Targeting Circadian and Cognitive Dysfunction in Bipolar Disorder With Modafinil
Completed · Phase 4 · Has a placebo group
Conditions studied: Bipolar Disorder
In brief
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.
Key facts
- Study ID
- NCT01965925
- Run by
- Icahn School of Medicine at Mount Sinai
- People needed
- 18
- Starts
- 2014-01-01
- Expected to finish
- 2017-11-09
- Last updated by the study team
- 2018-03-21
Who can join
Age: 18 and older, up to 65. Sex: any. Healthy volunteers: not accepted.
You may qualify if…
- 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.
You may not qualify if…
- 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
Where it is running
- Icahn School of Medicine at Mount Sinai — New York, New York, United States
Full record on ClinicalTrials.gov
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