Efficacy and Safety of Lisdexamfetamine Dimesylate in Adults With Chronic Fatigue Syndrome

PHASE4CompletedINTERVENTIONAL
Enrollment

26

Participants

Timeline

Start Date

November 30, 2009

Primary Completion Date

March 31, 2011

Study Completion Date

March 31, 2011

Conditions
Chronic Fatigue SyndromeCognitive Impairments
Interventions
DRUG

Lisdexamfetamine Dimesylate

Will be randomly assigned to one of two treatment arms in a 1:1 ratio of either LDX or placebo for 6 weeks. Subjects will be started with a single pill containing 30mg of LDX or comparable placebo, depending on the treatment assignment. At the week 2 visit, the dose will be increased to 50 mg (or comparable placebo) if the patient exhibits no significant adverse effects as judged by the Investigator. At the week 4 visit, the dose will be increased to 70 mg (or comparable placebo) if the patient exhibits no significant adverse effects as judged by the investigator.

DRUG

"Placebo 30, 50 or 70 mg"

Will be randomly assigned to one of two treatment arms in a 1:1 ratio of either LDX or placebo for 6 weeks. Subjects will be started with a single pill containing 30mg of LDX or comparable placebo, depending on the treatment assignment. At the week 2 visit, the dose will be increased to 50 mg (or comparable placebo) if the patient exhibits no significant adverse effects as judged by the Investigator. At the week 4 visit, the dose will be increased to 70 mg (or comparable placebo) if the patient exhibits no significant adverse effects as judged by the investigator.

Trial Locations (1)

48307

Rochester Center for Behavioral Medicine, Rochester Hills

Sponsors

Collaborators (1)

All Listed Sponsors
collaborator

Shire

INDUSTRY

lead

Rochester Center for Behavioral Medicine

OTHER