PharmacokineticsPAPANCT04806230
Serum Concentrations of Antidepressant Drugs in Pregnant Women - a Naturalistic Study
An observational study of Pharmacokinetics and Antidepressive Agents, run by Linkoeping University at 1 site in Sweden.
Trial 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). Read more about this study
- Who is it for?
- Ages 18 years and older, women only
- Conditions the study is for
- Pharmacokinetics, Antidepressive Agents, Pregnancy
- What is being tested?
- sertraline, mirtazapine, venlafaxine, citalopram, escitalopram
- How many people
- 81 participants
- Where
- 1 siteSweden
- Study dates
- 1 Apr 2011to 30 Sep 2013
- Phase
- Observational
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 years and older
- Women only
- Adult, Older adult
Study population: At inclusion, median age (min-max) was 31 years (21-42) and median BMI was 25.6 (18.9-47.0)
Who may be able to join
- Pregnancy
- Ongoing treatment with one of the five studied antidepressants.
Who cannot join
- None
Trial locations and contacts
1 site in 1 country.
About this study
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.
Read the detailed description
Serum samples for the antidepressant drug and metabolite(s) concentrations, albumin and creatinine were collected at the first prenatal appointment and at gestational week 15, 20, 25, 35 and at partus. The time interval between drug intake and sampling was registered in all cases. At partus, a serum samples from the umbilical cord was collected drug concentration was assessed. At the first prenatal appointment a blood sample for analyzing the CYP2D6 and CYP2C19 genotype was also collected. All drug concentration analysis were executed post hoc, after last partus, whereas physiological parameters were part of normal routine sampling. Concomitant medication, weight changes and smoking habits were registered throughout the pregnancies.
Our main findings were that dose corrected serum concentrations of neither sertralin nor citalopram changed during the pregnancy. In addition, concentrations of escitalopram and venlafaxine and their metabolites appeared to be stable throughout pregnancy, even though a linear mixed models statistic calculation could not be done due small number of samples.
Results from previous research on sertraline PK during pregnancy are inconclusive. Two studies suggested decreased levels (Freeman, Sit 2), while one study indicated increased levels (Westin). Previous studies, except for Westin's are, however, limited by small sample sizes (six and eight) and a substantial inter-individual variance.
- Conditions
- Pharmacokinetics, Antidepressive Agents, Pregnancy
- Being tested
- sertraline, mirtazapine, venlafaxine, citalopram, escitalopram
- Keywords
- Pharmacokinetics, antidepressants, pregnancy
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
sertraline, mirtazapine, venlafaxine, citalopram, escitalopramDrug
Naturalistic treatment
| Study group | Role | What they receive |
|---|---|---|
| Observed | Not described Receives: Drug: sertraline, mirtazapine, venlafaxine, citalopram, escitalopram |
What is being measured
The primary outcome is the main question the study is designed to answer.
Serum concentrations of drugs and metabolites
levels of parent compound and metabolites in serum
Measured: 9 months
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted19 Mar 2021
- Study start1 Apr 2011
- Primary completion30 Sep 2013
- Study completion30 Sep 2013
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for PharmacokineticsStudies of the same condition, open and under way.
- More trials run by Linkoeping UniversityThe sponsor's other registered studies.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Observational
- Observational model
- Cohort
- Time perspective
- Prospective
- Enrolment
- 81 participants (actual)
Sponsor and investigators
- Lead sponsor
- Linkoeping University
- Sponsor type
- Other government
- Responsible party
- Principal investigator, Erik Nilzén, Linkoeping University
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT04806230
- Sponsor's protocol ID
- PAPA123
- Acronym
- PAPA
- Status last verified
- Mar 2021
- First submitted
- 15 Mar 2021
- Last updated
- 19 Mar 2021
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- Yes
- FDA-regulated device
- No
- Individual data sharing
- No
Study at a glance
From the registry record, last updated by the sponsor on 19 Mar 2021. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Serum Concentrations of Antidepressant Drugs in Pregnant Women - a Naturalistic Study
- ClinicalTrials.gov ID
- NCT04806230
- Acronym / sponsor ID
- PAPA / PAPA123
- Conditions
- Pharmacokinetics, Antidepressive Agents, Pregnancy
- Keywords
- Pharmacokinetics, antidepressants, pregnancy
- Study type
- Observational
- Recruitment status
- Completed
- Enrolment
- 81 participants (actual)
- Lead sponsor
- Linkoeping UniversityOther government
- Study start
- 1 Apr 2011 (actual)
- Primary completion
- 30 Sep 2013 (actual)
- Study completion
- 30 Sep 2013 (actual)
- First posted
- 19 Mar 2021 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
Detailed description
Serum samples for the antidepressant drug and metabolite(s) concentrations, albumin and creatinine were collected at the first prenatal appointment and at gestational week 15, 20, 25, 35 and at partus. The time interval between drug intake and sampling was registered in all cases. At partus, a serum samples from the umbilical cord was collected drug concentration was assessed. At the first prenatal appointment a blood sample for analyzing the CYP2D6 and CYP2C19 genotype was also collected. All drug concentration analysis were executed post hoc, after last partus, whereas physiological parameters were part of normal routine sampling. Concomitant medication, weight changes and smoking habits were registered throughout the pregnancies.
Our main findings were that dose corrected serum concentrations of neither sertralin nor citalopram changed during the pregnancy. In addition, concentrations of escitalopram and venlafaxine and their metabolites appeared to be stable throughout pregnancy, even though a linear mixed models statistic calculation could not be done due small number of samples.
Results from previous research on sertraline PK during pregnancy are inconclusive. Two studies suggested decreased levels (Freeman, Sit 2), while one study indicated increased levels (Westin). Previous studies, except for Westin's are, however, limited by small sample sizes (six and eight) and a substantial inter-individual variance.
Study design
- Observational model
- Cohort
- Time perspective
- Prospective
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| Observed | – | Drug: sertraline, mirtazapine, venlafaxine, citalopram, escitalopram |
Who may qualify
- Ages
- 18 years and older
- Sex
- Female only
- Age groups
- Adult, Older adult
- Study population
- At inclusion, median age (min-max) was 31 years (21-42) and median BMI was 25.6 (18.9-47.0)
Key inclusion criteria (2 listed)
- Pregnancy
- Ongoing treatment with one of the five studied antidepressants.
Key exclusion criteria (1 listed)
- None
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| sertraline, mirtazapine, venlafaxine, citalopram, escitalopramNaturalistic treatment | Drug | Observed |
Primary outcome
Serum concentrations of drugs and metabolites
Time frame: 9 months
levels of parent compound and metabolites in serum
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 19 Mar 2021.
- Individual participant dataSharing planned: No
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
The record lists no contact. Use the official record to reach the sponsor.
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
An observational study of Pharmacokinetics and Antidepressive Agents, run by Linkoeping University at 1 site in Sweden.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 2 inclusion and 1 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: finished, as of the sponsor's last update on 19 Mar 2021. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in Sweden. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Serum concentrations of drugs and metabolites (time frame: 9 months). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 19 Mar 2021.