Light Therapy for Elderly Depression

August 12, 2008 updated by: GGZ Buitenamstel

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.

Study Overview

Status

Terminated

Conditions

Intervention / Treatment

Detailed Description

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

Enrollment (Actual)

89

Phase

  • Phase 2
  • Phase 3

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Locations

  • Netherlands
    • Noord-Holland
      • Amsterdam, Noord-Holland, Netherlands, 1081HL
        • GGZ Buitenamstel

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

60 years and older (ADULT, OLDER_ADULT)

Accepts Healthy Volunteers

No

Genders Eligible for Study

All

Description

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.

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Primary Purpose: TREATMENT
  • Allocation: RANDOMIZED
  • Interventional Model: PARALLEL
  • Masking: QUADRUPLE

Arms and Interventions

Participant Group / Arm
Intervention / Treatment
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 Names:
  • 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 Names:
  • Dim red light

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Time Frame
Hamilton Depression Rating Scale (HADRS-17)
Time Frame: at T0, T1 and T2
at T0, T1 and T2

Secondary Outcome Measures

Outcome Measure
Time Frame
Actimetry
Time Frame: continuous measurement during complete 7 week study period
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).
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)
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.
complete 7-week study period.
Groningen Activity Restriction Scale (GARS)
Time Frame: at T0, T1 and T2
at T0, T1 and T2
Algemene Competentieverwachtingen Schaal (ALCOS)
Time Frame: at T0, T1 and T2
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
at T0, T1 and T2
MOS-short form General Health Survey (SF-20)
Time Frame: T0, T1 and T2
T0, T1 and T2
Pittsburgh Sleep Quality Inventory (PSQI)
Time Frame: at T0, T1 and T2
at T0, T1 and T2
Neuropsychological test battery
Time Frame: at T0, T1 and T2
at T0, T1 and T2
fMRI (encoding task, recognition task, N-Back)
Time Frame: at T0 and T1
at T0 and T1
structural MRI scanning (brain and volumetry of adrenals)
Time Frame: at T0 and T1
at T0 and T1
MADRS
Time Frame: at T0, T1 and t2
at T0, T1 and t2
Adverse effects inventarisation
Time Frame: 3-5 times during treatment
3-5 times during treatment

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

GGZ Buitenamstel

Collaborators

Netherlands Institute for Brain Research, Amsterdam, The Netherlands.

Investigators

  • 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

Publications and helpful links

The person responsible for entering information about the study voluntarily provides these publications. These may be about anything related to the study.

General Publications

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start

January 1, 2003

Primary Completion (ACTUAL)

June 1, 2007

Study Completion (ACTUAL)

June 1, 2007

Study Registration Dates

First Submitted

May 31, 2006

First Submitted That Met QC Criteria

May 31, 2006

First Posted (ESTIMATE)

June 2, 2006

Study Record Updates

Last Update Posted (ESTIMATE)

August 15, 2008

Last Update Submitted That Met QC Criteria

August 12, 2008

Last Verified

August 1, 2008

More Information

Terms related to this study

Keywords

Additional Relevant MeSH Terms

Other Study ID Numbers

  • SOW 014-91-049
  • ZonMw SOW nr 014-91-049
  • ZonMw AGIKO nr 940-37-033

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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