Clinical trial NCT01858948: SGA-induced Metabolic Syndrome in Bipolar Youth
Official title: Risk and Protective Factors for SGA-induced Metabolic Syndrome in Bipolar Youth
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: PHASE3
Conditions: Bipolar Youth Treated With Second-generation Antipsychotics
Keywords: Bipolar disorder
Second-generation antipsychotics
Obesity
Cardiometabolic risk
Lead sponsor: University of Cincinnati
Sponsor class: OTHER
Collaborators: name: National Institute of Diabetes and Digestive and Kidney Diseases (NIDDK)
First posted: 2013-05-21
Enrollment: 19
Sex: ALL
Minimum age (years): 10
Maximum age (years): 17
Standard ages: CHILD
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: TREATMENT

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.

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.

Eligibility 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

Primary outcomes:
measure: Body Mass Index (BMI)
timeFrame: 24 weeks
measure: Fasting Blood Triglycerides Levels
timeFrame: 24 weeks
Secondary outcomes:
measure: Manic Symptom Severity
timeFrame: 24 weeks
Other outcomes:
Locations:
city: Cincinnati
country: United States
facility: University of Cincinnati
state: Ohio
Study officials:
affiliation: University of Cincinnati
name: Robert K McNamara, PhD
role: PRINCIPAL_INVESTIGATOR
References: