SGA-induced Metabolic Syndrome in Bipolar Youth

NCT01858948 | Completed Phase 3 Results DMC

• 2 other identifiers: DK097599-01A15R01DK097599
• Study Type: interventional
• Target: 19
• Locations: 1 country
• Sites: 1

Brief 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.

Conditions

Bipolar Youth Treated With Second-generation Antipsychotics

Keywords

Bipolar disorder; Second-generation antipsychotics; Obesity; Cardiometabolic risk

Outcome Measures

Primary Outcomes (2)

• Body Mass Index (BMI)

  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.

  24 weeks

• Fasting Blood Triglycerides Levels

  Triglycerides are the chemical form in which most fat exists in food as well as in the body. They're also present in blood plasma and, in association with cholesterol, form the plasma lipids. Levels are categorized as follows: Normal - Less than 150 milligrams per deciliter (mg/dL); Borderline high - 150 to 199 mg/dL; High - 200 to 499 mg/dL; Very high - 500 mg/dL or above. Greater reductions blood triglyceride levels are a better outcome.

  24 weeks

Secondary Outcomes (1)

• Manic Symptom Severity

  24 weeks

Study Arms (2)

Quetiapine plus Omega

EXPERIMENTAL

Patients will be randomized to EPA+DHA supplements (OmegaRx) at fixed dose of 3.0 g/day (EPA: 2.0 g, DHA: 1.0 g; 5 capsules/d) for 24 weeks.

Drug: Omega; Drug: Quetiapine fumarate

Quetiapine plus Placebo

PLACEBO COMPARATOR

Patients will be randomized to similar in shape an color placebo supplements (corn oil)

Drug: Placebo; Drug: Quetiapine fumarate

Interventions

Omega DRUG

Omega-3 supplements

Also known as: EPA+DHA supplements (OmegaRx)

Quetiapine plus Omega

Placebo DRUG

Similar in shape and color to Omega supplements

Also known as: Placebo supplements (corn oil) provided by the Inflammation Research Foundation

Quetiapine plus Placebo

Quetiapine fumarate DRUG

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.

Also known as: Seroquel

Quetiapine plus Omega; Quetiapine plus Placebo

Eligibility Criteria

• Age: 10 Years - 17 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Child (0-17)

You may qualify if:

• DSM-IV-TR criteria for bipolar disorder, type I, manic or mixed episode
• Baseline YMRS score \> 20
• Ages 10-17 years
• Tanner scale stages III-V
• No prior exposure to SGA medications
• Fluent in English
• Provision of written informed consent by a legal guardian and written assent by the subject
• Manic or depressive symptoms do not result entirely from acute medical illness or acute intoxication or withdrawal from drugs or alcohol as determined by medical evaluation and rapid symptom resolution
• Receiving a stable therapeutic dose of quetiapine for a minimum of 1 week (i.e., patients who achieved remission (YMRS total score 7 during Phase I)
• Not requiring concomitant use of antidepressant or mood-stabilizer medications (see Section C.4.c. Concomitant Medications).

You may not qualify if:

• IQ \< 70, as determined by The Wechsler Abbreviated Scale of Intelligence
• Positive pregnancy test (to avoid teratogenesis)
• A history of major cardiovascular or neurological illness
• Any lifetime DSM-IV-TR substance use disorder (nicotine dependence is permitted)
• A lifetime DSM-IV-TR diagnosis of any pervasive developmental disorder
• Any history of a hematological disorder in themselves or a first-degree relative will be excluded (since omega-3 fatty acids may be associated with anti-thrombotic effects). Similarly, concomitant use of medications with anticoagulant effects (e.g. aspirin) will be prohibited
• Allergy to fish/seafood; 8) Currently taking omega-3 fatty acid supplements

Sponsors & Collaborators

• University of Cincinnati: lead
• National Institute of Diabetes and Digestive and Kidney Diseases (NIDDK): collaborator

Study Sites (1)

University of Cincinnati

Cincinnati, Ohio, 45219, United States

Location

MeSH Terms

Conditions

Bipolar Disorder; Obesity

Interventions

Corn Oil; Quetiapine Fumarate

Condition Hierarchy (Ancestors)

Bipolar and Related Disorders; Mood Disorders; Mental Disorders; Overweight; Overnutrition; Nutrition Disorders; Nutritional and Metabolic Diseases; Body Weight; Signs and Symptoms; Pathological Conditions, Signs and Symptoms

Intervention Hierarchy (Ancestors)

Dietary Fats, Unsaturated; Dietary Fats; Fats; Lipids; Fats, Unsaturated; Plant Oils; Oils; Plant Preparations; Biological Products; Complex Mixtures; Food; Diet, Food, and Nutrition; Physiological Phenomena; Food and Beverages; Dibenzothiazepines; Thiazepines; Thiepins; Sulfur Compounds; Organic Chemicals; Heterocyclic Compounds, 3-Ring; Heterocyclic Compounds, Fused-Ring; Heterocyclic Compounds

Results Point of Contact

• Title: Dr. Robert McNamara
• Organization: University of Cincinnati

robert.mcnamara@uc.edu

513-558-5601

Study Officials

• Robert K McNamara, PhD

  University of Cincinnati

  PRINCIPAL INVESTIGATOR

Publication Agreements

• PI is Sponsor Employee: No
• Restrictive Agreement: No

Study Design

• Study Type: interventional
• Phase: phase 3
• Allocation: RANDOMIZED
• Masking: QUADRUPLE
• Who Masked: PARTICIPANT, CARE PROVIDER, INVESTIGATOR, OUTCOMES ASSESSOR
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Associate Professor of Psychiatry

Study Record Dates

• First Submitted: May 16, 2013
• First Posted: May 21, 2013
• Study Start: July 1, 2013
• Primary Completion: April 1, 2018
• Study Completion: April 1, 2018
• Last Updated: November 25, 2022
• Results First Posted: November 25, 2022

Record last verified: 2022-11

Locations

US (1)