DepressionNCT00553917
Study to Evaluate the Effectiveness of Certain Selective Serotonin Reuptake Inhibitor (SSRI) Antidepressants During Pregnancy and Evaluate Newborn Outcomes
An observational study of Depression, run by Indiana University at 1 site in United States.
Trial summary
The purpose of this study is to evaluate if during pregnancy, a common group of antidepressant medications (SSRI's) adequately treats the symptoms of depression and to evaluate if there are any effects of these medications on the newborn infant. Read more about this study
- Who is it for?
- Ages 18 to 40 years, women onlyHealthy volunteers can take part
- Conditions the study is for
- Depression
- How many people
- 18 participants
- Where
- 1 siteUnited States
- Study dates
- Nov 2007to Jul 2011
- 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 to 40 years
- Women only
- Healthy volunteers accepted
- Adult
Study population: Pregnant women up to 26 weeks gestation currently diagnosed with depression.
Who may be able to join
- Pregnant woman between 18 and 40 years of age
- Have depression as their only mental health disorder
- Have been receiving fluoxetine or citalopram for the treatment of depression for at least one month on the day of study entry for patients in the fluoxetine and citalopram arms, or no pharmacological treatment for patients in the control arm
- ≤ 26 weeks pregnant by estimated date of confinement
- Ability to give informed consent
- Singleton pregnancy
- Pregnant women no history of depression
Who cannot join
- Having any comorbid mental disorder other than generalized anxiety disorder as a secondary disorder
- History of or current epilepsy, endocrine, cardiac, pulmonary, renal or hepatic dysfunction that could negatively influence pregnancy and/or neonatal outcome
- Abusing alcohol or drugs
- Use of any self prescribed herbal treatments for depression
Trial locations and contacts
1 site in 1 country.
About this study
Official title: Study of the Pharmacokinetics and Pharmacogenetics of Selective Serotonin Reuptake Inhibitors During Pregnancy
The purpose of this study is to evaluate if during pregnancy, a common group of antidepressant medications (SSRI's) adequately treats the symptoms of depression and to evaluate if there are any effects of these medications on the newborn infant.
Read the detailed description
The amount or levels of some antidepressant medications in the blood (e.g. selective serotonin reuptake inhibitors or SSRIs) seem to be decreased during pregnancy. If the levels of SSRIs in the blood are low, the medication may not be adequately treating depression. The objective of our study is to evaluate whether pregnant women have decreased levels of SSRIs and a resultant decreased improvement of depression with SSRIs. We also want to evaluate whether variations in the genes related to how the body eliminates the SSRIs or how the SSRIs work influence the improvement in the depression pregnant women experience from these drugs. We will conduct a study in 100 pregnant women who are receiving fluoxetine (n = 25) or sertraline (n = 25) for the treatment of depression, who are not receiving any medication for depression (n = 25), or who are pregnant no history or treatment for depression (n= 25). Participants will be enrolled any time before 26 weeks of pregnancy. Blood samples will be collected for genetic analysis in all subjects, and for drug level measurements during pregnancy, at delivery, and post partum in the subjects taking antidepressant medication. We will also be monitoring monthly platelet serotonin levels in all groups. In addition, the scores of a rating scale to measure the severity of depression and two rating scales to measure the undesirable effects of the treatment will be obtained on enrollment and monthly for up to 12 weeks after delivery. Maternal and umbilical cord blood samples will be obtained at delivery for determination of SSRI levels, platelet serotonin levels (a marker that SSRIs are working), and for collection of neonatal DNA. After delivery all mothers will complete a survey about how she is feeling about herself and the baby, and the baby's behavior will be observed for a 1 hour time interval. Babies of mothers taking medication will have a blood sample drawn at 2-3 months after birth to measure the drug level as compared with cord blood sample at delivery. We plan to collect a breastmilk sample from the mothers in the medicated arms that have chosen to breastfeed. Clinical data related to pregnancy and neonatal health will be obtained from the prenatal and neonatal charts.
- Conditions
- Depression
- Keywords
- Pregnancy, Depression, Antidepressants
- Medical subject headings
- Depression
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
| Study group | Role | What they receive |
|---|---|---|
| 1 | Pregnant women currently taking Prozac for the treatment of depression | |
| 2 | Pregnant women currently taking Zoloft for the treatment of depression | |
| 3 | Pregnant women not currently using medication for the treatment of depression | |
| 4 | Pregnant women with no history of, symptoms of, or treatment for depression |
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted6 Nov 2007 (estimated)
- Study startNov 2007
- Primary completionJul 2011
- Study completionJul 2011
Why it stopped: Poor recruitment to experimental arms and study remained unfunded
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for DepressionStudies of the same condition, open and under way.
