ANZCTR - Registration

Did you know?

The ANZCTR now automatically displays published trial results and simplifies the addition of trial documents such as unpublished protocols and statistical analysis plans.

These enhancements will offer a more comprehensive view of trials, regardless of whether their results are positive, negative, or inconclusive.

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been endorsed by the ANZCTR. Before participating in a study, talk to your health care provider and refer to this information for consumers

Trial registered on ANZCTR

Registration number

ACTRN12624001329550p

Ethics application status

Submitted, not yet approved

Date submitted

23/08/2024

Date registered

1/11/2024

Date last updated

1/11/2024

Date data sharing statement initially provided

1/11/2024

Type of registration

Prospectively registered

Titles & IDs

Public title

Circadian mechanism for serotonin reuptake inhibitor treatment efficacy

Scientific title

The effect of selective serotonin reuptake inhibitors (SSRIs) on the circadian systems response to light in individuals aged 18 to 30 years with depression

Secondary ID [1]

Nil

Universal Trial Number (UTN)

Trial acronym

Linked study record

Health condition

Health condition(s) or problem(s) studied:

Depression

Condition category

Condition code

Mental Health

Depression

Neurological

Studies of the normal brain and nervous system

Intervention/exposure

Study type

Interventional

Description of intervention(s) / exposure

Participants will be asked to attend a 3-day laboratory visit for a light sensitivity assessment pre-treatment (first night will be dim light exposure (<1 lux), second night will be light exposure (100 lux) and final night dim light exposure (<1 lux)).

Participants will then undergo 8 weeks of treatment with Cipramil 20mg (oral tablet), a Selective Serotonin Reuptake Inhibitor (SSRI), delivered daily.

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

Adherence will be monitored using daily 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

Timepoint [1]

Baseline and after 8 weeks of intervention (citalopram treatment) - Saliva samples will be taken hourly over a 9-hour period on day 1, 6-hour period on day 3 and a 10-hour period of day 3.

Secondary outcome [1]

Pupil light responses

Timepoint [1]

Baseline and after 8 weeks of intervention (citalopram treatment).

Eligibility

Key inclusion criteria

A current diagnosis of depression and the 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 (including
- Recent shift work or travel across time-zones
- History of psychosis or 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

1/12/2024

Actual

Date of last participant enrolment

Anticipated

24/02/2026

Actual

Date of last data collection

Anticipated

24/03/2026

Actual

Sample size

Target

Accrual to date

Final

Recruitment in Australia

Recruitment state(s)

Recruitment postcode(s) [1]

5042 - Bedford Park

Funding & Sponsors

Funding source category [1]

Charities/Societies/Foundations

Name [1]

Wellcome Trust

Address [1]

Country [1]

Australia

Primary sponsor type

University

Name

Flinders University

Address

Country

Australia

Secondary sponsor category [1]

None

Name [1]

Address [1]

Country [1]

Ethics approval

Ethics application status

Submitted, not yet approved

Ethics committee name [1]

Flinders University Human Research Ethics Committee

Ethics committee address [1]

https://staff-projects.flinders.edu.au/research-support/integrity/human-ethics

Ethics committee country [1]

Australia

Date submitted for ethics approval [1]

23/08/2024

Approval date [1]

Ethics approval number [1]

#7614

Summary

Brief summary

Depression is a mental illness which is the leading cause of disease burden in middle and high-income countries. It is characterised by low mood (i.e., feeling sad), loss of interest in or pleasure from things that were previously enjoyable, changes in appetite or weight, fatigue and sleep disturbances. Up to 90% of people with depression 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. It has been found that antidepressants increase the effect of light on the body clock, which may contribute to variability in treatment outcomes. 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. Better understanding the impacts of antidepressants, and light exposure, on treatment outcomes in depression may lead to simple ways for improving the efficacy of those very common medications. 

We aim to investigate the effect of citalopram use on the response of the circadian system to light and test the hypothesis that increased light sensitivity is predictive of better SSRI treatment efficacy for depression.

Trial website

Trial related presentations / publications

Public notes

Contacts

Principal investigator

Name

Prof Sean Cain

Address

Flinders Health and Medical Research Institute, College of Medicine and Public Health, 5 Laffer Drive Bedford Park SA 5062

Country

Australia

Phone

+61 08 8432 4242

Fax

sean.cain@flinders.edu.au

Contact person for public queries

Name

Alicia Lander

Address

Flinders Health and Medical Research Institute, College of Medicine and Public Health, 5 Laffer Drive Bedford Park SA 5062

Country

Australia

Phone

+61 08 8432 4760

Fax

alicia.lander@flinders.edu.au

Contact person for scientific queries

Name

Sean Cain

Address

Flinders Health and Medical Research Institute, College of Medicine and Public Health, 5 Laffer Drive Bedford Park SA 5062

Country

Australia

Phone

+61 08 8432 4760

Fax

sean.cain@flinders.edu.au

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

Did you know?

Documents added manually

Documents added automatically