Study to Evaluate the Effectiveness of Certain Selective Serotonin Reuptake Inhibitor (SSRI) Antidepressants During Pregnancy and Evaluate Newborn Outcomes

This study has been terminated.
(Poor recruitment to experimental arms and study remained unfunded)
Sponsor:
Information provided by:
Indiana University
ClinicalTrials.gov Identifier:
NCT00553917
First received: November 5, 2007
Last updated: June 21, 2011
Last verified: June 2011
  Purpose

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.


Condition
Depression

Study Type: Observational
Study Design: Observational Model: Case-Only
Time Perspective: Prospective
Official Title: Study of the Pharmacokinetics and Pharmacogenetics of Selective Serotonin Reuptake Inhibitors During Pregnancy

Resource links provided by NLM:


Further study details as provided by Indiana University:

Biospecimen Retention:   Samples With DNA

whole Blood Plasma human milk


Enrollment: 18
Study Start Date: November 2007
Estimated Study Completion Date: December 2012
Groups/Cohorts
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

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.

  Eligibility

Ages Eligible for Study:   18 Years to 40 Years
Genders Eligible for Study:   Female
Accepts Healthy Volunteers:   Yes
Sampling Method:   Non-Probability Sample
Study Population

Pregnant women up to 26 weeks gestation currently diagnosed with depression.

Criteria

Inclusion Criteria:

  • 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

Exclusion Criteria:

  • 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
  Contacts and Locations
Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the Contacts provided below. For general information, see Learn About Clinical Studies.

Please refer to this study by its ClinicalTrials.gov identifier: NCT00553917

Locations
United States, Indiana
IUPUI
Indianapolis, Indiana, United States, 46202
Sponsors and Collaborators
Indiana University School of Medicine
Investigators
Principal Investigator: Jamie L Renbarger, MD Indiana University School of Medicine Department of Medicine and Pediatrics
  More Information

No publications provided

Responsible Party: Dr. Jamie L. Renbarger, Indiana University School of Medicine Department of Pediatrics and Medicine
ClinicalTrials.gov Identifier: NCT00553917     History of Changes
Other Study ID Numbers: IRB 0708-10
Study First Received: November 5, 2007
Last Updated: June 21, 2011
Health Authority: United States: Institutional Review Board

Keywords provided by Indiana University:
Pregnancy
Depression
Antidepressants

Additional relevant MeSH terms:
Depression
Depressive Disorder
Behavioral Symptoms
Mood Disorders
Mental Disorders
Antidepressive Agents
Serotonin
Serotonin Uptake Inhibitors
Psychotropic Drugs
Central Nervous System Agents
Therapeutic Uses
Pharmacologic Actions
Serotonin Receptor Agonists
Serotonin Agents
Neurotransmitter Agents
Molecular Mechanisms of Pharmacological Action
Physiological Effects of Drugs
Neurotransmitter Uptake Inhibitors

ClinicalTrials.gov processed this record on August 28, 2014