Circadian Phase in Bipolar Depression: Is it Delayed and Does it Normalize With Remission? (NCT01784341) | Clinical Trial Compass
CompletedNot Applicable
Circadian Phase in Bipolar Depression: Is it Delayed and Does it Normalize With Remission?
United States10 participantsStarted 2011-08
Plain-language summary
The overall aim of this project is to compare sleep patterns and melatonin profiles in individuals with bipolar disorder during depression and after remission. The hypothesis is that sleep time, rest-activity cycles and melatonin onset will be delayed during depression and become less delayed after remission.
Who can participate
Age range
18 Years – 55 Years
Sex
ALL
See this in plain English?
AI-rewrites the medical criteria so a patient or caregiver can understand them. Always confirm with the trial site.
Inclusion Criteria:
* Ages between 18 and 55
* Bipolar Disorder Type I or II, with current major depression.
* Currently receiving active treatment from a psychiatrist for bipolar disorder
Exclusion Criteria:
* Recent history of, or current Diagnostic and Statistical Manual IV, Text Revision criteria for alcohol or substance abuse/dependence disorders
* circadian rhythm sleep disorders or sleep apnea
* current stimulant use
* any recent or planned transmeridian travel across more than two time zones
* recent, current, or planned shift work schedules
* pregnancy or plan to become pregnant
* a Young Mania Rating Scale Score of greater than or equal to seven
* received in the past two weeks or plan to receive bright light therapy, dawn simulation, sleep deprivation, or other forms of chronotherapy.
Questions worth asking your doctor
Bring these to your next appointment. They're a starting point for a shared conversation — not a sign you qualify or a recommendation to enrol.
1Based on my diagnosis and history, is this trial worth exploring for me — or is there a standard treatment we should try first?
2What does this trial's phase tell us about how much is already known about its safety and benefit?
3What would taking part actually involve for me — visits, tests, time, and travel?
4What are the known and possible risks or side effects I should weigh, and how would they be monitored?
5If this trial isn't the right fit, what other options or trials would you suggest I look into?
Generated to help you prepare — always confirm anything about your own eligibility and care with the study team and your doctor.
Questions for the trial coordinator
The trial coordinator is the person who runs the study day to day. These cover the practical side — logistics, costs, and what taking part would actually mean for your life. The study team confirms whether you meet the criteria; these are questions to ask, not a sign you qualify.
1What does taking part actually involve week to week — how many visits, where, and how long does each one take?
2What costs are covered by the study, and what might I have to pay for myself, including travel, parking, or time off work?
3What happens during screening, and what happens if the study team confirms I don't meet the criteria after those tests?
4Who pays for the scans, blood work, and other tests the trial requires — the study, my insurance, or me?
5How will being in the trial affect my regular care, and will my own doctor stay informed and involved?
6Can I leave the trial at any point if I change my mind, and what would happen to my care if I do?
A starting point for the conversation — always confirm anything about your own eligibility, costs, and care with the study team and your doctor.
What they're measuring
1
Change in Dim Light Melatonin Onset from Depression to Remission
Timeframe: Collected at end of first and second weeks of actigraphy.