Efficacy and Safety of Lisdexamfetamine Dimesylate in Adults With Chronic Fatigue Syndrome
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|ClinicalTrials.gov Identifier: NCT01071044|
Recruitment Status : Completed
First Posted : February 18, 2010
Results First Posted : June 26, 2014
Last Update Posted : April 3, 2015
Rochester Center for Behavioral Medicine
Information provided by (Responsible Party):
Joel L. Young, M.D., Rochester Center for Behavioral Medicine
|Study Design||Allocation: Randomized; Intervention Model: Parallel Assignment; Masking: Double (Participant, Investigator); Primary Purpose: Treatment|
Chronic Fatigue Syndrome
Drug: Lisdexamfetamine Dimesylate
Drug: Placebo "30, 50 or 70 mg"
|Recruitment Details||Study site began recruiting for the trial in Oct 2009 and the last subject completed the final visit on 3/7/11. Recruitment was done from within the Rochester Center (a private mental health practice), as well as some local advertising and community outreach.|
Relatively small sample size, imbalance of participants in active vs. placebo group due to pre-randomization, heterogenous sample (only one male participant in the study, who was in the control group and not the treatment group).