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Imaging the Effects of Stimulant Medication on Emotional Lability in Patients With ADHD

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ClinicalTrials.gov Identifier: NCT01415440
Recruitment Status : Completed
First Posted : August 12, 2011
Results First Posted : September 11, 2019
Last Update Posted : September 11, 2019
Sponsor:
Collaborator:
Shire
Information provided by (Responsible Party):
Jonathan Posner, New York State Psychiatric Institute

Study Type Interventional
Study Design Allocation: Randomized;   Intervention Model: Parallel Assignment;   Masking: Quadruple (Participant, Care Provider, Investigator, Outcomes Assessor);   Primary Purpose: Treatment
Condition Attention Deficit Hyperactivity Disorder
Interventions Drug: Lisdexamfetamine
Drug: Placebo
Enrollment 117
Recruitment Details Recruitment started in 2011 and ended in 2018. Participants were primarily recruited from the community through advertisements in local newspapers and flyers posted in local establishments. Participants were also recruited from other research studies and doctor's offices.
Pre-assignment Details 18 ADHD participants withdrew or were excluded from the study prior to randomization and thus are not included. Participants who withdrew were no longer interested in treatment or were lost to follow-up. Participants were excluded due to subthreshold ADHD symptoms, comorbid psychiatric conditions, & MRI contraindications.
Arm/Group Title Healthy Control ADHD - Placebo ADHD - Vyvanse
Hide Arm/Group Description Baseline evaluation only ADHD participants randomized to receive placebo for 12 weeks of treatment ADHD participants randomized to receive 12 weeks of medication treatment with Vyvanse
Period Title: Overall Study
Started 41 29 29
Completed 37 28 27
Not Completed 4 1 2
Reason Not Completed
Lost to Follow-up             0             1             2
Physician Decision             3             0             0
Withdrawal by Subject             1             0             0
Arm/Group Title Healthy Control ADHD - Placebo ADHD - Vyvanse Total
Hide Arm/Group Description Baseline evaluation only ADHD participants randomized to receive placebo for 12 weeks of treatment ADHD participants randomized to receive 12 weeks of medication treatment with Vyvanse Total of all reporting groups
Overall Number of Baseline Participants 37 28 27 92
Hide Baseline Analysis Population Description
Analysis population includes participants who completed the study.
Age, Continuous   [1] 
Mean (Standard Deviation)
Unit of measure:  Years
Number Analyzed 37 participants 28 participants 27 participants 92 participants
16.54  (6.03) 11.93  (5.72) 12.85  (5.68) 14.16  (6.15)
[1]
Measure Analysis Population Description: Analysis population includes participants who completed the study.
Sex: Female, Male  
Measure Type: Count of Participants
Unit of measure:  Participants
Number Analyzed 37 participants 28 participants 27 participants 92 participants
Female
15
  40.5%
9
  32.1%
9
  33.3%
33
  35.9%
Male
22
  59.5%
19
  67.9%
18
  66.7%
59
  64.1%
Race/Ethnicity, Customized  
Measure Type: Count of Participants
Unit of measure:  Participants
Race/Ethnicity Number Analyzed 37 participants 28 participants 27 participants 92 participants
White
21
  56.8%
6
  21.4%
9
  33.3%
36
  39.1%
Black or African American
6
  16.2%
11
  39.3%
4
  14.8%
21
  22.8%
Hispanic
7
  18.9%
7
  25.0%
10
  37.0%
24
  26.1%
Asian or Pacific Islander
1
   2.7%
3
  10.7%
2
   7.4%
6
   6.5%
American Indian/Alaska Native
0
   0.0%
0
   0.0%
0
   0.0%
0
   0.0%
Other or Unknown
2
   5.4%
1
   3.6%
2
   7.4%
5
   5.4%
Brain Structure Volume   [1] 
Mean (Standard Deviation)
Unit of measure:  Mm^3
Number Analyzed 37 participants 28 participants 27 participants 92 participants
Left Hippocampal Volume 4182.87  (418.83) 3933.96  (433.45) 4121.96  (392.76) 4090.25  (424.92)
Left Amygdala Volume 1504.81  (217.54) 1423.08  (199.23) 1489.02  (235.93) 1475.62  (218.31)
Right Hippocampal Volume 4288.01  (358.26) 4011.48  (413.65) 4185.40  (379.97) 4174.96  (395.07)
Right Amygdala Volume 1695.09  (187.81) 1577.34  (204.15) 1665.87  (234.17) 1651.16  (210.79)
[1]
Measure Analysis Population Description: Analysis population includes participants who completed the study.
1.Primary Outcome
Title Brain Structure Volume
Hide Description Brain structure volume measured in mm^3
Time Frame 12 weeks
Hide Outcome Measure Data
Hide Analysis Population Description
ADHD participants who completed 12 weeks of treatment.
Arm/Group Title ADHD - Placebo ADHD - Vyvanse
Hide Arm/Group Description:
ADHD participants randomized to receive placebo for 12 weeks of treatment
ADHD participants randomized to receive 12 weeks of medication treatment with Vyvanse
Overall Number of Participants Analyzed 27 28
Mean (Standard Deviation)
Unit of Measure: mm^3
Left Hippocampal Volume 3909.85  (535.35) 4069.72  (426.46)
Left Amygdala Volume 1431.31  (245.40) 1485.05  (235.17)
Right Hippocampal Volume 4048.10  (454.37) 4206.41  (413.38)
Right Amygdala Volume 1573.57  (240.03) 1641.88  (207.45)
Time Frame Adverse event data were collected through study completion, an average of 12 weeks.
Adverse Event Reporting Description Adverse events were routinely collected from ADHD participants receiving treatment using the Pittsburgh Side Effects Rating Scale. A physician met with participants in person approximately once per week during treatment. The physician was also available by phone between visits.
 
Arm/Group Title Healthy Control ADHD - Placebo ADHD - Vyvanse
Hide Arm/Group Description Baseline evaluation only ADHD participants randomized to receive placebo for 12 weeks of treatment ADHD participants randomized to receive 12 weeks of medication treatment with Vyvanse
All-Cause Mortality
Healthy Control ADHD - Placebo ADHD - Vyvanse
Affected / at Risk (%) Affected / at Risk (%) Affected / at Risk (%)
Total   0/41 (0.00%)   0/29 (0.00%)   0/29 (0.00%) 
Show Serious Adverse Events Hide Serious Adverse Events
Healthy Control ADHD - Placebo ADHD - Vyvanse
Affected / at Risk (%) Affected / at Risk (%) Affected / at Risk (%)
Total   0/41 (0.00%)   0/29 (0.00%)   0/29 (0.00%) 
Show Other (Not Including Serious) Adverse Events Hide Other (Not Including Serious) Adverse Events
Frequency Threshold for Reporting Other Adverse Events 5%
Healthy Control ADHD - Placebo ADHD - Vyvanse
Affected / at Risk (%) Affected / at Risk (%) Affected / at Risk (%)
Total   0/41 (0.00%)   0/29 (0.00%)   0/29 (0.00%) 
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: Jonathan Posner, MD
Organization: NYSPI
Phone: 6467745735
EMail: jonathan.posner@nyspi.columbia.edu
Layout table for additonal information
Responsible Party: Jonathan Posner, New York State Psychiatric Institute
ClinicalTrials.gov Identifier: NCT01415440     History of Changes
Other Study ID Numbers: 6235/7261R
First Submitted: July 26, 2011
First Posted: August 12, 2011
Results First Submitted: July 5, 2019
Results First Posted: September 11, 2019
Last Update Posted: September 11, 2019