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Trial registered on ANZCTR


Registration number
ACTRN12610000918022
Ethics application status
Approved
Date submitted
26/10/2010
Date registered
28/10/2010
Date last updated
9/02/2011
Type of registration
Retrospectively registered

Titles & IDs
Public title
Study about the relationship between quality of life and clinical and biological characteristic of ilness in patients affected by Mood Disorder
Scientific title
Optimized light therapy for non-seasonal major depressive disorder: effects of timing and season
Secondary ID [1] 252954 0
Number of Protocol 10-06-SO, ASL Citta' Di Milano (Member of AIFA)
Universal Trial Number (UTN)
Trial acronym
Linked study record

Health condition
Health condition(s) or problem(s) studied:
Major Depression 258485 0
Condition category
Condition code
Mental Health 258653 258653 0 0
Depression

Intervention/exposure
Study type
Observational
Patient registry
Target follow-up duration
Target follow-up type
Description of intervention(s) / exposure
Patients treated with oral tablets of venlafaxine up to 225mg(After a 3 days washout period, venlafaxine was up-titrated to a dose of 150 mg/day within the first week. The drug dose was increased till 225 mg/day within the second week and it was then kept unchanged) and bright lihgt therapy (exposure daily for 30 minutes to a 10000 lux bright light) for three weeks: we will study the difference in response according to light therapy timing and season of recurrence and treatment
Intervention code [1] 257483 0
Not applicable
Comparator / control treatment
Not applicable-Observational study
Control group
Uncontrolled

Outcomes
Primary outcome [1] 259504 0
Reduction of Hamilton Depression Rating Scale scores
Timepoint [1] 259504 0
three weeks
Secondary outcome [1] 266098 0
Changes in circadian rhythm profile (activity-rets and sleep-wake rhythms) using actimetric registration, done during the first three days of each week of treatment.
Timepoint [1] 266098 0
three weeks

Eligibility
Key inclusion criteria
The sample includes inpatients affected by Major Depressive Disorder, current depressive episode without psychotic features (DSM-IV criteria; SCID interview).
Minimum age
18 Years
Maximum age
65 Years
Gender
Both males and females
Can healthy volunteers participate?
No
Key exclusion criteria
Additional diagnoses on axis I; mental retardation on axis II; pregnancy, major medical and neurological disorders, treatment with slow release neuroleptic drugs in the last month before admission.

Study design
Purpose
Natural history
Duration
Longitudinal
Selection
Defined population
Timing
Prospective
Statistical methods / analysis

Recruitment
Recruitment status
Completed
Date of first participant enrolment
Anticipated
Actual
Date of last participant enrolment
Anticipated
Actual
Date of last data collection
Anticipated
Actual
Sample size
Target
Accrual to date
Final
Recruitment outside Australia
Country [1] 2998 0
Italy
State/province [1] 2998 0

Funding & Sponsors
Funding source category [1] 257932 0
Hospital
Name [1] 257932 0
Ospedale San Raffaele-Turro, Department of Clinical Neurosciences
Address [1] 257932 0
Via Stamira di Ancona 20,
Milano
Country [1] 257932 0
Italy
Primary sponsor type
Hospital
Name
Ospedale San Raffaele-Turro, Department of Clinical Neurosciences
Address
Via Stamira di Ancona 20,
Milano
Country
Italy
Secondary sponsor category [1] 257123 0
University
Name [1] 257123 0
University Vita-Salute San Raffaele
Address [1] 257123 0
Milano
Country [1] 257123 0
Italy

Ethics approval
Ethics application status
Approved
Ethics committee name [1] 259944 0
ASL Citta' di Milano
Ethics committee address [1] 259944 0
via statuto 5,
Milano
Ethics committee country [1] 259944 0
Italy
Date submitted for ethics approval [1] 259944 0
Approval date [1] 259944 0
30/06/2006
Ethics approval number [1] 259944 0

Summary
Brief summary
Light therapy (LT) was first developed and has been established as the treatment of choice for winter seasonal affective disorder (SAD). The use of light therapy has then expanded beyond SAD, with recent studies providing evidence for the efficacy of bright LT in non-seasonal major depression. Light Therapy (LT) when combined with standard antidepressant treatment for unipolar depression hastens recovery, with benefits that can be perceived during the first week of treatment. Several questions remain unanswered in the field: which is the best schedule of light therapy administration in non SAD patients? Given that the photoperiod continuously change over the seasons, with a phase-delay of natural morning light exposure during autumn and winter and a phase-advance during spring and summer, do the season of treatment and season of recurrence influence the efficacy? Is the antidepressant response to combined LT paralleled by changes in sleep and activity-rest rhythms?The aim of the present study is to provide a preliminary answer to these questions in a homogeneous sample of patients affected by non-seasonal Major Depression and treated with combined antidepressant LT and venlafaxine.
Trial website
Trial related presentations / publications
Public notes

Contacts
Principal investigator
Name 31832 0
Address 31832 0
Country 31832 0
Phone 31832 0
Fax 31832 0
Email 31832 0
Contact person for public queries
Name 15079 0
Sara Dallaspezia
Address 15079 0
Istituto Scientifico Ospedale San Raffaele Turro, Department of Clinical Neurosciences
Via Stamira di Ancona 20,
Milano, Italy
Country 15079 0
Italy
Phone 15079 0
+39/02/26433156
Fax 15079 0
Email 15079 0
dallaspezia.sara@hsr.it
Contact person for scientific queries
Name 6007 0
Sara Dallaspezia
Address 6007 0
Istituto Scientifico Ospedale San Raffaele Turro, Department of Clinical Neurosciences
Via Stamira di Ancona 20,
Milano, Italy
Country 6007 0
Italy
Phone 6007 0
+39/02/26433156
Fax 6007 0
Email 6007 0
dallaspezia.sara@hsr.it

No information has been provided regarding IPD availability
Summary results
Have study results been published in a peer-reviewed journal?
Other publications
Have study results been made publicly available in another format?
Results – basic reporting
Results – plain English summary