Light Therapy for Elderly Depression

NCT00332670 | Terminated Phase 2

• 3 other identifiers: SOW 014-91-049ZonMw SOW nr 014-91-049ZonMw AGIKO nr 940-37-033
• Study Type: interventional
• Target: 89
• Locations: 1 country
• Sites: 1

Brief Summary

The purpose of this study is to investigate the following two hypotheses:

1. 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. 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.

Conditions

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

Outcome Measures

Primary Outcomes (1)

• Hamilton Depression Rating Scale (HADRS-17)

  at T0, T1 and T2

Secondary Outcomes (14)

• 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

Study Arms (2)

1

ACTIVE COMPARATOR

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

2

PLACEBO COMPARATOR

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

Interventions

10.000lux blue 1 hour every day during three weeks PROCEDURE

10.000lux during 60 minutes, starting 1 hour after wake-up, during 3 weeks

Also known as: Bright light

1

50lux dim red 1 hour every day during three weeks PROCEDURE

50 lux red light, 60 minutes every morning, starting 1 hour after wake-up, during three weeks

Also known as: Dim red light

2

Eligibility Criteria

• Age: 60 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• Understanding and speaking Dutch language
• 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.

You may not qualify if:

• 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.

Sponsors & Collaborators

• GGZ Buitenamstel: lead
• Netherlands Institute for Brain Research, Amsterdam, The Netherlands.: collaborator

Study Sites (1)

GGZ Buitenamstel

Amsterdam, North Holland, 1081HL, Netherlands

Location

Related Publications (14)

• 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.

  PMID: 9154571 BACKGROUND

• 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.

  PMID: 9547118 BACKGROUND

• 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.

  PMID: 9393943 BACKGROUND

• 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.

  PMID: 16390913 BACKGROUND

• 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.

  PMID: 9609674 BACKGROUND

• 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.

  PMID: 15800134 BACKGROUND

• 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.

  PMID: 14739440 BACKGROUND

• 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.

  PMID: 16045060 BACKGROUND

• 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.

  PMID: 15992393 BACKGROUND

• 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.

  PMID: 15877712 BACKGROUND

• 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.

  PMID: 9554575 BACKGROUND

• 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.

  PMID: 11448372 BACKGROUND

• 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.

  PMID: 21199966 DERIVED

• 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.

  PMID: 18671864 DERIVED

MeSH Terms

Conditions

Depressive Disorder, Major; Depression

Condition Hierarchy (Ancestors)

Depressive Disorder; Mood Disorders; Mental Disorders; Behavioral Symptoms; Behavior

Study Officials

• 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 DIRECTOR

• 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

  STUDY CHAIR

• 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

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: interventional
• Phase: phase 2
• Allocation: RANDOMIZED
• Masking: QUADRUPLE
• Who Masked: PARTICIPANT, CARE PROVIDER, INVESTIGATOR, OUTCOMES ASSESSOR
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: OTHER

Study Record Dates

• First Submitted: May 31, 2006
• First Posted: June 2, 2006
• Study Start: January 1, 2003
• Primary Completion: June 1, 2007
• Study Completion: June 1, 2007
• Last Updated: August 15, 2008

Record last verified: 2008-08

Locations

NL (1)