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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.

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ClinicalTrials.gov Identifier: NCT01148979
Recruitment Status : Completed
First Posted : June 23, 2010
Results First Posted : May 23, 2017
Last Update Posted : May 23, 2017
Sponsor:
Collaborator:
Shire
Information provided by (Responsible Party):
J. Alexander Bodkin, Mclean Hospital

Study Type Interventional
Study Design Allocation: Randomized;   Intervention Model: Crossover Assignment;   Masking: Double (Participant, Investigator);   Primary Purpose: Treatment
Condition Major Depressive Disorder
Interventions Drug: Lisdexamfetamine Dimesylate (Vyvanse)
Drug: Placebo
Enrollment 35
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.
Arm/Group Title Placebo, Then Vyvanse Vyvanse, Then Placebo
Hide Arm/Group Description

Participants first received Placebo capsule (matching Lisdexamfetamine Dimesylate(Vyvanse) 20-50 mg capsule) each morning for 4 weeks. After a washout period of 2 weeks, they then received Lisdexamfetamine Dimesylate (Vyvanse) capsule each morning for 4 weeks, starting with initial dose 30 mg/d.

Lisdexamfetamine Dimesylate (Vyvanse): Lisdexamfetamine Dimesylate (Vyvanse) capsules dose ranging from 20mg to 50 mg.

Placebo: Lisdexamfetamine Dimesylate (Vyvanse)-matched placebo capsules.

Participants first received Lisdexamfetamine Dimesylate (Vyvanse) 20-50 mg capsule each morning for 4 weeks, staring with initial dose 30 mg/d. After a washout period of 2 weeks, they then received Placebo capsule (matching Lisdexamfetamine Dimesylate (Vyvanse) capsule) each morning for 4 weeks.

Lisdexamfetamine Dimesylate (Vyvanse): Lisdexamfetamine Dimesylate (Vyvanse) capsules dose ranging from 20mg to 50 mg.

Placebo: Lisdexamfetamine Dimesylate (Vyvanse)-matched placebo capsules.

Period Title: Overall Study
Started 13 16
Completed 13 15
Not Completed 0 1
Reason Not Completed
Lost to Follow-up             0             1
Arm/Group Title Placebo, Then Vyvanse Vyvanse, Then Placebo Total
Hide Arm/Group Description

Participants first received Placebo capsule (matching Lisdexamfetamine Dimesylate(Vyvanse) 20-50 mg capsule) each morning for 4 weeks. After a washout period of 2 weeks, they then received Lisdexamfetamine Dimesylate capsule each morning for 4 weeks.

Lisdexamfetamine Dimesylate (Vyvanse): Lisdexamfetamine Dimesylate (Vyvanse) capsules dose ranging from 20mg to 50 mg.

Placebo: Lisdexamfetamine Dimesylate (Vyvanse)-matched placebo capsules.

Participants first received Lisdexamfetamine Dimesylate 20-50 mg capsule each morning for 4 weeks. After a washout period of 2 weeks, they then received Placebo capsule (matching Lisdexamfetamine Dimesylate (Vyvanse) capsule) each morning for 4 weeks.

Lisdexamfetamine Dimesylate (Vyvanse): Lisdexamfetamine Dimesylate (Vyvanse) capsules dose ranging from 20mg to 50 mg.

Placebo: Lisdexamfetamine Dimesylate (Vyvanse)-matched placebo capsules.

Total of all reporting groups
Overall Number of Baseline Participants 13 16 29
Hide Baseline Analysis Population Description
[Not Specified]
Age, Continuous  
Mean (Standard Deviation)
Unit of measure:  Years
Number Analyzed 13 participants 16 participants 29 participants
52.8  (10.6) 48.9  (11.4) 50.6  (11.0)
Sex: Female, Male  
Measure Type: Count of Participants
Unit of measure:  Participants
Number Analyzed 13 participants 16 participants 29 participants
Female
5
  38.5%
7
  43.8%
12
  41.4%
Male
8
  61.5%
9
  56.3%
17
  58.6%
Region of Enrollment  
Measure Type: Count of Participants
Unit of measure:  Participants
United States Number Analyzed 13 participants 16 participants 29 participants
13
 100.0%
16
 100.0%
29
 100.0%
1.Primary Outcome
Title Change From Baseline in the Dysphoric Apathy/Retardation Sub-factor (MDAR) of Montgomery-Asberg Depression Rating Scale (MADRS) at 4 Weeks.
Hide Description 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.
Time Frame Baseline to 4 weeks of treatment
Hide Outcome Measure Data
Hide Analysis Population Description
All participants who completed all 4 weeks on both treatments (i.e., Placebo and Vyvanse) were included in the analysis.
Arm/Group Title Placebo Adjunct Lisdexamfetamine Dimesylate (Vyvanse)
Hide Arm/Group Description:

Participants first received Placebo capsule (matching Lisdexamfetamine Dimesylate(Vyvanse) 20-50 mg capsule) each morning for 4 weeks. After a washout period of 2 weeks, they then received Lisdexamfetamine Dimesylate (Vyvanse) capsule each morning for 4 weeks, starting with initial dose 30 mg/d.

Lisdexamfetamine Dimesylate (Vyvanse): Lisdexamfetamine Dimesylate (Vyvanse) capsules dose ranging from 20mg to 50 mg.

Placebo: Lisdexamfetamine Dimesylate (Vyvanse)-matched placebo capsules.

