NCT01858948

SGA-induced Metabolic Syndrome in Bipolar Youth

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

• Status: Completed
• Phase: Phase 3
• Study type: Interventional
• Enrollment: 19 (actual)
• Sponsor: University of Cincinnati · Academic / Other
• Sex: All
• Age: 10 Years – 17 Years
• Healthy volunteers: Not accepted

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.

Detailed description

Following acute (6-week) open-label treatment with quetiapine, first-episode adolescent manic patients (ages 10-17 years) were randomized to double-blind adjunctive treatment with long-chain omega-3 (LCn-3) fatty acids or placebo for 24 weeks to investigate protective effects on the of adverse cardiometabolic events and weight gain during quetiapine maintenance therapy. They will have 6 visits over a 24-week period.

Conditions

• Bipolar Youth Treated With Second-generation Antipsychotics

Interventions

Type	Name	Description
DRUG	Omega	Omega-3 supplements
DRUG	Placebo	Similar in shape and color to Omega supplements
DRUG	Quetiapine fumarate	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.

Timeline

• Start date: 2013-07-01
• Primary completion: 2018-04-01
• Completion: 2018-04-01
• First posted: 2013-05-21
• Last updated: 2022-11-25
• Results posted: 2022-11-25

Locations

1 site across 1 country: United States