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A double-blind randomized controlled trial to assess the effect of bright light therapy on depression in patients with Parkinson's disease.

ABSTRACT: A disturbed circadian rhythm seems to be a causal factor in the occurrence of depressive disorders in patients with Parkinson's disease (PD). The circadian rhythm can be restored with light. Therefore, Bright Light Therapy (BLT) might be a new treatment option for depression in PD patients.In this double-blind controlled trial, 84 subjects with idiopathic PD are randomized to either BLT or a control light condition. The BLT condition emits white light with an intensity of 10,000 Lux, while the control device emits dim white light of 200 Lux, which is presumed to be too low to influence the circadian rhythm. Subjects receive 30 min of home treatment twice daily for three months. Timing of treatment is based on the individual chronotype. After finishing treatment, subjects enter a follow-up period of six months. The primary outcome of the study is the severity of depressive symptoms, as measured with the Hamilton Depression Rating Scale. Secondary outcomes are alternative depression measures, objective and subjective sleep measures, and salivary melatonin and cortisol concentrations. For exploratory purposes, we also assess the effects on motor symptoms, global cognitive function, comorbid psychiatric disorders, quality of life and caregiver burden. Data will be analyzed using a linear mixed models analysis.Performing a placebo-controlled trial on the effects of BLT in PD patients is challenging, as the appearance of the light may provide clues on the treatment condition. Moreover, fixed treatment times lead to an improved sleep-wake rhythm, which also influences the circadian system. With our study design, we do not compare BLT to placebo treatment, i.e. an ineffective control treatment. Rather, we compare structuring of the sleep-wake cycle in both conditions with additional BLT in the experimental condition, and additional dim light in the control condition. Participants are not informed about the exact details of the two light devices and the expected therapeutic effect, and expectancies are rated prior to the start of treatment. Ideally, the design of a future study on BLT should include two extra treatment arms where BLT and control light are administered at random times.This trial was registered on ClinicalTrials.gov on May 17th 2012 (ClinicalTrials.gov Identifier: NCT01604876 ).

SUBMITTER: Rutten S

PROVIDER: S-EPMC5073442 | biostudies-literature | 2016 Oct

REPOSITORIES: biostudies-literature

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A double-blind randomized controlled trial to assess the effect of bright light therapy on depression in patients with Parkinson's disease.

Rutten Sonja S Vriend Chris C Smit Jan H JH Berendse Henk W HW Hoogendoorn Adriaan W AW van den Heuvel Odile A OA van der Werf Ysbrand D YD

BMC psychiatry 20161021 1

<h4>Background</h4>A disturbed circadian rhythm seems to be a causal factor in the occurrence of depressive disorders in patients with Parkinson's disease (PD). The circadian rhythm can be restored with light. Therefore, Bright Light Therapy (BLT) might be a new treatment option for depression in PD patients.<h4>Methods/design</h4>In this double-blind controlled trial, 84 subjects with idiopathic PD are randomized to either BLT or a control light condition. The BLT condition emits white light wi ...[more]

PMID: 27769202

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Project description:ObjectivesApproximately 11%-13% of pregnant women suffer from depression. Bright light therapy (BLT) is a promising treatment, combining direct availability, sufficient efficacy, low costs and high safety for both mother and child. Here, we examined the effects of BLT on depression during pregnancy.DesignRandomised, double-blind controlled trial.SettingPrimary and secondary care in The Netherlands, from November 2016 to March 2019.Participants67 pregnant women (12-32 weeks gestational age) with a DSM-5 diagnosis of depressive disorder (Diagnostic and Statistical Manual of Mental Disorders).InterventionsParticipants were randomly allocated to treatment with either BLT (9000 lux, 5000 K) or dim red light therapy (DRLT, 100 lux, 2700 K), which is considered placebo. For 6 weeks, both groups were treated daily at home for 30 min on awakening. Follow-up took place weekly during the intervention, after 6 weeks of therapy, 3 and 10 weeks after treatment and 2 months postpartum.Primary and secondary outcome measuresDepressive symptoms were measured primarily with the Structured Interview Guide for the Hamilton Depression Scale-Seasonal Affective Disorder. Secondary measures were the Hamilton Rating Scale for Depression and the Edinburgh Postnatal Depression Scale. Changes in rating scale scores of these questionnaires over time were analysed using generalised linear mixed models.ResultsMedian depression scores decreased by 40.6%-53.1% in the BLT group and by 50.9%-66.7% in the DRLT group. We found no statistically significant difference in symptom change scores between BLT and DRLT. Sensitivity and post-hoc analyses did not change our findings.ConclusionsDepressive symptoms of pregnant women with depression improved in both treatment arms. More research is necessary to determine whether these responses represent true treatment effects, non-specific treatment responses, placebo effects or a combination hereof.Trial registration numberNTR5476.