Participants first received Lisdexamfetamine Dimesylate (Vyvanse) 20-50 mg capsule each morning for 4 weeks, staring with initial dose 30 mg/d. After a washout period of 2 weeks, they then received Placebo capsule (matching Lisdexamfetamine Dimesylate (Vyvanse) capsule) each morning for 4 weeks.

Lisdexamfetamine Dimesylate (Vyvanse): Lisdexamfetamine Dimesylate (Vyvanse) capsules dose ranging from 20mg to 50 mg.

Placebo: Lisdexamfetamine Dimesylate (Vyvanse)-matched placebo capsules.

Overall Number of Participants Analyzed 13 15
Mean (Standard Deviation)
Unit of Measure: scores on a scale
Baseline Mean MDAR score 12.57  (3.98) 13.46  (3.94)
Week 4 Mean MDAR score 9.08  (5.51) 6.36  (5.54)
Change from BL in mean MDAR score -3.49  (4.66) -7.08  (5.03)
Show Statistical Analysis 1 Hide Statistical Analysis 1
Statistical Analysis Overview Comparison Group Selection Placebo Adjunct, Lisdexamfetamine Dimesylate (Vyvanse)
Comments The statistical analysis represents a within-subject comparison of change under treatment with Vyvanse versus change under treatment with placebo, using paired t-tests with each subject as their own control. All tests reported are two-tailed.
Type of Statistical Test Other
Comments A Paired sample t-test was used to test the null hypothesis of no difference in MDAR score change after 4 weeks of treatment with Vyvanse versus placebo.
Statistical Test of Hypothesis P-Value <0.05
Comments [Not Specified]
Method t-test, 2 sided
Comments [Not Specified]
Time Frame Adverse event data were collected over the 4 years of active subject participation.
Adverse Event Reporting Description [Not Specified]
 
Arm/Group Title Adjunct Lisdexamfetamine (Vyvanse) Adjunct Placebo
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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.

Lisdexamfetamine Dimesylate (Vyvanse): Lisdexamfetamine Dimesylate (Vyvanse) capsules dose ranging from 20mg to 50 mg.

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.

Placebo: Lisdexamfetamine Dimesylate (Vyvanse)-matched placebo capsules.

All-Cause Mortality
Adjunct Lisdexamfetamine (Vyvanse) Adjunct Placebo
Affected / at Risk (%) Affected / at Risk (%)
Total   0/28 (0.00%)   0/28 (0.00%) 
Show Serious Adverse Events Hide Serious Adverse Events
Adjunct Lisdexamfetamine (Vyvanse) Adjunct Placebo
Affected / at Risk (%) Affected / at Risk (%)
Total   0/28 (0.00%)   0/28 (0.00%) 
Show Other (Not Including Serious) Adverse Events Hide Other (Not Including Serious) Adverse Events
Frequency Threshold for Reporting Other Adverse Events 5%
Adjunct Lisdexamfetamine (Vyvanse) Adjunct Placebo
Affected / at Risk (%) Affected / at Risk (%)
Total   23/28 (82.14%)   18/28 (64.29%) 
Cardiac disorders     
tachycardia *  3/28 (10.71%)  0/28 (0.00%) 
Gastrointestinal disorders     
gastrointesinal disturbance *  1/28 (3.57%)  4/28 (14.29%) 
General disorders     
decreased appetite *  8/28 (28.57%)  2/28 (7.14%) 
headache *  3/28 (10.71%)  5/28 (17.86%) 
dry mouth *  7/28 (25.00%)  1/28 (3.57%) 
insomnia *  10/28 (35.71%)  3/28 (10.71%) 
fatigue *  1/28 (3.57%)  2/28 (7.14%) 
diaphoresis * [1]  2/28 (7.14%)  1/28 (3.57%) 
decreased libido *  2/28 (7.14%)  1/28 (3.57%) 
Infections and infestations     
upper respiratory infection *  1/28 (3.57%)  2/28 (7.14%) 
stomach virus *  0/28 (0.00%)  3/28 (10.71%) 
Musculoskeletal and connective tissue disorders     
muscle tension *  4/28 (14.29%)  0/28 (0.00%) 
Nervous system disorders     
tinnitus *  2/28 (7.14%)  0/28 (0.00%) 
paresthesia *  2/28 (7.14%)  0/28 (0.00%) 
Psychiatric disorders     
irritability *  3/28 (10.71%)  0/28 (0.00%) 
anxiety *  4/28 (14.29%)  4/28 (14.29%) 
increased activation *  0/28 (0.00%)  2/28 (7.14%) 
*
Indicates events were collected by non-systematic assessment
[1]
increased sweating
The small sample size and crossover design both weaken group differences.
Certain Agreements
Principal Investigators are NOT employed by the organization sponsoring the study.
There is NOT an agreement between Principal Investigators and the Sponsor (or its agents) that restricts the PI's rights to discuss or publish trial results after the trial is completed.
Results Point of Contact
Layout table for Results Point of Contact information
Name/Title: J. Alexander Bodkin, MD
Organization: McLean Hospital
Phone: 617-855-3186
EMail: abodkin@mclean.harvard.edu
Publications:
Layout table for additonal information
Responsible Party: J. Alexander Bodkin, Mclean Hospital
ClinicalTrials.gov Identifier: NCT01148979     History of Changes
Other Study ID Numbers: 2010-P-000871
First Submitted: June 21, 2010
First Posted: June 23, 2010
Results First Submitted: March 8, 2017
Results First Posted: May 23, 2017
Last Update Posted: May 23, 2017