Effects and Consequences for Mother and Child From Treatment for Depression

Pregnancy Clinical Trial

— 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

Clinical Trial Details — Status: Terminated

Administrative data

• NCT number: NCT02185547
• Other study ID #: KWMP001
• Status: Terminated
• Phase: Phase 4
• Start date: February 21, 2016
• Est. completion date: November 4, 2019

Study information

• Verified date: January 2020
• Source: Karolinska University Hospital
• Contact: n/a
• Is FDA regulated: No
• Study type: Interventional

Clinical 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.

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.

Recruitment information / eligibility

• Status: Terminated
• Enrollment: 17
• Est. completion date: November 4, 2019
• Est. primary completion date: November 4, 2019
• Accepts healthy volunteers: No
• Gender: All
• Age group: 18 Years to 55 Years

Eligibility

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

Related Conditions & MeSH terms

• Depression
• Depressive Disorder
• Moderate Depression
• Pregnancy

Intervention

Drug:
• Zoloft
Sertraline treatment 25 mg

Behavioral:
• ICBT
Internet behavioral cognitive therapy only

Locations

Country	Name	City	State
Sweden	Karolinska University Hospital	Stockholm

Sponsors (1)

Lead Sponsor	Collaborator
Katarina Wide

Country where clinical trial is conducted

Sweden, 

References & Publications (8)

Fahnehjelm KT, Wide K, Ygge J, Hellström A, Tomson T, Winbladh B, Strömland K. Visual and ocular outcome in children after prenatal exposure to antiepileptic drugs. Acta Ophthalmol Scand. 1999 Oct;77(5):530-5. — View Citation

Forsberg L, Wide K, Källén 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. — View 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. — View 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. — View 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. — View Citation

Wide K, Winbladh B, Källén 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. — View Citation

Wide K, Winbladh B, Tomson T, Källén B. Body dimensions of infants exposed to antiepileptic drugs in utero: observations spanning 25 years. Epilepsia. 2000 Jul;41(7):854-61. — View 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. Erratum in: Dev Med Child Neurol 2000 May;42(5):356. — View Citation

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	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)®.	2 years
Secondary	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	12 weeks, 14 weeks and 30 weeks
Secondary	Stresshormone level	Effects on levels of S-hCG, cytokines,	up to 3 months postpartum
Secondary	Pharmacological assessment	Plasma sertraline concentrations.	4, 14, 18 weeks
Secondary	Pharmacological assessment	Pharmacokinetic variations in the metabolism of sertraline. Assess activity of enzymes regulating the metabolism of sertralin.	4, 14, 18 weeks
Secondary	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.	4, 14, 18 weeks
Secondary	Pharmacological assessment	Effects on prolactin levels. Assess prolactin.	4, 14, 18 weeks