CI

At a glance

ClinicalIndex Comparison Record
Phase 3Completed· 19 enrolled
Drug / intervention
Omega +2 moredrug
Likely dose
Quetiapine fumarate 100 mgfrom record
Structured eligibility isn't available for this trial yet — see the full criteria in the Eligibility tab below.

Standardized by ClinicalIndex from the ClinicalTrials.gov record · verify against the source.

Search/NCT01858948
NCT01858948Phase 3Completed
CompareCT.gov

Risk and Protective Factors for SGA-induced Metabolic Syndrome in Bipolar Youth

University of Cincinnati·interventional·Posted May 21, 2013·Updated Nov 25, 2022

In Brief

A Phase 3 clinical trial evaluating Omega, Placebo, and 1 other intervention for Bipolar Youth Treated With Second-generation Antipsychotics. Completed, enrolled 19 participants across 1 site.

Detailed 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.

Study Details

Study Typeinterventional
Allocation--
Masking--
Primary Purpose--
ConditionsBipolar Youth Treated With Second-generation Antipsychotics
CountriesUnited States
CollaboratorsNational Institute of Diabetes and Digestive and Kidney Diseases (NIDDK)

Timeline

Phase 3CompletedFinished
2014201520162017201820192020202120222023202420252026
First PostedMay 21, 2013
Enrollment StartJul 1, 2013
Primary CompletionApr 1, 2018
TodayJul 2, 2026
Enrollment to primary: 4.8 yearsPosted 13.1 years ago

Interventions

Omegadrug

Omega-3 supplements

Placebodrug

Similar in shape and color to Omega supplements

Quetiapine fumaratedrug

Prior to randomization to Omega/placebo, patients were started on 100 mg BID of quetiapine, and the dose adjusted based on tolerability and response. The quetiapine target dose is 400-600 mg.