Light Therapy for Elderly Depression
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|ClinicalTrials.gov Identifier: NCT00332670|
Recruitment Status : Terminated (End of research time, time-resources)
First Posted : June 2, 2006
Last Update Posted : August 15, 2008
The purpose of this study is to investigate the following two hypotheses:
- Treatment with bright light improves their sleep, mood, concentration and self-sufficiency of elderly depressed subjects. This clinical improvement is accompanied by decreases in cortisol/DHEA ratio and increases in melatonin concentration in urine and saliva.
- The eventual beneficial effect of bright light treatment can be predicted by the presence of sleep-wake rhythm disturbances as found using muscle activity registration, and by cortisol/DHEA and melatonin concentrations in saliva and urine over the day and the night.
|Condition or disease||Intervention/treatment||Phase|
|Major Depressive Disorder||Procedure: 10.000lux blue 1 hour every day during three weeks Procedure: 50lux dim red 1 hour every day during three weeks||Phase 2 Phase 3|
Background: Depression frequently occurs in the elderly. In normal aging, and in depression, the functioning of the suprachiasmatic nucleus (SCN) is impaired, as evidenced by an increased prevalence of day-night rhythm perturbations, e.g. sleeping disorders. Also, the normal inhibition of SCN neurons on corticotrophin-releasing hormone (CRH) producing cells is decreased, which could be responsible for the hyperactive hypothalamus-pituitary adrenocortical axis (HPA-axis). This raises the question whether elderly patients with depression have more impaired SCN activity and whether HPA-activity is enhanced. Using bright light therapy (BLT) the SCN can be stimulated. And, the beneficial effects of BLT on seasonal depressive disorders are well accepted. Nevertheless, the effects of BLT in aged depressed patients have never been studied, as yet.
Aims: The aim of this study is to test the hypothesis that BLT improves sleep, mood, concentration and self-efficacy of older people with depression and this improvement is accompanied by a normalization of HPA-indices.
Methods: Randomised double blind placebo controlled trial in 120 subjects of 60 years and older with a diagnosis of major depressive disorder (DSM-IV/SCID-I). Subjects are recruited through referrals of psychiatric outpatient clinics and from case-finding from databases of general practitioners and old-people homes in the Amsterdam region. After inclusion subjects are randomly allocated to bright blue light vs. dim red light groups using two Philips Bright Light Energy boxes type HF 3304 per subject from which the light bulbs have been covered with bright blue or dim red light permitting filters. Criteria for stratification are the use of SSRIs. Prior to treatment a 1-week run-in period without treatment will be used as a baseline condition. At three time points several endocrinological, psychophysiological, psychometrically, neuropsychological, and neuroimaging measures are performed: just before start of light therapy (T0), after completion of the three week light therapy period (T1), and three weeks thereafter (T2).
Relevance: This study is designed to show whether light therapy can reduce depressive symptoms of elderly patients with a major depressive disorder. If this is the case, then additional lightning may easily be installed in the homes of patients to serve as a maintenance treatment. Also, if our data support the role of a dysfunctional biological clock in depressed elderly subjects, such a finding may guide the further development of drugs that inhibit the HPA axis.
|Study Type :||Interventional (Clinical Trial)|
|Actual Enrollment :||89 participants|
|Intervention Model:||Parallel Assignment|
|Masking:||Quadruple (Participant, Care Provider, Investigator, Outcomes Assessor)|
|Official Title:||High Cortisol Levels as a Risk Factor for Depression in the Elderly and the Effect of Bright Light Treatment on Mood, Sleep-Wake Pattern and Self-Sufficiency|
|Study Start Date :||January 2003|
|Actual Primary Completion Date :||June 2007|
|Actual Study Completion Date :||June 2007|
Active Comparator: 1
10.000lux bright blue light 1hour every morning 1 hour after wake-up time during three weeks
Procedure: 10.000lux blue 1 hour every day during three weeks
10.000lux during 60 minutes, starting 1 hour after wake-up, during 3 weeks
Other Name: Bright light
Placebo Comparator: 2
50lux dim red light 1 hour every morning 1 hr after wake-up time during 3 weeks
Procedure: 50lux dim red 1 hour every day during three weeks
50 lux red light, 60 minutes every morning, starting 1 hour after wake-up, during three weeks
Other Name: Dim red light
- Hamilton Depression Rating Scale (HADRS-17) [ Time Frame: at T0, T1 and T2 ]
- Actimetry [ Time Frame: continuous measurement during complete 7 week study period ]
- 24-hour urinary cortisol measurements [ Time Frame: at T0, T1 and T2 (saliva melatonin evening curve (bedtime minus 4 hours, minus 3 hours, minus 2 hours, minus 1 hour). ]
- saliva cortisol daytime curve [ Time Frame: T0, T1 and t2 (get-up time plus 30 minutes, plus 60 minutes, plus 90 minutes, plus 120 minutes,bedtime minus 4 hours, minus 3 hours, minus 2 hours, minus 1 hour) ]
- Social Rhythm Metric [ Time Frame: complete 7-week study period. ]
- Groningen Activity Restriction Scale (GARS) [ Time Frame: at T0, T1 and T2 ]
- Algemene Competentieverwachtingen Schaal (ALCOS) [ Time Frame: at T0, T1 and T2 ]
- Social Support List interactions, discrepancies and negative (SSL-i, SSL-d, SSL-n) [ Time Frame: at T0, T1 and T2 ]
- MOS-short form General Health Survey (SF-20) [ Time Frame: T0, T1 and T2 ]
- Pittsburgh Sleep Quality Inventory (PSQI) [ Time Frame: at T0, T1 and T2 ]
- Neuropsychological test battery [ Time Frame: at T0, T1 and T2 ]
- fMRI (encoding task, recognition task, N-Back) [ Time Frame: at T0 and T1 ]
- structural MRI scanning (brain and volumetry of adrenals) [ Time Frame: at T0 and T1 ]
- MADRS [ Time Frame: at T0, T1 and t2 ]
- Adverse effects inventarisation [ Time Frame: 3-5 times during treatment ]
To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.
Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT00332670
|Amsterdam, Noord-Holland, Netherlands, 1081HL|
|Study Director:||Witte JG Hoogendijk, prof. dr.||Center for Neurogenomics and Cognitive Research, Free University, Amsterdam, the Netherlands; Department of Psychiatry VU University Medical Center, Amsterdam, The Netherlands; GGZ Buitenamstel, Amsterdam, The Netherlands|
|Study Chair:||Eus van Someren, PhD||Netherlands Institute for Brain Research, Amsterdam, The Netherlands; VU University Medical Center, Amsterdam, The Netherlands|
|Study Chair:||Marjan MA Nielen, PhD||Center for Neurogenomics and Cognitive Research, Free University, Amsterdam, the Netherlands; Department of Psychiatry VU University Medical Center, Amsterdam, The Netherlands; GGZ Buitenamstel, Amsterdam, The Netherlands|
|Principal Investigator:||Ritsaert Lieverse, MD||Center for Neurogenomics and Cognitive Research, Free University, Amsterdam, the Netherlands; Department of Psychiatry VU University Medical Center, Amsterdam, The Netherlands; GGZ Buitenamstel, Amsterdam, The Netherlands|