Ignite Creation Date:
2024-05-05 @ 4:52 PM
Last Modification Date:
2024-10-26 @ 9:25 AM
Study NCT ID:
NCT00332670
Status:
TERMINATED
Last Update Posted:
2008-08-15
First Post:
2006-05-31
Brief Title:
Light Therapy for Elderly Depression
Sponsor:
GGZ Buitenamstel
Organization:
GGZ Buitenamstel
Study Overview
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
Status:
TERMINATED
Status Verified Date:
2008-08
Last Known Status:
None
Delayed Posting:
No
If Stopped, Why?:
End of research time time-resources
Has Expanded Access:
False
If Expanded Access, NCT#:
N/A
Has Expanded Access, NCT# Status:
N/A
Acronym:
None
Brief Summary:
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 cortisolDHEA 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 cortisolDHEA and melatonin concentrations in saliva and urine over the day and the night
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 cortisolDHEA 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 cortisolDHEA 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 eg 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-IVSCID-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
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-IVSCID-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 Oversight
Has Oversight DMC:
None
Is a FDA Regulated Drug?:
None
Is a FDA Regulated Device?:
None
Is an Unapproved Device?:
None
Is a PPSD?:
None
Is a US Export?:
None
Is an FDA AA801 Violation?:
None
Secondary IDs
| Secondary ID | Type | Domain | Link |
|---|---|---|---|
| ZonMw AGIKO nr 940-37-033 | None | None | None |
| ZonMw SOW nr 014-91-049 | None | None | None |