Pilot Randomized Controlled Trial of Omega-3 and Individual-Family Psychoeducational Psychotherapy for Children and Adolescents With Depression.

The goal of this study is to evaluate feasibility and estimate effect sizes of omega-3 fatty acids (Ω3), individual-family psychoeducational psychotherapy (PEP), their combination, and moderating effects of maternal depression and psychosocial stressors in youth with depression. In a pilot 2 × 2 randomized controlled trial, 72 youth (ages 7-14; 57% Caucasian, 57% male) with major depression, dysthymia, or depression not otherwise specified were randomized to 12 weeks of Ω3, PEP+placebo, Ω3+PEP, or placebo. Ω3 versus placebo was double-masked. Evaluators masked to condition assessed depressive severity at baseline (randomization) and at 2, 4, 6, 9, and 12 weeks using the Children's Depression Rating Scale-Revised. Side effects were either absent or mild. PEP was administered with 74% fidelity. Remission was 77%, Ω3+PEP; 61%, PEP+placebo; 44%, Ω3; 56%, placebo. Intent-to-treat analyses found small to medium effects of combined treatment (d = .29) and Ω3 monotherapy (d = .42), but negligible effect for PEP+placebo (d < .10), all compared to placebo alone. Relative to placebo, youth with fewer social stressors responded better to Ω3 (p = .04), PEP (p = .028), and their combination (p = .035), and those with maternal depression responded better to PEP (p = .020) than did those without maternal depression. Remission rates were favorable compared to other studies of psychotherapy and comparable to an existing randomized controlled trial of Ω3; results warrant further evaluation in a larger sample. Ω3 was well tolerated. Active treatments show significantly more placebo-controlled depression improvement in the context of maternal depression and fewer stressors, suggesting that they may benefit depression with a more endogenous than environmental origin.

Predicting enrollment in two randomized controlled trials of nonpharmacologic interventions for youth with primary mood disorders.

BACKGROUND: As recruitment and retention are often challenging in randomized controlled trials (RCTs), this study sought to identify predictors of participation (i.e., trial enrollment). METHOD: These analyses identified predictors of enrollment among 119 youth, ages 7-14, with a primary mood disorder, who screened eligible for the Omega-3 and Therapy pilot studies; 95 (79.8%) actually participated in the treatment. RESULTS: Youth who received some form of travel assistance (16.0%) almost uniformly enrolled in the treatment portion of the RCT. Youth who lived further away from the study site (p = .047) or whose primary caregiver never married (p = .01) were less likely to enroll. Of note, socioeconomic status (SES) variables (parent education and child insurance status) did not significantly predict enrollment, suggesting that study incentives or accommodations may have adequately addressed barriers commonly associated with SES. LIMITATIONS: Due to the fairly high trial enrollment rate (approximately 80%), there likely was limited power to detect some differences between groups. Generalizability may be limited to youth with a primary mood disorder diagnosis. CONCLUSIONS: Despite retaining a large proportion of the youth who screened eligible, participant self-selection is a limitation of any RCT. A silent inclusion criterion of any RCT is willingness to be randomized.

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

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