Effects and Consequences for Mother and Child From Treatment for Depression

NCT02185547 | Terminated Phase 4

• 1 other identifier: KWMP001
• Study Type: interventional
• Target: 17
• Locations: 1 country
• Sites: 1

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.

Conditions

Pregnancy; Moderate Depression

Keywords

women

Outcome Measures

Primary Outcomes (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)®.

  2 years

Secondary Outcomes (6)

• measure in MADRS_S

  12 weeks, 14 weeks and 30 weeks

• Stresshormone level

  up to 3 months postpartum

• Pharmacological assessment

  4, 14, 18 weeks

• Pharmacological assessment

  4, 14, 18 weeks

• Pharmacological assessment

  4, 14, 18 weeks

Study Arms (2)

ICBT in combination with sertraline treatment

EXPERIMENTAL

Internet cognitive behavioral therapy in combination with sertraline treatment

Drug: Zoloft; Behavioral: ICBT

ICBT

ACTIVE COMPARATOR

Only Internet cognitive behavioral treatment, no additional depression treatment

Behavioral: ICBT

Interventions

Zoloft DRUG

Sertraline treatment 25 mg

ICBT in combination with sertraline treatment

ICBT BEHAVIORAL

Internet behavioral cognitive therapy only

ICBT; ICBT in combination with sertraline treatment

Eligibility Criteria

• Age: 18 Years - 55 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64)

You may qualify if:

• 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

You may not qualify if:

• \. 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.
• \. 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.
• \. 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.
• \. Other factors that are clinical significant and could jeopardize study results or its intention, as judged by study psychiatrist or study obstetrician

Sponsors & Collaborators

• Katarina Wide: lead

Study Sites (1)

Karolinska University Hospital

Stockholm, 14186, Sweden

Location

Related Publications (9)

• 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.

  PMID: 15046269 BACKGROUND

• 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.

  PMID: 10698324 BACKGROUND

• 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.

  PMID: 16752253 BACKGROUND

• 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.

  PMID: 10897157 BACKGROUND

• 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.

  PMID: 12061356 BACKGROUND

• 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.

  PMID: 17996635 BACKGROUND

• 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.

  PMID: 10551294 BACKGROUND

• 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.

  PMID: 21054354 BACKGROUND

• 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.

  PMID: 33751155 DERIVED

MeSH Terms

Interventions

Sertraline

Intervention Hierarchy (Ancestors)

1-Naphthylamine; Amines; Organic Chemicals; Naphthalenes; Polycyclic Aromatic Hydrocarbons; Hydrocarbons, Aromatic; Hydrocarbons, Cyclic; Hydrocarbons; Polycyclic Compounds

Study Design

• Study Type: interventional
• Phase: phase 4
• Allocation: RANDOMIZED
• Masking: QUADRUPLE
• Who Masked: PARTICIPANT, CARE PROVIDER, INVESTIGATOR, OUTCOMES ASSESSOR
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: SPONSOR INVESTIGATOR
• PI Title: M.D associated professor

Study Record Dates

• First Submitted: July 6, 2014
• First Posted: July 9, 2014
• Study Start: February 21, 2016
• Primary Completion: November 4, 2019
• Study Completion: November 4, 2019
• Last Updated: January 18, 2020

Record last verified: 2020-01

Locations

SE (1)