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Circadian mechanism for serotonin reuptake inhibitor treatment efficacy

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

Status
Recruiting
Phases
Unknown
Study type
Interventional
Source
ANZCTR
Registry ID
ACTRN12624001329550
Enrollment
0
Registered
2024-11-01
Start date
2025-07-31
Completion date
2026-02-24
Last updated
2025-09-08

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

None listed

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.

Interventions

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 reasses

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.

Sponsors

Flinders University
Lead SponsorUniversity

Study design

Allocation
Non-randomised trial
Intervention model
Single group
Primary purpose
Treatment
Masking
Open (masking not used)

Eligibility

Sex/Gender
All
Age
18 Years to 30 Years
Healthy volunteers
No

Inclusion criteria

A current diagnosis of depression and the willingness to undergo treatment with citalopram.

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

Outcome results

None listed

Source: ANZCTR · Data processed: Feb 4, 2026