Effects and Consequences for Mother and Child From Treatment for Depression

Phase 4

Terminated

• Conditions: Pregnancy; Moderate Depression
• Interventions: Drug: Zoloft; Behavioral: ICBT

• Registration Number: NCT02185547
• Lead Sponsor: Katarina Wide

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.

Study Timeline

• Study First Submitted: 2014-07-06
• Study First Submitted QC: 2014-07-08
• Study First Posted: 2014-07-09
• Study Start: 2016-02-21
• Primary Completion: 2019-11-04
• Study Completion: 2019-11-04
• Status Verified: 2020-01
• Last Update Submitted: 2020-01-13
• Last Update Posted: 2020-01-18

Recruitment & Eligibility

• Status: TERMINATED
• Sex: All
• Target Recruitment: 17

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.

  2. 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.

  3. 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 & Design

• Study Type: INTERVENTIONAL
• Study Design: PARALLEL

Arm && Interventions

Group	Intervention	Description
ICBT in combination with sertraline treatment	ICBT	Internet cognitive behavioral therapy in combination with sertraline treatment
ICBT	ICBT	Only Internet cognitive behavioral treatment, no additional depression treatment
ICBT in combination with sertraline treatment	Zoloft	Internet cognitive behavioral therapy in combination with sertraline treatment

Primary Outcome Measures

Name	Time	Method
Cognitive development	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)®.

Secondary Outcome Measures

Name	Time	Method
measure in MADRS_S	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
Stresshormone level	up to 3 months postpartum	Effects on levels of S-hCG, cytokines,
Pharmacological assessment	4, 14, 18 weeks	Effects on prolactin levels. Assess prolactin.

Trial Locations

Locations (1)

Karolinska University Hospital; 🇸🇪 Stockholm, Sweden