search
Back to results

Light Therapy for Elderly Depression

Primary Purpose

Major Depressive Disorder

Status
Terminated
Phase
Phase 2
Locations
Netherlands
Study Type
Interventional
Intervention
10.000lux blue 1 hour every day during three weeks
50lux dim red 1 hour every day during three weeks
Sponsored by
GGZ Buitenamstel
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional treatment trial for Major Depressive Disorder focused on measuring (Non-seasonal) Depression, bright light therapy, randomized controlled trial, suprachiasmatic nucleus, HPA-axis, DHEA, melatonin, actigraphy, elderly, self-efficacy, social support

Eligibility Criteria

60 Years - undefined (Adult, Older Adult)All SexesDoes not accept 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.

Sites / Locations

  • GGZ Buitenamstel

Arms of the Study

Arm 1

Arm 2

Arm Type

Active Comparator

Placebo Comparator

Arm Label

1

2

Arm Description

10.000lux bright blue light 1hour every morning 1 hour after wake-up time during three weeks

50lux dim red light 1 hour every morning 1 hr after wake-up time during 3 weeks

Outcomes

Primary Outcome Measures

Hamilton Depression Rating Scale (HADRS-17)

Secondary Outcome Measures

Actimetry
24-hour urinary cortisol measurements
saliva cortisol daytime curve
Social Rhythm Metric
Groningen Activity Restriction Scale (GARS)
Algemene Competentieverwachtingen Schaal (ALCOS)
Social Support List interactions, discrepancies and negative (SSL-i, SSL-d, SSL-n)
MOS-short form General Health Survey (SF-20)
Pittsburgh Sleep Quality Inventory (PSQI)
Neuropsychological test battery
fMRI (encoding task, recognition task, N-Back)
structural MRI scanning (brain and volumetry of adrenals)
MADRS
Adverse effects inventarisation

Full Information

First Posted
May 31, 2006
Last Updated
August 12, 2008
Sponsor
GGZ Buitenamstel
Collaborators
Netherlands Institute for Brain Research, Amsterdam, The Netherlands.
search

1. Study Identification

Unique Protocol Identification Number
NCT00332670
Brief Title
Light Therapy for Elderly Depression
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 Type
Interventional

2. Study Status

Record Verification Date
August 2008
Overall Recruitment Status
Terminated
Why Stopped
End of research time, time-resources
Study Start Date
January 2003 (undefined)
Primary Completion Date
June 2007 (Actual)
Study Completion Date
June 2007 (Actual)

3. Sponsor/Collaborators

Name of the Sponsor
GGZ Buitenamstel
Collaborators
Netherlands Institute for Brain Research, Amsterdam, The Netherlands.

4. Oversight

Data Monitoring Committee
No

5. 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.
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.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Major Depressive Disorder
Keywords
(Non-seasonal) Depression, bright light therapy, randomized controlled trial, suprachiasmatic nucleus, HPA-axis, DHEA, melatonin, actigraphy, elderly, self-efficacy, social support

7. Study Design

Primary Purpose
Treatment
Study Phase
Phase 2, Phase 3
Interventional Study Model
Parallel Assignment
Masking
ParticipantCare ProviderInvestigatorOutcomes Assessor
Allocation
Randomized
Enrollment
89 (Actual)

