Light Therapy for Elderly Depression

This study has been terminated.
(End of research time, time-resources)
Sponsor:
Collaborator:
Netherlands Institute for Brain Research, Amsterdam, The Netherlands.
Information provided by:
GGZ Buitenamstel
ClinicalTrials.gov Identifier:
NCT00332670
First received: May 31, 2006
Last updated: August 12, 2008
Last verified: August 2008

May 31, 2006
August 12, 2008
January 2003
June 2007   (final data collection date for primary outcome measure)
Hamilton Depression Rating Scale (HADRS-17) [ Time Frame: at T0, T1 and T2 ] [ Designated as safety issue: No ]
  • Montgomery-Asberg Depression Rating Scale (MADRS) at T0, T1 and at T2
  • 29-item Structured Interview Guide for the Hamilton Depression Rating Scale, SAD version (SIGH-SAD) at T0, T1 and T2.
Complete list of historical versions of study NCT00332670 on ClinicalTrials.gov Archive Site
  • Actimetry [ Time Frame: continuous measurement during complete 7 week study period ] [ Designated as safety issue: No ]
  • 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). ] [ Designated as safety issue: No ]
  • 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) ] [ Designated as safety issue: No ]
  • Social Rhythm Metric [ Time Frame: complete 7-week study period. ] [ Designated as safety issue: No ]
  • Groningen Activity Restriction Scale (GARS) [ Time Frame: at T0, T1 and T2 ] [ Designated as safety issue: No ]
  • Algemene Competentieverwachtingen Schaal (ALCOS) [ Time Frame: at T0, T1 and T2 ] [ Designated as safety issue: No ]
  • Social Support List interactions, discrepancies and negative (SSL-i, SSL-d, SSL-n) [ Time Frame: at T0, T1 and T2 ] [ Designated as safety issue: No ]
  • MOS-short form General Health Survey (SF-20) [ Time Frame: T0, T1 and T2 ] [ Designated as safety issue: No ]
  • Pittsburgh Sleep Quality Inventory (PSQI) [ Time Frame: at T0, T1 and T2 ] [ Designated as safety issue: No ]
  • Neuropsychological test battery [ Time Frame: at T0, T1 and T2 ] [ Designated as safety issue: No ]
  • fMRI (encoding task, recognition task, N-Back) [ Time Frame: at T0 and T1 ] [ Designated as safety issue: No ]
  • structural MRI scanning (brain and volumetry of adrenals) [ Time Frame: at T0 and T1 ] [ Designated as safety issue: No ]
  • MADRS [ Time Frame: at T0, T1 and t2 ] [ Designated as safety issue: No ]
  • Adverse effects inventarisation [ Time Frame: 3-5 times during treatment ] [ Designated as safety issue: Yes ]
  • Actimetry continuous measurement during complete 7 week study period.
  • 24-hour urinary cortisol measurements 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 at 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 during complete 7-week study period.
  • Groningen Activity Restriction Scale (GARS) at T0, T1 and T2.
  • Algemene Competentieverwachtingen Schaal (ALCOS)at T0, T1 and T2
  • Social Support List interactions, discrepancies and negative (SSL-i, SSL-d, SSL-n)at T0, T1 and T2.
  • MOS-short form General Health Survey (SF-20)at T0, T1 and T2.
  • Pittsburgh Sleep Quality Inventory (PSQI)at T0, T1 and T2.
  • Neuropsychological test battery at T0, T1 and T2.
  • fMRI at T0 and T1 (encoding task, recognition task, N-Back)
  • structural MRI scanning at T0 and T1 (brain and volumetry of adrenals)
Not Provided
Not Provided
 
Light Therapy for Elderly Depression
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

The purpose of this study is to investigate the following two hypotheses:

  1. 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.
  2. 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.

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.

Interventional
Phase 2
Phase 3
Allocation: Randomized
Endpoint Classification: Efficacy Study
Intervention Model: Parallel Assignment
Masking: Double Blind (Subject, Caregiver, Investigator, Outcomes Assessor)
Primary Purpose: Treatment
Major Depressive Disorder
  • 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
  • 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
  • Active Comparator: 1
    10.000lux bright blue light 1hour every morning 1 hour after wake-up time during three weeks
    Intervention: Procedure: 10.000lux blue 1 hour every day during three weeks
  • Placebo Comparator: 2
    50lux dim red light 1 hour every morning 1 hr after wake-up time during 3 weeks
    Intervention: Procedure: 50lux dim red 1 hour every day during three weeks

*   Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline.
 
Terminated
89
June 2007
June 2007   (final data collection date for primary outcome measure)

Inclusion Criteria:

  • Understanding and speaking Dutch language
  • 60 years of age or older
  • Presence of a Major Depressive Disorder according to DSM-IV (SCID-based)
  • When under treatment of an ophthalmologist, his / her approval for participation.

Exclusion Criteria:

  • Progressive eye diseases, glaucoma or cataract for which an operation is scheduled in near future, aphakia, retinopathies like maculopathy, retinitis pigmentosa or ablatio retina.
  • Physical problems or disorders which require specific medical treatment like Lupus, untreated diabetes, malignancies, organic brain disorders, chronic infections, thyroid disorders not adequately treated, thyroid associated ophthalmopathies, M. Parkinson.
  • Presence of any concurrent substance abuse problem
  • Presence of other actual axis-I disorders like bipolar disorder, dementias, delirium, all psychotic disorders, Posttraumatic stress disorder.
  • Use of tricyclic antidepressants, MAOIs.
  • Use of corticosteroids.
  • Use of tetracyclic antibiotics.
  • Treatment with antidepressants shorter than 2 months
  • Use of oral contraceptives.
  • Treatment with light therapy in the past.
Both
60 Years and older
No
Contact information is only displayed when the study is recruiting subjects
Netherlands
 
NCT00332670
SOW 014-91-049, ZonMw SOW nr 014-91-049, ZonMw AGIKO nr 940-37-033
No
R. Lieverse, GGZBuitenamstel
GGZ Buitenamstel
Netherlands Institute for Brain Research, Amsterdam, The Netherlands.
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
GGZ Buitenamstel
August 2008

ICMJE     Data element required by the International Committee of Medical Journal Editors and the World Health Organization ICTRP