OBJECTIVE: This pilot study evaluates efficacy of @entity4599 supplementation (  3), individual family psychoeducational psychotherapy (IF-PEP), and their combination in youth with @entity162 ( @entity162 not otherwise specified [BP-NOS], cyclothymic disorder [CYC]). METHODS: This study was a 12 week, randomized trial of   3 versus placebo and IF-PEP versus active monitoring (AM) using a 2 * 2 design (  3 + @entity7955 : n = 5;   3 + 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. @entity1 could be taking stable medication for @entity71 and sleep aids, but no other psychotropics. Independent evaluators assessed @entity1 at screen, baseline, and 2, 4, 6, 9, and 12 weeks. Primary outcome measures were the Kiddie Schedule for Affective Disorders (K-SADS) @entity308 (KDRS) and @entity162 (KMRS) Rating Scales, @entity1 's @entity308 Rating Scale-Revised (CDRS-R), and Young @entity162 Rating Scale (YMRS).   3/placebo conditions were double-blind; independent evaluators were @entity1939 . RESULTS: Most @entity1 (83%) completed the 12 week trial. Side effects were uncommon and mild. Intent-to-treat analyses indicated significant improvement in @entity308 (KDRS) for combined treatment relative to placebo and AM (p = 0.01, d = 1.70). Across groups, @entity162 improved over time without significant treatment effects. Effect of IF-PEP on @entity1 @entity308 compared with AM was medium (d = 0.63, CDRS-R) to large (d = 1.24, KDRS). Effect of   3 on @entity308 was medium (d = 0.48, KDRS). CONCLUSION: IF-PEP and   3 are well tolerated and associated with improved mood symptoms among youth with BP-NOS and CYC. Clinicaltrials.gov Identifier: NCT01507753.

A Randomized Controlled Trial of Individual Family Psychoeducational Psychotherapy and Omega-3 Fatty Acids in Youth with XXXX .

@entity4599 :: ('CHEBI:25681', 'Chemical') :: ['omega-3 fatty acid'] @entity1 :: ('9606', 'Species') :: ['participants', 'Children', 'Participants', 'child'] @entity162 :: ('MESH:D001714', 'Disease') :: ['bipolar disorder', 'subsyndromal bipolar disorders', 'Mania', 'manic symptoms'] @entity7955 :: ('MESH:C073248', 'Chemical') :: ['PEP'] @entity308 :: ('MESH:D003866', 'Disease') :: ['Depression', 'depressive symptoms', 'depression'] @entity71 :: ('MESH:D001289', 'Disease') :: ['attention-deficit/hyperactivity disorder'] @entity1939 :: ('MESH:D001766', 'Disease') :: ['blind to psychotherapy condition']
@entity162 :: (MESH:D001714,Disease) :: ['Subsyndromal Bipolar Disorder']
