Major Depressive DisorderPhase 2/3NCT00332670
Light Therapy for Elderly Depression
A Phase 2/3 study testing 10.000lux blue 1 hour every day during three weeks and 50lux dim red 1 hour every day during three weeks in people with Major Depressive Disorder, run by GGZ Buitenamstel at 1 site in Netherlands.
Trial 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. Read more about this study
- Who is it for?
- Ages 60 years and older
- Conditions the study is for
- Major Depressive Disorder
- What is being tested?
- 10.000lux blue 1 hour every day during three weeks and 50lux dim red 1 hour every day during three weeks
- Type of treatment
- Surgery or procedure
- Could I receive a placebo?
- Yes, some participants may receive a placebo
- How many people
- 89 participants
- Where
- 1 siteNetherlands
- Study dates
- Jan 2003to Jun 2007
- Phase
- Phase 2/3
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 60 years and older
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- 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.
Who cannot join
- 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.
Show all 10Show fewer
- Use of tetracyclic antibiotics.
- Treatment with antidepressants shorter than 2 months
- Use of oral contraceptives.
- Treatment with light therapy in the past.
Trial locations and contacts
1 site in 1 country.
About this study
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
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.
Read the 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.
- Conditions
- Major Depressive Disorder
- Being tested
- 10.000lux blue 1 hour every day during three weeks, 50lux dim red 1 hour every day during three weeks
- Keywords
- (Non-seasonal) Depression, bright light therapy, randomized controlled trial, suprachiasmatic nucleus, HPA-axis, DHEA, melatonin, actigraphy, elderly, self-efficacy, social support
- Medical subject headings
- Depressive Disorder, Major, Depression
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
10.000lux blue 1 hour every day during three weeksProcedure or surgery
Also called Bright light
10.000lux during 60 minutes, starting 1 hour after wake-up, during 3 weeks
50lux dim red 1 hour every day during three weeksProcedure or surgery
Also called Dim red light
50 lux red light, 60 minutes every morning, starting 1 hour after wake-up, during three weeks
| Study group | Role | What they receive |
|---|---|---|
| 1 | Active comparator | 10.000lux bright blue light 1hour every morning 1 hour after wake-up time during three weeks Receives: Procedure: 10.000lux blue 1 hour every day during three weeks |
| 2 | Placebo comparator | 50lux dim red light 1 hour every morning 1 hr after wake-up time during 3 weeks Receives: Procedure: 50lux dim red 1 hour every day during three weeks |
What is being measured
The primary outcome is the main question the study is designed to answer.
Hamilton Depression Rating Scale (HADRS-17)
Measured: at T0, T1 and T2
Secondary outcomes (14)
Actimetry
Measured: continuous measurement during complete 7 week study period
24-hour urinary cortisol measurements
Measured: 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
Measured: 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
Measured: complete 7-week study period.
Groningen Activity Restriction Scale (GARS)
Measured: at T0, T1 and T2
Algemene Competentieverwachtingen Schaal (ALCOS)
Measured: at T0, T1 and T2
Social Support List interactions, discrepancies and negative (SSL-i, SSL-d, SSL-n)
Measured: at T0, T1 and T2
MOS-short form General Health Survey (SF-20)
Measured: T0, T1 and T2
Pittsburgh Sleep Quality Inventory (PSQI)
Measured: at T0, T1 and T2
Neuropsychological test battery
Measured: at T0, T1 and T2
fMRI (encoding task, recognition task, N-Back)
Measured: at T0 and T1
structural MRI scanning (brain and volumetry of adrenals)
Measured: at T0 and T1
MADRS
Measured: at T0, T1 and t2
Adverse effects inventarisation
Measured: 3-5 times during treatment
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted2 Jun 2006 (estimated)
- Study startJan 2003
- Primary completionJun 2007
- Study completionJun 2007
Why it stopped: End of research time, time-resources
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (14)Papers the sponsor has linked to this study.
- Other trials for Major Depressive DisorderStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase 2/3
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Quadruple blind
- Who is masked
- Participant, Care provider, Investigator, Outcomes assessor
- Enrolment
- 89 participants (actual)
Sponsor and investigators
- Lead sponsor
- GGZ Buitenamstel
- Sponsor type
- University, hospital or other
- Collaborators
- Netherlands Institute for Brain Research, Amsterdam, The Netherlands.
- Investigators
- Witte JG Hoogendijk, prof. dr., Study director, 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 NetherlandsEus van Someren, PhD, Study chair, Netherlands Institute for Brain Research, Amsterdam, The Netherlands; VU University Medical Center, Amsterdam, The NetherlandsMarjan MA Nielen, PhD, Study chair, 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 NetherlandsRitsaert Lieverse, MD, Principal investigator, 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
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT00332670
- Sponsor's protocol ID
- SOW 014-91-049
- Other IDs
- ZonMw SOW nr 014-91-049, ZonMw AGIKO nr 940-37-033
- Status last verified
- Aug 2008
- First submitted
- 31 May 2006
- Last updated
- 15 Aug 2008
- Results posted
- No
- Data monitoring committee
- No
Publications
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.
PubMed 9154571Beekman 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.
PubMed 9547118Deuschle 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.
PubMed 9393943Kripke 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.
PubMed 16390913Kripke 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.
PubMed 9609674Golden 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.
PubMed 15800134Wirz-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.
