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
|Condition or disease||Intervention/treatment||Phase|
|Major Depressive Disorder||Drug: Lisdexamfetamine Dimesylate (Vyvanse) Drug: Placebo||Phase 4|
|Study Type :||Interventional (Clinical Trial)|
|Actual Enrollment :||35 participants|
|Intervention Model:||Crossover Assignment|
|Intervention Model Description:||This is a double-blind, placebo-controlled, crossover study in which each subject will act as their own control after being randomly assigned to placebo or Lisdexamfetamine Dimesylate (Vyvanse) for the first 4 weeks of study treatment, then receiving the other for the second 4 weeks of treatment. The two 4-week treatment periods are separated by a washout of 2 weeks.|
|Masking:||Double (Participant, Investigator)|
|Masking Description:||Both the study participant and the study investigators making evaluations are blinded to which treatment arm the participants are assigned to (i.e., whether they are receiving placebo or Vyvanse at any given point). Placebo and active medication capsules look identical.|
|Official Title:||Double-Blind, Placebo-Controlled, Randomized Trial of Adjunctive Lisdexamfetamine Dimesylate in Residual Symptoms of Major Depressive Disorder Partially Responsive to Selective Serotonin or Norepinephrine Reuptake Inhibitor Monotherapy|
|Study Start Date :||September 2010|
|Actual Primary Completion Date :||September 2014|
|Actual Study Completion Date :||October 2014|
Experimental: Adjunct Lisdexamfetamine (Vyvanse)
Participants receive Lisdexamfetamine Dimesylate 20-50 mg capsule each morning for 4 weeks. After a washout period of 2 weeks, they receive Placebo capsule (matching Lisdexamfetamine Dimesylate (Vyvanse) capsule) each morning for 4 weeks.
Drug: Lisdexamfetamine Dimesylate (Vyvanse)
Lisdexamfetamine Dimesylate (Vyvanse) capsules dose ranging from 20mg to 50 mg.
Other Name: Vyvanse
Placebo Comparator: Adjunct Placebo
Participants receive Placebo capsule (matching Lisdexamfetamine Dimesylate (Vyvanse) 20-50 mg capsule) each morning for 4 weeks. After a washout period of 2 weeks, they receive Lisdexamfetamine Dimesylate capsule each morning for 4 weeks.
Lisdexamfetamine Dimesylate (Vyvanse)-matched placebo capsules.
Other Name: Sugar pill
- Change From Baseline in the Dysphoric Apathy/Retardation Sub-factor (MDAR) of Montgomery-Asberg Depression Rating Scale (MADRS) at 4 Weeks. [ Time Frame: Baseline to 4 weeks of treatment ]The Montgomery-Asberg Depression Rating Scale Dysphoric Apathy Retardation subfactor (MDAR) is a 5-item subscale of the clinician-administered 10-item Montgomery-Asberg Depression Rating Scale (MADRS). MDAR score can range from 0-30 with a higher score representing a greater severity of depressive symptoms.
Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT01148979
|United States, Massachusetts|
|Belmont, Massachusetts, United States, 02478|
|Principal Investigator:||J. Alexander Bodkin Bodkin, MD||Mclean Hospital|