Light Therapy for Elderly Depression

Sponsor

GGZ Buitenamstel (Other)

Overall Status

Terminated

CT.gov ID

NCT00332670

Collaborator

Netherlands Institute for Brain Research, Amsterdam, The Netherlands. (Other)

Enrollment

Location

Arms

Duration (Months)

1.7

Patients Per Site Per Month

Study Details

Study Description

Brief Summary

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

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 Design

Study Type:

Interventional

Actual Enrollment :

89 participants

Allocation:

Randomized

Intervention Model:

Parallel Assignment

Masking:

Quadruple (Participant, Care Provider, Investigator, Outcomes Assessor)

Primary Purpose:

Treatment

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 :

Jan 1, 2003

Actual Primary Completion Date :

Jun 1, 2007

Actual Study Completion Date :

Jun 1, 2007

Arms and Interventions

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

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

Outcome Measures

Primary Outcome Measures

Hamilton Depression Rating Scale (HADRS-17) [at T0, T1 and T2]

Secondary Outcome Measures

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 [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 [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) [T0, T1 and T2]
Pittsburgh Sleep Quality Inventory (PSQI) [at T0, T1 and T2]
Neuropsychological test battery [at T0, T1 and T2]
fMRI (encoding task, recognition task, N-Back) [at T0 and T1]
structural MRI scanning (brain and volumetry of adrenals) [at T0 and T1]
MADRS [at T0, T1 and t2]
Adverse effects inventarisation [3-5 times during treatment]

Eligibility Criteria

Criteria

Ages Eligible for Study:

60 Years and Older

Sexes Eligible for Study:

All

Accepts Healthy Volunteers:

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.

Contacts and Locations

Locations

	Site	City	State	Country	Postal Code
1	GGZ Buitenamstel	Amsterdam	Noord-Holland	Netherlands	1081HL

Sponsors and Collaborators

GGZ Buitenamstel
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