SGA-induced Metabolic Syndrome in Bipolar Youth

This study is currently recruiting participants. (see Contacts and Locations)
Verified May 2014 by University of Cincinnati
Sponsor:
Collaborator:
Information provided by (Responsible Party):
Robert McNamara, University of Cincinnati
ClinicalTrials.gov Identifier:
NCT01858948
First received: May 16, 2013
Last updated: May 1, 2014
Last verified: May 2014
  Purpose

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 Intervention Phase
Bipolar Youth Treated With Second-generation Antipsychotics
Drug: Omega
Drug: Placebo
Drug: Quetiapine fumarate
Phase 3

Study Type: Interventional
Study Design: Allocation: Randomized
Endpoint Classification: Safety/Efficacy Study
Intervention Model: Parallel Assignment
Masking: Double Blind (Subject, Caregiver, Investigator, Outcomes Assessor)
Primary Purpose: Treatment
Official Title: Risk and Protective Factors for SGA-induced Metabolic Syndrome in Bipolar Youth

Resource links provided by NLM:


Further study details as provided by University of Cincinnati:

Primary Outcome Measures:
  • BMI [ Time Frame: 24 weeks ] [ Designated as safety issue: No ]
    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)

  • Fasting Triglycerides [ Time Frame: 24 weeks ] [ Designated as safety issue: No ]
    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:
  • Mood Symptoms [ Time Frame: 24 weeks ] [ Designated as safety issue: No ]
    Symptom ratings will be obtained using the Young Mania Rating Scale (YMRS)


Other Outcome Measures:
  • SEFCA [ Time Frame: 24 weeks ] [ Designated as safety issue: Yes ]
    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


Estimated Enrollment: 94
Study Start Date: July 2013
Estimated Study Completion Date: June 2018
Estimated Primary Completion Date: June 2018 (Final data collection date for primary outcome measure)
Arms Assigned Interventions
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

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.

  Eligibility

Ages Eligible for Study:   10 Years to 17 Years
Genders Eligible for Study:   Both
Accepts Healthy Volunteers:   No
Criteria

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
Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the Contacts provided below. For general information, see Learn About Clinical Studies.

Please refer to this study by its ClinicalTrials.gov identifier: NCT01858948

Contacts
Contact: Laura R Imhoff 513-558-7700 imhofflr@ucmail.uc.edu

Locations
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
Investigators
Principal Investigator: Robert K McNamara, PhD University of Cincinnati
  More Information

No publications provided

Responsible Party: Robert McNamara, Associate Professor of Psychiatry, University of Cincinnati
ClinicalTrials.gov Identifier: NCT01858948     History of Changes
Other Study ID Numbers: DK097599-01A1
Study First Received: May 16, 2013
Last Updated: May 1, 2014
Health Authority: United States: Data Safety Monitoring Board

Keywords provided by University of Cincinnati:
Bipolar disorder
Second-generation antipsychotics
Obesity
Cardiometabolic risk

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

ClinicalTrials.gov processed this record on August 27, 2014