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

Stopped early

Conditions studied: Depression

In brief

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.

Key facts

Study ID

NCT00553917

Run by

Indiana University

People needed

18

Starts

2007-11-01

Expected to finish

2011-07-01

Last updated by the study team

2024-04-02

Who can join

Age: 18 and older, up to 40. Sex: female. Healthy volunteers: accepted.

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

Where it is running

• IUPUI — Indianapolis, Indiana, United States

Full record on ClinicalTrials.gov

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