Evidence map›Paper›PMID 26682997›Full record

Trial reportJournal of child and adolescent psychopharmacology2015

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

Mary A Fristad, Andrea S Young, Anthony T Vesco, Elias S Nader, K Zachary Healy, William Gardner, Hannah L Wolfson, L Eugene Arnold

Registry-linked trialOpen access · greenAbstract readRandomized Controlled Trial
In one paragraph

Trial report in Journal of child and adolescent psychopharmacology, 2015. The graph could read no effect estimate from its abstract, so it casts no vote on the map. It is linked to trial NCT01507753 (Omega-3 Fatty Acids & Psychoeducational Psychotherapy for Childhood Bipolar Disorder- Not Otherwise Specified), which is not on this map. Cited by 34 papers, 5 of them syntheses that pooled it.

0numbers the graph read from it
0cells of the map it votes in
34citing papers in PubMed, 5 pooled it
4.4field-weighted citation impact, top 5% of its field
1 · What the graph read from it

What it found

Each row is one number read from the abstract, on the scale the paper reported it, with its interval. Left of the dashed line favours the treatment, right favours the comparator. Under each row is the sentence it came from. New to these charts? A ten-minute tutorial.

The abstract states no effect estimate the extractor could read, or names no intervention and outcome on the map, so this paper lights no cell and moves no belief. It is still indexed, cited and linked below.

2 · The registry

The trial behind it

Trials whose registry record cites this paper, or whose number appears in the abstract. A trial that started after this paper was published is citing it as background, not reporting it.

NCT01507753 phase1completednot on this map

Omega-3 Fatty Acids & Psychoeducational Psychotherapy for Childhood Bipolar Disorder- Not Otherwise Specified

TypeinterventionalSponsorL. Eugene ArnoldRan2011 to 2014Enrolled23ConditionsBipolar DisorderArmsOmega-3 Supplementation, Psychoeducational Psychotherapy (PEP), Placebo
3 · Its place in the literature

Who cites it

34 citing papers in PubMed, 5 syntheses or guidelines pooled it, 65 citations in OpenAlex.

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  4. Nutraceuticals in Psychiatric Disorders: A Systematic Review.International journal of molecular sciences · 2024
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  9. Pilot Randomized Controlled Trial of Omega-3 and Individual-Family Psychoeducational Psychotherapy for Children and Adolescents With Depression.Journal of clinical child and adolescent psychology : the official journal for the Society of Clinical Child and Adolescent Psychology, American Psychological Association, Division 53 · 2019
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4 · The record

Corrections and comments

PubMed lists nothing against this paper. Absence here is not a guarantee, only a check that was made.

5 · Who and what money

Authors and funding

8 authors at 2 institutions in 2 countries.

Mary A Fristad1 Department of Psychiatry and Behavioral Health, The Ohio State University , Columbus, Ohio.
Andrea S Young1 Department of Psychiatry and Behavioral Health, The Ohio State University , Columbus, Ohio.
Anthony T Vesco1 Department of Psychiatry and Behavioral Health, The Ohio State University , Columbus, Ohio.
Elias S Nader1 Department of Psychiatry and Behavioral Health, The Ohio State University , Columbus, Ohio.
K Zachary Healy1 Department of Psychiatry and Behavioral Health, The Ohio State University , Columbus, Ohio.
William Gardner3 Children's Hospital of Eastern Ontario , Ottawa, Ontario, Canada .
Hannah L Wolfson1 Department of Psychiatry and Behavioral Health, The Ohio State University , Columbus, Ohio.
L Eugene Arnold1 Department of Psychiatry and Behavioral Health, The Ohio State University , Columbus, Ohio.
The Ohio State University · USChildren's Hospital of Eastern Ontario · CA

Funding

University of Iowa Clinical and Translational Science Program (TL1)UL1RR025755 · NCRR · OHIO STATE UNIVERSITY · PI JACKSON, REBECCA D · 2008 to 2011
$26.3M
Omega-3 Fatty Acids & Psychoeducational Psychotherapy for Child Bipolar NOSR34MH090148 · NIMH · OHIO STATE UNIVERSITY · PI ARNOLD, L EUGENE, FRISTAD, MARY A · 2011 to 2013
$689k
NCRR NIH HHS UL1RR025755NIMH NIH HHS R034 MH090148-03NIMH NIH HHS R34 MH090148
6 · The paper itself

Abstract

objectiveThis 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]).

methodsThis 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.

resultsMost 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).

conclusionIF-PEP and Ω3 are well tolerated and associated with improved mood symptoms among youth with BP-NOS and CYC. Clinicaltrials.gov Identifier: NCT01507753.

Indexed as

Family TherapyAttention Deficit Disorder with HyperactivityBipolar DisorderChildCombined Modality TherapyCyclothymic DisorderDouble-Blind MethodFamilyFatty Acids, Omega-3FemaleHumansMalePilot ProjectsPsychiatric Status Rating ScalesFatty Acids, Omega-3

Identifiers

PMID26682997
PMCPMC4691654
OpenAlexW2197678865

What OpenQuestion holds

Textmetadata
Read underepoch 390

Registered trials

Read under generation 80e0d062 · epoch 390. Bibliography from PubMed, PubMed Central and OpenAlex; grants from NIH RePORTER; trial links from ClinicalTrials.gov; estimates, votes and beliefs from the OpenQuestion graph.