Study to Evaluate the Effectiveness of Certain Selective Serotonin Reuptake Inhibitor (SSRI) Anti… (NCT00553917) | Clinical Trial Compass
TerminatedNot Applicable
Study to Evaluate the Effectiveness of Certain Selective Serotonin Reuptake Inhibitor (SSRI) Antidepressants During Pregnancy and Evaluate Newborn Outcomes
Stopped: Poor recruitment to experimental arms and study remained unfunded
United States18 participantsStarted 2007-11
Plain-language 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.
Who can participate
Age range18 Years – 40 Years
SexFEMALE
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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