NCT04806230

Brief Summary

The study was a prospective naturalistic PK study of five frequently used antidepressant drugs in pregnant women; citalopram (CIT), escitalopram (ECIT), sertraline (SERT), mirtazapine (MIRT) and venlafaxine VEN) and their major metabolites (Table 1). After signing informed consent pregnant women with ongoing antidepressant treatment, regardless of indication, were recruited at nine antenatal care centers in mid- and small cities and villages in the Southeast Sweden between April 2011 and September 2013.

Trial Health

87
On Track

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
81

participants targeted

Target at P50-P75 for all trials

Timeline
Completed

Started Apr 2011

Typical duration for all trials

Geographic Reach
1 country

1 active site

Status
completed

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

Study Start

First participant enrolled

April 1, 2011

Completed
2.5 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

September 30, 2013

Completed
Same day until next milestone

Study Completion

Last participant's last visit for all outcomes

September 30, 2013

Completed
7.5 years until next milestone

First Submitted

Initial submission to the registry

March 15, 2021

Completed
4 days until next milestone

First Posted

Study publicly available on registry

March 19, 2021

Completed
Last Updated

March 19, 2021

Status Verified

March 1, 2021

Enrollment Period

2.5 years

First QC Date

March 15, 2021

Last Update Submit

March 17, 2021

Conditions

PharmacokineticsAntidepressive AgentsPregnancy

Keywords

Pharmacokineticsantidepressantspregnancy

Outcome Measures

Primary Outcomes (1)

  • Serum concentrations of drugs and metabolites

    levels of parent compound and metabolites in serum

    9 months

Study Arms (1)

Observed

Drug: sertraline, mirtazapine, venlafaxine, citalopram, escitalopram

Interventions

sertraline, mirtazapine, venlafaxine, citalopram, escitalopramDRUG

Naturalistic treatment

Observed

Eligibility Criteria

Age18 Years+
Sexfemale(Gender-based eligibility)
Age GroupsAdult (18-64), Older Adult (65+)
Sampling MethodProbability Sample
Study Population

At inclusion, median age (min-max) was 31 years (21-42) and median BMI was 25.6 (18.9-47.0)

You may qualify if:

  • Pregnancy
  • Ongoing treatment with one of the five studied antidepressants.

You may not qualify if:

  • None

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

Linköping University

Linköping, Sweden

Location

Biospecimen

Retention: SAMPLES WITH DNA

Blood samples

MeSH Terms

Interventions

SertralineMirtazapineVenlafaxine HydrochlorideCitalopramEscitalopram

Intervention Hierarchy (Ancestors)

1-NaphthylamineAminesOrganic ChemicalsNaphthalenesPolycyclic Aromatic HydrocarbonsHydrocarbons, AromaticHydrocarbons, CyclicHydrocarbonsPolycyclic CompoundsDibenzazepinesHeterocyclic Compounds, 3-RingHeterocyclic Compounds, Fused-RingHeterocyclic CompoundsCyclohexanolsHexanolsFatty AlcoholsAlcoholsPhenethylaminesEthylaminesCyclohexanesCycloparaffinsHydrocarbons, AlicyclicLipidsPropylaminesNitrilesBenzofuransHeterocyclic Compounds, 2-Ring

Study Design

Study Type
observational
Observational Model
COHORT
Time Perspective
PROSPECTIVE
Sponsor Type
OTHER GOV
Responsible Party
PRINCIPAL INVESTIGATOR
PI Title
MD

Study Record Dates

First Submitted

March 15, 2021

First Posted

March 19, 2021

Study Start

April 1, 2011

Primary Completion

September 30, 2013

Study Completion

September 30, 2013

Last Updated

March 19, 2021

Record last verified: 2021-03

Data Sharing

IPD Sharing
Will not share

Locations

SE(1)