ANZCTR - Registration

Please note the ANZCTR will be unattended from Friday 20 December 2024 for the holidays. The Registry will re-open on Tuesday 7 January 2025. Submissions and updates will not be processed during that time.

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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]

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

Condition category

Condition code

Mental Health

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]

Treatment: Drugs

Comparator / control treatment

No control group - pre-post design.

Control group

Uncontrolled

Outcomes

Primary outcome [1]

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]

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]

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]

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?

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

Accrual to date

Final

Recruitment in Australia

Recruitment state(s)

VIC

Recruitment postcode(s) [1]

3168 - Notting Hill

Funding & Sponsors

Funding source category [1]

Government body

Name [1]

National Health and Medical Research Council

Address [1]

National Health and Medical Research Council
GPO Box 1421
Canberra ACT 2601

Country [1]

Australia

Primary sponsor type

University

Name

Monash University

Address

Wellington Road
Clayton, Victoria, 3800, Australia

Country

Australia

Secondary sponsor category [1]

None

Name [1]

None

Address [1]

None

Country [1]

Ethics approval

Ethics application status

Approved

Ethics committee name [1]

Monash University Human Research Ethics Committee (MUHREC)

Ethics committee address [1]

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]

Australia

Date submitted for ethics approval [1]

11/02/2020

Approval date [1]

06/04/2020

Ethics approval number [1]

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

A/Prof Sean Cain

Address

Turner Institute for Brain and Mental Health, School of Psychological Sciences, Monash University, 18 Innovation Walk, Clayton, VIC, 3800

Country

Australia

Phone

+61 03 9905 1194

Fax

sean.cain@monash.edu

Contact person for public queries

Name

Elise McGlashan

Address

Turner Clinics, 1/270 Ferntree Gully Road, Notting Hill, Victoria, 3168

Country

Australia

Phone

+61 03 9905 9444

Fax

elise.mcglashan@monash.edu

Contact person for scientific queries

Name

Sean Cain

Address

Turner Institute for Brain and Mental Health, School of Psychological Sciences, Monash University, 18 Innovation Walk, Clayton, VIC, 3800

Country

Australia

Phone

+61 03 9905 1194

Fax

sean.cain@monash.edu

Data sharing statement

Will individual participant data (IPD) for this trial be available (including data dictionaries)?

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.

Trial Review

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