The criterion question that screens patients for the study is focused on intensity, and not distress or impact of the symptom. There are important issues to consider in this approach

Study Methods

Procedures: Eligible patients will provide signed informed consent and will undergo a screening history and physical examination by a study physician (study visit #1) and screening laboratory tests.

Patients who remain eligible will complete a baseline questionnaire packet and be randomly assigned to receive a morning capsule containing modafinil 100 mg or an identically-appearing placebo in double-blind fashion. All other medications will be held at their usual doses during the study period unless a change is mandated by the clinical situation.

Every 7 days, the blinded dose of either modafinil or placebo may be increased by one additional capsule, if the investigator deems it clinically appropriate and the patient agrees. This may continue for a maximum of three dose changes (maximum of 400 mg modafinil). Once a stable dose is selected, this number of capsules will be taken until the end of the study (week 4).

A study nurse will maintain frequent contact with the patient throughout the study period. Patients will return for study visits at the end of week 2 (study visit #2) and week 4 (study visit #3). At the time of each visit, patients will complete the questionnaire packet, respond to an open-ended query about adverse events, and review study procedures. At study visit #3, unused study drug will be returned, and patients will undergo repeat history and physical examination by the study physician. Patients who drop out of the study early will return for an end-of-study visit.