Targeting Circadian and Cognitive Dysfunction in Bipolar Disorder With Modafinil (NCT01965925) | Clinical Trial Compass
CompletedPhase 4
Targeting Circadian and Cognitive Dysfunction in Bipolar Disorder With Modafinil
United States18 participantsStarted 2014-01
Plain-language summary
This is an 8-week, randomized, placebo-controlled trial of modafinil in stable bipolar disorder patients. Results will provide information on a promising treatment for simultaneously treating both sleep and cognitive problems in stable bipolar patients. These disabling symptoms persist despite stable mood and are strongly associated with functional disability, making them important treatment targets that have not yet been adequately addressed.
Who can participate
Age range
18 Years – 65 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:
* DSM-IV Bipolar Disorder I or Bipolar Disorder II diagnosis
* Affectively stable
* Clinically acceptable, stably-dosed, mood stabilizing medication regimen for \> 1 month prior to enrollment, with no medication changes planned over the 8-week study period.
* Objective evidence of either a subjective sleep quality complaint and/or clinically-significant cognitive impairment at screening.
Exclusion Criteria:
* History of Central Nervous System trauma, neurological disorder, ADHD, or a learning disability.
* Positive urine toxicology or DSM-IV diagnosis of substance abuse/dependence within 3 months
* Active, unstable medical problem that may interfere with sleep and/or cognition.
* History of substance induced mania
* Recent history of rapid cycling
* Score of 2 or greater on the decreased need for sleep item on CARS-M
* Any drug known to interfere with modafinil
* More than 2 psychotropic medications
* Abnormal lab or ECG result at screen
* Significant suicidal ideation at baseline or at risk for suicidal behavior based on clinical judgment
* participation in any other investigational cognitive enhancement study within 6 months
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.