Trial record 89 of 1314 for: "Depressive Disorder" [DISEASE] AND Rating AND Major Depressive Disorder AND weeks
Lisdexamfetamine Dimesylate in Residual Symptoms and Cognitive Impairment in Major Depressive Disorder.
|The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details.|
|ClinicalTrials.gov Identifier: NCT01148979|
Recruitment Status : Completed
First Posted : June 23, 2010
Results First Posted : May 23, 2017
Last Update Posted : May 23, 2017
Information provided by (Responsible Party):
J. Alexander Bodkin, Mclean Hospital
|Study Design||Allocation: Randomized; Intervention Model: Crossover Assignment; Masking: Double (Participant, Investigator); Primary Purpose: Treatment|
Major Depressive Disorder
Drug: Lisdexamfetamine Dimesylate (Vyvanse)
|Recruitment Details||35 potential subjects were screened for eligibility between September 2010 and April 2014 at McLean Hospital in Belmont, MA.|
|Pre-assignment Details||Of the 35 subjects screened, 29 were randomized. Of the 6 not randomized, 3 did not meet inclusion criteria, 1 withdrew consent, and 2 were lost to follow post screening. Of the 29 randomized, 28 completed both parts of the study. One subject was lost to follow after 3 weeks in the first half. Data were analyzed for the 28 completers only.|
The small sample size and crossover design both weaken group differences.