Trial Review

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Trial registered on ANZCTR


Registration number
ACTRN12621000581864
Ethics application status
Approved
Date submitted
5/03/2021
Date registered
17/05/2021
Date last updated
17/05/2021
Date data sharing statement initially provided
17/05/2021
Type of registration
Prospectively registered

Titles & IDs
Public title
Circadian mechanisms for selective serotonin reuptake inhibitor treatment responses
Scientific title
The effect of selective serotonin reuptake inhibitors on melatonin suppression as a marker of circadian light sensitivity
Secondary ID [1] 303465 0
Nil
Universal Trial Number (UTN)
Nil
Trial acronym
LITE - Light informed treatment efficacy
Linked study record

Health condition
Health condition(s) or problem(s) studied:
depression
 320773 0
Condition category
Condition code
Mental Health 318598 318598 0 0
Depression

Intervention/exposure
Study type
Interventional
Description of intervention(s) / exposure
8 weeks of treatment with cipramil 20mg (oral tablet) delivered daily, a selective serotonin reuptake inhibitor.

All patients will undergo at least 8 weeks of treatment before light sensitivity is reassessed, reassessment will take place as close to the 8 week mark as is feasible given patient and resource availability.

Adherence will be monitored daily using a self-report diary.
Intervention code [1] 319757 0
Treatment: Drugs
Comparator / control treatment
No control group - pre-post design.
Control group
Uncontrolled

Outcomes
Primary outcome [1] 326561 0
Melatonin suppression
Percent melatonin suppression will be calculated by comparing melatonin levels during a 100 lux light exposure to melatonin levels during a dark control (<1 lux).
Melatonin will be assessed from saliva samples taken hourly in the evening using radio-immunoassay (RIA).
Timepoint [1] 326561 0
Baseline and after 8 weeks of intervention (citalopram treatment)

Saliva samples for melatonin assay will be taken hourly between 3 hours before habitual bedtime, and 3 hours after habitual bedtime (individually timed for each patient).
Secondary outcome [1] 392023 0
Pupil light responses
Sustained pupil responses during darkness following a ~5 minute blue light exposure (monochromatic light, peak nm=480). Assessed using a custom-built desk-mounted pupillometer.
Timepoint [1] 392023 0
baseline and after 8 weeks of intervention (citalopram treatment)

Eligibility
Key inclusion criteria
A current diagnosis of depression
Willingness to undergo treatment with citalopram
Minimum age
18 Years
Maximum age
30 Years
Sex
Both males and females
Can healthy volunteers participate?
No
Key exclusion criteria
Major medical conditions, current use of medications which may affect sleep or circadian rhythms, recent shit-work or travel across time-zones, a history of psychosis or a family history of bipolar disorder, current substance use disorder.

Study design
Purpose of the study
Treatment
Allocation to intervention
Non-randomised trial
Procedure for enrolling a subject and allocating the treatment (allocation concealment procedures)
Methods used to generate the sequence in which subjects will be randomised (sequence generation)
Masking / blinding
Open (masking not used)
Who is / are masked / blinded?



Intervention assignment
Single group
Other design features
Phase
Not Applicable
Type of endpoint/s
Pharmacodynamics
Statistical methods / analysis

Recruitment
Recruitment status
Not yet recruiting
Date of first participant enrolment
Anticipated
24/05/2021
Actual
Date of last participant enrolment
Anticipated
1/11/2022
Actual
Date of last data collection
Anticipated
31/12/2022
Actual
Sample size
Target
36
Accrual to date
Final
Recruitment in Australia
Recruitment state(s)
VIC
Recruitment postcode(s) [1] 33365 0
3168 - Notting Hill

Funding & Sponsors
Funding source category [1] 307882 0
Government body
Name [1] 307882 0
National Health and Medical Research Council
Country [1] 307882 0
Australia
Primary sponsor type
University
Name
Monash University
Address
Wellington Road
Clayton, Victoria, 3800, Australia
Country
Australia
Secondary sponsor category [1] 309343 0
None
Name [1] 309343 0
None
Address [1] 309343 0
None
Country [1] 309343 0

Ethics approval
Ethics application status
Approved
Ethics committee name [1] 307882 0
Monash University Human Research Ethics Committee (MUHREC)
Ethics committee address [1] 307882 0
Monash University Human Research Ethics Committee (MUHREC)
Room 111, Chancellery Building D,
26 Sports Walk, Clayton Campus
Research Office
Monash University VIC 3800
Ethics committee country [1] 307882 0
Australia
Date submitted for ethics approval [1] 307882 0
11/02/2020
Approval date [1] 307882 0
06/04/2020
Ethics approval number [1] 307882 0
22905

Summary
Brief summary
Depression is a mental illness which is the leading cause of disease burden in middle-income and high-income countries. It is characterised by low mood (i.e., feeling sad or down), loss of interest in or pleasure from things that were previously enjoyable, changes in appetite or weight, fatigue and sleep disturbance, difficulties with different thinking skills, and suicidal thoughts or behaviours. Most people with depression (up to 90%) experience sleep problems, which often precede the onset of mood symptoms. Problems with the circadian system, or ‘body clock,’ can contribute to sleep problems, and may play a role in the development of depression. We have previously found that a single dose of citalopram (an antidepressant) increases the effect of light on the body clock in health persons. This may contribute to variability in treatment outcomes in patient with depression. For example, increased light sensitivity may be beneficial for patients who were previously insensitive to light, or for those who exhibit healthy light exposure patterns (as the positive effects would be enhanced). However, for patients with unhealthy light patterns, or who are already hypersensitive, increased sensitivity due to antidepressant treatment may lead to the exacerbation of symptoms.

Here, we aim to investigate the effect of chronic citalopram use on the response of the circadian system to light. Our main outcomes are the suppression of melatonin (a sleep-related hormone) and pupillary markers of light responses.
Trial website
Trial related presentations / publications
Public notes

Contacts
Principal investigator
Name 108806 0
A/Prof Sean Cain
Address 108806 0
Turner Institute for Brain and Mental Health, School of Psychological Sciences, Monash University, 18 Innovation Walk, Clayton, VIC, 3800
Country 108806 0
Australia
Phone 108806 0
+61 03 9905 1194
Fax 108806 0
Email 108806 0
sean.cain@monash.edu
Contact person for public queries
Name 108807 0
Dr Elise McGlashan
Address 108807 0
Turner Clinics, 1/270 Ferntree Gully Road, Notting Hill, Victoria, 3168
Country 108807 0
Australia
Phone 108807 0
+61 03 9905 9444
Fax 108807 0
Email 108807 0
elise.mcglashan@monash.edu
Contact person for scientific queries
Name 108808 0
A/Prof Sean Cain
Address 108808 0
Turner Institute for Brain and Mental Health, School of Psychological Sciences, Monash University, 18 Innovation Walk, Clayton, VIC, 3800
Country 108808 0
Australia
Phone 108808 0
+61 03 9905 1194
Fax 108808 0
Email 108808 0
sean.cain@monash.edu

Data sharing statement
Will individual participant data (IPD) for this trial be available (including data dictionaries)?
No
No/undecided IPD sharing reason/comment
We do not currently have ethical approval for sharing this kind of data.


What supporting documents are/will be available?

No Supporting Document Provided



Results publications and other study-related documents

Documents added manually
No documents have been uploaded by study researchers.

Documents added automatically
No additional documents have been identified.