Project description:BackgroundDepressive disorders are among the most prominent health problems in youth. Even with the best available pharmacological and non-pharmacological treatments, remission rates are low. Without early treatment, depression in youth is associated with a high risk of symptom progression, chronicity, co-morbidity, and suicidal behavior. Thus, adolescent depression is a prime candidate for innovation in treatment. In depressive adults, meta-analytic evidence has proven that bright light therapy (BLT) is a potent low-threshold intervention, promising due to easy application, low side effects, and optimized compliance. In adolescents, studies with small samples show promising effects. This randomized controlled trial will examine the effectiveness of BLT in youth inpatients.Methods/designIn this randomized, controlled, double-blind multicenter parallel group trial, morning BLT is applied for four weeks in addition to treatment as usual (TAU) for depressed youth inpatients (daily morning exposure to bright light via light-emitting glasses, 10,000 lx, for 30 min) and will be compared to a control condition (placebo light treatment, red light, identical light glasses). The primary objective is to assess whether BLT reduces symptoms of depression in youth with greater effect compared to placebo light therapy. Secondary objectives are to examine the impact of BLT on responder status, application of antidepressant medication, and further depression-related symptoms (sleep, activity, quality of life, satisfaction with health, general psychopathology, alertness, and circadian function). N?=?224 patients will be recruited in a naturalistic inpatient setting. A follow-up will be carried out after three and six months.DiscussionThe study aims to discuss and evaluate BLT as an additive method supporting standardized clinical procedures dealing with severe to moderate depressive symptoms in youth.Trial registrationGerman Clinical Trials Register, DRKS00013188 . Registered on November 30, 2017.

Project description:Bright light treatment is effective for seasonal affective disorder (SAD), although the mechanisms of action are still unknown. We investigated whether transcranial bright light via the ear canals has an antidepressant effect in the treatment of SAD.During the four-week study period, 89 patients (67 females; 22 males, aged 22-65, mean ± SD age: 43.2 ± 10.9 years) suffering from SAD were randomized to receive a 12-min daily dose of photic energy of one of three intensities (1 lumen/0.72 mW/cm(2); 4 lumens/2.881 mW/cm(2); 9 lumens/6.482 mW/cm(2)) via the ear canals. The light was produced using light-emitting diodes. The severity of depressive symptoms was assessed with the Hamilton Depression Rating Scale - Seasonal Affective Disorder (SIGH-SAD), the Hamilton Anxiety Rating Scale (HAMA), and the Beck Depression Inventory (BDI). Cognitive performance was measured by the Trail Making Test (TMT). The within-group and between-group changes in these variables throughout the study were analysed with a repeated measures analysis of variance (ANOVA), whereas gender differences at baseline within the light groups were analysed using Student's t-tests.Patients in all three groups showed significant decreases in their BDI, HAMA, and SIGH-SAD scores. Response rates, i.e., an at least 50% decrease of symptoms as measured by the BDI, were 74%-79% in the three treatment groups. Corresponding variations for the SIGH-SAD and the HAMA were 35-45% and 47-62%, respectively. No intensity-based dose-response relationships in the improvement of anxiety and depressive symptoms or cognitive performance between treatment groups were observed. Approximately one in four patients experienced mild adverse effects, of which the most common were headache, insomnia, and nausea.These results suggests that transcranial bright light treatment may have antidepressant and anxiolytic effect in SAD patients, as both self- and psychiatrist-rated depressive and anxiety symptoms decreased in all treatment groups. These improvements are comparable to findings of earlier bright light studies that used conventional devices. The lack of dose response may be due to a saturation effect above a certain light intensity threshold. Further studies on the effects of transcranial bright light with an adequate placebo condition are needed.NCT01293409, ClinicalTrials.gov.

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A double-blind randomized controlled trial to assess the effect of bright light therapy on depression in patients with Parkinson's disease.

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A double-blind randomized controlled trial to assess the effect of bright light therapy on depression in patients with Parkinson's disease.

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