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

Primary Purpose

Pregnancy, Moderate Depression

Status
Terminated
Phase
Phase 4
Locations
Sweden
Study Type
Interventional
Intervention
Zoloft
ICBT
Sponsored by
Katarina Wide
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional treatment trial for Pregnancy focused on measuring women

Eligibility Criteria

18 Years - 55 Years (Adult)All SexesDoes not accept healthy volunteers

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

Sites / Locations

  • Karolinska University Hospital

Arms of the Study

Arm 1

Arm 2

Arm Type

Experimental

Active Comparator

Arm Label

ICBT in combination with sertraline treatment

ICBT

Arm Description

Internet cognitive behavioral therapy in combination with sertraline treatment

Only Internet cognitive behavioral treatment, no additional depression treatment

Outcomes

Primary Outcome Measures

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)®.

Secondary Outcome Measures

measure in MADRS_S
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
Stresshormone level
Effects on levels of S-hCG, cytokines,
Pharmacological assessment
Plasma sertraline concentrations.
Pharmacological assessment
Pharmacokinetic variations in the metabolism of sertraline. Assess activity of enzymes regulating the metabolism of sertralin.
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.
Pharmacological assessment
Effects on prolactin levels. Assess prolactin.

Full Information

First Posted
July 6, 2014
Last Updated
January 13, 2020
Sponsor
Katarina Wide
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1. Study Identification

Unique Protocol Identification Number
NCT02185547
Brief Title
Effects and Consequences for Mother and Child From Treatment for Depression
Acronym
MAGDALENA
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
Study Type
Interventional

2. Study Status

Record Verification Date
January 2020
Overall Recruitment Status
Terminated
Why Stopped
Difficulties in recruiting participants.
Study Start Date
February 21, 2016 (Actual)
Primary Completion Date
November 4, 2019 (Actual)
Study Completion Date
November 4, 2019 (Actual)

3. Sponsor/Collaborators

Responsible Party, by Official Title
Sponsor-Investigator
Name of the Sponsor
Katarina Wide

4. Oversight

Data Monitoring Committee
No

5. Study Description

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.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Pregnancy, Moderate Depression
Keywords
women

7. Study Design

Primary Purpose
Treatment
Study Phase
Phase 4
Interventional Study Model
Parallel Assignment
Masking
ParticipantCare ProviderInvestigatorOutcomes Assessor
Allocation
Randomized
Enrollment
17 (Actual)

8. Arms, Groups, and Interventions

Arm Title
ICBT in combination with sertraline treatment
Arm Type
Experimental
Arm Description
Internet cognitive behavioral therapy in combination with sertraline treatment
Arm Title
ICBT
Arm Type
Active Comparator
Arm Description
Only Internet cognitive behavioral treatment, no additional depression treatment
Intervention Type
Drug
Intervention Name(s)
Zoloft
Intervention Description
Sertraline treatment 25 mg
Intervention Type
Behavioral
Intervention Name(s)
ICBT
Intervention Description
Internet behavioral cognitive therapy only
Primary Outcome Measure Information:
Title
Cognitive development
Description
The differences in cognitive development at 2 years evaluated by the standard Bayley Scales of Infant and Toddler Development third edition (BSID-III)®.
Time Frame
2 years
Secondary Outcome Measure Information:
Title
measure in MADRS_S
Description
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
Time Frame
12 weeks, 14 weeks and 30 weeks
Title
Stresshormone level
Description
Effects on levels of S-hCG, cytokines,
Time Frame
up to 3 months postpartum
Title
Pharmacological assessment
Description
Plasma sertraline concentrations.
Time Frame
4, 14, 18 weeks
Title
Pharmacological assessment
Description
Pharmacokinetic variations in the metabolism of sertraline. Assess activity of enzymes regulating the metabolism of sertralin.
Time Frame
4, 14, 18 weeks
Title
Pharmacological assessment
Description
Genetic variations in the metabolism of sertraline. Assess concentration of sertralin and markers for metabolism of sertralin on specific regions of sertralin pathways.
Time Frame
4, 14, 18 weeks
Title
Pharmacological assessment
Description
Effects on prolactin levels. Assess prolactin.
Time Frame
4, 14, 18 weeks

10. Eligibility

Sex
All
Minimum Age & Unit of Time
18 Years
Maximum Age & Unit of Time
55 Years
Accepts Healthy Volunteers
No
Eligibility Criteria
Inclusion Criteria: 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 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
Facility Information:
Facility Name
Karolinska University Hospital
City
Stockholm
ZIP/Postal Code
14186
Country
Sweden

12. IPD Sharing Statement

Citations:
PubMed Identifier
15046269
Citation
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.
Results Reference
background
PubMed Identifier
10698324
Citation
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. Erratum In: Dev Med Child Neurol 2000 May;42(5):356.
Results Reference
background
PubMed Identifier
16752253
Citation
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.
Results Reference
background
PubMed Identifier
10897157
Citation
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.
Results Reference
background
PubMed Identifier
12061356
Citation
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.
Results Reference
background
PubMed Identifier
17996635
Citation
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.
Results Reference
background
PubMed Identifier
10551294
Citation
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.
Results Reference
background
PubMed Identifier
21054354
Citation
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.
Results Reference
background
PubMed Identifier
33751155
Citation
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.
Results Reference
derived

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Effects and Consequences for Mother and Child From Treatment for Depression

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