Conditions: Excessive Sleepiness Shift Work Sleep Disorder
Keywords: Excessive Sleepiness Chronic Shift Work Sleep Disorder Chronic SWSD Circadian Rhythm Disorder Shift Worker Cephalon Cephalon, Inc Nuvigil
Allocation: RANDOMIZED | Intervention model: PARALLEL
Enrollment: 254
Healthy volunteers: no

Brief summary:
The primary objective of this study is to determine whether treatment with Armodafinil (CEP-10953) is more effective than placebo treatment for patients with excessive sleepiness associated with chronic shift work sleep disorder (SWSD) by measuring mean sleep latency from the Multiple Sleep Latency Test (MSLT) (20 minutes) (average of 4 naps at 0200, 0400, 0600, and 0800) and by Clinical Global Impression of Change (CGI-C) ratings.

Detailed description:

Arms:
arm 1: Armodafinil 150 mg/day arm 2: Placebo

Interventions: intervention 1: Armodafinil 150 mg/day intervention 2: Placebo
Intervention descriptions: intervention 1: Armodafinil 150 mg taken 30 minutes to 1 hour before the start of the night shift, but no later than 2300, only on nights worked. intervention 2: Matching placebo tablets once daily

Protocol document: