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

NCT00553917 | Terminated DMC

• 1 other identifier: IRB 0708-10
• Study Type: observational
• Target: 18
• Locations: 1 country
• Sites: 1

Brief 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.

Conditions

Depression

Keywords

Pregnancy; Depression; Antidepressants

Study Arms (4)

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

Eligibility Criteria

• Age: 18 Years - 40 Years
• Sex: female
• Healthy Volunteers: Yes
• Age Groups: Adult (18-64)
• Sampling Method: Non-Probability Sample

Study Population

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

You may qualify if:

• 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

You may not qualify if:

• 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

Sponsors & Collaborators

• Indiana University: lead

Study Sites (1)

IUPUI

Indianapolis, Indiana, 46202, United States

Location

Biospecimen

Retention: SAMPLES WITH DNA

whole Blood Plasma human milk

MeSH Terms

Conditions

Depression

Condition Hierarchy (Ancestors)

Behavioral Symptoms; Behavior

Study Officials

• Jamie L Renbarger, MD

  Indiana University School of Medicine Department of Medicine and Pediatrics

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: observational
• Observational Model: CASE ONLY
• Time Perspective: PROSPECTIVE
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: November 5, 2007
• First Posted: November 6, 2007
• Study Start: November 1, 2007
• Primary Completion: July 1, 2011
• Study Completion: July 1, 2011
• Last Updated: April 2, 2024

Record last verified: 2024-04

Locations

US (1)