Quality of life in children and adolescents with bipolar I depression treated with olanzapine/fluoxetine combination

Abstract

BackgroundWe examined the efficacy of olanzapine/fluoxetine combination (OFC) in improving health-related quality of life (QoL) in the treatment of bipolar depression in children and adolescents.MethodsPatients aged 10–17 years with bipolar I disorder, depressed episode, baseline children’s depression rating scale-revised (CDRS-R) total score ≥40, Young Mania Rating Scale (YMRS) total score ≤15, and YMRS-item 1 ≤ 2 were randomized to OFC (6/25–12/50 mg/day olanzapine/fluoxetine; n = 170) or placebo (n = 85) for up to 8 weeks of double-blind treatment. Patients and parents completed the revised KINDL questionnaire for measuring health-related QoL in children and adolescents (KINDL-R) at baseline and endpoint. The mean change in CDRS-R total and item scores were used to compare improvement in symptomatology in patients taking OFC and placebo. Tests were 2-sided using a Type I error cutoff of 0.05, and no adjustments for multiple comparisons were made.ResultsBaseline QoL as measured by the KINDL-R was substantially impaired relative to published norms for a healthy school-based sample. OFC-treated patients demonstrated an improvement over placebo at endpoint with respect to mean change from baseline in the patient-rated KINDL-R Self-esteem subscale score (p = 0.028), and in the parent KINDL-R ratings of emotional well-being (p = 0.020), Self-esteem (p = 0.030), and Family (p = 0.006). At endpoint, OFC-treated patients still had a lower QoL compared to the normative population. OFC showed significant improvement (p ≤ 0.05) versus placebo on the CDRS-R total score and on 7 of the 17 CDRS-R items.ConclusionsPatients aged 10–17 years with an acute episode of bipolar depression and their parents reported greater improvements (parents noticed improvements in more areas than did their offspring) on some aspects of QoL when treated with OFC compared with placebo. However, after 8 weeks of treatment, KINDL-R endpoint scores remained lower than those of the, presumably healthy, control population. Clinical trial registration information A Study for Assessing Treatment of Patients Ages 10–17 with Bipolar Depression; http://www.clinicaltrials.gov; NCT00844857

Improving Functioning, Quality of Life, and Well-being in Patients With Bipolar Disorder

“…Similarly, Gonda and colleagues (2016) found that patients enhanced both their work functional outcome and QoL after receiving prophylactic lamotrigine therapy at 6-months follow-up. In young patients (10–17 years old) with an acute episode of bipolar depression, it was found that those who received olanzapine/fluoxetine combination presented better QoL scores compared with those receiving placebo (Walker et al, 2017).…”

Patient-reported outcome measures used to improve youth mental health services: a systematic review

“…Among 34 studies, there were 28 numbers of unique PROMs identified. Thirteen measures were unique generic profile PROMs, among the most common were KIDSCREEN [ 29 , 43 , 44 , 48 , 51 ], Strengths and Difficulties Questionnaire (SDQ) [ 21 , 38 , 40 , 42 , 49 ], KINDL-R [ 45 – 47 ], [ 58 , 59 ], Pediatric Quality of Life Enjoyment and Satisfaction (PQ-LES-Q) [ 30 , 54 – 56 ], and the Pediatric Quality of Life Inventory (PedsQl) 4.0 [ 33 , 34 , 41 ]. There were two generic preference-based PROMs, the Euroqol (EQ-5D 3L and 5L), Health Utilities Index (HUI2/3) and thirteen measures were disease-specific, most of which were used in depression such as beck depression inventory (BDI) and child depression inventory (CDI) (Additional file 2 : S2).…”

“…Many of the PROMs in the included studies were administered to the child for self-report [ 27 – 33 , 35 , 38 , 40 , 44 , 48 – 50 , 52 , 54 – 58 ]. Twelve measures included both self-report and proxy report [ 21 , 28 , 29 , 41 – 47 , 51 , 58 ] and five measures have been reported by proxy only [ 34 , 36 , 37 , 41 , 44 ]. Proxy reporting was used in some studies due to a child’s young age and cognitive abilities (Additional file 2 : S2).…”

Novel approaches to tackling emotional loss of control of eating across the weight spectrum

“…Fluoxetine is a serotonergic antidepressant which has been shown to lead to emotional stability across a broad spectrum of mental health conditions such as premenstrual emotional problems (92) , disruptive behaviour (93) , borderline personality disorder (94) and bipolar depression (95) . Therefore, it seems natural to use fluoxetine in people with bulimia nervosa, who suffer particularly from emotional dysregulation (96) .…”