase 4 studies take place after a treatment is approved, to learn more about its long-term benefits and risks in everyday use.

Not every study follows the same path, and some studies (observational studies, device studies) have no phase.

Are results available for this study?

The study was stopped early (reason given: Difficulties in recruiting participants.). Results are not available in the source record.

How can a doctor refer a patient or contact the research team?

The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.

What does the primary outcome measure?

Cognitive development (time frame: 2 years). It is what the study was designed to measure, not a finding.

Where can I read the original study information?

On the ClinicalTrials.gov record for NCT02185547, which also lists 9 linked publications.

Does a listing mean the treatment is approved or proven to work?

No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.

How often is this information updated?

AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 18 Jan 2020.

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