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SGA-induced Metabolic Syndrome in Bipolar Youth

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ClinicalTrials.gov Identifier: NCT01858948
Recruitment Status : Recruiting
First Posted : May 21, 2013
Last Update Posted : July 21, 2017
Information provided by (Responsible Party):

Study Description
Brief Summary:
The investigators will test the hypothesis that the adverse effects of second-generation antipsychotics exposure and the beneficial effects of long-chain omega-3 (LCn-3) fatty acids are mediated by opposing effects on the enzyme implicated in the metabolic syndrome and obesity.

Condition or disease Intervention/treatment Phase
Bipolar Youth Treated With Second-generation Antipsychotics Drug: Omega Drug: Placebo Drug: Quetiapine fumarate Phase 3

Detailed Description:

This will be a two-phase study design:

Phase I: to prospectively investigate the relationship between baseline LCn-3 fatty acid status and treatment-emergent adverse cardiometabolic events and weight gain in response to acute (6-week) open-label quetiapine in first-episode adolescent manic patients (ages 12-17 years). SGA-naïve acutely manic patients will be treated with open-label quetiapine for 6-weeks. Patients will be started on 100 mg BID of quetiapine, and the dose adjusted based on tolerability and response. The quetiapine target dose is 400-600 mg, with subjects in the range of 200-500 mg.

Phase II: Patients from Phase I will be randomized to double-blind adjunctive treatment with LCn-3 fatty acids or placebo for an additional 24 weeks to investigate protective effects on the progression and resolution of adverse cardiometabolic events and weight gain during quetiapine maintenance therapy. They will have 6 visits over a 24-week period.

Study Design

Study Type : Interventional  (Clinical Trial)
Estimated Enrollment : 94 participants
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Quadruple (Participant, Care Provider, Investigator, Outcomes Assessor)
Primary Purpose: Treatment
Official Title: Risk and Protective Factors for SGA-induced Metabolic Syndrome in Bipolar Youth
Study Start Date : July 2013
Estimated Primary Completion Date : June 2018
Estimated Study Completion Date : June 2018

Arms and Interventions

Arm Intervention/treatment
Experimental: Quitiapine plus Omega
Patients will be randomized to EPA+DHA supplements (OmegaRx) for 24 weeks
Drug: Omega
Omega-3 supplements
Other Name: EPA+DHA supplements (OmegaRx)
Drug: Quetiapine fumarate
Patients will be started on 100 mg BID of quetiapine, and the dose adjusted based on tolerability and response. The quetiapine target dose is 400-600 mg.
Other Name: Seroquel
Placebo Comparator: Quetiapine plus Placebo
Patients will be randomized to similar in shape an color placebo supplements (corn oil)
Drug: Placebo
Similar in shape and color to Omega supplements
Other Name: Placebo supplements (corn oil) provided by the Inflammation Research Foundation
Drug: Quetiapine fumarate
Patients will be started on 100 mg BID of quetiapine, and the dose adjusted based on tolerability and response. The quetiapine target dose is 400-600 mg.
Other Name: Seroquel

Outcome Measures

Primary Outcome Measures :
  1. BMI [ Time Frame: 24 weeks ]
    Body Mass Index, which is a measure of body fat based on height and weight. Calculated as weight in kilograms divided by height in meters squared (kg/m2)

  2. Fasting Triglycerides [ Time Frame: 24 weeks ]
    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.

Secondary Outcome Measures :
  1. Mood Symptoms [ Time Frame: 24 weeks ]
    Symptom ratings will be obtained using the Young Mania Rating Scale (YMRS)

Other Outcome Measures:
  1. SEFCA [ Time Frame: 24 weeks ]
    Side Effects Form for Children and Adolescents (SEFCA), which measures the frequency and severity of specific cardiovascular, gastrointestinal, central nervous system, ocular, mouth and nasal, genitourinary, dermatological, and musculoskeletal side effects

Eligibility Criteria

Information from the National Library of Medicine

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Ages Eligible for Study:   10 Years to 17 Years   (Child)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No

Inclusion Criteria:

  • 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
  • If female and of child bearing potential, agrees to use one of the following method of birth control: complete abstinence from sexual intercourse, barrier (diaphragm or condom), or oral/injectable contraceptive. For Phase II, additional Inclusion criteria are
  • 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).

Exclusion Criteria:

  • 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
Contacts and Locations

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT01858948

Contact: Lauren R Miller, MS 513-558-4112 Lauren.miller@uc.edu
Contact: Miranda Westbrook, MA 513-558-8606 Miranda.westbrook@ucmail.uc.edu

United States, Ohio
University of Cincinnati Recruiting
Cincinnati, Ohio, United States, 45219
Contact: Robert K McNamara, PhD    513-558-5601    robert.mcnamara@uc.edu   
Principal Investigator: Robert K McNamara, PhD         
Principal Investigator: Robert K McNamara, Ph.D.         
Sponsors and Collaborators
University of Cincinnati
National Institute of Diabetes and Digestive and Kidney Diseases (NIDDK)
Principal Investigator: Robert K McNamara, PhD University of Cincinnati
More Information

Responsible Party: Robert McNamara, Associate Professor of Psychiatry, University of Cincinnati
ClinicalTrials.gov Identifier: NCT01858948     History of Changes
Other Study ID Numbers: DK097599-01A1
First Posted: May 21, 2013    Key Record Dates
Last Update Posted: July 21, 2017
Last Verified: July 2017

Keywords provided by Robert McNamara, University of Cincinnati:
Bipolar disorder
Second-generation antipsychotics
Cardiometabolic risk

Additional relevant MeSH terms:
Metabolic Syndrome X
Insulin Resistance
Glucose Metabolism Disorders
Metabolic Diseases
Quetiapine Fumarate
Antipsychotic Agents
Tranquilizing Agents
Central Nervous System Depressants
Physiological Effects of Drugs
Psychotropic Drugs