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NCT01858948 · ClinicalTrials.gov registry record · Phase 3
SGA-induced Metabolic Syndrome in Bipolar Youth
A Phase 3 study, sponsored by University of Cincinnati.
- Completed
- Registry status
- Phase 3
- Development phase
- 19
- Enrollment target
NCT01858948: Completed Phase 3 study, sponsored by University of Cincinnati.
NCT01858948 is a Phase 3 study that has completed, run by University of Cincinnati. The registered enrollment target is 19 participants, below the 772-participant average among 15,282 other Phase 3 trials with a reported enrollment target (98% lower). According to ClinicalTrials.gov, the official US trial registry.
The verdict
NCT01858948, a Phase 3 study, has completed, sponsored by University of Cincinnati.
- COMPLETED
- Registry status
- Phase 3
- Development phase
- 19 participants
- Enrollment target
Study Summary
The investigators tested the hypothesis that long-chain omega-3 (LCn-3) fatty acid supplementation will attenuate the adverse cardiometabolic effects of second-generation antipsychotics exposure in first-episode adolescent manic patients.
Primary Outcome
Body Mass Index (BMI) is a measure of body fat calculated as weight in kilograms divided by height in meters squared (kg/m\^2). BMI Categories are: Underweight = \<18.5; Normal weight = 18.5-24.9; Overweight = 25-29.9; Obesity = BMI of 30 or greater. Greater decreases in BMI are a better outcome.
Interventions
- DRUG Placebo
- DRUG Quetiapine fumarate
- DRUG Omega
Trial Details
| Field | Value |
|---|---|
| Enrollment Target | 19 participants |
| Start Date | 2013-07 |
| Est. Completion | 2018-04 |
| Phase | Phase 3 |
What the finished NCT01858948 record still lists
NCT01858948 is an interventional study that assigns participants to a tested intervention. The registry caps enrollment at 19 participants, a relatively small participant target, below the 772-participant average among 15,282 other Phase 3 trials with a reported enrollment target (98% lower).
The record links to 0 conditions, and to 3 interventions - of which Placebo is the first listed.
NCT01858948 does not publish any study locations in the registry export this page uses.
Frequently Asked Questions
What is clinical trial NCT01858948 about?
NCT01858948 is a clinical study titled "SGA-induced Metabolic Syndrome in Bipolar Youth". The investigators tested the hypothesis that long-chain omega-3 (LCn-3) fatty acid supplementation will attenuate the adverse cardiometabolic effects of second-generation antipsychotics exposure in first-episode adolescent manic patients.
What is the current status of trial NCT01858948?
This trial is currently completed. It is a Phase 3 study. The enrollment target is 19 participants. The study started on 2013-07. Estimated completion is 2018-04.
What interventions are being tested in trial NCT01858948?
The interventions under investigation include: Placebo (DRUG), Quetiapine fumarate (DRUG), Omega (DRUG).
Who is sponsoring clinical trial NCT01858948?
This trial is sponsored by University of Cincinnati, which has 245 total clinical trials registered on ClinicalTrials.gov.
Learn More About Clinical Trials
How this trial's enrollment target compares
Where NCT01858948's enrollment target sits among peer trials
19 1969th of 2000 higher than 31 of 2,000 other Phase 3 trials
participants (enrollment target), bucketed by value
Each bar is a band; taller bars hold more other Phase 3 trials. The dashed line + filled bar mark this entry. Hover or tap any bar for its full count and share, and where it sits relative to this entry.
Source ClinicalTrials.gov registry export · 2026-08-08
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