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NCT02492347: SSRIs
Effect of Antenatal SSRI Exposure on the QT Interval of Neonates
NA trial testing Electrocardiogram in Qt Interval, Variation in in 88 participants. Completed in 18 August 2017.
18 August 2017
Quick facts
| Lead sponsor | University of Southampton |
|---|---|
| Phase | NA |
| Status | Completed |
| Study type | INTERVENTIONAL |
| Allocation | non randomized |
| Design | parallel |
| Masking | none |
| Primary purpose | screening |
| Enrollment | 88 |
| Start date | 18 February 2016 |
| Primary completion | 18 August 2017 |
| Estimated completion | 18 August 2017 |
| Sites | 1 location across United Kingdom |
Drugs / interventions tested
- Electrocardiogram
Conditions studied
- Qt Interval, Variation in — all drugs for Qt Interval, Variation in →
- Adverse Effect of Selective Serotonin Reuptake Inhibitors — all drugs for Adverse Effect of Selective Serotonin Reuptake Inhibitors →
Sponsor
University of Southampton
Who can join
Adults 2 Days to 3 Days, any sex, with Qt Interval, Variation in or Adverse Effect of Selective Serotonin Reuptake Inhibitors. Patients with the condition only — healthy volunteers not accepted.
Sponsor's own description
Selective Serotonin Reuptake Inhibitors (SSRIs) are a group of antidepressants that suppress the re-absorption of a chemical called Serotonin in the brain, and improve mood. SSRI use in the treatment of mental health problems has increased greatly since their introduction in the 1980's. When given in pregnancy they cause less fetal effects than other antidepressants. However they are still known to cause premature birth, heart defects and withdrawal symptoms in the baby. Withdrawal symptoms can occur in up to 30% of exposed babies, where as heart defects have been found to increase by 2-3 times against the normal rate of 1%. There is very limited information available, but it is also thought it may cause lengthening of a certain portion of the heart beat, the QT interval, which has been shown to lead to sudden death in adults. The QT interval will be looked at in this study, comparing babies exposed to SSRIs in pregnancy with unexposed babies. The study will be based in the United Kingdom (UK), at the Maternity Unit of a District General Hospital, and will be carried out over 12-18 months. A group of babies whose mothers took SSRIs whilst pregnant will have an Electrocardiogram (ECG) done when they are 2-3 days old. These will be compared with babies whose mothers did not, but whose babies were still in hospital because they were at risk of having an infection, but were found to be healthy. The study hopes to see whether there is a link between SSRI use in pregnancy and lengthening of the QT interval and if so, extra surveillance may be considered for this group of babies.
Publications & conference data
No peer-reviewed publications indexed yet for this trial. Completed trials usually publish results within 12-18 months.
Verify or expand the search:
- PubMed search for NCT02492347
- Europe PMC full search
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Verify against primary sources
- ClinicalTrials.gov — authoritative US registry record
- WHO ICTRP — international registry index
- EU Clinical Trials Register
- Sponsor press releases (Google)
- Trial protocol + status: ClinicalTrials.gov NCT02492347 (US National Library of Medicine, public domain)
- Drug + disease cross-links: matched in real time against Drug Landscape's normalised drug + company + condition tables
- Sponsor: as reported to ClinicalTrials.gov by University of Southampton
- Last refreshed: 6 November 2017
Drug Landscape aggregates and links these public records for informational use only. Always verify against the primary source before clinical or regulatory decisions. Canonical URL: https://druglandscape.com/trial/NCT02492347.
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