title: A Randomized Controlled Trial of Individual Family Psychoeducational Psychotherapy and Omega-3 Fatty Acids in Youth with Subsyndromal Bipolar Disorder.
abstract: OBJECTIVE
  This pilot study evaluates efficacy of omega-3 fatty acid supplementation (Ω3), individual family psychoeducational psychotherapy (IF-PEP), and their combination in youth with subsyndromal bipolar disorders (bipolar disorder not otherwise specified [BP-NOS], cyclothymic disorder [CYC]).
  
  
  METHODS
  This study was a 12 week, randomized trial of Ω3 versus placebo and IF-PEP versus active monitoring (AM) using a 2 × 2 design (Ω3 + PEP: n = 5; Ω3 + AM: n = 5; placebo + PEP: n = 7; placebo + AM: n = 6). Twenty-three youth ages 7-14 with BP-NOS or CYC were recruited via community advertisements and clinician referrals. Participants could be taking stable medication for attention-deficit/hyperactivity disorder and sleep aids, but no other psychotropics. Independent evaluators assessed participants at screen, baseline, and 2, 4, 6, 9, and 12 weeks. Primary outcome measures were the Kiddie Schedule for Affective Disorders (K-SADS) Depression (KDRS) and Mania (KMRS) Rating Scales, Children's Depression Rating Scale-Revised (CDRS-R), and Young Mania Rating Scale (YMRS). Ω3/placebo conditions were double-blind; independent evaluators were blind to psychotherapy condition.
  
  
  RESULTS
  Most participants (83%) completed the 12 week trial. Side effects were uncommon and mild. Intent-to-treat analyses indicated significant improvement in depressive symptoms (KDRS) for combined treatment relative to placebo and AM (p = 0.01, d = 1.70). Across groups, manic symptoms improved over time without significant treatment effects. Effect of IF-PEP on child depression compared with AM was medium (d = 0.63, CDRS-R) to large (d = 1.24, KDRS). Effect of Ω3 on depression was medium (d = 0.48, KDRS).
  
  
  CONCLUSIONS
  IF-PEP and Ω3 are well tolerated and associated with improved mood symptoms among youth with BP-NOS and CYC. Clinicaltrials.gov Identifier: NCT01507753.
authors.affiliation: 1 Department of Psychiatry and Behavioral Health, The Ohio State University , Columbus, Ohio.|2 Departments of Psychology and Nutrition, The Ohio State University , Columbus, Ohio.
authors.forename: Mary A
authors.initials: MA
authors.lastname: Fristad
authors.affiliation: 1 Department of Psychiatry and Behavioral Health, The Ohio State University , Columbus, Ohio.
authors.forename: Andrea S
authors.initials: AS
authors.lastname: Young
authors.affiliation: 1 Department of Psychiatry and Behavioral Health, The Ohio State University , Columbus, Ohio.
authors.forename: Anthony T
authors.initials: AT
authors.lastname: Vesco
authors.affiliation: 1 Department of Psychiatry and Behavioral Health, The Ohio State University , Columbus, Ohio.
authors.forename: Elias S
authors.initials: ES
authors.lastname: Nader
authors.affiliation: 1 Department of Psychiatry and Behavioral Health, The Ohio State University , Columbus, Ohio.
authors.forename: K Zachary
authors.initials: KZ
authors.lastname: Healy
authors.affiliation: 3 Children's Hospital of Eastern Ontario , Ottawa, Ontario, Canada .
authors.forename: William
authors.initials: W
authors.lastname: Gardner
authors.affiliation: 1 Department of Psychiatry and Behavioral Health, The Ohio State University , Columbus, Ohio.
authors.forename: Hannah L
authors.initials: HL
authors.lastname: Wolfson
authors.affiliation: 1 Department of Psychiatry and Behavioral Health, The Ohio State University , Columbus, Ohio.
authors.forename: L Eugene
authors.initials: LE
authors.lastname: Arnold
mesh_terms: D001289:Attention Deficit Disorder with Hyperactivity / Q000188:drug therapy; D001714:Bipolar Disorder / Q000188:drug therapy* / Q000628:therapy; D002648:Child; D003131:Combined Modality Therapy; D003527:Cyclothymic Disorder / Q000188:drug therapy* / Q000628:therapy; D004311:Double-Blind Method; D005190:Family / Q000523:psychology*; D005196:Family Therapy; D015525:Fatty Acids, Omega-3 / Q000627:therapeutic use*; D005260:Female; D006801:Humans; D008297:Male; D010865:Pilot Projects; D011569:Psychiatric Status Rating Scales / Q000706:statistics & numerical data
chemical_list: D015525:Fatty Acids, Omega-3