Clinical trial NCT01604876: Effect of Bright Light on Mood and Sleep in Parkinson's Disease
Official title: Effect of Bright Light on Mood and Sleep in Parkinson's Disease
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: NA
Conditions: Parkinson's Disease
Depression
Keywords: Parkinson's disease
depression
light therapy
sleeping problems
Lead sponsor: Amsterdam UMC, location VUmc
Sponsor class: OTHER
Collaborators: name: International Parkinson Foundation ('IPF'), Hoofddorp, The Netherlands
name: Parkinsonvereniging, Bunnik, the Netherlands
name: Netherlands Brain Foundation
name: Netherlands Institute for Neurosciences, Amsterdam, The Netherlands
name: GGZ inGeest
First posted: 2012-05-24
Enrollment: 83
Sex: ALL
Standard ages: CHILD
ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: TREATMENT

Brief summary: The purpose of this clinical trial is to investigate whether light therapy is a suitable treatment option for depression and insomnia in Parkinson's disease.

Detailed description: The quality of life of patients with Parkinson's disease and their caretakers is mainly influenced by so called non-motor symptoms. This includes neuropsychiatric consequences of the disease like depression and sleeping problems. The incidence of depressed mood in patients with Parkinson is approximately 50%, the incidence for sleeping problems is 90%. These symptoms are often overlooked and even if recognized, inadequately treated. The treatment of mood and sleep disturbances in Parkinson patients is hampered by adverse effects, incomplete responses to the usual treatments and the absence of specific treatment options for these symptoms in Parkinson's disease. On the basis of the hypothesis of disturbed functioning of the suprachiasmatic nucleus in Parkinson's disease it is expected that stimulation of this nucleus by bright light therapy will result in improved functioning on multiple different domains: mood, sleep, motor functions, quality of life and circadian rhythms. Because there are virtually no side effects and the possibility of home treatment, light therapy is expected to be highly appreciated by the patients.

Eligibility criteria: Inclusion Criteria:

* Parkinson's disease
* depression

Exclusion Criteria:

* psychosis
* mania
* suicidality
* retinopathy
* previous light treatment
* use of photosensitising medication

Primary outcomes:
measure: Mood
timeFrame: T0: baseline, T1: change from T0, T2: change from T0, T3: follow-up, change from T0, T4: follow-up, change from T0, T5: follow-up, change from T0
Secondary outcomes:
measure: Sleep
timeFrame: T0: baseline, T1: change from T0, T2: change from T0, T3: follow-up, change from T0, T4: follow-up, change from T0, T5: follow-up, change from T0
measure: Motor function
timeFrame: T0: baseline, T2: after three months therapy, change from T0, T5: six month follow-up, change from T0
measure: Quality of Life of patient
timeFrame: T0: baseline, T2: after three months therapy, change from T0, T5: six month follow-up, change from T0
measure: Circadian rhythm
timeFrame: T0: baseline, T1: change from T0, T2: change from T0, T3: follow-up, change from T0, T4: follow-up, change from T0, T5: follow-up, change from T0
measure: Quality of life of caregiver
timeFrame: T0: baseline, T2: after three months therapy, change from T0, T5: six month follow-up, change from T0
Other outcomes:
Locations:
city: Amsterdam
country: Netherlands
facility: VU University Medical Center
state: North-Holland
Study officials:
affiliation: Amsterdam UMC, location VUmc
name: Odile A van den Heuvel, MD PHD
role: PRINCIPAL_INVESTIGATOR
affiliation: Amsterdam UMC, location VUmc
name: Ysbrand D van der Werf, PHD
role: PRINCIPAL_INVESTIGATOR
affiliation: Amsterdam UMC, location VUmc
name: Jan H Smit, PHD
role: STUDY_DIRECTOR
References:
citation: Rutten S, Vriend C, Smit JH, Berendse HW, van Someren EJW, Hoogendoorn AW, Twisk JWR, van der Werf YD, van den Heuvel OA. Bright light therapy for depression in Parkinson disease: A randomized controlled trial. Neurology. 2019 Mar 12;92(11):e1145-e1156. doi: 10.1212/WNL.0000000000007090. Epub 2019 Feb 15.
citation: Rutten S, Vriend C, Smit JH, Berendse HW, Hoogendoorn AW, van den Heuvel OA, van der Werf YD. A double-blind randomized controlled trial to assess the effect of bright light therapy on depression in patients with Parkinson's disease. BMC Psychiatry. 2016 Oct 21;16(1):355. doi: 10.1186/s12888-016-1050-z.