PubMed 14739440Wirz-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.
PubMed 16045060Martiny 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.
PubMed 15992393Martiny 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.
PubMed 15877712Gordijn 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.
PubMed 9554575Zhou 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.
PubMed 11448372Lieverse 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.
PubMed 21199966Lieverse 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.
PubMed 18671864
Study at a glance
From the registry record, last updated by the sponsor on 15 Aug 2008. Recruitment status is as the sponsor reported it: confirm with the study team.
- 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
- ClinicalTrials.gov ID
- NCT00332670
- Acronym / sponsor ID
- SOW 014-91-049
- Conditions
- Major Depressive Disorder
- Keywords
- (Non-seasonal) Depression, bright light therapy, randomized controlled trial, suprachiasmatic nucleus, HPA-axis, DHEA, melatonin, actigraphy
- Phase
- Phase 2/3
- Study type
- Interventional
- Recruitment status
- TerminatedReason stopped: End of research time, time-resources
- Enrolment
- 89 participants (actual)
- Lead sponsor
- GGZ BuitenamstelUniversity, hospital or other
- Collaborators
- Netherlands Institute for Brain Research, Amsterdam, The Netherlands.
- Study start
- Jan 2003
- Primary completion
- Jun 2007 (actual)
- Study completion
- Jun 2007 (actual)
- First posted
- 2 Jun 2006 (estimated)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Quadruple blind (participant, care provider, investigator, outcomes assessor)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| 1 | Active comparator | Procedure: 10.000lux blue 1 hour every day during three weeks10.000lux bright blue light 1hour every morning 1 hour after wake-up time during three weeks |
| 2 | Placebo comparator | Procedure: 50lux dim red 1 hour every day during three weeks50lux dim red light 1 hour every morning 1 hr after wake-up time during 3 weeks |
Who may qualify
- Ages
- 60 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (4 listed)
- 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.
Key exclusion criteria (10 listed)
- 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.
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| 10.000lux blue 1 hour every day during three weeksAlso: Bright light10.000lux during 60 minutes, starting 1 hour after wake-up, during 3 weeks | Procedure or surgery | 1 |
| 50lux dim red 1 hour every day during three weeksAlso: Dim red light50 lux red light, 60 minutes every morning, starting 1 hour after wake-up, during three weeks | Procedure or surgery | 2 |
Primary outcome
Hamilton Depression Rating Scale (HADRS-17)
Time frame: at T0, T1 and T2
14 secondary outcomes
Actimetry
Time frame: 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).
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)
Social Rhythm Metric
Time frame: complete 7-week study period.
Groningen Activity Restriction Scale (GARS)
Time frame: at T0, T1 and T2
Algemene Competentieverwachtingen Schaal (ALCOS)
Time frame: 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
MOS-short form General Health Survey (SF-20)
Time frame: T0, T1 and T2
Pittsburgh Sleep Quality Inventory (PSQI)
Time frame: at T0, T1 and T2
Neuropsychological test battery
Time frame: at T0, T1 and T2
fMRI (encoding task, recognition task, N-Back)
Time frame: at T0 and T1
structural MRI scanning (brain and volumetry of adrenals)
Time frame: at T0 and T1
MADRS
Time frame: at T0, T1 and t2
Adverse effects inventarisation
Time frame: 3-5 times during treatment
Results and safety
The study was stopped early (reason given: End of research time, time-resources). Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 15 Aug 2008.
- Background: PubMed 9154571Hoogendijk 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.
- Background: PubMed 9547118Beekman 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.
- Background: PubMed 9393943Deuschle 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.
- Background: PubMed 16390913Kripke 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.
- Background: PubMed 9609674Kripke 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.
- Background: PubMed 15800134Golden 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.
- Background: PubMed 14739440Wirz-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.
- Background: PubMed 16045060Wirz-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.
- Background: PubMed 15992393Martiny 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.
- Background: PubMed 15877712Martiny 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.
- Background: PubMed 9554575Gordijn 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.
- Background: PubMed 11448372Zhou 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.
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Witte JG Hoogendijk, prof. dr. study director
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
Eus van Someren, PhD study chair
Netherlands Institute for Brain Research, Amsterdam, The Netherlands; VU University Medical Center, Amsterdam, The Netherlands
Marjan MA Nielen, PhD study chair
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
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A Phase 2/3 study testing 10.000lux blue 1 hour every day during three weeks and 50lux dim red 1 hour every day during three weeks in people with Major Depressive Disorder, run by GGZ Buitenamstel at 1 site in Netherlands.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 4 inclusion and 10 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: stopped early, as of the sponsor's last update on 15 Aug 2008. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in Netherlands. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. Some participants in this study may receive a placebo. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
What does this combined phase mean?
Phase 2 studies give the treatment to a larger group to see whether it has the intended effect and to keep checking safety.
Phase 3 studies compare the treatment with the current standard treatment or a placebo in a large group, to confirm how well it works and watch for side effects.
Not every study follows the same path, and some studies (observational studies, device studies) have no phase.
Are results available for this study?
The study was stopped early (reason given: End of research time, time-resources). Results are not available in the source record.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Hamilton Depression Rating Scale (HADRS-17) (time frame: at T0, T1 and T2). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
On the ClinicalTrials.gov record for NCT00332670, which also lists 14 linked publications.
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 15 Aug 2008.