8. Arms, Groups, and Interventions

Arm Title
1
Arm Type
Active Comparator
Arm Description
10.000lux bright blue light 1hour every morning 1 hour after wake-up time during three weeks
Arm Title
2
Arm Type
Placebo Comparator
Arm Description
50lux dim red light 1 hour every morning 1 hr after wake-up time during 3 weeks
Intervention Type
Procedure
Intervention Name(s)
10.000lux blue 1 hour every day during three weeks
Other Intervention Name(s)
Bright light
Intervention Description
10.000lux during 60 minutes, starting 1 hour after wake-up, during 3 weeks
Intervention Type
Procedure
Intervention Name(s)
50lux dim red 1 hour every day during three weeks
Other Intervention Name(s)
Dim red light
Intervention Description
50 lux red light, 60 minutes every morning, starting 1 hour after wake-up, during three weeks
Primary Outcome Measure Information:
Title
Hamilton Depression Rating Scale (HADRS-17)
Time Frame
at T0, T1 and T2
Secondary Outcome Measure Information:
Title
Actimetry
Time Frame
continuous measurement during complete 7 week study period
Title
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).
Title
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)
Title
Social Rhythm Metric
Time Frame
complete 7-week study period.
Title
Groningen Activity Restriction Scale (GARS)
Time Frame
at T0, T1 and T2
Title
Algemene Competentieverwachtingen Schaal (ALCOS)
Time Frame
at T0, T1 and T2
Title
Social Support List interactions, discrepancies and negative (SSL-i, SSL-d, SSL-n)
Time Frame
at T0, T1 and T2
Title
MOS-short form General Health Survey (SF-20)
Time Frame
T0, T1 and T2
Title
Pittsburgh Sleep Quality Inventory (PSQI)
Time Frame
at T0, T1 and T2
Title
Neuropsychological test battery
Time Frame
at T0, T1 and T2
Title
fMRI (encoding task, recognition task, N-Back)
Time Frame
at T0 and T1
Title
structural MRI scanning (brain and volumetry of adrenals)
Time Frame
at T0 and T1
Title
MADRS
Time Frame
at T0, T1 and t2
Title
Adverse effects inventarisation
Time Frame
3-5 times during treatment

10. Eligibility

Sex
All
Minimum Age & Unit of Time
60 Years
Accepts Healthy Volunteers
No
Eligibility Criteria
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.
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Witte JG Hoogendijk, prof. dr.
Organizational Affiliation
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
Official's Role
Study Director
First Name & Middle Initial & Last Name & Degree
Eus van Someren, PhD
Organizational Affiliation
Netherlands Institute for Brain Research, Amsterdam, The Netherlands; VU University Medical Center, Amsterdam, The Netherlands
Official's Role
Study Chair
First Name & Middle Initial & Last Name & Degree
Marjan MA Nielen, PhD
Organizational Affiliation
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
Official's Role
Study Chair
First Name & Middle Initial & Last Name & Degree
Ritsaert Lieverse, MD
Organizational Affiliation
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
Official's Role
Principal Investigator
Facility Information:
Facility Name
GGZ Buitenamstel
City
Amsterdam
State/Province
Noord-Holland
ZIP/Postal Code
1081HL
Country
Netherlands

