Mode
Text Size
Log in / Sign up
Phase 3 Completed N=19 Randomized Quadruple-blind Treatment

SGA-induced Metabolic Syndrome in Bipolar Youth

Bipolar Youth Treated With Second-generation Antipsychotics
Source: ClinicalTrials.gov NCT01858948 ↗
Enrolled (actual)
19
Serious AEs
0.0%
Results posted
Nov 2022
Primary outcomePrimary: Body Mass Index (BMI) — 24.4; 26.3 kg/m^2
◆ Published Evidence
No publication linked

No peer-reviewed publication reporting this trial's results has been linked yet. This can indicate results are unpublished — a known publication-bias signal. We re-check periodically.

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.

Outcome Measures

OutcomeResultp-value
PRIMARY
Body Mass Index (BMI)
24.4; 26.3
PRIMARY
Fasting Blood Triglycerides Levels
99.7; 88
SECONDARY
Manic Symptom Severity
4.3; 7.2

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
View full record on ClinicalTrials.gov →

Data sourced from ClinicalTrials.gov (NCT01858948). Outcome figures and adverse-event rates are extracted automatically from the registry's posted results and are provided for clinician reference, not as a substitute for the primary publication. Informational only — not medical advice.

Back to search