220 Participants NeededMy employer runs this trial

Light and Citalopram for Delayed Sleep-Wake Phase Disorder

SA
Overseen BySabra Abbott, MD, PhD
No Placebo GroupAll trial participants will receive the active study treatment (no placebo)

What You Need to Know Before You Apply

What is the purpose of this trial?

This trial explores how individuals with delayed sleep-wake phase disorder (a condition where sleep patterns shift later) respond to light and whether the medication citalopram (an antidepressant) can alter this response. Researchers aim to determine if light affects people with this disorder differently and if citalopram can increase melatonin suppression, potentially helping to adjust sleep timing. Participants will conduct at-home tests to monitor their sleep schedules and then complete light response tests in a clinic. Ideal candidates for this trial have delayed sleep-wake phase disorder and do not take medications that affect eye responses or have eye issues. As an unphased trial, this study offers a unique opportunity to contribute to understanding and potentially improving treatments for sleep disorders.

Is there any evidence suggesting that this trial's treatments are likely to be safe?

A previous study showed that citalopram improves sleep quality and reduces sleep disturbances, suggesting it may be well-tolerated for sleep-related issues. The FDA has already approved citalopram for treating major depressive disorder, indicating it has been tested for safety in other conditions. Common side effects include nausea, dry mouth, and drowsiness. Serious side effects are rare but can include changes in heart rhythm. Overall, existing research suggests that citalopram's safety profile for treating sleep disorders is favorable.12345

Why are researchers excited about this trial?

Researchers are excited about using Citalopram for Delayed Sleep-Wake Phase Disorder because it offers a different approach compared to the standard treatments like melatonin or light therapy alone. Unlike these typical treatments, Citalopram is an antidepressant that may help regulate sleep-wake cycles by affecting serotonin levels in the brain, which can influence sleep patterns. Additionally, combining Citalopram with bright light therapy might enhance the overall effectiveness, potentially offering a more comprehensive solution for individuals struggling with this disorder.

What evidence suggests that citalopram might be an effective treatment for delayed sleep-wake phase disorder?

Research has shown that citalopram, an SSRI, may improve sleep patterns and the body's internal clock, often disrupted in people with delayed sleep-wake phase disorder (DSWPD). Studies indicate that citalopram can enhance sleep quality, reduce disturbances, and help reset the body's internal clock. Some research also suggests that citalopram can prevent memory problems related to sleep and support brain function. In previous trials, many participants taking citalopram reported improvements in their sleep issues. While more research is needed, these findings offer a promising basis for using citalopram to manage sleep disorders like DSWPD. In this trial, participants will receive either a placebo or citalopram followed by bright light therapy, with all participants experiencing both interventions in a random order.16789

Are You a Good Fit for This Trial?

Inclusion Criteria

I have delayed sleep-wake phase disorder.

Exclusion Criteria

I am taking medications that change the size of my pupils.
Unstable medical or psychiatric condition
Caffeine consumption >400mg/day
See 2 more

Timeline for a Trial Participant

Screening

Participants are screened for eligibility to participate in the trial

2-4 weeks

Home Testing

Participants complete activity and melatonin testing at home to determine their circadian timing

1-2 weeks

Inpatient Testing

Participants undergo two inpatient admissions for melatonin sampling and exposure to bright light, with one session involving placebo and the other involving citalopram

2 sessions, each lasting 8 hours

Follow-up

Participants are monitored for safety and effectiveness after inpatient testing

4 weeks

What Are the Treatments Tested in This Trial?

Interventions

  • Citalopram

How Is the Trial Designed?

1

Treatment groups

Experimental Treatment

Group I: DSWPDExperimental Treatment1 Intervention

Find a Clinic Near You

Who Is Running the Clinical Trial?

Northwestern University

Lead Sponsor

Trials
1,674
Recruited
989,000+

National Heart, Lung, and Blood Institute (NHLBI)

Collaborator

Trials
3,987
Recruited
47,860,000+

Citations

The Association Between Delayed Sleep-Wake Phase ... - PMC

Thirteen out of 15 studies demonstrated that young individuals with DSWPD had a significantly greater severity of depressive symptoms than young individuals ...

Differential effects of citalopram on sleep-deprivation ...

Citalopram prevents sleep-deprivation-induced reduction in pCaMKII and pCREB levels. •. Citalopram prevents synaptic plasticity deficits, memory impairments and ...

Efficacy and safety evaluation of citalopram and doxepin on ...

The data showed that both citalopram and doxepin treatment gradually improved sleep latency, quality, duration, disturbances and efficiency, as well as ...

Determination of the Circadian Resetting Effects of ...

Primary Aim # 1: To determine whether the antidepressant medication escitalopram has a resetting effect on the human biological clock (circadian pacemaker).

Effects of daylight on sleep and circadian rhythms in patients ...

Current research has shown depressive symptoms are associated with sleep disturbances and misalignment of circadian rhythms.

Citalopram: uses, dosing, warnings, adverse events, ...

Citalopram hydrobromide is used in the treatment of major depressive disorder. In addition, citalopram has been used for the treatment of ...

Naturalistic light exposure patterns in relation to medication ...

Increased sensitivity of the circadian system to light in delayed sleep-wake phase disorder. J. Physiol. 596, 6249–6261 (2018). Article CAS ...

Citalopram and its use in sleep-deprivation-induced ...

These findings indicate that acute and chronic administration of escitalopram alter gamma activity differently, moreover, in a sleep-wake stage dependent manner ...

The effects of SSRIs and SNRIs on circadian rhythms

Many studies have found that upon taking antidepressants (i.e. serotonin agonists), individuals with depression experience normalized sleep and ...