12. IPD Sharing Statement

Citations:
PubMed Identifier
9154571
Citation
Hoogendijk WJ, van Someren EJ, Mirmiran M, Hofman MA, Lucassen PJ, Zhou JN, Swaab DF. Circadian rhythm-related behavioral disturbances and structural hypothalamic changes in Alzheimer's disease. Int Psychogeriatr. 1996;8 Suppl 3:245-52; discussion 269-72. doi: 10.1017/s1041610297003426. No abstract available.
Results Reference
background
PubMed Identifier
9547118
Citation
Beekman AT, Penninx BW, Deeg DJ, Ormel J, Braam AW, van Tilburg W. Depression and physical health in later life: results from the Longitudinal Aging Study Amsterdam (LASA). J Affect Disord. 1997 Dec;46(3):219-31. doi: 10.1016/s0165-0327(97)00145-6.
Results Reference
background
PubMed Identifier
9393943
Citation
Deuschle M, Gotthardt U, Schweiger U, Weber B, Korner A, Schmider J, Standhardt H, Lammers CH, Heuser I. With aging in humans the activity of the hypothalamus-pituitary-adrenal system increases and its diurnal amplitude flattens. Life Sci. 1997;61(22):2239-46. doi: 10.1016/s0024-3205(97)00926-0.
Results Reference
background
PubMed Identifier
16390913
Citation
Kripke DF, Tuunainen A, Endo T. Benefits of light treatment for depression. Am J Psychiatry. 2006 Jan;163(1):162-3; author reply 163. doi: 10.1176/appi.ajp.163.1.162-b. No abstract available.
Results Reference
background
PubMed Identifier
9609674
Citation
Kripke DF. Light treatment for nonseasonal depression: speed, efficacy, and combined treatment. J Affect Disord. 1998 May;49(2):109-17. doi: 10.1016/s0165-0327(98)00005-6.
Results Reference
background
PubMed Identifier
15800134
Citation
Golden RN, Gaynes BN, Ekstrom RD, Hamer RM, Jacobsen FM, Suppes T, Wisner KL, Nemeroff CB. The efficacy of light therapy in the treatment of mood disorders: a review and meta-analysis of the evidence. Am J Psychiatry. 2005 Apr;162(4):656-62. doi: 10.1176/appi.ajp.162.4.656.
Results Reference
background
PubMed Identifier
14739440
Citation
Wirz-Justice A, Terman M, Oren DA, Goodwin FK, Kripke DF, Whybrow PC, Wisner KL, Wu JC, Lam RW, Berger M, Danilenko KV, Kasper S, Smeraldi E, Takahashi K, Thompson C, van den Hoofdakker RH. Brightening depression. Science. 2004 Jan 23;303(5657):467-9. doi: 10.1126/science.303.5657.467c. No abstract available.
Results Reference
background
PubMed Identifier
16045060
Citation
Wirz-Justice A, Benedetti F, Berger M, Lam RW, Martiny K, Terman M, Wu JC. Chronotherapeutics (light and wake therapy) in affective disorders. Psychol Med. 2005 Jul;35(7):939-44. doi: 10.1017/s003329170500437x.
Results Reference
background
PubMed Identifier
15992393
Citation
Martiny K, Lunde M, Unden M, Dam H, Bech P. Adjunctive bright light in non-seasonal major depression: results from clinician-rated depression scales. Acta Psychiatr Scand. 2005 Aug;112(2):117-25. doi: 10.1111/j.1600-0447.2005.00574.x.
Results Reference
background
PubMed Identifier
15877712
Citation
Martiny K, Lunde M, Unden M, Dam H, Bech P. Adjunctive bright light in non-seasonal major depression: results from patient-reported symptom and well-being scales. Acta Psychiatr Scand. 2005 Jun;111(6):453-9. doi: 10.1111/j.1600-0447.2005.00532.x.
Results Reference
background
PubMed Identifier
9554575
Citation
Gordijn MC, Beersma DG, Korte HJ, Van den Hoofdakker RH. Testing the hypothesis of a circadian phase disturbance underlying depressive mood in nonseasonal depression. J Biol Rhythms. 1998 Apr;13(2):132-47. doi: 10.1177/074873098128999989.
Results Reference
background
PubMed Identifier
11448372
Citation
Zhou JN, Riemersma RF, Unmehopa UA, Hoogendijk WJ, van Heerikhuize JJ, Hofman MA, Swaab DF. Alterations in arginine vasopressin neurons in the suprachiasmatic nucleus in depression. Arch Gen Psychiatry. 2001 Jul;58(7):655-62. doi: 10.1001/archpsyc.58.7.655.
Results Reference
background
PubMed Identifier
21199966
Citation
Lieverse R, Van Someren EJ, Nielen MM, Uitdehaag BM, Smit JH, Hoogendijk WJ. Bright light treatment in elderly patients with nonseasonal major depressive disorder: a randomized placebo-controlled trial. Arch Gen Psychiatry. 2011 Jan;68(1):61-70. doi: 10.1001/archgenpsychiatry.2010.183.
Results Reference
derived
PubMed Identifier
18671864
Citation
Lieverse R, Nielen MM, Veltman DJ, Uitdehaag BM, van Someren EJ, Smit JH, Hoogendijk WJ. Bright light in elderly subjects with nonseasonal major depressive disorder: a double blind randomised clinical trial using early morning bright blue light comparing dim red light treatment. Trials. 2008 Jul 31;9:48. doi: 10.1186/1745-6215-9-48.
Results Reference
derived

Learn more about this trial

Light Therapy for Elderly Depression

We'll reach out to this number within 24 hrs