Condition category
Mental and Behavioural Disorders
Date applied
20/12/2005
Date assigned
20/12/2005
Last edited
05/01/2010
Prospective/Retrospective
Retrospectively registered
Overall trial status
Completed
Recruitment status
No longer recruiting

Plain English Summary

Not provided at time of registration

Trial website

Contact information

Type

Scientific

Primary contact

Dr F.F.T. (Tessa) Ververs

ORCID ID

Contact details

University Medical Center Utrecht
Division of Perinatology and Gynaecology/Division of Laboratory and Pharmacy
Room D.00.218
P.O. Box 85500
Utrecht
3508 GA
Netherlands
+31 (0)30 250 7190
f.f.t.ververs@apoth.azu.nl

Additional identifiers

EudraCT number

ClinicalTrials.gov number

Protocol/serial number

CCMO P03.0335, UMC U 03-024; NTR346

Study information

Scientific title

Acronym

OAZE (Dutch: Onderzoek Antidepressiva tijdens Zwangerschap, een Evaluatie)

Study hypothesis

The use of modern antidepressants during pregnancy is associated with changes in foetal movement and development and can lead to serious withdrawal syndromes after birth. Antidepressant use as well as discontinuation of medication during pregnancy will have an effect on the mental development of the child.

Ethics approval

Received from the local medical ethics committee

Study design

Multicentre, non-randomised, two armed, parallel group trial

Primary study design

Interventional

Secondary study design

Randomised controlled trial

Trial setting

Hospitals

Trial type

Quality of life

Patient information sheet

Condition

Depression and pregnancy

Intervention

The study is a prospective observational study and therefore there are no interventions. Subjects enter the study as antidepressant user (group A) or as having stopped taking medication (group B).

Intervention type

Drug

Phase

Not Specified

Drug names

Antidepressants

Primary outcome measures

The effects of antidepressants are evaluated through measurements of foetal movement and development, registration of withdrawal syndromes after birth and measurement of child behaviour and development until the age of 2 years. Of 200 women who are on antidepressants during pregnancy (group A) and 200 women who stopped medication in the first trimester (group B) the social-economical status, smoking/drinking habits, co-medication, mental status (Edinburgh Depression Scale and State Trait Anxiety Inventory), specific pregnancy anxiety and blood level of the antidepressant are registered at 17, 28 and 37 weeks of pregnancy. Ultrasound recording of the foetal movements is also planned around these three time points. after delivery pregnancy outcome and observations of the baby during the first 10 days after birth are registered using the Finnigan score on withdrawal symptoms. Foetal drug exposure and neonatal drug elimination kinetics are estimated using umbilical cord blood and a blood sample of the child several hours after birth.

At 3 months, 8 months and 2 years after birth, behaviour and mental development are tested using the CBCL, child behaviour list and the IBQ infant behaviour questionnaire. The results of the two study groups A and B are compared. Dose-effect relations and level of exposure-effect relations are evaluated in relation to the severity of the withdrawal symptoms.

Secondary outcome measures

1. The positive effects of antidepressant use on the mental state of the mother during pregnancy and delivery versus the effects of discontinuation of pharmacotherapy
2. Pharmacokinetic changes of the different antidepressants in the three phases of pregnancy

Overall trial start date

12/07/2003

Overall trial end date

23/12/2006

Reason abandoned

Eligibility

Participant inclusion criteria

Women who are pregnant and use one of the modern antidepressants (selective serotonin re-uptake inhibitor [SSRI] and non-SSRI) are included at 16 weeks of pregnancy, group A. Women who stopped taking antidepressants in the first trimester or just before pregnancy are included in group B. Women must be willing and give informed consent and must be able to read in Dutch in order to fill in the questionnaires.

Participant type

Patient

Age group

Adult

Gender

Both

Target number of participants

400

Participant exclusion criteria

1. Co-medication with a similar or higher pregnancy risk factor
2. Alcohol or drug addiction

Recruitment start date

12/07/2003

Recruitment end date

23/12/2006

Locations

Countries of recruitment

Netherlands

Trial participating centre

University Medical Center Utrecht
Utrecht
3508 GA
Netherlands

Sponsor information

Organisation

University Medical Centre Utrecht (UMCU) (Netherlands)

Sponsor details

P.O. Box 85500
Utrecht
3508 GA
Netherlands

Sponsor type

University/education

Website

http://www.umcutrecht.nl/zorg/

Funders

Funder type

Industry

Funder name

Eli Lilly Nederland BV (The Netherlands)

Alternative name(s)

Funding Body Type

Funding Body Subtype

Location

Funder name

Pfizer Netherlands (The Netherlands)

Alternative name(s)

Funding Body Type

Funding Body Subtype

Location

Funder name

The Netherlands Brain Foundation (Hersenstichting Nederland) (The Netherlands)

Alternative name(s)

Funding Body Type

Funding Body Subtype

Location

Funder name

Stichting Doelmatig Geneesmiddelengebruik Midden Nederland (The Netherlands)

Alternative name(s)

Funding Body Type

Funding Body Subtype

Location

Funder name

Arijan Porsius Fonds (The Netherlands)

Alternative name(s)

Funding Body Type

Funding Body Subtype

Location

Results and Publications

Publication and dissemination plan

Not provided at time of registration

Intention to publish date

Participant level data

Not provided at time of registration

Results - basic reporting

Publication summary

2009 results in http://www.ncbi.nlm.nih.gov/pubmed/19743889

Publication citations

  1. Results

    Ververs FF, Voorbij HA, Zwarts P, Belitser SV, Egberts TC, Visser GH, Schobben AF, Effect of cytochrome P450 2D6 genotype on maternal paroxetine plasma concentrations during pregnancy., Clin Pharmacokinet, 2009, 48, 10, 677-683, doi: 10.2165/11318050-000000000-00000.

Additional files

Editorial Notes