- More trials run by Indiana 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
- Case only
- Time perspective
- Prospective
- Enrolment
- 18 participants (actual)
Sponsor and investigators
- Lead sponsor
- Indiana University
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor
- Investigators
- Jamie L Renbarger, MD, Principal investigator, Indiana University School of Medicine Department of Medicine and Pediatrics
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT00553917
- Sponsor's protocol ID
- IRB 0708-10
- Status last verified
- Apr 2024
- First submitted
- 5 Nov 2007
- Last updated
- 2 Apr 2024
- Results posted
- No
- Data monitoring committee
- Yes
Study at a glance
From the registry record, last updated by the sponsor on 2 Apr 2024. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Study of the Pharmacokinetics and Pharmacogenetics of Selective Serotonin Reuptake Inhibitors During Pregnancy
- ClinicalTrials.gov ID
- NCT00553917
- Acronym / sponsor ID
- IRB 0708-10
- Conditions
- Depression
- Keywords
- Pregnancy, Depression, Antidepressants
- Study type
- Observational
- Recruitment status
- TerminatedReason stopped: Poor recruitment to experimental arms and study remained unfunded
- Enrolment
- 18 participants (actual)
- Lead sponsor
- Indiana UniversityUniversity, hospital or other
- Study start
- Nov 2007 (actual)
- Primary completion
- Jul 2011 (actual)
- Study completion
- Jul 2011 (actual)
- First posted
- 6 Nov 2007 (estimated)
- 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 purpose of this study is to evaluate if during pregnancy, a common group of antidepressant medications (SSRI's) adequately treats the symptoms of depression and to evaluate if there are any effects of these medications on the newborn infant.
Detailed description
The amount or levels of some antidepressant medications in the blood (e.g. selective serotonin reuptake inhibitors or SSRIs) seem to be decreased during pregnancy. If the levels of SSRIs in the blood are low, the medication may not be adequately treating depression. The objective of our study is to evaluate whether pregnant women have decreased levels of SSRIs and a resultant decreased improvement of depression with SSRIs. We also want to evaluate whether variations in the genes related to how the body eliminates the SSRIs or how the SSRIs work influence the improvement in the depression pregnant women experience from these drugs. We will conduct a study in 100 pregnant women who are receiving fluoxetine (n = 25) or sertraline (n = 25) for the treatment of depression, who are not receiving any medication for depression (n = 25), or who are pregnant no history or treatment for depression (n= 25). Participants will be enrolled any time before 26 weeks of pregnancy. Blood samples will be collected for genetic analysis in all subjects, and for drug level measurements during pregnancy, at delivery, and post partum in the subjects taking antidepressant medication. We will also be monitoring monthly platelet serotonin levels in all groups. In addition, the scores of a rating scale to measure the severity of depression and two rating scales to measure the undesirable effects of the treatment will be obtained on enrollment and monthly for up to 12 weeks after delivery. Maternal and umbilical cord blood samples will be obtained at delivery for determination of SSRI levels, platelet serotonin levels (a marker that SSRIs are working), and for collection of neonatal DNA. After delivery all mothers will complete a survey about how she is feeling about herself and the baby, and the baby's behavior will be observed for a 1 hour time interval. Babies of mothers taking medication will have a blood sample drawn at 2-3 months after birth to measure the drug level as compared with cord blood sample at delivery. We plan to collect a breastmilk sample from the mothers in the medicated arms that have chosen to breastfeed. Clinical data related to pregnancy and neonatal health will be obtained from the prenatal and neonatal charts.
Study design
- Observational model
- Case only
- Time perspective
- Prospective
- Number of arms
- 4
| Arm | Type | Receives |
|---|---|---|
| 1 | – | –Pregnant women currently taking Prozac for the treatment of depression |
| 2 | – | –Pregnant women currently taking Zoloft for the treatment of depression |
| 3 | – | –Pregnant women not currently using medication for the treatment of depression |
| 4 | – | –Pregnant women with no history of, symptoms of, or treatment for depression |
Who may qualify
- Ages
- 18 to 40 years
- Sex
- Female only
- Healthy volunteers
- Accepted
- Age groups
- Adult
- Study population
- Pregnant women up to 26 weeks gestation currently diagnosed with depression.
Key inclusion criteria (7 listed)
- Pregnant woman between 18 and 40 years of age
- Have depression as their only mental health disorder
- Have been receiving fluoxetine or citalopram for the treatment of depression for at least one month on the day of study entry for patients in the fluoxetine and citalopram arms, or no pharmacological treatment for patients in the control arm
- ≤ 26 weeks pregnant by estimated date of confinement
- Ability to give informed consent
Key exclusion criteria (4 listed)
- Having any comorbid mental disorder other than generalized anxiety disorder as a secondary disorder
- History of or current epilepsy, endocrine, cardiac, pulmonary, renal or hepatic dysfunction that could negatively influence pregnancy and/or neonatal outcome
- Abusing alcohol or drugs
- Use of any self prescribed herbal treatments for depression
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Primary outcome
Not reported in the source record.
Results and safety
The study was stopped early (reason given: Poor recruitment to experimental arms and study remained unfunded). Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 2 Apr 2024.
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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.
Jamie L Renbarger, MD principal investigator
Indiana University School of Medicine Department of Medicine and Pediatrics
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 Depression, run by Indiana University at 1 site in United States.
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 7 inclusion and 4 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: stopped early, as of the sponsor's last update on 2 Apr 2024. 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 United States. 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 was stopped early (reason given: Poor recruitment to experimental arms and study remained unfunded). Results are not available in the source record.
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.
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 2 Apr 2024.