Targeting Circadian and Cognitive Dysfunction in Bipolar Disorder With Modafinil

• Status: Completed
• Trial end date: 2017-11-09
• Target enrollment: 0
• Participant gender: All

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.

• Phase: Phase 4
• Accepts Healthy Volunteers?: No

Details

• Lead Sponsor: Icahn School of Medicine at Mount Sinai
• Collaborator: National Institute of Mental Health (NIMH)
• Treatments: Armodafinil; Modafinil

Criteria

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